Analytical Methods

11
Oct

Connect With the Lachman Consultants Team at the 2023 ISPE Annual Meeting

ISPE 2023 Annual Meeting Mandalay Bay Resort Las Vegas, NV October 16th – 18th, 2023 We are looking forward to seeing you at the 2023 ISPE Annual Meeting & Expo. This annual event will usher in a revitalized focus on excellence, modernization, and harmonization in pharmaceutical science and manufacturing. MEET WITH LACHMAN CONSULTANTS AT BOOTH […]

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04
Aug

New Guidance for Industry- Acceptable Intake Limits for NDSRIs and a New Webpage from FDA

Unless you’ve been living under a (pharmaceutical) rock, you are aware of the struggle that both FDA and industry are having with Nitrosamines impurities in pharmaceutical products.  As a reminder, APIs are at risk of forming nitrosamine drug substance-related impurities (NDSRIs) when they contain secondary amines or dimethyl tertiary amines. We have published many blogs […]

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23
Dec

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

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 […]

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12
Dec

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

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 […]

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19
Jul

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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06
Apr
Hand Holding a Chemical Solution Test-tube in a bio-Chemistry DNA Research Laboratory

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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21
Feb
Leadership Concepts with Arrows on Blackboad Background

Data Integrity – Management’s Responsibilities

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 […]

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18
Feb
Businessman examines a tablet with a magnifying glass. Concept of internet security

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

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 […]

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14
Feb
Hand Holding a Chemical Solution Test-tube in a bio-Chemistry DNA Research Laboratory

CBER Publishes a Boatload of New Gene Therapy Guidances

  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 […]

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13
Feb
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What Is It? – Identity Testing Re-visited

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 […]

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