The Chinese market is becoming more and more important for many pharmaceutical companies. Therefore, it is essential to know the relevant regulatory requirements in China, especially the requirements on dissolution testing as they aren't harmonised with the other pharmacopeias (Ph.Eur., USP and JP). Read more here in the News.
At the beginning of April 2014, the European Medicines Agency (EMA) published a concept paper which describes the need for a revision of the existing documents about complying with the current state of art with regard to terminal sterilisation and aseptic procedures. Read more here
Many pharmaceutical water facility operators are not aware of the Biocidal Product Regulation which came into force on 1st September 2013 which implies a product registration for ozone equipment. Read more here.
Further information has now been released about EU Commission's delegated acts on the Counterfeit Directive after a workshop involving stakeholders took place on 28 April 2014. Read more here about the recommendations made for the implementation of future safety features.
With the publication of a draft on the revision of Annex 15 at the beginning of February 2014, movement was brought into the GMP requirements on validation and qualification - also in Europe. Changes attributable to revision of Annex 15 should not be underestimated. The European Compliance Academy (ECA) has carried out a survey and determined how industry assesses these possible changes and which uncertainties exist concerning the revision draft. To get a conclusion on the analysis of the survey read this news.
Dated April 2014 the WHO published a proposal for the revision of appendix 7 (non-sterile process validation) as a supplementary to the Guidelines on Good Manufacturing Practices. The reason given for the revision is compliance with actual GMP requirements. The following is an in-depth analysis.
In the framework of a modernisation initiative including a new and a revised general chapter, the USP has set new standards for the control of impurities in APIs and medicinal products. Read more here.
GMP Compliance problems found at more and more manufacturers in India are a major concern of EU and FDA regulators. Again the FDA has issued an Import Alert for an Indian Manufacturer. Please read more.
The new EU GDP Guideline requires that a Responsible Person for GDP has been named. In the UK an organisation has published a "Gold Standard for a Responsible Person". Read more about the Gold Standard.
Prof. Schwerdtfeger, president of the BfArM (Bundesinstitut für Arzneimittel und Medizinprodukte, the Federal Institute for Drugs and Medical Devices) has demanded a rethinking in policy and pharmaceutical industry in an interview with the the daily paper "Die Welt". In the interview which has attracted much attention he also talked about the actual supply shortages. Read more about the interview with the president of the BfArM.
The EMA has recently extended its Q&As document with 2 questions/answers about differences between the properties of a generic product and those of an innovator product which could lead to medication errors. Read more here.
For the EMA, it was necessary to develop an independent guideline on the topic as - despite the existence of harmonised ICH documents - specific aspects of the validation of biotechnology-derived products have been missing. A draft is now available.
Both the ECA and the European QP Association are often contacted by people who would like to become a Qualified Person in a Member State of the European Union or outside the EU to release products for the EU market. Read more.
The European Compliance Academy now counts a new working group. In addition to the already existing working groups on validation, GDP, QC, rapid microbiology methods and the QP Association, a new group was created at the beginning of the year to address GMP Compliance in the visual inspection of parenterals. Read more here.
The British Medicines Authority MHRA is performing GMP and GDP Inspections on a risk based strategy. Based on the experience the MHRA answers frequent asked questions. One very interesting Q&A refers to Mean Kinetic Temperature Calculations (MKT). Read more about MKT here
The European Compliance Academy (ECA) and the Pharmaceutical Quality Group (PQG) have announced the availability of chapter 7 "Outsourcing" on the interpretation of the new EU GDP Guideline. Read more about the GDP interpretation.