GMP News

The U.S. Food and Drug Administration (FDA) has issued a Warning Letter to a firm that manufactures and distributes OTC products. The Warning Letter summarizes significant violations of current Good Manufacturing Practice (CGMP). The company failed, amongst others, to have the proper controls in place to prevent the unauthorized manipulation of laboratory raw electronic data. Furthermore, the laboratory management could not provide an adequate explanation for several unofficial HPLC injections.

The WHO published the revised draft of its guideline "Good Manufacturing Practices: water for pharmaceutical use" already end of July. The first revised draft of the guideline was published in May 2020. The new, second version contains further changes.

USP´s Expert Committee for Botanical Dietary Supplements and Herbal Medicines proposes a new general chapter on Pyrrolizidine Alkaloids (PAs).

The FDA issued a new guideline entitled “Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research”. The draft guidance also introduces key FDA regulatory concepts to stakeholders who may be less familiar with the FDA and the FDA’s authorities than other drug developers.

The EU-GDP Guidelines require that wholesale distributors have to appoint a responsible person (RP) for GDP. A written job description of the responsible person should define their authority to take decisions with regard to their responsibilities. But what are the elements which should be covered in such a job description?

The European Commission (EC) published an updated Version 2.4 of the Questions & Answers relating to the Clinical Trials Regulation.

The European Commission has published a communication to prepare for the end of the transition period. There are also indications for the pharmaceutical sector.

The US Food & Drug Administration (FDA) explicitly explains the deficiencies in the area of quality control in its Warning Letter for the company "Signa SA de CV".

At the end of July, the FDA (CDER) published a draft guidance document for setting endotoxin limits during the development of drugs for oncology and biological products.

In addition to the publication of a large number of guidelines and supporting documents in the field of cell and tissue products, the FDA also provides insights into the biological research projects of its scientists on its website.

The new ISO Technical Report on Post-Market Surveillance for medical devices has been published this month. It shall help to implement a Post-Market Surveillance Process according to (EU) MDR 2017 / 745.

Inspectorates are restarting domestic on-site inspections. Announcements were made by FDA and MHRA.