Publishing of 21 CFR Part - Current Good Manufacturing Practice for Finished Pharmaceuticals established requirements concerning the expiration date on a drug product and stability testing to assure the appropriateness of that date. Each drug product may be a unique article because of, for instance, differences in 1 chemical and physical properties of the active ingredients or the excipients, 2 manufacturing procedures, 3 formulations, 4 containers and closures, 5 proposed storage conditions, and 6 the stability of the article to maintain its quality or purity through the use of antioxidants or preservatives. Because of the uniqueness of each drug product, it is virtually impossible to provide one set of rules that can apply to all situations. The CGMPs were purposely written broadly to allow for such unique differences. The absence of an expiration date on any drug product packaged after September 29, , except for those drugs specifically exempt by OTC drug products meeting the exemption of
Stability Testing for Cosmetics Shelf Life - Parameter
While it is generally good manufacturing practice, the U. Food and Drug Administration FDA does not yet require cosmetic manufacturers to conduct stability testing on products before commercially marketing them. Such information can prove useful to companies both externally and internally; externally in terms of creating successful products, and internally in terms of product development, material procurement and management, and lifecycle management. This paper provides an overview of the basics manufacturers should consider when developing a stability testing protocol for cosmetic products. As is well-known, stability testing essentially is an experiment in which a batch of formula is created and placed into different environmental conditions for a set period of time. These conditions vary in temperature and humidity and are meant to simulate what happens to the product during its life cycle. In the pharmaceuticals field, both the FDA and the European Medicines Agency require the stability testing of products before they can be sold to consumers.
Designing and Sustaining New and Existing Product Stability Testing Program
A similar statement is made for API. As discussed in previous sections, confirmation that batches continually conform to the stability related material attributes should be an acceptable scientific justification to negate the need to do further routine including annual stability studies. As an example, Table 2 contains a summary of the stability studies outlined in the FDA guideline for scale-up and post-approval changes for immediate release solid oral dosage forms . The FDA guidelines on post-approval changes are essentially pragmatic risk management matrices classifying the risks associated with changes in a way to give a simple common position for all products in the absence of any specific data. For example, a change in mixing times may have no effect at all on any of the stability related material attributes but a batch would be placed on long-term stability regardless.
Understandably, the FDA and other regulatory agencies require this data as part of a registration application for the drug substance or product. Usually, pharmaceutical companies begin stability studies during clinical trials and manufacturing and some even continue these studies after gaining approval. Pharmaceutical companies arrive at optimum storage conditions and the expiration date of a drug substance or drug product which can be seen commonly on drug labels after collecting stability data over months to years. This data includes the effects of environmental conditions which can significantly alter the physicochemical characteristics, biological activity and other attributes of the drug substance or product. Stability studies are performed for medical devices and raw materials as well.