Quality Systems

Articles

CMA fines Advanz and investors for more than £100 million (approximately US$139 million) after the company increased the price of thyroid tablet packs from £20 (US$23.74) in 2009 to £248 (approximately US$295) in 2017.

CMA Fines Advanz for Over-Pricing Liothyronine Tablets

FDA approved an expanded Botox label, which now includes eight new muscles to treat adults with upper limb spasticity.

FDA Approves Expanded Label of Allergan’s Botox to Treat Upper Limb Spasticity

FDA has approved AstraZeneca’s Saphnelo, a type I interferon receptor antibody for treating systemic lupus erythematosus.

FDA Approves AstraZeneca’s Lupus mAb, Saphnelo

FDA has accepted Genetech’s BLA for faricimab, a bispecific antibody in development for treating wet age-related macular degeneration and diabetic macular edema.

FDA Accepts Genentech’s Application for Bispecific Antibody to Treat Eye Diseases 

The European Commission has entered into a supply agreement with GlaxoSmithKline and Vir Biotechnology for up to 220,000 doses of sotrovimab, an investigational mAb for treating COVID-19.

EC Makes Supply Agreement with GSK and Vir Biotechnology for mAb COVID-19 Treatment

Richard J. Forsyth is principal consultant with Forsyth Pharmaceutical Consulting, 907 Shamrock Ct, Royersford, PA 19468, tel. 484.535.1688, forsythpharmaconsulting@gmail.com.

A robust selection of which product(s) and equipment to validate for cleaning is the cornerstone of a successful cleaning validation program. A strategy for selection of products and equipment for cleaning validation is presented.

Grouping Products and Equipment for a Worst-Case Cleaning Validation Study

An effective data structure and simple communication between production, logistics, and sales are essential for delivering this level of accountability, traceability, and security.

Serialization: Reducing Counterfeit Drugs and Increasing Sales

Felicity Thomas is the former Associate Editorial Director of Pharmaceutical Technology, Pharmaceutical Technology Europe, BioPharm International.

Pharma and biotech supply chain companies are working together to help facilitate the transition of the pharma industry to net zero emissions compliance.

Working Towards Zero Emissions

The expanded authorization from FDA enables the use of Regeneron Pharmaceuticals’ REGEN-COV antibody cocktail therapy for post-exposure prophylaxis in certain people exposed to SARS-CoV-2.

Regeneron Receives Expanded Authorized Use from FDA for Antibody COVID-19 Treatment

FDA has approved Mylan Pharmaceuticals’ Semglee, the first interchangeable biosimilar insulin product for treating diabetes.

Regulatory Oversight and Compliance