Comparability Protocols

The CDER has issued a final guidance titled Comparability Protocols for Postapproval Changes to the Chemistry, Manufacturing, and Controls Information in an NDA, ANDA, or BLA (here), addressing the role of comparability protocols (CPs) for post-approval changes to the CMC sections of NDAs, ANDAs, and BLAs where the CP is a prospectively written plan for […]

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Know Your Systems!

It is evident from reviewing recent health agency citations that the FDA expects that firms have a deep understanding of any systems that generate data/records and that this is reflected in the firm’s lifecycle management of those systems. What does that mean, in a practical sense? Well, a component of this understanding must extend to […]

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System and Sample Suitability – Know the Whole Story!

Within the draft ICH Q14 “Analytical Procedure Development” guidance document (here), Section 6 refers to  the Analytical Procedure Control Strategy. This should be developed prior to and confirmed via Analytical Method Validation. A key component of the Analytical Procedure Control Strategy is System Suitability (SST), but the guidance document also makes reference to sample suitability: […]

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The Role of QC Testing

The EU recently issued the comprehensive GMP Annex 1 for the manufacture of sterile drug products. This guidance is broad and thorough covering all aspects of sterile product manufacture. Under the Quality Control section, (10.5) the following is referenced: The sterility test applied to the finished product should only be regarded as the last in […]

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Is It Time to Revisit USP <1058>?

With the issuance of draft ICH Quality Guideline ICH Q14 on Analytical Procedure Development (here) and revision of ICH Q2(R2) Guideline on Validation of Analytical Procedures (here), along with the issuance of USP <1220> Analytical Procedure Lifecycle, perhaps it may be time to revisit USP <1058> Analytical Instrument Qualification (AIQ). USP <1058> is a critical chapter providing key guidance on […]

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The Significance of Data Invalidation

When reviewing health agency citations, investigators are naturally concerned when observing cases of data invalidation during investigations and may well question the motives/justification accordingly. This can lead to some uncomfortable exchanges between firms and health agencies! So how should a laboratory protect themselves from such a situation? First, you want to ensure that, per your […]

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ICH Q14: Analytical Procedure Development and Revision of Q2(R2) Analytical Validation

The ICH has developed a draft of the new ICH Quality Guideline, ICH Q14, Analytical Procedure Development, and revision of ICH Q2(R2), Guideline on Validation of Analytical Procedures, both endorsed on March 22, 2022 for public consultation.  The draft, along with other ICH guidances on validation and analytical procedures, can be found here. The draft revision of […]

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The Importance of Data Integrity Risk Assessment

Paul Mason, Ph.D., Lachman Consultants, wrote an article for Contract Pharma covering “The Importance of Data Integrity Risk Assessment.” Here is a brief excerpt from the article: “The FDA and other Health Agencies have an expectation that companies understand the capability of their systems that generate and store data/records including any data integrity risks associated […]

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The Importance of Hypothesis Testing During Investigations

Paul Mason, PhD, Lachman Consultants, wrote a recent article for Contract Pharma discussing why it is critical to have controls in place during out-of-specification investigations to provide quality assurance. Here is a brief excerpt from the article: “While being audited by government health agencies, it can be expected that quality investigations will be reviewed since […]

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Understanding Risk as It Applies to Data Integrity

The PDA published Technical Report 84, Introducing Data Integrity Requirements into Manufacturing and Packaging Operations (here), which reaffirms that Data Integrity is not only a concern for the laboratory but for any aspect of the pharmaceutical industry where data/records are generated and handled.  There are excellent tools within the document as it applies to the […]

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