Industry News
FDA is hosting a 3-hour webinar on Electronic Submission of Adverse Event Reports to FDA Adverse Event Reporting System (FAERS) using International Council for Harmonisation (ICH) E2B(R3) Standards on November 7, 2023. The purpose is to provide the pharmaceutical industry…
Read More
FDA is hosting a webinar on Electronic Systems, Electronic Record, and Electronic Signatures on April 25, 2023. This is your opportunity to get information on FDA’s thinking regarding 21 CFR Part 11 and its application to electronic systems, records and…
Read More
FDA has published Guidance “Q13 Continuous Manufacturing of Drug Substances and Drug Products“ on 1 March 2023 for Industry. The guidance describes scientific and regulatory considerations for the development, implementation, operation, and lifecycle management of continuous manufacturing (CM). Building on…
Read More
ICH has published a Revised Guideline on Quality Risk Management Q9(R1) on 18 January 2023. GMP Consultants can provide you with a word by word comparison of the 2005 vs 2023 documents. If you would like to purchase a copy…
Read More
FDA has published a revised version of the Guidance on “Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production“ on 16 May 2022. GMP Consultants can provide you with a word by word comparison of the 2006 vs 2022 documents. If…
Read More