Lab Testing & OOS Investigations

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In this episode of RCA Radio, host, Brandon Miller, and Regulatory Compliance Associates Inc.® Senior Director of Quality Control and Consulting Services, Walter Mason, take a deep dive into lab testing, laboratory Out-of-Specification (OOS) investigations and how to get to the root cause.

Listen in as we go over lab testing best practices for dealing with laboratory OOS investigations, relevant guidance documents, and a few examples from warning letters that are available to the public.

About RCA’s Lab Testing Services

Regulatory Compliance Associates (RCA) has helped clients from around the world develop stage-ready lab testing based on each product’s regulatory pathway. Our comprehensive lab testing services include supporting pre-formulation, process development for formulation, and formulation manufacturing. The following includes a high level overview of lab testing solutions, solubility and dissolution testing, stability testing, solid form testing we conduct for new product development clients.

RCA Pharmaceutical & Medical Device Testing

Biocompatibility
Toxicology
Extractables & Leachables
Sterility Assurance
Validation

Cosmetic Testing & Skin Care Testing

Personal and Professional products
- Moisturization/Hydration
  - Moisturization Testing
  - Dermatologically tested claims
- Anti-aging
  - Claim Testing
    - Fine Lines and Wrinkles
    - Evens Skin Tone
    - Moisturizes/Hydrates
    - Exfoliates
    - Promotes Healing
    - Barrier Repair
    - Restores Damaged Skin
    - Anti-Inflammatory
    - Reduces Erythema
    - Reduces Pore Size
    - Non-Irritating
    - Wound Healing
    - Hypoallergenic
    - Dermatologist Testing
    - Ophthalmologist Tested
    - Acne
    - Onychomycosis
    - Antiperspirant
    - Plaque Reduction (PGRM)
    - Whitening
- Skin Tone
- Acne Spot Reduction
- Lesion Reduction
- Image Analysis
- Water Loss (Barrier Properties)
- In-Use Studies

RCA Validation Testing

Facility & Process validation

Cleanroom Validation
- Installation Qualification
- Operational Qualification
- Performance Qualification
Water System Validation
- Sampling
- Microbiological Testing
- Alert and Action Limits
Process Validation
- RMM
- Surfaces
Sterilization Validation
- ISO 11135 (ethylene oxide)
- ISO 11137 (radiation sterilization)
Re-Use Validation
- Device reprocessing
- Cleaning
- Disinfection
- Sterilization
Packaging Validation
- ISO 11607-1:2019
  - Requirements for materials
  - Sterile barrier systems
  - Packaging systems
- ISO 11607-2:2019
  - Validation requirements
  - Forming
  - Sealing

Biological evaluation testing

Biological Evaluation Plan
In Vitro Biocompatibility
- Cytotoxicity testing
- Hemocompatibility testing
- Genotoxicity testing
In Vivo Biocompatibility
- Implantation testing
- Irritation testing
- Thrombogenicity testing
- Sensitization testing
- Systemic Toxicity testing
- Genotoxicity
Chemical Characterization (E&L)
- Gas Chromatography/Mass Spectrometry
- Liquid Chromatography/Mass Spectrometry
- LC Chromatogram
- Inductively Coupled Plasma
Toxicology Assessment
- Hazard identification
- Data evaluation
- Exposure assessment
- Dose-response analysis
- Risk characterization

Sterilization validation testing services

Radiation validation testing

Product Sterility
- Product shelf life
- Stability and/or package integrity
Verification Dosing
- Maximum Dose
- Dose Mapping
Bioburden
- Test Method Validation
Bacteriostasis/Fungistasis
- Microbial contamination
- Method suitability
- Method validation
BET/Particulates

EO validation testing

BI Sterility
- Steam Sterilization (Autoclaves)
- Vaporized Hydrogen Peroxide Sterilization
Product Sterility
Bioburden
EO Residuals
BET/Particulates
PCD’s

Re-Use validation testing

Cleaning
Disinfection
Sterilization
Clinical Monitoring
Simulated Use
Lifecycle Testing

Packaging validation testing

Aging (real-time)
Aging (accelerated)
Strength and Integrity
Distribution Studies
Thermal & RH Cycling
Stability Testing

Sterility assurance testing

QDA (Radiation)
- Product Sterility
- Verification Dosing
- Bioburden
- BET/Particles
ED Lot Release
- BI Sterility
- EO Residuals
- BET/Particulates
- PCD’s
Other Sterility Assurance
- Bioburden
- Organism ID’s
- Cytotoxicity

Coronavirus – Disinfectant Claim Testing

Testing standards for SARS-COV-2:
- ASTM – E1053
- ASTM – E1052
- EN – 14476
- ISO – 18184
- ISO – 21702

Monkeypox – Virus Efficacy Testing

Testing standards for Monkeypox:
- ASTM – E1053
- ASTM – E1052
- EN – 14476
- ISO – 18184
- ISO – 21702

Lab compliance services

ALCOA+ data integrity programs
Analytical instrument qualification (AIQ)
Chromatography data system (CDS)
Custom validation services
Computer system validation (CSV)
Custom procedure writing

Cyber-security software protection
Equipment qualification plans (EQPs)
Equipment qualification reports (EQRs)
Instrument and software qualifications (IQOQ, OQ ,and RQ)
IVD Test Implementation
Qualification electronic traceability

About RCA

pharmaceutical consultants Regulatory Compliance Associates^® (RCA) provides healthcare consulting services to the following industries for resolution of compliance and regulatory 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 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

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