Tag: regulatory enforcement

Postmarket Surveillance: Leveraging Outsourcing

Posted on by Brandon Miller

Companies within the life sciences industry have been increasing their use of third parties to manage postmarket surveillance activities in recent years. If you are thinking about outsourcing some of your company’s more time-consuming tasks, it’s important to keep in mind that there are both advantages and disadvantages to this method.

 

Interested in Outsourcing your Postmarket Surveillance activities? Contact RCA Now →

 

Below, we will discuss some of the pros and cons of outsourcing so that you have the knowledge to make the right choice for your business.

 

Pros

 

  • Reduced costs: Outsourcing your post market surveillance activities will improve upon your overall business functions, thereby reducing operating costs and increasing profits. You can use those savings to foster growth for your company.
  • Leveraging resources: While cost is one of the main benefits to outsourcing quality assurance, the advantages offer so much more. For example, you can use the time and effort you save on post market surveillance to leverage your talent and resources on other high-value tasks. By delegating less complex work to a team of compliance experts, you can make the most of your valuable employees with riskier responsibilities.
  • Taking advantage of core competencies: What are your team members’ strengths in relation to your customers’ needs? This question will weigh heavily in your decision to outsource, especially if your internal resources lack the qualifications necessary to handle regulatory affairs. Outsourcing allows you to focus on your own core competencies while using a third party’s core competencies to increase productivity.
  • Improved speed and efficiency: If a task falls outside your core competency, it will take longer to complete it, with a greater risk for error. However, outsourcing to an expert speeds up your processes and helps create a more efficient work process for all parties involved.

 

Cons

 

  • Less direct control: When you outsource business processes, you release direct control you might otherwise have over those processes. It’s important to keep this in mind if you know that a mistake or failure of a task could have serious implications on the business.
  • Pressure on supplier management control: Outsourcing places pressure on your supplier management controls, which could result in losses for your company if poorly handled. As a result, you will need to establish a co-governance plan that allows you to retain some control.
  • Quality of the process: Potential negative impact on quality of the process outcome or services and its impact on profitability and customer satisfaction.

 

About RCA’s Pharmaceutical Consulting Services

 

Regulatory Compliance Associates (RCA) has helped thousands of pharmaceutical companies meet regulatory, compliance, quality assurance, and remediation challenges. With more than 20 years of experience with FDA, Health Canada, EU and global regulatory agencies worldwide, Regulatory Compliance Associates® offers leading pharmaceutical consultants. We’re one of the few pharma consulting companies that can help you navigate the challenges associated with industry regulations.

 

Our pharmaceutical consulting firm includes over 500 seasoned FDA, Health Canada & EU compliance consultants and regulatory affairs experts who understand industry complexities. It’s a pharma consultancy founded by regulatory compliance executives from the pharmaceutical industry. Every pharmaceutical industry consultant on the Regulatory Compliance Associates team knows the unique inner workings of outsourcing quality assurance. 

 

Client Solutions

 

Whether you’re in the product planning, development or pharmaceutical lifecycle management stage or need a remediation strategy for a compliance crisis, Regulatory Compliance Associates will guide you through every pharmaceutical consulting step of the regulatory process. Our pharmaceutical consulting Experts will create a customized approach depending on your product and company’s individual needs. Our regulatory compliance clients include:

 

  • Companies new to FDA, Health Canada or EU regulations and regulatory compliance
  • Start-up organizations with novel submissions to 510(k) submissions from multi-national corporations
  • Investment firms seeking private equity due diligence for pre-acquisition and post-deal research
  • Law firms seeking pharmaceutical consulting firm expertise in the remediation of warning letters, consent decrees, 483’s or import bans

 

Regulatory Affairs

 

Regulatory affairs is Regulatory Compliance Associates backbone. We exceed other pharma consulting companies with industry experts experienced in complexities of the pharmaceutical and biopharmaceutical industries. Our pharma consulting expertise spans all facets and levels of Regulatory Affairs. Additionally, we specialize in Regulatory Support for New Products to Life Cycle Management, Outsourced Regulatory Affairs, Submissions, Training, and more.

 

As your partner, we can negotiate the potential assessment minefield of regulatory compliance services with insight, hindsight, and the clear advantage of our breadth and depth of knowledge and regulatory compliance consulting. We offer the following pharma consulting regulatory affairs services for pharmaceutical companies.

 

  • New Product Support
  • Product Lifecycle
  • Other Regulatory Services
  • Combination Products

 

Compliance Assurance

 

The regulations process surrounding pharmaceutical companies can be tricky for even the most experienced industry veteran to understand. Just one misstep could mean significant and lasting consequences for your business. At Regulatory Compliance Associates, we offer the pharma consulting experience and pharma consultants necessary to guide you through the outsourcing quality assurance process.

 

  • Assessments
  • Audits
  • Regulatory Agency Response
  • Preparation and Training
  • Inspection Readiness
  • Data Integrity

 

Quality Assurance

 

Regulatory Compliance Associates Quality consulting includes assessments, strategy, implementations, staff augmentations, and identification of quality metrics to ensure continuous improvement. Our pharma consultants understand the strategic thinking needed to align your business needs and goals. Regulatory Compliance Associates quality assurance services include quality experts with experience spanning major corporations and start-ups. Our pharmaceutical consulting firm knows firsthand how to achieve, maintain, and improve quality. Finally, our outsourcing quality assurance team excels in transferring continuous improvement knowledge to your organization.

