GMP News - Inspections/Audits

26.09.23

Ethylene and Diethylene Glycol Testing again in Focus of FDA Warning Letters

In recent months, the awareness for the impurities diethylene glycol (DEG) and ethylene glycol (EG) in pharmaceutical products was increased due to several FDA Warning Letters. We have reported on different examples where manufacturers failed to conduct proper identity testing of glycerin and other high-risk components. Now two more Warning Letters have been published, which also deal with this issue.

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25.09.23

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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20.09.23

New ZLG Document on Transport Verification Published

At the end of August, the German Central Authority of the Länder for Health Protection with regard to Medicinal Products and Medical Devices (Zentralstelle der Länder für Gesundheitsschutz bei Arzneimitteln und Medizinprodukten, ZLG) has published a newly prepared GDP relevant document. The German-language resource entitled "Inspektion der Eignung von Transportprozessen" focuses on transport verification and its inspections by the competent authorities.

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20.09.23

GDP in the US: Additional FDA Guidances on DSCSA

In the last few days and weeks, the U.S. Food and Drug Administration (FDA) has published several guidance documents related to the requirements under the Drug Supply Chain Security Act (DSCSA). Under the DSCSA, trading partners (manufacturers, repackagers, wholesale distributors, and dispensers) are subject to certain requirements for enhanced drug distribution security.

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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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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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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

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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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.

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17.08.23

GDP Audit Check List for Road Transport Operations

When conducting GDP audits, it can be helpful to work with question lists. We have compiled typical questions for road transport operations.

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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.

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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.

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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.

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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.

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26.07.23

FDA Warning Letter: Using non-validated and not appropriate Test Methods from an Internet Search is not a good Idea

The U.S. Food and Drug Administration (FDA) has published a new Warning Letter. The company in question manufactures over-the-counter (OTC) topical drug products, e.g. antibacterial hand soaps and hand sanitizers. The list of GMP violations is quite extensive and concerns, among others, QU oversight, handling of out-of-specification (OOS) results, identity testing, and laboratory controls in general.

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