EU GMP Annex 1 Compliance: Global Requirements & PIC/S Alignment
The 2023 revision of EU GMP Annex 1 reset the global standard for sterile manufacturing. It expands the guidance, tightens contamination-control expectations and aligns requirements...
Read MoreAddressing the Biotech Workforce Shortage: CAI’s Role in Strengthening Industry Talent
A critical challenge persists in today’s biotech and pharmaceutical industries: the shortage of a skilled workforce. For innovation in biotechnology to thrive, there must be...
Read MoreLESSONS LEARNED FROM IMPLEMENTING THE FDA’s CSA GUIDANCE: PART 3 –SUMMARIZING
This is the last installment of a three-article series that presents several lessons learned by our validation team while completing a pair of validation projects...
Read MorePlanning for a Talented Workforce: Building a Staffing Plan for New or Expanding GMP Facilities
Let’s contrast two very real scenarios: You are responsible for bringing a new GMP facility or line to full-scale production. Your board or shareholders expect...
Read MoreAnnex 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 MoreLESSONS LEARNED FROM IMPLEMENTING THE FDA’s CSA GUIDANCE: PART 2– EXECUTING
This is the second in a series of three articles that present lessons that our validation team learned while completing a pair of validation projects...
Read MoreLESSONS LEARNED FROM IMPLEMENTING THE FDA’s CSA GUIDANCE: PART 1 – PLANNING
After several years of conversation with drug manufacturers and consultants about the state of computer system validation, the FDA issued a draft of the Computer...
Read MoreReflecting 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...
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