GMP News - Quality Assurance

27.09.23

CAPAs after Validation Deficiencies

The FDA Warning Letters are a very good source to get to know how the FDA reacts to GMP deficiencies. In a current Warning Letter, the FDA comments on deficiencies in the context of process validation, among other things. What "CAPA" measures did it call for?

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26.09.23

FDA's Guidance on Track & Trace Standards

The FDA published the final guidance on standards for the interoperable exchange of track & trace information for certain human prescription drugs.

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20.09.23

Electronic Submission Portal for Cosmetics

The U.S. FDA is seeking comments on its newly developed draft electronic submission portal (Cosmetics Direct).

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20.09.23

US Verification Requirements: 1 Year Additional Time for Wholesale Distributors & Dispensers

To minimize possible disruptions in the distribution of certain prescription drugs in the United States, the FDA does not intend to take action before 27 November 2024 against dispensers who do not verify the product identifiers of suspect or illegitimate products.

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20.09.23

Swissmedic launches own GMDP Database

Swissmedic is bringing a SwissGMDP database into operation, similar to the EudraGMDP database, listing GMP and GDP certificates of all companies in Switzerland.

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20.09.23

Product Recall Due to Possible Pest Control Problems and Temperature Excursions at the Facility

The required storage conditions for medicinal products must always be met. If deviations are discovered after the product has left the warehouse, a recall may be the consequence. This is shown by an example from the US, which is about possible pest control problems and temperatures in excess of the storage condition instructions on the product labeling.

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20.09.23

USP: Comments possible on the Topic "Balances <41>"

The latest valid version of the USP chapter "Balances <41>" has been substantially revised and is now posted for comment on the USP Pharmacopeial Forum website. This revision follows updates to the USP chapter "Weighing on an Analytical Balance <1251>" and the general chapter "Balances" of the European Pharmacopoeia (Ph. Eur.). Comments on this draft can be submitted until 30 November 2023.

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13.09.23

Serious GMP Violations in the Aseptic Area

The FDA uncovered serious deficiencies in the aseptic area during an inspection of a US manufacturer. Deficiencies in smoke studies, media fills, pressure monitoring and cleaning validation are listed.

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13.09.23

FDA issues Guidance for Registration and Listing of Cosmetic Product Facilities and Products

The FDA is currently working on approaches to strengthen its oversight in regard to the safety of cosmetic products. Therefore, the agency issued a draft Guidance for Registration and Listing of Cosmetic Product Facilities and Products.

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12.09.23

Critical Quality Attributes for Topical Dosage Forms

A recently issued USP stimuli article describes advances in product quality and performance tests for topical and transdermal delivery systems (TDS). In particular, the article focuses on physicochemical and structural characterization tests for semisolid drug products.

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12.09.23

Storage and Transportation of IMPs

The USP revised the general chapter <1079.1> Storage and Transportation of Investigational Drug Products. With the revision reference is made to the new USP Chapter <1079.3> Monitoring Devices - Time, Temperature, and Humidity which will become official on 1 December 2023.

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06.09.23

U.S. Warning Letter caused by Data Integrity Failures

In August 2023, the U.S. FDA issued a Warning Letter to the US American company "Cosmobeauti Laboratories & Manufacturing Inc." after having inspected its site in March 2023. The significant violations of cGMP regulations for drug products, which are mentioned in the Warning Letter, can be checked here.

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30.08.23

The possible Impact of Artificial Intelligence on the Role of the Qualified Person

Artificial intelligence (AI) is revolutionising industry, and the pharmaceutical sector is no exception. One might think AI reaches its limits when it comes to GMP. But there are promising possibilities.

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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".

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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?

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