SQA Regulatory Surveillance Summary | October 2020
By Laurel Hacche and Debra Cortner, SQA Associates ANVISA (Agência Nacional de Vigilância Sanitária) There were no updates for ANVISA for October 2020. http://antigo.anvisa.gov.br/updates China Guidances and Regulations Regulation of Pharmaceutical Production will be Stricter with the Cancellation of Good Manufacturing Practice (GMP) Certification in China, CPhI & P-MEC China, 26 October 2020 The Amendment […]
SQA Regulatory Surveillance Summary | September 2020
By Laurel Hacche and Debra Cortner, SQA Associates Eudralex – Volume 4 – Good Manufacturing Practice (GMP) Guidelines and Annexes There were no updates noted for Eudralex – Volume 4 – GMP Guidelines and Annexes for September 2020. https://ec.europa.eu/health/documents/eudralex/vol-4_en European Federation for Cosmetic Ingredients (EFfCI) There were no updates noted for EFfCI for September 2020. […]
SQA News | Summer 2020
Wins & Challenges In SQA’s 25 years, we’ve never seen the changes and challenges like those we’ve been through since the last newsletter. Like most businesses, we’ve had our share of struggles and wins, but to stay on the right side of the equation, we’ve had to pivot in several key areas along the way. […]
SQA Regulatory Surveillance Summary | August 2020
By Laurel Hacche and Debra Cortner, SQA Associates European Pharmacopoeia (Ph. Eur.) Recombinant Factor C: New Ph. Eur. Chapter, 01 July 2020 Published in Ph. Eur. Supplement 10.3, the new general chapter 2.6.32., “Test for bacterial endotoxins using recombinant factor C,” describes a test for bacterial endotoxins (BET) that can be used as an alternative to the […]
SQA Mini Series Episode 4
You Won’t Believe What We’ve Seen: Beauty Secrets By Sarah Barnes-Humphrey I’m so sad to say that this is the final episode in our ‘You Won’t Believe What We’ve Seen’ mini-series, in partnership with SQA services. But over the course of these four episodes we’ve had a blast! We’ve chatted to some inspirational people, learned a […]
SQA Mini Series Episode 3
You Won’t Believe What We’ve Seen: High Stakes By Sarah Barnes-Humphrey We’re back with Episode 3 of our ‘You Won’t Believe What We’ve Seen’ mini-series, in partnership with SQA services, and I’m sure you’re enjoying it just as much as I am. In last week’s episode ‘Saving Lives’, we were joined by SQA founder and President […]
SQA Mini Series Episode 2
You Won’t Believe What We’ve Seen: Saving Lives By Sarah Barnes-Humphrey I hope you’re enjoying our fascinating ‘You Won’t Believe What We’ve Seen’ mini-series, in partnership with SQA services. In last week’s episode ‘Mission Control’ (insert link), we talked to SQA founder and President Mike McKay, and industry professional and advisor to SQA Jeff Luckey, […]
SQA Mini Series Episode 1
You Won’t Believe What We Have Seen: Mission Control By Sarah Barnes-Humphrey I’m incredibly excited to bring you a brand new 4-part series, in partnership with SQA Services. SQA Services has over 25 years’ experience and is now widely recognized as a flexible global resource and a proven solution provider for today’s complex supply environments. […]
SQA Regulatory Surveillance Summary | July 2020
By Laurel Hacche and Debra Cortner, SQA Associates European Medicines Agenda (EMA) Parenteral Drug Association (PDA) News – EMA: Final Assessment Report on Nitrosamines, 22 July 2020 The Committee for Medicinal Products for Human Use (CHMP) of the EMA published a final assessment report on nitrosamine impurities on 25 June 2020. The report calls on […]
SQA Regulatory Surveillance Summary | June 2020
By Laurel Hacche and Debra Cortner, SQA Associates United States Food and Drug Administration (US FDA) Guidances Patient-Focused Drug Development: Collecting Comprehensive and Representative Input, June 2020 US FDA is publishing a series of guidances (a total of four) intended to facilitate the advancement and use of systematic approaches to collect and use robust and […]