21 CFR 211.194 – Tips for Laboratory Records Compliance for QC Laboratories

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21 CFR 211.194 – Tips for Laboratory Records Compliance for QC Laboratories

April 15th, 2013 // 4:59 pm @

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Audit Your Lab Like an Expert FDA Auditor: A Roadmap to Lab Compliance

April 15, 2013

There are major implications for the pharmaceutical laboratory regarding FDA’s requirements for risk assessment and management all through the product life cycle. The onus is now on the pharmaceutical industry. You need to address every phase of your drug process and make sure that your laboratory is up to cGMP guidelines.

Audit Your Lab Like an Expert FDA Auditor: A Roadmap to Lab Compliance

This has a major effect on quality control laboratories, by mandating risk management across the spectrum. We are seeing a good deal of focus on laboratory controls in recent FDA 483s and warning letters. Here are some recent observations we have seen:

  • The failure to have adequate laboratory facilities for the testing and approval (or rejection) of components, drug product containers, closures, packaging materials, in-process materials, and drug products available to the Quality Control Unit as required by:  21 CFR 211.22 (b)
  • The failure to appropriately test each batch of drug product to determine satisfactory conformance to final specifications, including the identity and strength of each active ingredient, prior to release as required by 21 CFR 211.165.
  • Laboratory records failed to include the initials or signature of a second person showing that the original records have been reviewed for accuracy, completeness, and compliance with established standards, as required by:  21 CFR 211.194(a)(8)
  • The failure to establish scientifically sound and appropriate specifications, standards, sampling plans and test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality, and purity, as required by:  21 CFR 211.160(b)

To reduce your lab’s compliance problems, you need to do a proper gap analysis and performance assessment of the following areas:

  • Facilities
  • Personnel (Training and Training database)
  • Instrumentation and Equipment (Qualification status, PM, log books, etc)
  • HPLC/System Suitability
  • GC/System Suitability
  • pH Meter
  • Conductivity Meter
  • Hydrometers
  • Thermometers
  • Balances
  • UV/VIS Spectrophotometers
  • Infrared
  • Calibration Program
  • PM Program
  • Reference Standards
  • Reagents/Solutions/Chemicals
  • Sample Controls
  • Contract Lab Qualification & Oversight
  • Raw Material Control
  • Final Product
  • General Housekeeping
  • Data Security and Integrity (What does this mean?)
  • Training Program
  • Good Documentation Practices
  • Lab data
  • Method Validation
  • Method Qualification
  • Computer Systems Validation (Part 11)
  • Method Transfer Program

The performance assessment needs to be followed by an effective needs analysis:

  • Identify where performance weaknesses are coming from
  • Design a strong cGMP-based plan to address them
  • Evaluate all mitigation

Also, remember these requirements for both foreign and domestic labs:

Laboratory Documentation

2. Control & Maintenance of Reference Standards/Reagents, Solutions and Media

3. Test Method Validation (including Tech Transfer of Analytical Methodology)

4. GMP Requirements for Laboratory Testing

5. Sampling Programs

6. Retained Sample Storage

To learn more about how to maintain cGMP compliance for your laboratory, please check out our webinar coming up – Audit Your Lab Like an Expert FDA Auditor: A Roadmap to Lab Compliance.

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