 

  • 21 CFR Part 11
  • Data Integrity
  • Manufacturing Support
  • Facility Support
  • Quality Metrics

 

Remediation Services 

 

Regulatory Compliance Associates has a proven remediation services approach to managing FDA Warning Letters, Consent Decrees, Remediation and other serious regulatory situations. Our pharma consultants know how to partner with executive, legal, and communication teams. Each RCA pharma consulting Expert will develop a response that will be accepted by the regulatory agency and be realistic to execute.

 

Regulatory Compliance Associates pharma regulatory consultants will develop a comprehensive proof book of documented evidence demonstrating the corrective action taken to remediate non-compliant issues. In addition, each Regulatory Compliance Associates pharma consulting Expert understands compliance enforcement. We’ll prepare a comprehensive pharma consulting strategy to assist in your remediation efforts, drive continuous improvement, and maintain regulatory compliance with the regulations.

 

  • Regulatory Action
  • Regulatory Compliance
  • Regulatory Enforcement
  • Warning Letter
  • 483 Observation
  • Oversight Services
  • Risk Management Plan

 

About Regulatory Compliance Associates

 

postmarket surveillanceRegulatory Compliance Associates® (RCA) provides outsourced quality assurance services to the following industries for the resolution of life science challenges:

 

 

We understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing. We are used to working on the front lines and thriving in the scrutiny of FDA, Health Canada, MHRA and globally-regulated companies.

 

As your partners, Regulatory Compliance Associates can negotiate the potential minefield of regulatory compliance and regulatory due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.

 

  • Founded in 2000
  • Headquartered in Wisconsin (USA)
  • Expertise backed by over 500 industry subject matter experts
  • Acquired by Sotera Health in 2021

 

About Sotera Health

 

The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health®.

 

Sotera Health Company, along with its three best-in-class businesses – Sterigenics®, Nordion® and Nelson Labs®, is a leading global provider of mission-critical end-to-end sterilization solutions and lab testing and advisory services for the healthcare industry. With a combined tenure across our businesses of nearly 200 years and our industry-recognized scientific and technological expertise, we help to ensure the safety of over 190 million patients and healthcare practitioners around the world every year.

 

We are a trusted partner to 5,800+ customers in over 50 countries, including 40 of the top 50 medical device companies and 9 of the top 10 pharmaceutical companies.

 

Commitment to Quality

 

Our Certificate of Registration demonstrates that our Quality Management System meets the requirements of ISO 9001:2015, an internationally recognized standard of quality.

 

To begin the Regulatory Compliance Associates scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage. 

 

DHF & Design Controls

Posted on by Brandon Miller

 

When you scale your Design Controls appropriately to the complexity and size of your company, it makes it easier to manage the scope of everyday work needed to keep your files current. Things to remember when scaling your Design History Files (DHF):

 

  • One size does not fit all
  • All classes of devices need design controls
  • The process is scaled based on the complexity of the device and the size of the company
  • Don’t wait for the regulators to identify any gaps

 

Also, identifying your gaps up front, closing them upon identification, then wrapping them into your entire DHF process with your team or with a third-party consultant like RCA helps ensure you have a rock-solid DHF and that you will be prepared when the regulators ask questions.

 

Click to listen to RCA’s full DHF & Design Control podcast Here!

 

FDA Design Control

 

RCA offers medical device consultants who will help you navigate through new product development and remediating legacy Design History Files (DHF). Our life science consultants have a thorough understanding of the specific design history requirements for U.S. and international medical device industries. We’ll support your team’s ability to ensure regulatory compliance and accelerate medical device DHF best practices.

 

In addition to DHF content, development, and management, download our handout to view more of our DHF-related support services, including:

 

  • FDA design control requirements
    • Quality System Regulation, 21 CFR Part 820
    • Design control medical device CGMPs and 21 CFR 820.30
    • Device Master Records (DMR)
    • Device History Record (DHR)
  • ISO 13485 design control
    • Design control procedures
    • Design control process evaluation
    • Design control documents
    • Design quality control
  • The EU’s Medical Device Regulations (MDR) including Technical File / Design Dossier
  • Risk management (ISO 14971) for medical devices including risk analysis, FMEA, risk evaluation, and risk controls through Corrective and Preventive Action (CAPA) plan and design control requirements
  • IEC 60601-1-11 (2010) including Programmable Electrical Medical Systems (PEMS) (Clause 14)
  • Total product life cycle (TPLC)
  • AAMI design control

 

 

 

To begin the Regulatory Compliance Associates® scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage. 

Crisis Management Playbook

Posted on by Brandon Miller

crisis management playbookDeveloping a crisis management playbook designed for the challenges of the pharmaceutical industry sector is vital to ensuring long term business continuity. Below are a few critical risk management elements you should consider for your team during crisis handling & developing a crisis management playbook.

 

Risk Management

 

Being able to identify factors that impacted product safety or regulatory compliance is one of the most important elements during the risk assessment phase. During RCA’s risk management services process, operational risk management is one of the first remediation steps to consider.

 

Identify Risk

 

Being able to identify the product hazards that caused the crisis is critical to understand scenario planning. Conduct due diligence to ensure that your product design outputs include no risks that are unnecessary to the consumer. Hazards that do include one or more risk factors must be analyzed why the patient benefit exceeds the financial risk.

 

Measure Risk

 

During scenario planning, identify the critical elements to measure your team and results by via a risk management framework. A risk profile for each product in question can support evaluating, reporting and monitoring adverse events. Systemic risk should be analyzed for product risk profiles with longer term, reoccurring events or specific pharmacovigilance indicators identified as proactive crisis control.

 

Mitigate Risk

 

Being able to work clearly and concisely with your regulatory agency is critical for the due diligence solutions presented for review. Examining all hazards that have been identified during the risk mitigation phase is essential to success during the risk management process. Consider any of the threats that are regarded as acceptable with known risks and document unusual activity in your risk management plan.

