Verifying material compliance and safety
Compendia, such as country-specific pharmacopeia and other international standards, define how materials must be tested to confirm their safe use in pharmaceutical products. For regulatory application and lifecycle surveillance, pharmaceutical companies are obliged to prove compliance with those regulations.
SCHOTT Pharma Services will execute compendial tests to confirm your material applicability, preparation of drug applications, and repetitive verification of supplied material batches.
Non-conformity and compendial testing by SCHOTT Pharma
Non-conformity and compendial tests focus on the materials in contact with the drug, ranging from the glass or polymer container to the elastomeric component, as well as needles and other materials such as the glue or lubricants used to complete the containment system. For all these different materials, the regulations define tests to address the specific risks associated with the storage life of the drug.
Compendial tests are typically described in a high level of detail in each national pharmacopeia, and are specific to the market where the product will be distributed. While the number of test methods that need to be established and kept in a validated state can quickly multiply when distributing drug products globally, compendial tests are infrequent and typically required just for the preparation of initial drug applications and annual re-verification. Consequently, outsourcing compendial testing to a third-party contract laboratory provides a convenient and efficient strategy for pharmaceutical companies.
Ready-to-run validated protocols for USP, EP, JP, and ChP
SCHOTT Pharma Services is ready-to-run your non-conformity and compendial tests on demand. We have validated protocols for all types of containment systems and contact materials that match the definitions set out in the US, European, Japanese, and Chinese pharmacopeias, as well as the most relevant international and national standards, such as ICH, ISO, ASTM, and YBB. Protocols for additional pharmacopeia can be added on request.
The advantage for pharmaceutical companies is that their containment solution materials are independently and effectively tested for each region, with compliance documentation provided by a trusted, FDA-registered, third-party laboratory.
Compendial testing: How to proceed
SCHOTT Pharma Services’ team of specialists offers support and advice about your pharmaceutical packaging challenge. We provide guidance and a complete process that will take you from initial request to effective solution.