One of the most important steps in the development process of a medicinal product is clinical trials. Compliance with GMP (Good Manufacturing Practice) during the manufacture, packaging and labelling of investigational medicinal products (IMPs) is therefore crucial for ensuring the quality of a medicinal product. What are the GMP requirements?
US FDA has published a Warning Letter highlighting weaknesses that can occur in any GMP process. In this Letter OOS investigations and changes in electronic systems were not adequately addressed in the CAPA system.
One of the hottest topics these days, is the discussion about the use of Artificial Intelligence (AI) in the GMP environment. How far much is the use of AI already used in equipment qualification? This we want to know - with this brief survey.
The European Medicines Agency (EMA) provides comprehensive guidance on the use of 3D printing (3DP) technologies in pharmaceutical manufacturing, focusing on GMP compliance, quality requirements, and process validation. The guidance highlights both the transformative potential of personalized medicines and the need for robust control strategies to ensure product quality, safety, and efficacy.
The FDA has issued a new Warning Letter to an OTC drug manufacturer in Palm Bay, Florida. The agency cites significant CGMP deficiencies, with a strong emphasis on laboratory control and analytical oversight, including missing finished-product testing prior to batch release, weaknesses in incoming-material testing and supplier/COA qualification, an inadequate stability program, and inadequate QU oversight.
In mid-April 2026, a new draft guidance document entitled 'Establishing Impurity Specifications for Antibiotics' was published on the FDA website. Comments on this 'Guidance for Industry' can now be submitted until 22 June 2026.
A new WHO draft working document "Bioequivalence for Immediate Release Oral Dosage Forms" (QAS/25.990) is currently open for public consultation. It is intended to update WHOs recommendations for demonstrating bioequivalence (BE) for orally administered immediate-release (IR) products such as tablets, capsules and oral suspensions. Comments can be submitted until 23 June 2026
Documentation fulfils several key functions within the GMP environment and is an indispensable component of quality assurance. This raises the question: what exactly is meant by the term 'Good Documentation Practice'?
Despite MRAs, not all types of inspections are recognised in practice; for example, "for-cause" inspections have so far not, or only rarely, been covered. These are also increasingly conducted without prior notice.
In February 2026, the EMA published a concept paper announcing a further revision of Annex 15 to the EU GMP Guidelines. This concept paper was open for comments until 9 April 2026. The ECA Validation Group took advantage of this opportunity. What comments were made?