GMP NEWS 2015

The U.S. Food and Drug Administration (FDA) has published its long awaited draft Guidance for Industry "Request for Quality Metrics", providing a lot of details on what FDA will expect.

A new draft Guideline on Manufacture of the finished Dosage Form has been published to provide clarification for the CTD Module 3 of the marketing authorisation dossier.

The issue of counterfeit medicines is often played down as it only affects the expensive blockbuster products anyway - mostly just products of the large pharmaceutical manufacturers. However, this is just as much a misconception as the belief that the products only show up in the internet trade and cannot be sold in the legal supply chain. Read more about a current counterfeit case affecting the company Desitin.

In June 2015 the MHRA, UK, has started an online blog particularly on data integrity. From their perspective the great misunderstanding is that failures with regard to the integrity of data are only caused by deliberate fraud. Read more about the MHRA Blog on Data Integrity.

The actual questions and answers on the quality of herbal medicines and traditional herbal medicines were revised in January 2015 within the fifth revision. The question on the testing with respect to benzene impurities was newly added. Find out more about the HMPC Q&A Document.

The Medicines and Healthcare Products Regulatory Agency (MHRA) has published a press release about a huge counterfeit case. Read more about the operation Pangea VIII.

While the focus of attention has been on Indian manufacturers during the last 2 years now also Chinese manufacturers are in the spot light. On 15 June 2015 the National Agency for Medicines and Medical Devices of Romania entered a GMP Non-Compliance Report for Zhuhai United Laboratories into EudraGMDP. Read more about the GMP deviations observed at Zhuhai United.

From July 1, the EU guidelines on Good Distribution Practice of medicinal products for human use (GDP Guidelines) will apply also in Switzerland. This is done by an Adaptation of Annex 2 of the Medicinal Products Approval Regulation (Arzneimittel-Bewilligungsverordnung - AMBV).

Establishments that manufacture human cells, tissues, and cellular and tissue-based products have to comply with a number of requirements under Title 21 of the Code of Federal Regulations Part 1271 (21 CFR Part 1271). This includes Investigating and reporting adverse reactions.