Assessment of climate for complementary medicine

Under the provisions of the Medicines and Related Substances Act (Act 101/ 1965), the South African Health Products Regulatory Authority (SAHPRA) is in charge of overseeing the administration of pharmaceutical products in South Africa. This law makes sure that all medications are secure before they are released onto the market, among other reasons. The Good Manufacturing Practice Guidelines for Pharmaceuticals (GMP) and the Guide to Specifications and Test Methods for Pharmaceutical Substances and Medicinal Products are two different categories of guidelines that the SAHPRA has issued. The Guide to Specifications and Test Methods offers detailed guidance on the test procedures and specifications that must be used during the development of pharmaceutical products, while the GMP guideline is a quality system that establishes the minimal requirements necessary to produce a quality product.

Environmental testing, a crucial prerequisite for pharmaceutical product registration, gives details on the product's physical and chemical stability under the influence of several environmental conditions. Environmental testing can be utilised as part of an accelerated or full development process and aids in the prediction of pharmacological ingredient degradation, particularly when there is no prior record of what occurred to the compound when exposed to certain stress elements like light, heat, or moisture. These tests can be carried out more quickly under expedited conditions, albeit they are typically carried out in a laboratory setting. LabSPACE Africa's climatic chambers will help our clients make better judgments about product commercialization at an earlier stage in development because environmental chambers are a crucial instrument for researching these circumstances.

The regulatory body, like SAHPRA, frequently demands environmental stability testing to show that a product will stay within its standards when stored under various environmental circumstances. The outcomes of these tests may also be utilised as a marketing tool to show the stability of the product. If pharmaceutical products are going to be kept in a refrigerator or an operating room, for example, they might also need to undergo some testing. Therefore, the product's final user should decide whether environmental testing is necessary.

Depending on the amount of time available, the anticipated environmental conditions needed, and the level of precision necessary, environmental testing may involve expedited and real-time testing.

Therefore, the goal of this paper is to give a quick summary of environmental testing for pharmaceutical products in South Africa.

The South African Health Product Regulatory Authority, or SAHPRA, recently said that it would tighten the rules for prescription alternative medicines. Before being approved for sale, complementary medicines are not examined for environmental stability. All nutritional supplements, herbal remedies, and essential oils used in supplementary medicines must undergo stability testing, according to SAHPRA. Additionally, SAHPRA requests that producers label their goods with important information on the best ways to store them. According to SAHPRA, the majority of Western nations have stringent laws governing supplementary medicines, but SA does not. Even though their producers claim they are up to twelve years old, SAHPRA stated that some of the herbal treatments sold in SA may be as little as three months old. Precious Matsoso, director-general of SAHPRA, outlined the organization's justifications for tightening these items' regulations: "The issue is that SAHPRA is unable to evaluate every drug available on the local market. Unregistered medications... can be hazardous because producers are not required to adhere to strict standards before releasing their goods onto SA markets."

Climatic chambers are sophisticated laboratory apparatuses used to examine how various product specimens respond to various environmental factors, such as temperature and humidity. SA pharmacists are now required by SAHPRA to notify the public about how SAHPRA controls supplemental medications. According to SAHPRA, anyone can create and sell herbal remedies under the country's current regulations, but the organisation wants the public to be aware of the dangers associated with these products. Information on the proper labelling, storage, and distribution of supplemental medications to South African patients is expressly requested by SAHPRA.

Small and medium-sized businesses can access cutting-edge research facilities at LabSPACE Africa, a one-of-a-kind lab space sharing facility, to develop their goods from concept to market. Three 2300 litre FDM Climate Chambers, among the largest freestanding models on the market, were recently purchased by LabSPACE Africa. LabSPACE Africa can do environmental stability studies on pharmacological compounds in these climate-controlled chambers, and it can also help clients establish pharmaceutical product development workflows.

The climate chambers are equipped with an air-lock door and a fully automated temperature system that creates an entirely controlled environment. The Chambers were installed in our Midrand facility, and starting in 2022, LabSPACE Africa will provide this service to its clients, along with stability monitoring using HPLC, LC-MS/MS, and FTIR.