Drug Batch Testing

Each batch of OTC drug products must be approved by the manufacturer’s/drug owner’s Quality Unit prior to its release for distribution. Quality Unit approvals are based upon certain verifications.

These verifications require that the batch was manufactured, packaged, sampled, tested, labeled and documented in accordance with an approved Master Production and Control Record, pre-established specifications and in compliance with all applicable requirements of the Current Good Manufacturing Practices (cGMP) for Drugs as published in 21 CFR Parts 210 and 211. The Quality Unit’s verification that a batch is suitable for approval is achieved by conducting a thorough Batch Record Review of each of the above-described elements. 

Componentry Testing

Drug batch testing activities associated with OTC drug batches are conducted prior to the start of manufacturing, at various stages during the manufacturing process and after its completion. The testing process begins with Componentry Testing.

This is an assessment of all “components” of which the batch will be comprised (raw materials) and in which it will be contained (packaging materials such as the primary container and closure system).  Componentry Testing is conducted to confirm compliance with pre-established specifications prior to their use in drug products.  

In-Process Testing

In-Process Testing is conducted at various stages during the manufacturing process to ensure batch uniformity and integrity. In-Process Testing is conducted according to the approved Master Production and Control Record. The results must meet pre-established specifications and acceptance criteria. 

Bulk Product Testing or Finished Product Testing

At the completion of the manufacturing process, batches are tested prior to being packaged. Although the name for this type of drug batch testing may vary, it is most commonly referred to as Bulk Product Testing or Finished Product Testing. Once again, all test results must meet pre-established specifications in order to be considered for approval by the Quality Unit.  

Drug Batch Testing that is conducted in any of the categories outlined above may consist of physical testing (e.g., viscosity, specific gravity and particle size), chemical testing (e.g., drug assay, level of impurities and preservative assay), microbiological testing and dimensional testing (e.g., measurement of container physical features). All testing must be conducted in accordance with an approved Master Production and Control Record and pre-established specifications.

Batch Record Review

Once the manufacturing and packaging processes have been completed, all required testing has been conducted and all test results have been determined to meet pre-established specifications, the entire Batch Production and Control Record is assembled, reviewed and submitted to the Quality Unit for a final Batch Record Review.

For a drug batch to be released for distribution, the Quality Unit must be satisfied that it has been manufactured, packaged, sampled, tested, labeled and documented in accordance with pre-established specifications, the Master Production and Control Record and all applicable cGMP requirements. Failure to meet all requirements and acceptance criteria will result in the rejection of the batch. 

CPT^SM can perform all levels of Drug Batch Testing in an efficient, accurate and compliant manner, to assist you in ensuring that your product is suitable for release to distribution. We can even meet strict time constraints for completing In-Process and Bulk Product Testing, thus allowing you to package your drug batches as quickly as possible.

Contact us today so that together we can develop a Drug Batch Testing Plan that best suits your needs.