Blog Post
Annex 21 – Are we on track and is there an impact?
Annex 21 went into effect on August 21, 2022. It’s time to check that processes and procedures have not fallen short of the actual requirements...
Read More
Blog Post
Reflecting Again on GMP Requirements for Marketing Authorization Holder
In July 2021, the European Medicines Agency (EMA) published their reflection paper entitled “Good Manufacturing Practice (GMP ) and the Marketing Authorisation Holder (MAH)”. This...
Read More
Blog Post
Compliance: Framing Success Utilizing PIC/S and EU GMP
Introduction PIC/S was founded in 1995 as an extension of PIC (Pharmaceutical Inspection Convention). They are a non-binding cooperative arrangement between 56 different Regulatory Authorities....
Read More