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Compendial testing

Proving compliance of your materials with pharmacopeia and international standards
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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.

SCHOTT Pharma’s non-conformity and compendial testing ensures the observation of strict materials regulations.

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.

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All material types – Our comprehensive testing services enable you to bundle all your compendial confirmations together.

Fully accredited – We are DIN EN ISO/IEC 17025-accredited and FDA-registered to guarantee the acceptability of your study results by regulatory authorities.

Global presence – With laboratories in North America and Europe, our experts are always close and able to provide fast response during business hours.

Best practices in compendial testing

In the white paper “Trust but Verify: the Importance of Packaging Compendial Testing” SCHOTT Pharma experts explain how to secure the supply chain for parenteral drugs.

SCHOTT Pharma’s “Trust but Verify: the Importance of Packaging Compendial Testing” whitepaper

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.

1. Get in touch

Tell us about your current needs using the contact form below, or phone us directly (see number in contact information below).

2. Receive a study proposal

Based on your information, our scientific experts will advise you and create a customized study proposal that conforms to the latest regulatory guidelines.

3. Quotation and sample requirements

Based on your feedback, we will provide a quotation, comprising a detailed study protocol and instructions for sample selection, packaging, and submission.

4. Sample submission

You then send the samples to our laboratories with a completed submission form, proforma invoice and material safety data sheet.

Get in touch

Dr. Matthias Bicker

Dr. Matthias Bicker

Scientific Advisor Pharma Services

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