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- All > Quality and Safety: Medicines > The International Pharmacopoeia
- Keywords > adverse drug reactions (ADRs)
- Keywords > efficacy
- Keywords > International Nonproprietary Names (INN)
- Keywords > International Pharmacopoeia (The)
- Keywords > Paediatric medicines Regulators Network (PmRN)
- Keywords > Prequalification of Medicines Programme - WHO
- Keywords > quality assurance
- Keywords > regulatory authority - medicines
- Keywords > safety
- Keywords > autorités de réglementation pharmaceutique
(2011; 122 pages)
The opening section for the number three issue of 2011 focuses on several important aspects of quality assurance. Recovery of solvents in API manufacturing describes the practice of recovering and using solvents in the pharmaceutical industry and implications for the quality of finished pharmaceutical products. Latest developments and collective provisions are presented based on experience gained during activities related to the WHO Prequalification of Medicines Programme. A survey conducted in six WHO Member States aimed at identifying possible quality problems in medicines provides a basis for the following article Chewable tablets: time to reassess a ‘neglected’ dosage form? The section is completed with summaries of the latest Pharmacopoeial Discussion Group meeting and the 45th report of the Expert Committee on Specifications for Pharmaceutical Preparations.
A feature article entitled Ensuring quality medicines: a decade of prequalification is proposed by A. J. van Zyl, first Programme Manager for the WHO Prequalification of Medicines Programme. The following section on Regulatory Support provides an overview of progress made by the Paediatric Medicines Regulatory Network.
The section on Safety and Efficacy highlights information on signals and reports of adverse drug reactions, with other news from around the world, including labelling changes. This is complemented by the section on Regulatory Action and News which provides the most recent developments from regulatory authorities, and particularly those having an impact on decision-making and risk assessment.
Consultation documents concerning the International Pharmacopoeia cover revision of General Methods in the 4th Edition: Microbial purity of pharmaceutical preparations; Microbiological examination of non-sterile products; Disintegration test for tablets and capsules; Extractable volume of parenteral preparations; Tests for particulate contamination, and Sulfated ash. This is followed by revised monographs for pyrantel embonate chewable tablets and pyrantel embonate oral suspension.
The journal concludes with the 66th Recommended List of International Nonproprietary Names (INN).