The leading journal for specialists and managers in pharmaceutical manufacturing and quality assurance
16.02.2023
Read more … Pharma Congress 2022
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
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