The management of pharmaceutical products,
Pharmaceutical products in South Africa is regulated by the South African Health Products Regulatory Authority (SAHPRA) under the Medicines and Related Substances Act (Act 101/ 1965). This act, among other things, ensures that all medicines are safe before they are placed on the market. The SAHPRA has published two different categories of guidelines, namely the Good Manufacturing Practice Guidelines for Pharmaceuticals (GMP) and the Guide to Specifications and Test Methods for Pharmaceutical Substances and Medicinal Products. The GMP guideline is a quality system that defines the minimum requirements necessary to produce a quality product, while the Guide to Specifications and Test Methods provides specific guidance on test methods and specifications that need to be used during the development of pharmaceutical products.
Requirement for the registration of pharmaceutical products
Environmental testing is a key requirement for the registration of pharmaceutical products and provides information on the physical and chemical stability of the product under the influence of various environmental factors. Environmental testing helps to predict the degradation of drug substances and can be used as part of an accelerated or full development process, especially in cases where there is no history of what happened to the compound when exposed to certain stress factors such as light, heat or moisture. These tests are usually conducted in a laboratory setting, but can also be performed under accelerated conditions to save time. Environmental chambers are an essential tool for studying these conditions and LabSPACE Africa’s climatic chambers will enable our clients to make better decisions about product commercialization at an earlier stage in development.\
Why is environmental stability testing required by the regulatory authority?
Environmental stability testing is often required by the regulatory authority, such as SAHPRA, to demonstrate that a product will remain within its specifications when stored under different environmental conditions. The results of these tests may also be used as a marketing tool to demonstrate product stability. Pharmaceutical products may also require certain testing if they are to be stored under specific conditions, such as refrigeration or operating theatres. The need for environmental testing should therefore be determined by the end-user of the product.
Environmental testing can include accelerated and real-time testing depending on how much time is available, the predicted environmental conditions required and what accuracy is needed.
The purpose of this article is therefore to provide a brief overview of environmental testing in South Africa for pharmaceutical products.
Tightening up on prescribing guidelines for complementary medicines.
SAHPRA, the South African Health Product Regulatory Authority, announced recently it will tighten up on prescribing guidelines for complementary medicines. Complementary medicines are not tested for their environmental stability before being allowed to be sold. SAHPRA wants all essential oils, herbal remedies and dietary supplements used in complementary medicines to be tested for stability. SAHPRA also wants manufacturers of these products to label them with key details on how best to store the product. SAHPRA said that most Western countries have strict regulations on complementary medicines, but SA had none. SAHPRA said that some of the herbal remedies on sale in SA could be less than three months old, while manufacturers say they are up to twelve years old. SAHPRA director-general Precious Matsoso explained SAHPRA’s reasons for tightening up on regulation on these products: “The problem is that SAHPRA lacks the capacity to test all medicines on the SA market. Unregistered medicines… can be dangerous because manufacturers do not have to meet stringent requirements before their products are allowed onto SA markets.”
What are Climatic chambers?
Climatic chambers are high-tech laboratory instruments that test the reaction of different product specimens to specific environmental conditions, like temperature and humidity. At SAHPRA’s request, SA pharmacies now have to display information on how SAHPRA regulates complementary medicines to the SA public. SAHPRA said that current SA laws mean that anyone can make up and sell herbal medicines, but SAHPRA wants SA public informed of the risks related to these products. SAHPRA specifically want information on how complementary medicines should be labelled, stored and dispensed to SA consumers.
LabSPACE Africa is a unique lab space sharing facility, where small and medium sized companies can access state-of-the art research facilities to develop their products from concept to market. LabSPACE Africa recently acquired three 2300 liter FDM climatic Chambers, some of the largest freestanding units available. These environmentally controlled chambers allow LabSPACE Africa to perform environmental stability studies on drug substances, as well as assist clients with the development of pharmaceutical product processes.
The climatic chambers are fitted with a fully automated climate system, which includes air-lock door to create a completely environmentally controlled environment. The chambers were installed at our Midrand facilities and LabSPACE Africa will offer this service to its clients, including monitoring of stability using HPLC, LC-MS/MS and FTIR from 2022.