Good Manufacturing Practices (GMP) for Pharmaceutical Excipients

Pharmaceutical Excipients Good Manufacturing Practices 363-2016

Pharmaceutical excipients are essential to the safety, quality, and efficacy of drug products, as they impact a variety of factors influencing how a drug enters and interacts with the body. These substances, defined as those present other than the pharmacologically active drug or prodrug, serve as part of the vehicle transporting the active drug to the site of the body where it is intended to exert its action by preventing the drug from releasing too early, helping the drug disintegrate into particles small enough to reach the blood stream more quickly, or simply making the product look and taste better.

Excipients are also integral for pharmaceutical manufacturing. The selection of excipients, such as diluents or fillers, binders, disintegrants, lubricants, coloring agents, and preservatives, can determine the chemical and physical properties of the final product. For example, if diluents are not chosen carefully, they can make the product unstable and lead to manufacturing problems. In addition, errors in the incorporation of excipients can make pharmaceutical products harmful during their use. For assistance in managing these issues, NSF/IPEC/ANSI 363-2019 – Good Manufacturing Practices (GMP) for Pharmaceutical Excipients has been released.

NSF/IPEC/ANSI 363-2019 defines Good Manufacturing Practices (GMP) for excipient manufacture and distribution. It is applicable to all commercially available excipients in drug products. The principles detailed in this standard have been written to achieve three main objectives:

  • Achieve excipient realization
  • Establish and maintain a state of control
  • Facilitate continual improvement

The fulfillment of these three goals results in meeting the requirements and expectations of customers, pharmaceutical users, and regulatory authorities. As addressed in NSF/IPEC/ANSI 363-2019, it is not possible to assure the consistent quality of excipients by testing alone. Instead, Excipient Good Manufacturing Practices must utilize a proper quality management system.

The quality management system detailed in NSF/IPEC/ANSI 363-2019 involves the process of defining individual and collective roles and responsibilities (with the involvement of management), determining the criteria and methods for controlling processes, assuring that there are suitable resources, and applying actions with a basis in science and knowledge.

NSF/IPEC/ANSI 363-2019 also details considerations for resource management, including infrastructure and work environment, as well as excipient realization. This includes planning for excipient realization, a series of customer-related processes, and the validation of any related processes.

Methods for measurement, analysis, and improvement for assuring conformity to the quality management practices and Good Manufacturing Processes are addressed in the standard.

NSF/IPEC/ANSI 363-2019 – Good Manufacturing Practices (GMP) for Pharmaceutical Excipients is available on the ANSI Webstore.

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