Medicines and supplements are primarily developed to help restore human health and well-being. Healing is the central tenet of the pharmaceutical industry, as evidenced by the $100 billion spent annually on research and development.
However, if products of questionable quality and reliability get to market there is substantial risk of harm to end users.
Pharmaceutical companies must be diligent in maintaining a manufacturing supply chain of proven, trusted partners — especially when outsourcing pharmaceutical toll processing. Each ingredient metric and handling touchpoint is critical in preventing potentially dangerous vulnerabilities.
While there are many toll processing facilities, only a select number can protect — and add value to — a pharma company’s supply chain. Here are 3 ways a toll processor’s product trials reveal how suited they are for performing this integral manufacturing step.
The Food and Drug Administration (FDA) oversees enforcement of quality standards pertaining to the manufacture of pharmaceutical products. Collectively, the principles and procedures the FDA follows are referred to as Current Good Manufacturing Practices (cGMP).
Toll processors carrying cGMP certification are compelled to ensure pharmaceutical applications are unerringly safe for human use and consumption. cGMP compliance occurs on multiple levels:
This brief list illustrates the importance of cGMP, and how it governs all aspects of pharmaceutical toll processing including product trials and validation testing.
Toll processors engaging with pharmaceutical applications are pivotal in validation testing. cGMP product trials guide the process in a clean room environment, focusing on two key areas:
Not all situations require that both validation tests be performed. For example, product repacks may only need cleaning validation. Excipients, on the other hand, are often trailed exclusively for product specifications.
Passing these product trials to cGMP standards gives pharmaceutical companies confidence in their toll processing partners’ capabilities in the pharma space.
Product trials performed by toll processors provide invaluable information to pharma companies as to the performance and composition of a product. The testing usually varies depending on the material and end product, making it impossible to take one standard approach to product trials.
An experienced toll processor understands the need to remain responsive and nimble during these critical phases of discovery. CPS has created an in-house infrastructure of product trial testing capabilities that negates the need for outsourcing results for further evaluation, including:
This unique setup gives CPS flexibility in providing customers with the custom solutions for even the most complex product trials and pharmaceutical toll processing.
There is no such thing as being too careful when choosing partners to help get safe, high-quality medicines and supplements to market. Strategic selection takes time, exploration, and tools like the Toll Processor Evaluation Checklist. Click the button below to download your copy of this valuable resource now.