 

Crisis Management Communications

 

An initial step recommended by RCA’s medical device consulting team is to identify and evaluate the regulatory compliance dangers and situations. For example, assessing the vulnerability of medical device cybersecurity must consider internal and external threat modeling. Any type of cyber breach that might impact your operations team, business reputation, or stakeholder relationships should have a detailed communication strategy.

 

Crisis Communication Plans

 

A veteran RCA medical device consultant suggests developing a universal shared space where team members can bookmark & access the crisis comms document. A communication strategy would then be shared with communication partners engaged in the public relations and crisis management campaign.

 

Risk Management Communications

 

Inside a successful crisis communication team, everyone knows their role and responsibilities. RCA’s regulatory consulting Experts often designate a process leader who clearly understands the team stakeholders and functions they represent. Refine your approval process so that messaging not only meets external approved communications from these stakeholders, but also legal concerns.

 

Crisis Control

 

A detailed risk management communication plan helps specify different examples for sharing risk messaging to either internal audiences or external stakeholders. Design your communication plan templates so that information is easy to understand for multiple audiences. Different types of tactics to be considered for templates (e.g. press release, social media) to confirm the messaging reliability of the crisis communication strategy.

 

 

To begin the Regulatory Compliance Associates scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage. You may also email us at [email protected].

GMP Inspection

Posted on by Brandon Miller

GMP inspectionHealth Canada, Therapeutic Goods Administration (TGA), and Medicines & Healthcare Regulatory Agency (MHRA) recently launched an innovative, new pilot focused on Good Manufacturing Practices (GMP). The Single Inspection Program is designed to help rationalize the number of inspections needed to increase efficiency during the regulatory process.

 

A primary objective is to maintain regulatory standards by eliminating redundancies and providing a more “global approach to GMP inspections of third-country manufacturers”. Additionally, the program design is intended to increase existing collaborative GMP arrangements to allow for:

 

  • More efficient inspection reliance processes
  • Reduced regulatory burden on healthcare industry
  • Enhanced regulatory oversight of global supply chains

 

Regulatory Authorities

 

In a proactive step toward harmonization, the three regulatory bodies will begin accepting a single inspection for a Canadian, Australian and British regulatory application (based on the drug establishment license, or DEL). The long-term strategy includes leveraging the inspection assets of each regulatory authority to collectively collaborate when additional data is available.

 

Additionally, by maximizing the global regulatory reach of multiple agencies, the pharmaceutical industry will benefit from fewer inspections needed at the same site or manufacturing facility. This should increase both the speed of the regulatory process and patient access to medical products. Both are a win-win for the life science industry as the regulatory process becomes more streamlined than previously experienced.

 

GMP Practices

 

All three regulatory bodies are members of the Pharmaceutical Inspection Co-operation Scheme (PIC/S). PIC/S is an international, non-binding cooperative between Regulatory Authorities in the field of Good Manufacturing Practice (GMP). Additionally, PIC/S membership is focused on companies that develop medicinal products for human or veterinary use, and over 50 countries from around the world currently participate. 

 

Finally, the mission of the current membership is to lead the “development, implementation, and maintenance of harmonized GMP standards and quality systems”. A more efficient inspection process will allow drug manufacturers to reduce any type of disruption to operations that multiple audits may induce. 

 

About RCA’s Pharmaceutical Consulting Services 

 

Regulatory Compliance Associates (RCA) has helped thousands of pharmaceutical companies meet regulatory, compliance, quality assurance, and remediation challenges. With more than 20 years of experience with FDA, Health Canada, EU and global regulatory agencies worldwide, Regulatory Compliance Associates® offers leading pharmaceutical consultants. We’re one of the few pharma consulting companies that can help you navigate the challenges associated with industry regulations.

 

Our pharmaceutical consulting firm includes over 500 seasoned FDA, Health Canada & EU compliance consultants and regulatory affairs experts who understand industry complexities. It’s a pharma consultancy founded by regulatory compliance executives from the pharmaceutical industry. Every pharmaceutical industry consultant on the Regulatory Compliance Associates team knows the unique inner workings of the regulatory process. 

 

Client Solutions

 

Whether you’re in the product planning, development or pharmaceutical lifecycle management stage or need a remediation strategy for a compliance crisis, Regulatory Compliance Associates will guide you through every pharmaceutical consulting step of the regulatory process. Our pharmaceutical consulting Experts will create a customized approach depending on your product and company’s individual needs. Our regulatory compliance clients include:

 

  • Companies new to FDA, Health Canada or EU regulations and regulatory compliance
  • Start-up organizations with novel submissions to 510(k) submissions from multi-national corporations
  • Investment firms seeking private equity due diligence for pre-acquisition and post-deal research
  • Law firms seeking pharmaceutical consulting firm expertise in the remediation of warning letters, consent decrees, 483’s or import bans

 

Regulatory Affairs

 

Regulatory affairs is Regulatory Compliance Associates backbone. We exceed other pharma consulting companies with industry experts experienced in complexities of the pharmaceutical and biopharmaceutical industries. Our pharma consulting expertise spans all facets and levels of Regulatory Affairs. Additionally, we specialize in Regulatory Support for New Products to Life Cycle Management, Outsourced Regulatory Affairs, Submissions, Training, and more.

 

As your partner, we can negotiate the potential assessment minefield of regulatory compliance services with insight, hindsight, and the clear advantage of our breadth and depth of knowledge and regulatory compliance consulting. We offer the following pharma consulting regulatory affairs services for pharmaceutical companies.

