GMP NEWS 2016

Dr Friedrich Haefele, Vice President Fill & Finish Biopharma at Boehringer Ingelheim talked in his keynote speech at the Pharma Congress 2016 about the revision of Annex 1 of the EU GMP Guide. Read here what the pharmaceutical industry expects form the new Annex 1.

The Europeam Medicines Agency (EMA) has published a "Reflection paper on collecting and reporting information on off-label use in pharmacovigilance“ for comment (deadline July 29, 2016). Read more about EMA's reflection paper on Off-Label-Use.

The European Medicines Agency, EMA, recently published questions and answers on what data is required for sterilisation processes of primary packaging materials subsequently used in an aseptic manufacturing process. Read more about "What data is required for sterilisation processes of primary packaging materials subsequently used in an aseptic manufacturing process?".

For medicinal products administrated in sterile form, the process to reduce the microbial level is a critical manufacturing step with regard to quality. The EMA has recently published the draft of a guideline on that topic which contains a range of clarifications. Read more about the coming requirements on sterilisation of medicinal products, APIs, excipients and final containers and how to document them in the marketing authorisation dossier.

In the Pharmacopoeial Forum (PF)  42(3) (May-June 2016) the USP General Chapters - Packaging and Distribution Expert Committee proposes a new general chapter  <661.3> Plastic Components and Systems Used in Pharmaceutical Manufacturing and a revised version of general chapter <1661> Evaluation of Plastic Packaging and Manufacturing Systems and Their Materials of construction with Respect to Their User Safety Impact. Read more about USPs Proposal on Plastic Components and Systems Used in Pharmaceutical Manufacturing.

Again, the US American FDA has issued a Warning Letter to a manufacturer of sterile medicinal products. Extensive and serious violations of the GMP principles have been discovered at the Indian manufacturer Emcure Pharmaceuticals Limited. Part 2 of this News addresses environment and personnel topics. Read more about the most significant deviations in this Warning Letter.

The US FDA has published a Warning Letter that clearly proposes some necessary actions and asks for appropriate corrective and preventive actions (CAPA).

Following a good clinical practice (GCP) inspection at the Alkem Laboratories Ltd site in Taloja, India, which raised concerns regarding study data used to support EU marketing authorisation applications, the European Medicines Agency (EMA) has started a review of medicines for which studies have been conducted at this site. Read more about the start of a review regarding study data generated at the Alkem Laboratories Ltd site in Taloja, India.

This year in February, European GMP inspectors discovered critical GMP deficiencies at an Indian API facility. Read more about the lack of transparency of the supply chain, the insufficient documentation system and the lack of data about process validation at this site.