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Pharmaceutical Excipient Audits

Good Manufacturing Practice (GMP) audits are critical for ensuring the quality of pharmaceutical excipients used in the manufacturing of medicinal products. These audits evaluate the compliance of excipient manufacturers with appropriate GMP requirements, which cover all aspects of production, from raw material procurement to final product distribution. The appropriate audit criteria need to be established in accordance with a formalized risk assessment as stated in EU Guidelines 2015/C 95/02. An excipient audit helps to ensure that these non-active ingredients meet stringent quality specifications and are free from contaminants.

Our Excipient Audit Service

Excipients for the manufacture of medicinal products are often used in other industries such as the food, cosmetic and chemical industry. The pharmaceutical industry, even though a smaller sector in terms of quantitative demand for excipients sets the most stringent requirements.

blue inspection body, accredited according to ISO 17020 for the performance of audits at pharmaceutical excipient manufacturers offer the following benefits to both clients and auditees:

• We verify that the excipients are manufactured in accordance with appropriate GMP requirements
• Adequate audit time for conducting the on-site audit ensured
• Audits support the verification of the purity and safety of the excipients used in the drug formulations
• Less resources required for risk-assessment for customers
• Less customer audits for excipient suppliers when organized as a shared audit
• All aspects of quality and safety covered
• Re-audits ensure appropriate GMP requirements are met

blue has extensive experience in the auditing of manufacturers of pharmaceutical excipients. Our professionally trained auditors are familiar with both the normative quality management systems (e.g. ISO 9001) and the GMP domain; hence, they are able to set the main goals of an excipient audit in a reasonable and risk-based manner.

GMP Audit Guidelines for Excipients

The Falsified Medicines Directive (Directive 2011/62/EU) stipulates that the holder of a manufacturing authorization for medicinal products may only use suitable excipients, which unequivocally meet the relevant GMP requirements for excipients. GMP requirements for excipients are stipulated in the Good Manufacturing Practices Guide by IPEC (The International Pharmaceutical Excipients Council) and PQG (Pharmaceutical Quality Group). This guideline, which is structurally based on the ISO 9001 standard, is universally recognized and provides a framework for conducting thorough audits. It encompasses the assessment of systems for quality control, personnel qualifications, cleanliness, equipment maintenance, and process validation. Additionally, the guideline emphasizes the importance of proper documentation and record-keeping, which facilitates traceability and accountability.

blue offers audits based on IPEC-PQG GMP guidelines and takes into account additional rules and regulations required for an audit at a pharmaceutical excipient manufacturer.
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Phone: +49 251 284 972 93
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+49 251 284 972 93
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