The Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human has updated the Best Practice Guides for the Submission and Processing of Variations in the Mutual Recognition Procedure. Find further information here.
Last year the European Commission has released the draft Chapter 1 Quality Management System of the EU Guidelines to GMP for public consultation. In order to get some broad feedback, the ECA decided to conduct a survey among its members. Outcome of the survey.
The USA is still systematically evaluating the experience in the Heparin case. More precisely this means that the former FDA inspections at Heparin manufacturers in China were analysed. Read more here.
Because the US GMP Regulations do not address Process Validation in an own paragraph, it is not easy to immediately catch deficiencies in this area in Warning Letters issued by the FDA. For that reason you will find a detailed analysis for process validation deficiencies for the fiscal year 2009 here.
Recently, the European Qualified Person Association made the database "QPSHARE" accessible to its members, which enables QPs to increase the efficienvcy of the supplier qualification of their companies. The database is already used intensively. Read more here.
A revised EMA paper specifies requirements on the preparation, conduct and follow-up of official inspections. In the sense of a changed perspective, the document is also worth reading for manufacturers of medicinal products, investigational medicinal products and active pharmaceutical ingredients. Read more.
The FDA has published a new Guidance for Industry: Q8, Q9, and Q10 Questions and Answers reflecting the current working procedure of the ICH Quality Implementation Working Group (Q-IWG) for implementing the Q8, Q9, and Q10 guidances. Summary
Currently, the European Pharmacopoeia only allows distillation for the production of Water for Injection (WFI). The EDQM has initiated a survey through industry associations to gather suitable information and data. You will find more here.
'Shared audits' are on everyone's lips. The term describes the fact that several firms hold a joint audit of the same supplier. Such a procedure can reduce the costs considerably. Read here how this can be done and what has to be taken into account.
The European Commission published the revised Draft of Annex 2 "Manufacture of Biological Medicinal Substances and Products for Human Use" for the second pubic consultation with deadline for comments 15th July 2010. More details can be found here.
A collaborative initiative between the FDA and the National Institute of Health is currently being developed to define a formulations framework for drugs that are used in pediatric patients. Read more.