 

  • New Product Support
  • Product Lifecycle
  • Other Regulatory Services
  • Combination Products

 

Compliance Assurance

 

The regulations process surrounding pharmaceutical companies can be tricky for even the most experienced industry veteran to understand. Just one misstep could mean significant and lasting consequences for your business. At Regulatory Compliance Associates, we offer the pharma consulting experience and pharma consultants necessary to guide you through the quality compliance process.

 

  • Assessments
  • Audits
  • Regulatory Agency Response
  • Preparation and Training
  • Inspection Readiness
  • Data Integrity

 

Quality Assurance

 

Regulatory Compliance Associates Quality consulting includes assessments, strategy, implementations, staff augmentations, and identification of quality metrics to ensure continuous improvement. Our pharma consultants understand the strategic thinking needed to align your business needs and goals. Regulatory Compliance Associates quality assurance services include quality experts with experience spanning major corporations and start-ups. Our pharmaceutical consulting firm knows firsthand how to achieve, maintain, and improve quality. Finally, our regulatory compliance services team excels in transferring continuous improvement knowledge to your organization.

 

  • 21 CFR Part 11
  • Data Integrity
  • Manufacturing Support
  • Facility Support
  • Quality Metrics

 

Remediation Services 

 

Regulatory Compliance Associates has a proven remediation services approach to managing FDA Warning Letters, Consent Decrees, Remediation and other serious regulatory situations. Our pharma consultants know how to partner with executive, legal, and communication teams. Each RCA pharma consulting Expert will develop a response that will be accepted by the regulatory agency and be realistic to execute.

 

Regulatory Compliance Associates pharma regulatory consultants will develop a comprehensive proof book of documented evidence demonstrating the corrective action taken to remediate non-compliant issues. In addition, each Regulatory Compliance Associates pharma consulting Expert understands compliance enforcement. We’ll prepare a comprehensive pharma consulting strategy to assist in your remediation efforts, drive continuous improvement, and maintain regulatory compliance with the regulations.

 

  • Regulatory Action
  • Regulatory Compliance
  • Regulatory Enforcement
  • Warning Letter
  • 483 Observation
  • Oversight Services
  • Risk Management Plan

 

About Regulatory Compliance Associates

 

pharmaceutical consultantsRegulatory Compliance Associates® (RCA) provides pharmaceutical consulting to the following industries for resolution of life science challenges:

 

 

We understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing. We are used to working on the front lines and thriving in the scrutiny of FDA, Health Canada, MHRA and globally-regulated companies.

 

As your partners, Regulatory Compliance Associates can negotiate the potential minefield of regulatory compliance and regulatory due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.

 

  • Founded in 2000
  • Headquartered in Wisconsin (USA)
  • Expertise backed by over 500 industry subject matter experts
  • Acquired by Sotera Health in 2021

 

About Sotera Health

 

The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health®.

 

Sotera Health Company, along with its three best-in-class businesses – Sterigenics®, Nordion® and Nelson Labs®, is a leading global provider of mission-critical end-to-end sterilization solutions and lab testing and advisory services for the healthcare industry. With a combined tenure across our businesses of nearly 200 years and our industry-recognized scientific and technological expertise, we help to ensure the safety of over 190 million patients and healthcare practitioners around the world every year.

 

We are a trusted partner to 5,800+ customers in over 50 countries, including 40 of the top 50 medical device companies and 9 of the top 10 pharmaceutical companies.

 

Commitment to Quality

 

Our Certificate of Registration demonstrates that our Quality Management System meets the requirements of ISO 9001:2015, an internationally recognized standard of quality.

 

To begin the Regulatory Compliance Associates scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage.

 

Best Practices for FDA Inspections

Posted on by Brandon Miller

Since the Pandemic became global in 2020, the FDA has been requesting documents from firms in advance of or in lieu of an inspection. This authority comes from the Federal Food, Drug, and Cosmetic Act (FD&C Act) in Section 704(a)(4). However, while they have not adopted doing FDA inspections remotely instead of an onsite inspection, they have stated publicly they are considering the possibility, and virtual audits have become very common. 

 

FDA is still conducting onsite inspections and has submitted for new employee headcount in 2022 to reduce the existing backlog. Each inspection is carefully considered on a case-by-case basis where there is an imminent public health need. Factors such as risk to the FDA investigator and site personnel are also considered when determining if a virtual audit is appropriate.

 

Onsite inspections could be the standard inspection with the investigators staying in the facility the entire time or it could be a hybrid approach where the investigators spend some time in the facility and other time doing remote FDA reviews and conducting video interviews.

 

2022 will bring a new wave of inspections to the medical device and pharmaceutical industry. So how can you prepare in advance? And what does good look like from a virtual inspection process? Below are some thoughts for your team to consider.

 

Ready to Conduct a Mock Virtual Audit? Contact Us Now →

 

How Does an FDA Inspection Work?

 

FDA registrations simply don’t end and some health authorities outside the US have already done remote FDA inspections (e.g. the EMA). However, while the FDA has not done a true remote inspection, they have done many hybrid inspections.

 

What does an FDA inspection mean?

 

With the FDA format, regulatory authority tools include video chat for activities inside the interview room. They also use technology like secure shared online folders for offsite document review. Companies prepared to manage FDA inspections under this new method stand the best chance of success after an inspection to have fewer FDA 483 observations in general.

 

The FDA could start with a records request and then come onsite, or vice versa. Remember, if it is a true inspection the FDA must provide the most senior ranking person at the site a Notice of Inspection, Form FDA 482, at the very start of the inspection. If the Form 482 isn’t issued, then it is likely a records request utilizing their Section 704(a)(4) authorities.

