Custom Processing Services Blog

3 Ways Product Trials Add Value to Pharma Toll Processing

Willow Slusser, Mar 30, 2023 4:18:13 PM

Various Medicine Pills

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.

 1. Current Good Manufacturing Practices (cGMP) Compliance

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:

  • Ingredient/product identity, purity, strength, and composition are maintained throughout the process, from raw material to finished product
  • Testing equipment, technology, and software that are up-to-date and capable of verifying/documenting final product quality as well as supporting continuous improvement initiatives
  • Process and facility design, monitoring, and control that actively prevents quality deviations, contamination, product defects, and other potentially detrimental failures

This brief list illustrates the importance of cGMP, and how it governs all aspects of pharmaceutical toll processing including product trials and validation testing.

 2. Validation Testing & Documentation

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:

  • Cleaning Validation: Conducted before a pharma product arrives for processing, cleaning validation helps toll processors prove that the previous material run on their production lines is no longer present within the equipment, or that residual traces fall below a certain PPM threshold. This is accomplished by running small amounts of the new material through the machinery, and testing it accordingly. CPS triple-verifies the cleaning validation by running material through equipment three times prior to implementing a project
  • Product Specifications Validation: Toll processors are held to milling parameters dictated by the material to be milled. Settings span from the bottom to the top of the spec and are used to dial in the preferred target for a certain material. The material is then run at a parameter somewhere in between the low and high spec numbers. Anticipated milling outcomes must occur within the identified range to be considered valid

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.

 3. The “Custom” of Custom Toll Processing

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:

  • A dedicated analytical laboratory for food and pharmaceutical testing
  • Comprehensive HPLC testing
  • Advanced instrumentation for measuring optimal cleaning practices, additional processes required for individual projects, etc.

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.

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