Analytical Methods Archives - Lachman Consultant Services, Inc.

Analytical Method Validation, Verification, or Qualification – What to use and when?

By Mrinmoy Nag Dec 23, 2022 Analytical Methods Compliance Drugs Regulatory Affairs

Analytical development and/or QC groups at early-stage pharmaceuticals and biopharmaceuticals often ask themselves about the level of level of confirmation of suitability required for their methods. Often the term ‘validation’ is used without understanding the full implications of the term. Sometimes, the terms validation, qualification and verification are used interchangeably. While ‘validation’ is well understood […]

Dec

Are your Analytical Methods Processing Settings Part of Your Analytical Lifecycle Management Program?

By Paul Mason, PhD. Dec 12, 2022 Analytical Methods Data Integrity FDA

Processing of the laboratory instrumentation output such as the processing of chromatographic raw data continues to be a focus of global health agency investigators. This is not surprising, as the investigator will be aware of the Data Integrity (DI) risks with such a manual operation, where there is the potential of selectively adjusting integration settings […]

Jul

Is It Time to Revisit USP <1058>?

By Paul Mason, PhD. Jul 19, 2022 Analytical Methods FDA Methods Methods validation Science & Technology

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 […]

Apr

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

By Paul Mason, PhD. Apr 06, 2022 Analytical Methods FDA ICH Science & Technology

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 […]

Feb

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Data Integrity – Management’s Responsibilities

By Tim Rhines, Ph.D Feb 21, 2020 Analytical Methods Bioanalytical Chemistry Data Integrity Laboratories Quality

Since the initial April 2016 draft published, the pharmaceutical industry has been working to toward complying with the FDA guidance on Data Integrity and Compliance With Drug CGMP (here) which was finalized in December 2018. One passage in the introduction of the guidance has resonated with me: “Management’s involvement in and influence on these strategies […]

Feb

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Out-of-Specification Investigations – Lessons Learned, or Not?

By Ron George, Ph.D. Feb 18, 2020 Analytical Methods Bioanalytical Bioequivalence CBER CDER Chemistry CMC Compliance Data Integrity Laboratories Manufacturing Quality

The FDA Guidance for Industry, Investigating Out‑of-Specification (OOS) Test Results for Pharmaceutical Production, was published in October 2006 (here). The pharmaceutical industry has had about 14 years to learn how to comply to this guidance. A quick survey of recent Form 483s and Warning Letters would indicate that there is still much to be learned […]

Feb

CBER Publishes a Boatload of New Gene Therapy Guidances

By Keith Webber Feb 14, 2020 Accelerated Approval Analytical Methods Bioequivalence Biologics BLA CBER Chemistry CMC Combination Products Compliance Emerging Technology FDA Guidance New Drugs Quality Regulatory Affairs

January was a gangbuster month for the FDA’s Center for Biologics Evaluation and Research (CBER) with regard to publication of gene therapy (GT) guidance documents! A total of six final guidelines and one draft guideline on GT products were issued. These included: Chemistry, Manufacturing, and Control Information for Human Gene Therapy Investigational New Drug […]

Feb

What Is It? – Identity Testing Re-visited

By James Davidson, Ph.D. Feb 13, 2020 Analytical Methods ANDAs BLA Chemistry CMC Compliance Excipients FDA Generics Inactive ingredients IND Manufacturing NDA New Drugs OGD Quality Regulatory Affairs Safety

In earlier blogs, we have written about specific technical items related to identity testing. However, a review of Warning Letters published on the US FDA website for the months of December 2019 and January 2020, revealed three Warning Letters citing instances of failures to perform identity testing of active pharmaceutical ingredients prior to the manufacturing […]

Feb

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The Importance of Sampling Plans for Uniformity of Dosage Testing

By Paul Mason, PhD. Feb 10, 2020 Analytical Methods Compliance Enforcement FDA Quality Science & Technology

Numerous health authorities have cited companies for inadequate sampling plans of finished drug products. A recent 483 issued to a finished drug‑product firm specifically mentions the firm’s lack of a scientifically sound statistical sampling plan during production of all strengths of its drug product. The FDA also mentions that this firm uses content uniformity results […]

Feb

Revisiting the “Novelty” of Novel Excipients

By Pete Manger Feb 06, 2020 Analytical Methods Approvals Biologics Biosimilars CBER CDER Chemistry CMC Complex Generics Compliance Excipients FDA Generics Inactive ingredients Manufacturing Regulatory Affairs

February 3, 2020 was the last day to comment on the Food and Drug Administration’s (FDA) notice in the Federal Register on the Novel Excipient Review Program Proposal; Request for Information and Comments (here), which we reported on in a previous blog post (here). In this notice, the FDA had proposed a pilot program related […]

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