 

FDA inspection

 

FDA record requests should follow the process and guidance outlined in their internal Staff Manual Guide, SMG 9004.1 Policy and Procedures for Requesting Records In Advance of or In Lieu of a Drug Inspection. Think of the SMG as an internal procedure for the FDA. If you are curious you can find it at this link: Staff Manual Guide 9004.1 (fda.gov)

 

 

Bottom line, if the FDA’s request comes through a call or email then it is not an inspection. It is a records request and should follow the procedures in SMG 9004.1. If they show up onsite, present a Form 482, then it is an inspection. Then the inspection could stay all onsite or it could be a hybrid approach, as noted above.  

 

Planning for an FDA Inspection

 

With the current pandemic, FDA has been providing a little advanced notice of the inspection, usually a few days to a week. The notice is directed less at giving companies time to prepare and instead intended to ensure the required personnel, who may be working offsite, are available. But prior planning precludes poor performance, so prepare well beforehand to manage a hybrid virtual inspection.

 

Some recommendations for inspection prep and readiness are as follows:

 

  • Determine who in the company will host the FDA inspection. Whether it’s onsite or virtual or hybrid you’ll want to designate a host. This distinction lets you train someone for the role, which helps streamline the process and eliminates last-minute challenges
  • Who will be the scribe and how will they take notes and communicate with the site team?
  • Determine who will step in as the back-up host and scribe in case the primaries are out sick.
  • Think through how the FDA inspection will flow, from the time it starts, through the facility tour, document requests and employee interviews.
  • If a virtual walk-through is conducted do you have sufficient Wi-Fi capabilities across the entire facility to avoid glitches in the audit and video.
  • How will you do the video? Use a phone camera or a real video camera.
  • Make sure you have the equipment ready to go and have tested it throughout the site.
  • How do you plan to maintain appropriate social distancing? Some companies have set up conference rooms complete with plexiglass barriers, tape markers on the floor and separated seating. In other cases, some activities are conducted outdoors, weather permitting.

 

Some additional helpful tips based on our experience with other clients are:

 

  • Collecting documents: This one can take a little time and it’s suggested that you start with the basics that you know the investigator will request, for example, a general site presentation, a batch record, deviation list, complaint list, facility layout, CAPA list, compliance documents, change controls and other master files.
  • Scanning and saving: Scan these documents ahead of time and upload them to an online company drive that is easily accessed by the inspection team.
  • Getting the right equipment: Whether you plan to use a smartphone or Wi-Fi camera, make sure the user knows how to operate it correctly and it works in every nook and cranny of your facility.
  • Running simulated inspections: A walkthrough lets you test video and audio quality. You can also identify and address poor Wi-Fi connectivity.

 

Virtual and hybrid inspections are a new format, and there can be challenges on both sides. Make sure your plan has some flexibility. Also, keep an eye on the FDA’s website for any announcements on virtual inspections. If the FDA does decide to start conducting virtual inspections it is likely that they will also roll out internal processes and procedures to ensure a harmonized approach. These items could be a Staff Manual Guide or a new chapter in their Investigations Operations Manual (Investigations Operations Manual | FDA).

 

About RCA’s Pharmaceutical Consulting Services 

 

Regulatory Compliance Associates (RCA) has helped thousands of pharmaceutical companies meet regulatory, compliance, quality assurance, and remediation challenges. With more than 20 years of experience with FDA, Health Canada, EU and global regulatory agencies worldwide, Regulatory Compliance Associates® offers leading pharmaceutical consultants. We’re one of the few pharma consulting companies that can help you navigate the challenges associated with industry regulations.

 

Our pharmaceutical consulting firm includes over 500 seasoned FDA, Health Canada & EU compliance consultants and regulatory affairs experts who understand industry complexities. It’s a pharma consultancy founded by regulatory compliance executives from the pharmaceutical industry. Every pharmaceutical industry consultant on the Regulatory Compliance Associates team knows the unique inner workings of the regulatory process. 

 

Client Solutions

 

Whether you’re in the product planning, development or pharmaceutical lifecycle management stage or need a remediation strategy for a compliance crisis, Regulatory Compliance Associates will guide you through every pharmaceutical consulting step of the regulatory process and create a customized approach depending on your product and your pharma company’s individual needs. Our regulatory compliance clients include:

 

  • Companies new to FDA, Health Canada or EU regulations and regulatory compliance
  • Start-up organizations with novel submissions to 510(k) submissions from multi-national corporations
  • Investment firms seeking private equity due diligence for pre-acquisition and post-deal research
  • Law firms seeking pharmaceutical consulting firm expertise in the remediation of warning letters, consent decrees, 483’s or import bans

 

Regulatory Affairs

 

Regulatory affairs is Regulatory Compliance Associates backbone. We exceed other pharma consulting companies with industry experts experienced in complexities of the pharmaceutical and biopharmaceutical industries. Our pharma consulting expertise spans all facets and levels of Regulatory Affairs, from Regulatory Support for New Products to Life Cycle Management, to other services like Outsourced Regulatory Affairs, Submissions, Training, and more.

 

As your partner, we can negotiate the potential assessment minefield of regulatory compliance services with insight, hindsight, and the clear advantage of our breadth and depth of knowledge and regulatory compliance consulting. We offer the following pharma consulting regulatory affairs services for pharmaceutical companies.

 

  • New Product Support
  • Product Lifecycle
  • Other Regulatory Services
  • Combination Products

 

Compliance Assurance

 

The regulations process surrounding pharmaceutical companies can be tricky for even the most experienced industry veteran to understand. Just one misstep could mean significant and lasting consequences for your business. At Regulatory Compliance Associates, we offer the pharma consulting experience and pharma consultants necessary to guide you through the quality compliance process.

