GMP News

After incomplete processing of defects listed in a 483, the Austin-based compounding manufacturer Texas Longhorn received a Warning Letter from the FDA.

During an inspection at the end of 2021, the FDA identified a manufacturer of umbilical cord blood products as lacking approval as well as numerous deviations with regard to common GMP requirements.

The US Food and Drug Administration (FDA) has updated two Compliance Program Guides (CPGs) on GMP inspections. One for pre-approval inspections (PAI) and one for routine surveillance inspections.

Also in September 2022, the EDQM has prepared its "CERTIFICATION MONTHLY REPORT" on the topic of "CEPs" (Certificate of Suitability of Monographs of the European Pharmacopoeia) and has now published it in the EDQM website newsroom.

The EDQM has announced the availability of a new document in the Knowledge database concerning the revised general chapter 2.2.46. Chromatographic separation techniques. It provides a comparison of the requirements included in the 10th Edition vs. the 11th Edition of the European Pharmacopoeia.

The U.S. Food and Drug Administration (FDA) has issued a Warning Letter to a drug manufacturing facility in Missouri. The company failed to adequately investigate the presence of foreign tablets in the drug products. Furthermore, during an FDA inspection, one operator was observed to pick individual tablets up off of the floor and place them directly into the feed hopper.

In August 2022, the National Agency for Medicines and Medical Devices of Romania added a new GDP Non-Compliance Report to the EudraGMDP database. The company in question "failed to comply with GDP legislation regarding activities performed (e.g. procuring from entities which are not authorized for wholesaling activities)".

Deficiencies in the quality system repeatedly lead to so-called GPD Non-Compliance Reports. But what are the requirements for the quality system in the GDP environment, and which processes must be in place within the company?

Particulate contamination and inadequate aseptic working techniques while performing interventions during production once again led to a serious Warning Letter from the FDA. What did the FDA criticise and what did it demand from the American company Cangene BioPharma, LLC dba Emergent BioSolutions?

To keep a pharmaceutical water system in the qualified state, a suitable maintenance strategy with appropriate maintenance intervals is required. This is demanded by GMP and also makes sense from an operational point of view. Maintenance intervals are already determined in the design phase based on the criticality of the individual components and are specified and controlled in the subsequent commissioning and qualification steps. But which procedures and specifications make sense for the maintenance of a pharmaceutical water system?

The EMA published a guidance for applicants / MAHs involved in GVP inspections. It includes a detailed list of documents to be provided to GVP inspectors.

The European Pharmacopoeia (Ph. Eur.) published the long-awaited draft of the Cannabis flower monograph in Pharmeuropa with a comment period until 31 December 2022. Once finalized and adopted it is expected that the Ph. Eur. monograph will replace the currently existing national monographs.