Know The Rules And Regulations That Can Govern RTP Usage
The goal of regulatory agencies that govern the manufacture of life science products around the world is to provide guidance and direction that enables the development of manufacturing practices that result in optimized product quality, improved safety and the avoidance of human errors. Admittedly, navigating the regulatory landscape can be intimidating and time-consuming, but ignoring or misinterpreting important regulations can have dire consequences for the operator, including excessive fines and, in the worse-case scenario, halting of the manufacturing operation. This makes intimate knowledge of, and adherence to, all relevant regulatory tenets a front-of-mind concern for all operators in the life science realm.
In the United States, the U.S. Food & Drug Administration (FDA) oversees the production of life science products. In this role, the FDA develops and disseminates Current Good Manufacturing Practices (CGMP), with those companies that fall out of compliance issued non-conformity notices that can result in the disallowance of finished pharmaceuticals from being sold to the public.
According to the FDA’s definition, CGMPs rely on systems that “assure proper design, monitoring, and control of manufacturing processes and facilities.” With that in mind, adherence to CGMP regulations will help “assure the identity, strength, quality and purity of drug products by requiring that manufacturers of medications adequately control manufacturing operations.” If adequately put into practice, this system of controls will “help prevent instances of contamination, mix-ups, deviations, failures and errors,” in the process assuring that all finished life science products meet their established quality standards.
Specifically, it is Title 21 of the Code of Federal Regulations (CFR), which interprets the Federal Food, Drug and Cosmetic Act, that is the foundation for the FDA’s CGMPs for life science-product manufacturing. The regulations that contain the requirements to be followed by drug manufacturers, applicants and the FDA include:
- 21 CFR Part 314: FDA approval to market a new drug
- 21 CFR Part 210: CGMP for manufacturing, processing, packaging or holding drugs
- 21 CFR Part 211: CGMP for finished pharmaceuticals
- 21 CFR Part 212: CGMP for positron-emission tomography drugs (those that help reveal the metabolic or biochemical function of human tissues and organs)
- 21 CFR Part 600: CGMP for general biological products
Non-conformity notices with any CGMPs are most commonly issued by the FDA for the following violations:
- Improper manufacturing methods
- Facilities that do not feature the proper manufacturing controls
- Unsafe or unsanitary processing methods
- Inadequate packaging
- Unclean or unsafe holding areas
The FDA is also very strict in developing and implementing new regulations in order to make sure that all CGMPs are followed, so that’s why the manufacturers of equipment and systems – such as Rapid Transfer Ports (RTPs) – that are used in the manufacture of life science products must work diligently to stay abreast of all current regulatory statutes.
Also, since the FDA is recognized around the world for its regulatory rules and strict dedication to enforcing compliance, many countries accept and enact FDA rules as their own, which can ease the burden on manufacturers of life science transfer systems to produce products that are regulatorily compliant around the globe.
Equipment manufacturers and operators within the life sciences must also be aware that many regulatory rules undergo a regular series of reviews and revisions. For instance, in 2022, the European Union completed a revision of its CGMP Annex 1, which governs the “Manufacture of Sterile Medicinal Products.” This revision includes new requirements, as well as additional detail related to many of the requirements that were included in the previous version of Annex 1, which was released in 2008. Therefore, it is imperative that the manufacturers and users of RTP systems be in tune with the latest regulatory rules and requirements, no matter in which country they operate.
To this end, CRL has designed its RTP technologies to be compliant with the latest regulatory edicts. CRL also works directly with its customers to identify the best solutions, from standard RTP product offerings to customized development, that can help ensure the creation of the best outcome possible when considering the safe and confident manufacture and handling of life science products.
