The leading journal for specialists and managers in pharmaceutical manufacturing and quality assurance
03.11.2022
Nine experts from the pharmaceutical industry and regulatory authorities answer frequently asked questions on cloud computing. Please read more here
Read more … Questions and Answers to Cloud Computing in a GxP Environment
Speaker Robert G. Schwarz answers frequently asked questions about cleaning validation. Please read more here
Read more … Questions and Answers about Cleaning Validation - Part 1
A look back at the ICH Q7 Week in November 2021. Please read more here
Read more … GMP for APIs - Live Online ICH Q7 Training Week - Interviews
Regulatory requirements, sample drawing and prerequisites for reduced sampling. Please read more here
Read more … Questions and Answers on (Reduced) Sampling
Consideration of some relevant points of the final version. Please read more here
Read more … Annex 1 Revision
26.10.2022
There are no specific regulatory requirements for what constitutes as good equipment design. The new ECA GMP Equipment Design Guide provides guidance. Please read more here
Read more … GMP-compliant equipment design: The GMP Equipment Design Guide
This article provides insight into the collection, assessment and application of data. Please read more here
Read more … Data flows, Data Lifecycle, and ALCOA+
25.10.2022
How can the two hot topics of cross-contamination and sustainability in pharmaceutical operations be balanced out? Please read more here
Read more … Cross-contamination and Sustainability: The Trouble with Contamination
How does the new Annex 21 to Eudralex Vol. 4 influence fiscal importation? Please read more here
Read more … Developments on GMP Classification of Fiscal Imports
29.07.2022
A summary of the last APIC/Cefic Global GMP & Regulatory API Conference, which took place inOctober 2021. Please read more here
Read more … Highlights of the 24th Active Pharmaceutical Ingredients Conference of APIC
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