GMP Requirements for Excipients

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blue inspection body has extensive experience in auditing of manufacturers of all kinds of excipients. Our professionally trained auditors are familiar with both the normative quality management systems (ISO 9001, ISO 13485, ISO 15378 etc.) and the GMP domain; hence, they are able to set the main goals of an audit in a reasonable and risk-based manner.

The EXCiPACT GMP- / GDP-Standard and the related certification scheme represent a new basis for the professional and independent qualification of excipient suppliers by accredited certification bodies. The EXCiPACT certification scheme is an initiative of industrial associations from excipient and pharma suppliers. The initiative provides a framework for the regular monitoring of excipient suppliers by qualified Third-Party audits from the accredited certification bodies. The resulting EXCiPACT certificate and the respective audit report may be issued from the excipient supplier to his pharmaceutical customers.

Excipients in Medicinal Products

Excipients are used in a number of ways in the manufacture of medicinal products. Along with the active ingredients and the packaging, excipients as the main components of pharmaceutical formulations often function not only as additives, but they are specifically responsible for the safe and efficacious mode of action of medicinal products. In pharmaceutical formulations, excipients are therefore iter alia used as swelling and retrading agents, disintegrants, wetting agents, antioxidants, preservatives, film-forming agents, viscosity enhancers, etc.

Excipients for the manufacture of medicinal products are often used in other industries besides the pharmaceutical industry, such as the food industry, cosmetic industry, chemical industry and construction industry. Pharmaceutical industry tends to be a small customer for excipients in terms of its quantity demands, yet at the same time it (often) sets the most stringent requirements for the manufacturing documentation and quality.

GMP Audit Guideline for Excipients

Falsified Medicines Directive (Directive 2011/62/EU), published in 2011, stipulates that the holder of a manufacturing authorisation 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 “Joint IPEC-PQG Good Manufacturing Practices Audit Guideline for Pharmaceutical Excipients” by IPEC (The International Pharmaceutical Excipients Council) and PQG (Pharmaceutical Quality Group). This guideline, which is structurally based on the ISO 9001 standard, is now universally recognised.

Manufacturers of excipients, who are often certified solely to ISO standrad 9001, are accordingly subject to a myriad of GMP audit requests by Qualified Persons.

blue offers audits which rest on the IPEC-PQG GMP guideline, EXCiPACT Certification Standards for Pharmaceutical Excipient Suppliers: Good Manufacturing Practices (GMP), Good Distribution Practices (GDP), and take into account additional recognised rules and regulations.

Among others, blue audits at/for:

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