Tag: Production

Click now to hear from Jordan Elder, RCA’s Director of Regulatory Affairs, regarding the latest info on Quality System Regulation (QSR) regulations and FDA harmonization efforts:

 

 

When developing a quality management system (QMS), it is important to understand any pitfalls that could arise as well as understand what each notified body looks for in a compliant quality system. Recently, one of the US Food and Drug Administration’s (FDA’s) top medical device regulators said harmonizing the agency’s current Quality System Regulation with the International Organization for Standardization (ISO) 13485:2016 is a “high priority”.

 


Click to learn about the latest updates to the QMSR File Rule.


 

QMS Harmonization

 

Currently, the US Food and Drug Administration (FDA) does not enforce ISO’s 13458:2016 standards set in place for Quality Management Systems, but uses its own Quality System Regulation (QSR) guidelines that do include parts of the 13458 standards. But this is set to change for the better. The FDA has recently proposed plans to align its quality system requirements with ISO 13485:2016, creating a new regulation dubbed the Quality Management System Regulation (QMRS). This shift came four years after the agency first proposed the regulatory alignment.

 

Quality Management System

 

Manufacturers who already conform to the ISO standard should not see much change and this move should help create efficiencies for them in the long run. The FDA proposed the alinement by incorporating the 2016 edition of the international standard specific for medical device quality management systems ISO13485. Through this rulemaking, the FDA is also proposing additional requirements that help connect and align ISO13485 with existing requirements in the FD&C Act and its implementing regulations. This will include making conforming edits to 21 CFR Part 4 to clarify the device CGMP requirements for combination products as well.

 

Risk Management

 

The most noticeable difference between the current quality systems regulation and ISO13485 is that the risk management requirements are integrated throughout the aspects of the quality management system in ISO13485. This differs from 21 CFR 820, in that the only risk-specific requirement in the QS regulation is listed in §820.30(g), as it relates to risk analysis as a part of design validation.

 

These revisions are intended to supplant the existing ISO13485 requirements with the specifications of an international consensus standard for medical device manufacturers. The revisions are expected to reduce device manufacturers’ burdens, specifically aspects of compliance and recordkeeping through the harmonization of domestic and international requirements.

 

ISO Standard

 

With a membership of 168 national standards bodies, ISO is an independent, non-governmental international organization that brings together experts from around the world to share knowledge and develop voluntary, consensus-based, market-relevant International Standards that support innovation and provide solutions to global challenges.

 

Although the standers set by ISO are recognized by organizations around the world, ISO compliance itself isn’t a legal requirement, the standards naturally align with different regulations across the industries. ISO compliance means using ISO standards as guidelines for aligning your policies, processes, and operating procedures to adhere to the standard.

 

ISO 13485:2016

 

ISO 13485:2016 specifies requirements for medical device quality management systems where an organization needs to demonstrate its ability to consistently meet customer and applicable regulatory requirements. This includes one or more stages of the product life cycle, including:

 

  • Design controls and development
  • Production and manufacturing
  • Storage and distribution
  • Installation
  • Servicing a medical device
  • Technical support

 

ISO13485:2016 can also be used by suppliers or external parties that provide products, including quality management system-related services to such organizations.

 

 

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. 

 

In today’s rapidly evolving global landscape, supply chain management faces unprecedented challenges. The convergence of geopolitical tensions, environmental concerns, and technological advancements has introduced complexities that demand innovative solutions.

 


Need help Optimizing your Supply Chain?  Talk to our Experts →


 

Geopolitical Instability and Trade Dynamics

Recent shifts in international relations have profoundly impacted global trade. For instance, the imposition of tariffs on Chinese-manufactured goods has compelled companies to reassess their sourcing strategies. Relocating supply chains, however, presents significant financial and operational hurdles, especially for businesses deeply integrated with established suppliers. The unpredictability of trade policies further complicates these decisions, underscoring the necessity for agile and adaptable supply chain strategies.

 

Technological Advancements and Digital Integration

The integration of advanced technologies, particularly artificial intelligence (AI), has become pivotal in modern supply chain management. AI-driven tools offer predictive analytics and inventory optimization, enabling companies to navigate complexities such as fluctuating tariffs and dynamic consumer demands.

 

Sustainability and Regulatory Compliance

Environmental sustainability is becoming a key priority for businesses as regulatory requirements and consumer expectations continue to evolve. Companies must now navigate a complex landscape of compliance standards, carbon reduction goals, and responsible sourcing initiatives. To streamline sustainability reporting and compliance, organizations are adopting data-driven strategies and collaborative frameworks that improve transparency and efficiency. Standardizing sustainability metrics and enhancing data sharing across supply chains can help businesses reduce redundancies, meet regulatory expectations, and achieve long-term environmental goals.

