European Pharmaceutical Review

OCTOBER 12, 2023

September 2023 saw a wave of new pharmaceutical manufacturing facility expansions and launches across Europe. Research by the Confederation of British Industry (CBI) , released in September this year, highlighted progress for UK manufacturing in its latest Industrial Trends Survey.

Pharmaceutical Manufacturing 104

Pharmaceutical Manufacturing Vaccines Dosage Pharmaceutical Companies 104

FDA Law Blog: Biosimilars

APRIL 16, 2024

Gaulkin — On April 10, the Fourth Circuit unanimously affirmed a summary judgment ruling for the Centers for Medicare & Medicaid Services (CMS) regarding the agency’s definitions of “line-extension drug” and “new formulation” for purposes of determining rebates that drug manufacturers may owe the Medicaid Drug Rebate Program (MDRP).

Dosage 57

Dosage Drug Pricing Pharmaceutical Manufacturing 57

Quality Matters

SEPTEMBER 15, 2023

PCM not ideal for every drug Continuous manufacturing “may not be fit for every pharmaceutical manufacturing process, but it can bring some advantages in some cases” compared with traditional batch manufacturing, summarized FDA’s Adam Fisher, Ph.D., kristine.gates… Fri, 09/15/2023 - 11:57 Supply Chain

Pharmaceutical Manufacturing 52

Pharmaceutical Manufacturing Pharmaceutical Companies Pharmaceutical Companies Dosage 52

European Pharmaceutical Review

APRIL 9, 2024

Delpharm has acquired the Meppel pharmaceutical manufacturing facility in the Netherlands from Astellas. The 31,600 square meter facility produces some 40 million finished solid dosage forms each year, including tablets, capsules and pellets. The company employs more than 6,500 people, generating revenues of €1.1

Pharmaceutical Manufacturing 98

Pharmaceutical Manufacturing Dosage Drug Development 98

Quality Matters

MAY 17, 2023

Paradigm Shift in Drug Development: Analytical Quality by Design and Analytical Procedure Life Cycle In today’s pharmaceutical manufacturing environment, companies face increasing pressure to respond to changing demands across the global medicines supply chain while still maintaining the quality of their drug products.

Drug Development 52

Drug Development Dosage Pharmaceutical Manufacturing 52

GMPSOP

SEPTEMBER 27, 2023

Cleaning validation protocol for pharmaceutical industry Pharmaceuticals quality assurance & validation procedures GMPSOP Cleaning validation protocol for pharmaceutical industry Last Updated on September 28, 2023 by Kazi Prev PREVIOUS POST Table of Contents What is cleaning validation in pharmaceutical industry?

Method Validation 98

Method Validation Documentation Pharmaceutical Manufacturing Dosage 98

GMPSOP

OCTOBER 28, 2023

Quality is everyone’s responsibility, and it should pervade every aspect of pharmaceutical manufacture and packaging. Quality should not be tested into products; instead, it must be built in at each step of manufacture. Pharmaceutical manufacturers must integrate the key functions of the quality control process.

Documentation 52

Documentation Method Validation Packaging Data Entry 52