GMP News - Analytical Quality Control

15.04.24

USP plans new Chapter on Process Analytical Technology (PAT)

The United States Pharmacopeia (USP) is developing a new General Chapter dedicated to Process Analytical Technology (PAT), aiming to provide guidance on its definition, attributes, enablers, and practical applications in the pharmaceutical industry. Comments on the proposed outline are due to the USP by 28 April 2024.

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15.04.24

FDA sends Warning Letter to Canadian OTC Manufacturer

A manufacturer of over-the-counter (OTC) drug products based in Canada received a Warning Letter from the U.S. Food and Drug Administration (FDA) regarding significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals.

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10.04.24

US FDA: Draft on Data Integrity for BE/BA Studies published

At the beginning of April 2024, the draft document "Data Integrity for In Vivo Bioavailability and Bioequivalence Studies" was published on the US FDA website and is now available for comment for 60 days. The document is intended to assist applicants and marketing authorisation holders in the area of data integrity for the clinical and bioanalytical part of bioequivalence and bioavailability studies.

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03.04.24

Warning Letter to Chinese OTC Manufacturer: Violations concerning Identity Testing, Stability Program and Quality Unit

The U.S. Food and Drug Administration (FDA) has published a new Warning Letter to a Chinese manufacturer of over-the-counter (OTC) drug products. The violations were identified during the FDA's review of records submitted by the company in response to an official request.

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27.03.24

Court Ruling: Suspended Sentence and Heavy Fine for Falsifying Stability Data

A court in the UK has sentenced a pharmaceutical company and its former director to heavy fines. The defendant had admitted to knowingly submitting falsified stability data to the MHRA in order to obtain a Marketing Authorization for a product. This was preceded by years of investigation by the authority.

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19.03.24

FDA Warning Letter to Drug Manufacturing Facility in Thailand

The U.S. Food and Drug Administration (FDA) has issued a Warning Letter to a drug manufacturing facility in Thailand. The violations include failure to conduct appropriate laboratory testing for identity and strength of active ingredients prior to release and distribution.

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19.03.24

EMA/CMDh: Appendix 1 for Nitrosamines Updated Again

The nitrosamine Q&A document "Questions and answers for marketing authorization holders/applicants on the CHMP Opinion for the Article 5(3) of Regulation (EC) No 726/2004 referral on nitrosamine impurities in human medicinal products" of the EMA/CMDh contains three annexes (Appendix 1-3) in its current version of October 2023. In February 2024, Appendix 1 was updated again and fifteen new substances were added.

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14.03.24

New USP Chapter on Cured Silicone Components

The final text for USP <383> Cured Silicone Elastomers for Pharmaceutical Packaging and Manufacturing Components has been published in the USP. The chapter will become official on 1 December 2027. Early adoption of the requirements in this chapter is permitted by USP.

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13.03.24

EDQM: Top Ten Deficiencies for CEPs

In February 2024, the EDQM has published its summary of the top ten deficiencies which occurred during the evaluations of the CEPs in 2023. This document called "TOP TEN DEFICIENCIES in New Applications for Certificates of Suitability for chemical purity" should help applicants to avoid such deficiencies in future and lists in detail the findings and its respective sections.

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13.03.24

FDA publishes Q2(R2) and Q14 Guidelines

After the ICH and the EMA had already made the documents available for download in December and January respectively, the FDA has now announced the availability of the final guidances for the industry entitled "Q2(R2) Validation of Analytical Procedures" and "Q14 Analytical Procedure Development."

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05.03.24

FDA Draft Guidance on Potency Assays for Cellular and Gene Therapy Products

At the end of December, the FDA published a new draft guidance document on potency assays for Cell and Gentherapeutics. In addition to recommendations for potency testing, this guidance is also intended to help with the overall strategy for ensuring potency.

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28.02.24

FDA Warning Letter: Data Integrity issues while manufacturing APIs

In February 2024, the U.S. FDA issued a Warning Letter to the Chinese company "Sichuan Deebio Pharmaceutical Co. Ltd." after having inspected its site in September 2023. According to the Warning Letter the firm has a lack of microbiology laboratory Data Integrity.

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21.02.24

Another FDA Warning Letter for Chinese Company based on Review of Records

The U.S. Food and Drug Administration (FDA) has issued another Warning Letter to a Chinese manufacturer regarding significant violations of cGMP regulations for finished pharmaceuticals, based on a review of records.

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21.02.24

Swissmedic: Nitrosamine Requirements updated

Swissmedic's nitrosamine Q&A document "Update of the requirements for dealing with nitrosamine impurities in medicinal products" was updated in January 2024 and is now available in the new version on the Swissmedic website.

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14.02.24

FDA Warning Letter: Observed particulates in repackaged drug components

In January 2024, the U.S. FDA issued a Warning Letter (WL) to the Mexican company "Glicerinas Industriales, S.A. de C.V." after having inspected its site in May 2023. According to U.S. FDA Warning Letter, the firm failed to do adequate investigations on observed contamination of particles in numerous packaged drugs.

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