 

Labor Practices and Ethical Sourcing

Ensuring ethical labor practices within supply chains has become increasingly scrutinized. Recent legal actions have highlighted the repercussions of non-compliance, prompting companies to implement rigorous oversight and corrective measures. Establishing robust organizational models and supplier control procedures is essential to uphold labor standards and mitigate legal risks.

 

Strategic Imperatives for Supply Chain Resilience

To navigate these multifaceted challenges, companies are advised to:

  • Enhance Supply Chain Visibility: Utilize advanced analytics and AI to achieve end-to-end transparency, facilitating proactive management of disruptions.
  • Diversify Sourcing Strategies: Mitigate risks associated with geopolitical uncertainties by exploring alternative suppliers and markets.
  • Invest in Technology Integration: Adopt digital tools that offer predictive insights and operational optimization, ensuring agility in response to market fluctuations.
  • Commit to Sustainable Practices: Align operations with environmental standards and streamline compliance reporting through collaborative platforms.
  • Strengthen Ethical Oversight: Implement comprehensive monitoring systems to ensure adherence to labor laws and ethical sourcing guidelines.

By proactively addressing these areas, organizations can build resilient supply chains capable of withstanding contemporary challenges and seizing emerging opportunities.

 

Partner with RCA for Supply Chain Resilience

Navigating the complexities of supply chain disruptions, regulatory compliance, and sustainability requirements requires a strategic and proactive approach. Regulatory Compliance Associates (RCA) specializes in helping businesses optimize their supply chain management, mitigate risks, and ensure compliance with evolving global standards. Contact us today to learn how RCA can support your organization in building a more resilient, compliant, and efficient supply chain.

 

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].

As with many industries these days, pharmaceutical manufacturers are now reevaluating the structure of their manufacturing operations. A specific focus area is whether returning some or all production processes to American shores (inshoring) is a more practical and cost-effective alternative to the offshoring trend that’s been prevalent for several decades. 

 


Are you Considering In-Shoring your Pharmaceuticals?  Talk to our Experts →


 

Factors That Impact the Inshoring/Off-Shoring Decision

 

Examples of crucial considerations when in-shoring pharma include:

 

Manufacturing

 

If yours is like many pharma operations, you chose to outsource due to the lower production and labor costs available overseas. If it’s been a while since you’ve compared manufacturing abroad vs. at home, consider conducting a comprehensive cost analysis. You might be surprised to learn that you can now produce a pharma product in the U.S. more cheaply than before. In some cases, the costs are now nearly as low as in China.

 

Suppose your manufacturing cost analysis yields favorable results and you determine to move forward with in-shoring. The next step is to decide the type of manufacturing facility that makes the most sense for your operation. Specifically, you should determine whether a brownfield (existing) or greenfield (brand-new) site is the better option. 

 

Technology

 

If you’re evaluating an existing structure, take a look at the current equipment and technology. Are they compatible with your projects’ demands? If not, can you make cost-effective upgrades or modifications to bring them up to speed? If these hurdles are prohibitive, building a greenfield facility will likely provide a more practical and affordable long-term solution. 

 

A greenfield site enables you to customize your manufacturing processes more effectively since you are building and equipping the facility from scratch. On the downside, the costs of a new building, compatible machinery, and hiring and training fresh personnel may not be affordable for some pharma operations. And constructing a new facility from the ground up takes time — a commodity that’s often in short supply in today’s ultra-competitive pharma industry. 

 

Supply Chain

 

Supply chain access is another vital factor when in-shoring pharma operations. Given that many of the raw materials and ingredients used to manufacture pharma products and medical devices come from outside the U.S., finding acceptable substitutes at home can pose a challenge. If you must import them, you’ll need to consider the added transportation and costs of these components.

 

You’ll also need to account for all applicable supply chain qualifications. For instance, if you’re partnering with new suppliers, you must ensure they meet your company’s unique qualification and quality criteria. Transportation concerns are another issue to evaluate. Will you be able to get the materials to your facility reliably on time to accommodate your production schedules? You’ll need to implement a qualified transportation system for certain essential ingredients and finished goods. 

 

Operations

 

From a business/operational perspective, consider how in-shoring pharma will impact your personnel. For instance, if you decide to move into an existing facility, determine if there will be sufficient space for your workers and any new equipment you add. Also, can the facility accommodate essential areas such as clean rooms, warehousing, waste treatment systems, and cold storage spaces?

 

If you’re relying on outdated technology systems, you’ll likely need to make upgrades to meet the changes in demand. Examples of systems that require careful evaluation include ERP, CAPA management, and eDoc, to name a few. 

 

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. 

 

 

ease enter your information in the blue form below and click the submit button at the bottom of the webpage.