Testing is based on international pharmacopeia and customer methods. The Pharmaceutical Chemistry department has a license to act as “Testing Laboratory” in terms of Section 22c (1)(b) of the Medicines and Related Substance Act, 1965. As an MCC GMP licence holder, it complies with the guidelines outlined in the Guide to Good Manufacturing Practice for Medicines in South Africa (SA Guide to GMP). The department is also ISO 17025 accredited.
The Pharmaceutical Chemistry department also tests medical devices for quality control and tender purposes, as well as alcohol content in sanitisers. The medical devices are tested according to SANS specification.
Assay
Identification
Uniformity of content
Hardness test
Disintegration tests
Purity tests
Loss on drying
Water determination by Karl Fisher
Density
pH
