The leading journal for specialists and managers in pharmaceutical manufacturing and quality assurance
03.11.2022
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
How will distant assessments be able to complement on-site audits? Please read more here
Read more … The Present and Future of Remote Audits
In-depth Questions and Answers on Biopharmaceutical Manufacturing. Please read more here
Read more … Q&A from European GMP Conference: "Bioburden - Regulatory Expectations and Practical Experiences"
An analysis of the Warning Letters of Fiscal Year 2021 and of the last 5 years. Please read more here
Read more … The FDA Warning Letter Report 2021
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