 

  • Assessments
  • Audits
  • Regulatory Agency Response
  • Preparation and Training
  • Inspection Readiness
  • Data Integrity

 

Quality Assurance

 

Regulatory Compliance Associates Quality consulting includes assessments, strategy, implementations, staff augmentations, and identification of quality metrics to ensure continuous improvement. Our pharma consultants understand the strategic thinking needed to align your business needs and goals. Regulatory Compliance Associates quality assurance services include quality experts with experience spanning major corporations and start-ups. Our pharmaceutical consulting firm knows firsthand how to achieve, maintain, and improve quality, and we excel in transferring pharma consulting knowledge to your organization.

 

  • 21 CFR Part 11
  • Data Integrity
  • Manufacturing Support
  • Facility Support
  • Quality Metrics

 

Remediation Services 

 

Regulatory Compliance Associates has a proven remediation services approach to managing FDA Warning Letters, Consent Decrees, Remediation and other serious regulatory situations. Our pharma consultants know how to partner with executive, legal, and communication teams. Each RCA pharma consulting Expert will develop a response that will be accepted by the regulatory agency and be realistic to execute.

 

Regulatory Compliance Associates pharma regulatory consultants will develop a comprehensive proof book of documented evidence demonstrating the corrective action taken to remediate non-compliant issues. In addition, each Regulatory Compliance Associates pharma consulting Expert understands compliance enforcement. We’ll prepare a comprehensive pharma consulting strategy to assist in your remediation efforts, drive continuous improvement, and maintain regulatory compliance with the regulations.

 

  • Regulatory Action
  • Regulatory Compliance
  • Regulatory Enforcement
  • Warning Letter
  • 483 Observation
  • Oversight Services
  • Risk Management Plan

 

About Regulatory Compliance Associates

 

FDA inspectionRegulatory Compliance Associates® (RCA) provides pharmaceutical consulting to the following industries for resolution of life science challenges:

 

 

We understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing. We are used to working on the front lines and thriving in the scrutiny of FDA, Health Canada, MHRA and globally-regulated companies.

 

As your partners, we can negotiate the potential minefield of regulatory compliance and regulatory due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.

 

  • Founded in 2000
  • Headquartered in Wisconsin (USA)
  • Expertise backed by over 500 industry subject matter experts
  • Acquired by Sotera Health in 2021

 

About Sotera Health

 

The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health®.

 

Sotera Health Company, along with its three best-in-class businesses – Sterigenics®, Nordion® and Nelson Labs®, is a leading global provider of mission-critical end-to-end sterilization solutions and lab testing and advisory services for the healthcare industry. With a combined tenure across our businesses of nearly 200 years and our industry-recognized scientific and technological expertise, we help to ensure the safety of over 190 million patients and healthcare practitioners around the world every year.

 

We are a trusted partner to 5,800+ customers in over 50 countries, including 40 of the top 50 medical device companies and 9 of the top 10 pharmaceutical companies.

 

Commitment to Quality

 

Our Certificate of Registration demonstrates that our Quality Management System meets the requirements of ISO 9001:2015, an internationally recognized standard of quality.

 

To begin the Regulatory Compliance Associates scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage. 

 

 

Process Analytical Technology

Posted on by Brandon Miller

Leveraging Process Analytical Technology for CMC

 

Introduction

 

In the evolving field of pharmaceutical development, the implementation of Process Analytical Technology (PAT) for manufacturing is an essential competitive advantage. PAT offers widely accepted methods to safeguard quality assurance and the general safety of pharmaceutical products. The goal of this article is to provide a summary of PAT, best practices of principles and adoption of PAT, and how to leverage increased process knowledge in your regulatory submission.

 

Understanding Process Analytical Technology (PAT)

 

Efficient pharmaceutical manufacturing is a significant facet of the global healthcare system. The well-being of patients is contingent on the accessibility of safe and effective treatments. The U.S. Food and Drug Administration (FDA) framework for process analytical technology was originally established based on insights to facilitate quality improvement. It includes risk-based regulatory outcomes that have been validated by both life science manufacturers and FDA regulators.

 

The Agency framework is based on two primary drivers:

 

  • Scientific principles and tools that support the development of innovation
  • Regulatory strategies that accommodate innovation during the submission process

 

Principles of Process Analytical Technology

 

CMC (Chemistry, Manufacturing, and Controls) is one of the most influential facets of drug product development. Traditional drug development in pharmaceutical manufacturing is completed using batch processing and production sample lab testing to evaluate quality. This approach has been effective in delivering quality pharmaceuticals to patients in need.

 

However, modern technologies now offer life science employees the opportunity for improving pharmaceutical development. Specifically, PAT principles and technologies focus on increasing quality assurance during the product development process. This often involves the use of unique quality controls from different types of technologies.

 

Process Analytical Technology and CMC

 

The implementation of process analytical technology encourages drug manufacturers to create a team-based regulatory approach to chemistry, manufacturing and controls. Further, the review of current good manufacturing practices (cGMP) is also essential to the success of process analytical technology.

 

Finally, in-depth CMC training is important to achieve certification in process analytical technology. This is important considering the regulatory inspection review by Agency auditors for each new drug in development. The ability to demonstrate regulatory compliance is a foundational training strategy that supports the use of process analytical technology in manufacturing.

 

Implementing Process Analytical Technology

 

In the past, many manufacturing procedures have been considered static due to regulatory constraints. Proposed process changes are often considered for feedback by FDA early in the regulatory submission process. However, this can also lead to ambiguity of what types of technology will be authorized or declined by the Agency going forward. Life science manufacturers often stick with what is approved to stay in compliance and not raise red flags with FDA.

