GMP News - Quality Assurance

30.08.23

CAPA and Investigations criticised in a recent FDA Warning Letter

A US drug manufacturing company received a Warning Letter from FDA mentioning several failures "to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components".

more

30.08.23

PIC/S publishes Annual Report for 2022

PIC/S is a collaboration of regulatory agencies in the field of GMP for human and veterinary medicines. The goal of PIC/S is to provide harmonized standards and training to ensure that one inspection per site will also be recognized by every other authority. The 2022 report provides an overview of PIC/S activities for that year. What does it include?

more

24.08.23

Semisolid Drug Product Quality and Performance Tests

The USP adopted the revised general chapters <1724> Semisolid Drug Products - Performance Tests and <1912> Measurement of Yield Stress of Semisolids. In particular, chapter <1724> now also includes information on in vitro permeation tests (IVPTs).

more

23.08.23

CMDh/HMA: Best Practice Guide on Variations

In July 2023, individual chapters of the "Best Practice Guides (BPGs) for the Submission and Processing of Variations in the Mutual Recognition Procedure" were updated and published on the HMA (Heads of Medicines Agencies) website.

more

23.08.23

Are Placebo Batches Allowed in Cleaning Validation?

In our News dated 16 August 2023, we referred to a Warning Letter issued to an Indian API manufacturer. Among other things, the FDA criticized the company for residues on internal surfaces of equipment parts. The deviations were found during an FDA inspection conducted in November 2022. In late January/early February 2023, the FDA was back at another site of this company for inspection. What did the FDA find this time?

more

23.08.23

Series of FDA Warning Letters due to inadequate Testing of Glycerin and Other High-Risk Drug Components

Just recently, we reported on a Warning Letter regarding a manufacturer who failed to conduct proper identity testing of glycerin and other high-risk components. The FDA has now published a whole series of Warning Letters that revolve around the same topic.

more

16.08.23

FDA Warning Letter: Inadequate Investigation of Humidity Excursions

The U.S. Food and Drug Administration (FDA) has published a new Warning Letter. During an inspection at an Indian company, the FDA investigators observed several GMP violations concerning inadequate investigation of humidity excursions, data integrity deficiencies, and inadequate testing of component lots used to manufacture the OTC drug products.

more

16.08.23

Even Non-Reactive Residues Are Considered Cross-Contamination and Require Validation

In a recent Warning Letter, the FDA presented its view on the topic of cleaning validation. What is it about?

more

09.08.23

Identity Testing of Glycerin in Focus of an FDA Warning Letter

At the beginning of August, the U.S. Food and Drug Administration (FDA) has published a new Warning Letter. As in several cases in recent months, it is again about a US manufacturer who failed to conduct proper identity testing of glycerin and other high-risk components. In addition, a number of other CGMP violations are documented.

more

09.08.23

EDQM: Nitrosamines and CEPs

As recently reported in our News, the 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" has been updated again. The EDQM has now defined the resulting measures for CEP holders and listed them in its Newsroom.

more

09.08.23

FDA's Draft Guidance on Postmarketing Noncompliance

The agency issued a draft guidance providing information for marketing authorization holders of human prescription drugs who are required to conduct postmarketing studies or clinical trials, commonly referred to as postmarketing requirements (PMRs). In case of PMR Noncompliance the MAH could be subject to an FDA warning letter.

more

02.08.23

MRA between Switzerland and the USA now effective

The Mutual Recognition Agreement (MRA) between Switzerland and the United States in the area of GMP for medicinal products has entered into force. It applies to both human and veterinary medicinal products.

more

02.08.23

EU-GMP Chapter 7: Is a "Chain of Contracts" allowed?

The EMA has updated its Questions and Answers and discusses where and when "Chain of Contracts" are accepted and which principles should be adhered to.

more

02.08.23

The New Annex to EMA's Question and Answer Document on the Determination of Acceptable Intake Levels of Nitrosamines

EMA's Q&A document has been extensively revised and supplemented with regard to the limits for nitrosamine impurities. The new Annex 2 describes the approach for determining acceptable intake levels for nitrosamines without data from in vivo mutagenicity studies.

more

26.07.23

FDA criticised over inadequate GMP Inspections in India and China

Republican Congress members are worried that the US is overly reliant on sourcing from foreign manufacturers with a demonstrated pattern of repeatedly violating FDA regulations and express this in a letter to the FDA Commissioner.

more

GMP Newsletter

Sign up for the free of charge newsletters.

Sign up now!

GMP Conferences by Topics