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).