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… read more →
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… read more →
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… read more →
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… read more →
By Laurel Hacche and Debra Cortner, SQA Associates Health Canada Regulations and Guidances Health Canada Announces Another Step to Accelerate Access to Health Products for COVID-19, 27 May 2020 The… read more →
By Laurel Hacche and Debra Cortner, SQA Associates United States Food and Drug Administration (US FDA) Guidances Biological Product Deviation Reporting for Blood and Plasma Establishments, March 2020 The US… read more →
By Laurel Hacche and Debra Cortner, SQA Associates Personal Care Products Council Personal Care Products Council (PCPC) COVID-19 Summary, 20 March 2020 In an effort to comply with health authorities’… read more →
By Laurel Hacche and Debra Cortner, SQA Associates United States Food and Drug Administration (US FDA) Guidances Current Good Manufacturing Practice – Guidance for Human Drug Compounding Outsourcing Facilities Under… read more →
By Laurel Hacche and Debra Cortner, SQA Associates Health Canada Regulations/Guidances Regulation of Vaping Products in Canada, December 2019 On 19 December 2019, Health Canada announced the final “Vaping Products Labelling… read more →