By Robert McGregor, Brookfield Engineering Laboratories, Inc.
How do you bring consistency to QC testing? Pharmaceutical products that meet manufacturability criteria and provide high level consumer satisfaction undergo a battery of tests before being distributed to the consumer. Using affordable instrumentation to perform QC tests, which certify that tablets, capsules, elixirs, ointments, etc. have the right physical properties, is essential for today’s successful business.
Major corporations willingly invest in devices used to test physical properties, such as viscosity of liquids and semi-solids, texture of tablets and capsules, use of syringes for injectable liquids, and flowability of powders. If unfamiliar with the methodology, they contact potential suppliers for help. Can smaller companies expect similar attention from vendors? How expensive is the outlay to bring these test methods in house? Or is it better to use contract labs?
Acceptance and implementation of QC test methodology is an R&D responsibility. In smaller companies, QC and R&D may be one and the same. It’s important to make sure that QC has a clear understanding of how the method works, the relevance of the data, and when to question the results.