The issue 27.3 of Pharmeuropa also comprises a revision of Chapter 2.6.27 "Microbial Examination of cell-based Preparations". It covers the cases where a test is not feasible according to chapter 2.6.1.
The FDA Draft Guidance on Methods Validation has recently been revised and finalised. Please read about some important points required by this Guidance regarding validation of analytical test procedures.
Usually, small volume ampules or vials for injectable drug products are slightly overfilled in order to guarantee the excess volume. Now, the FDA has made its position clear. Read more about the actual Guidance for Industry "Allowable Excess Volume and Labeled Vial Fill Size in Injectable Drug and Biological Products".
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 integrity of data is currently in the focus of international authorities. In particular the US FDA issued serious violations in Warning Letters to the companies concerned. Read more about the current complaints in a Warning Letter issued to the API manufacturer VUAB Pharma.
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 "European Medicines Verification Organisation" (EMVO) has developed a model for the practical and cost effective implementation of the system for data storing and has also signed framework agreements with three partners. Find out more about the EMVO model.
Already in October 2012 the International Conference on Harmonisation (ICH) has started to develop the ICH Q7 Q&As. Now the ICH has published the ICH Q7 Questions and Anwers on GMP for Active Pharmaceutical Ingredients. It is the intension of the guideline to clarify uncertainties due to different interpretations of requirements laid down in the ICH Q7 Guideline. Please read more about the ICH Q7 Question and Answer Guideline published by ICH.
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.
The International Conference on Harmonisation (ICH) wants to facilitate the implementation of their Guidelines and other documents through issuing new training materials. Just recently the ICH has updated their website with new materials on Q3D.
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).
The EMA/HMPC Reflection paper on microbiological aspects of herbal medicinal products and traditional herbal medicinal products has been published in its final version. Find further information on the EMA/HMPC Reflection Paper.
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.
With the new draft the US FDA wants to replace the guidance document "Revised Recommendations for the Prevention of Human Immunodeficiency Virus (HIV) Transmission by Blood and Blood Products," issued in 1992. Learn more about the draft Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products.