 

Recognizing the need to reduce this ambiguity for embracing innovation, FDA launched an initiative called Pharmaceutical CGMPs for the 21st Century: A Risk-Based Approach. The goal of this program is to ensure process analytical technology principles are known by life science companies and include:

 

  • Modern concepts of risk management
  • Quality system approaches are incorporated into pharmaceutical manufacturing while maintaining product quality
  • Life science manufacturers are encouraged to use modern innovations in pharmaceutical manufacturing technology
  • FDA’s submission review and inspection programs operate in a coordinated manner
  • Regulations and manufacturing standards are applied consistently by FDA and the manufacturer

 

Benefits of Implementing Process Analytical Technology

 

FDA considers process analytical technology to be:

 

“a system for designing, analyzing, and controlling manufacturing through timely measurements of critical quality and performance attributes of raw and in-process materials and processes, with the goal of ensuring final product quality.”

 

The primary benefit of implementing process analytical technology is to enhance understanding and control of the manufacturing process. Consequently, the tools and principles of process analytical technology should increase the level of manufacturing process understanding in general.

 

Manufacturing Process

 

Further, meeting the regulatory requirement of validating the manufacturing process can only benefit from this understanding of what quality looks like. Five core ingredients of process analytical technology strategy that should help users boost their understanding include:

 

  • Enhanced process understanding and knowledge
  • Improved process control and efficiency
  • Reduction in production costs and waste
  • Faster and more efficient product development
  • Enhanced regulatory compliance

 

Adoption of Process Analytical Technology

 

Equally important, for the manufacturing team’s adoption of new technologies to be successful, employees must recognize the importance of quality assurance and patient safety. Moreover, proposing innovative approaches to pharmaceutical development should not lead to a regulatory stalemate between FDA and the life science manufacturer.

 

FDA encourages manufacturers to use the process analytical technology framework in clinical documentation, so a stalemate doesn’t occur during the regulatory process. This can include clinical evidence that helps demonstrate:

 

  • Process understanding and control strategy
  • Real-time process monitoring
  • Multivariate data analysis (MVDA)
  • Process control and optimization
  • Continuous manufacturing and quality by design (QbD)

 

Process Analytical Technology Manufacturing Examples

 

FDA has provided process analytical technology examples of the tools available that facilitate manufacturing process understanding. These converge at the intersection of scientific, risk-managed pharmaceutical development, manufacturing, and quality assurance.  

 

When used within an effective manufacturing system, process analytical technology can provide effective and efficient means for facilitating process understanding. Further, continuous improvement, and development of risk-mitigation strategies. In the PAT framework, PAT manufacturing examples can be categorized according to the following:  

 

  • Multivariate tools for design, data acquisition, and analysis
  • Process analyzers
  • Process control tools
  • Continuous improvement and knowledge management tools

 

Process Analytical Technology and Quality Assurance

 

Process analytical technology and quality assurance go hand in hand when it comes to manufacturing innovation. The above performance metrics for measuring quality focus on designing, analyzing, and controlling manufacturing through timely measurements of raw and in-process materials and processes.

 

For the same reason, process analytical technology commonly includes tools that can improve chemical, physical, microbiological, mathematical, and risk analysis. Simultaneously, these quality assurance tools that aid process understanding can also support meeting existing regulatory submission requirements to validate the manufacturing process.

 

Process Analytical Technology and Regulatory Approval

 

Achieving regulatory submission approval for a new product is rarely an easy process. The clinical evidence needed to support efficacy must include documentation of quality assurance delivered by the manufacturer.

 

Innovation in development, manufacturing and quality assurance that leverages process analytical technology should help answer these common regulatory questions from FDA experts:

 

  • What are the mechanisms of degradation, drug release, and absorption?
  • What are the effects of product components on quality?
  • What sources of variability are critical?
  • How does the process manage variability?

 

Regulatory Submission

 

Regulatory considerations that can help document quality assurance improvements from process analytical technology often are found in:

 

  • Reducing production cycle times by using on-, in-, and/or at-line measurements and controls
  • Preventing rejects, scrap, and re-processing
  • Real time release
  • Increasing automation to improve operator safety and reduce human errors
  • Improving energy and material use and increasing capacity
  • Facilitating continuous processing to improve efficiency and manage variability

 

Regulatory Documentation

 

Quality assurance improvements are centered around the manufacturing process and system processes involved. FDA considers a process to be well understood if regulatory documentation shows:

 

  • Why sources of variability can be identified and explained
  • When production variability can be managed by owners of the process
  • How quality attributes can be accurately and reliably predicted

This type of regulatory documentation provides insights for FDA regulators into materials used, an understanding of process parameters, changes in manufacturing, and environmental conditions.

 

The ability to predict these three items can show a high degree of process understanding. The goal is for your regulatory application to demonstrate your team and company understand how to reproduce process capability data and maintain a consistent state of control.

 

Conclusion

 

Process analytical technology is used to improve the scientific basis for regulatory specifications and promoting continuous improvement. The ability to enhance manufacturing while retaining or improving product quality is essential to helping patients and population health in general. Life science manufacturers should document technology improvements to FDA and demonstrate the ability to quickly resolve production-related technical issues.  

 

About the Author

 

Erika PorcelliAs Vice President of Regulatory Services for Regulatory Compliance Associates® (RCA), Erika Porcelli touches all aspects of the customer experience. RCA provides consulting services to life science organizations for the resolution of compliance and regulatory challenges. RCA is a global business unit of Sotera Health, a trusted partner to more than 5,800 customers in over 50 countries, including 40 of the top 50 medical device companies and 8 of the top 10 pharmaceutical companies.

