Recently, the FDA published a new Guidance for Industry draft document. It is intended to help medical gas manufacturers introduce and implement GMP regulations. Read more about GMP requirements for medical gases.
The International Council for Harmonisation ICH Q4B - Harmonisation of pharmacopoeial chapters on Sterility Test with step 5 has now been finalized.
The FDA issued a Q&A document correlated to the final rule on Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use.
In July the FDA published the revised version of BAM: Bacteriological Analytical Manual Chapter 23 Microbiological Methods for Cosmetics.
The ECA Validation Group was established with the goal to gather knowledge on validation, for example by continuously developing a Process Validation Good Practice Guide. Find out more about what is new in the ECA Validation Group.
After the European Medicines Agency EMA in particular spoke out on the possible future of the trade with medicinal products on European Union level, the British now provide some input - e.g.. about the role of the Qualified Person (QP). Read how the Britisch imagine the trade with medicinal products in the future.
After the change to the European Pharmacopoeia, it is possible to produce water for injection by other methods than distillation since April 1st 2017. The European Medicines Agency (EMA) published a Q&A draft document in 2016 as an additional guideline. These Questions & Answers on WFI have now been published in its final version.
The FDA is proposing a more restrictive expiration dating for unit-dose repackaged solid oral dosage forms. Read more about FDA´s draft guidance Expiration Dating of Unit-Dose Repackaged Solid Oral Dosage Form Drug Products.
The ICH E19 Concept Paper and Business Plan have been released. Read more about the E19 Concept Paper on Optimization of Safety Data Collection.
The European Medicines Agency (EMA) recently published a collaborative clinical trials approach together with the FDA for rare paediatric diseases. Read more about the joint proposal "Paediatric Gaucher disease - A strategic collaborative approch from EMA and FDA".