Classical Pharmaceutical Formulation & Manufacturing

Excipient GMP: The industry journey from guides to standards

GMP requirements for excipients have evolved over the past ten years from guides to standards. The focus on the importance of excipient GMP is ever-increasing. It is clear that regulatory bodies see the value in having drug manufacturers understand and assess the risk of the excipients in their drug products as it relates to appropriate GMP.

How do pharmaceutical manufacturers decide which excipient suppliers are best prepared to incorporate the regulatory standards for excipient GMP into the supply and documentation support of excipients used in pharmaceuticals? EXCiPACT certification of the excipient supplier and Emprove^® documentation approach can help pharmaceutical manufacturers to address regulatory requirements.

Taking the fast track to obtaining regulatory approval

In March 2016, the European "Guidelines on Formalized Risk Assessment for Ascertaining the Appropriate GMP for Excipients of Medicinal Products for Human Use" became official, emphasizing the need for drug manufacturers to understand and assess the risk of the excipients in their drug products as it relates to appropriate GMP. The innovative Emprove^® program can accelerate the pathway to regulatory approval by providing comprehensive product information and documentation. It simplifies processes by:

• Facilitating the qualification process
• Supporting risk assessment, management, and mitigation
• Increasing supply chain transparency
• Expediting approval preparation and extending compliance – saving time and money

Emprove^® dossiers contain detailed documentation on pharmaceutical raw and starting materials as well as filters and single-use components.

Selecting appropriate raw materials for transition to a commercial scale

A major challenge in small molecule drug development is the change in quality and supply chains as manufacturers progress from discovery to commercialization. A key risk consideration is whether the chemicals used in drug synthesis have the appropriate quality level for use in clinical trials and commercialization. If the right products are not used early in the development process, additional time and costs are required to convert to the correct quality level of raw materials at later stages in development. Changes in later steps also require more validation. This can lead to a higher total cost of ownership.

When transitioning to a commercial manufacturing process, understanding raw material requirements and cost implications is essential. A consistent supplier strategy should be developed, allowing manufacturers to identify the changes needed to convert to raw materials that are fit for purpose in a regulated product. An appropriately rigorous approach includes evaluation and assessment of raw materials used to manufacture a small molecule drug during development.