 

About RCA’s Pharmaceutical Consulting Services 

 

Regulatory Compliance Associates (RCA) has helped thousands of pharmaceutical companies meet regulatory, compliance, quality assurance, and remediation challenges. With more than 20 years of experience with FDA, Health Canada, EU and global regulatory agencies worldwide, Regulatory Compliance Associates® offers leading pharmaceutical consultants. We’re one of the few pharma consulting companies that can help you navigate the challenges associated with industry regulations.

 

Our pharmaceutical consulting firm includes over 500 seasoned FDA, Health Canada & EU compliance consultants and regulatory affairs experts who understand industry complexities. It’s a pharma consultancy founded by regulatory compliance executives from the pharmaceutical industry. Every pharmaceutical industry consultant on the Regulatory Compliance Associates team knows the unique inner workings of the regulatory process. 

 

Client Solutions

 

Whether you’re in the product planning, development or pharmaceutical lifecycle management stage or need a remediation strategy for a compliance crisis, Regulatory Compliance Associates will guide you through every pharmaceutical consulting step of the regulatory process and create a customized approach depending on your product and your pharma company’s individual needs. Our regulatory compliance clients include:

 

  • Companies new to FDA, Health Canada or EU regulations and regulatory compliance
  • Start-up organizations with novel submissions to 510(k) submissions from multi-national corporations
  • Investment firms seeking private equity due diligence for pre-acquisition and post-deal research
  • Law firms seeking pharmaceutical consulting firm expertise in the remediation of warning letters, consent decrees, 483’s or import bans

 

Regulatory Affairs

 

Regulatory affairs is Regulatory Compliance Associates backbone. We exceed other pharma consulting companies with industry experts experienced in complexities of the pharmaceutical and biopharmaceutical industries. Our pharma consulting expertise spans all facets and levels of Regulatory Affairs, from Regulatory Support for New Products to Life Cycle Management, to other services like Outsourced Regulatory Affairs, Submissions, Training, and more.

 

As your partner, we can negotiate the potential assessment minefield of regulatory compliance services with insight, hindsight, and the clear advantage of our breadth and depth of knowledge and regulatory compliance consulting. We offer the following pharma consulting regulatory affairs services for pharmaceutical companies.

 

  • New Product Support
  • Product Lifecycle
  • Other Regulatory Services
  • Combination Products

 

Compliance Assurance

 

The regulations process surrounding pharmaceutical companies can be tricky for even the most experienced industry veteran to understand. Just one misstep could mean significant and lasting consequences for your business. At Regulatory Compliance Associates, we offer the pharma consulting experience and pharma consultants necessary to guide you through the quality compliance process.

 

  • Assessments
  • Audits
  • Regulatory Agency Response
  • Preparation and Training
  • Inspection Readiness
  • Data Integrity

 

Quality Assurance

 

Regulatory Compliance Associates Quality consulting includes assessments, strategy, implementations, staff augmentations, and identification of quality metrics to ensure continuous improvement. Our pharma consultants understand the strategic thinking needed to align your business needs and goals. Regulatory Compliance Associates quality assurance services include quality experts with experience spanning major corporations and start-ups. Our pharmaceutical consulting firm knows firsthand how to achieve, maintain, and improve quality, and we excel in transferring pharma consulting knowledge to your organization.

 

  • 21 CFR Part 11
  • Data Integrity
  • Manufacturing Support
  • Facility Support
  • Quality Metrics

 

Remediation Services 

 

Regulatory Compliance Associates has a proven remediation services approach to managing FDA Warning Letters, Consent Decrees, Remediation and other serious regulatory situations. Our pharma consultants know how to partner with executive, legal, and communication teams. Each RCA pharma consulting Expert will develop a response that will be accepted by the regulatory agency and be realistic to execute.

 

Regulatory Compliance Associates pharma regulatory consultants will develop a comprehensive proof book of documented evidence demonstrating the corrective action taken to remediate non-compliant issues. In addition, each Regulatory Compliance Associates pharma consulting Expert understands compliance enforcement. We’ll prepare a comprehensive pharma consulting strategy to assist in your remediation efforts, drive continuous improvement, and maintain regulatory compliance with the regulations.

 

  • Regulatory Action
  • Regulatory Compliance
  • Regulatory Enforcement
  • Warning Letter
  • 483 Observation
  • Oversight Services
  • Risk Management Plan

 

About Regulatory Compliance Associates

 

pharmaceutical consultantsRegulatory Compliance Associates® (RCA) provides pharmaceutical consulting to the following industries for resolution of life science challenges:

 

 

We understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing. We are used to working on the front lines and thriving in the scrutiny of FDA, Health Canada, MHRA and globally-regulated companies.

 

As your partners, we can negotiate the potential minefield of regulatory compliance and regulatory due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.

 

  • Founded in 2000
  • Headquartered in Wisconsin (USA)
  • Expertise backed by over 500 industry subject matter experts
  • Acquired by Sotera Health in 2021

 

About Sotera Health

 

The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health®.

 

Sotera Health Company, along with its three best-in-class businesses – Sterigenics®, Nordion® and Nelson Labs®, is a leading global provider of mission-critical end-to-end sterilization solutions and lab testing and advisory services for the healthcare industry. With a combined tenure across our businesses of nearly 200 years and our industry-recognized scientific and technological expertise, we help to ensure the safety of over 190 million patients and healthcare practitioners around the world every year.

 

We are a trusted partner to 5,800+ customers in over 50 countries, including 40 of the top 50 medical device companies and 9 of the top 10 pharmaceutical companies.

 

Commitment to Quality

 

Our Certificate of Registration demonstrates that our Quality Management System meets the requirements of ISO 9001:2015, an internationally recognized standard of quality.

 

To begin the Regulatory Compliance Associates scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage.