Total Excipient Control: A Pathway to Increased Patient Safety - Pharmaceutical Technology

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Total Excipient Control: A Pathway to Increased Patient Safety
The author focuses on how industry can build a system for Total Excipient Control.


Pharmaceutical Technology
Volume 35, pp. s34-s38

Utilizing the full excipient control toolkit

In recent years, IPEC worked to pull together its various guidelines to create an Excipient Qualification guideline. The 2008 guideline provides overall guidance on how to use a number of related IPEC guidelines to build a credible excipient qualification program from both the maker's and the user's perspective.

As IPEC moves into its third decade, the council is taking this concept further to develop a system of Total Excipient Control (TEC). The system will use all existing IPEC guidelines, programs, and proposals to build an overall control system from the time an excipient manufacturer thinks of marketing a chemical as an excipient to the pharmaceutical manufacturing industry's use of that excipient to the time the patient takes the drug product containing the excipient.


Figure 1: Total Excipient Control (TEC) involves control in three main areas to maximize patient safety. QA is quality assurance.
The TEC system involves three areas of control: excipient design, excipient safety, and excipient manufacturing process control and distribution (see Figure 1). Excipient design controls address setting design criteria in a way that meets the perfromance requirements for the intended use. The controls also take into account quality-by-design (QbD) principles.

Ensuring excipient safety involves using information that has been developed to support the safe use of the excipient in the intended application at the levels of use expected to be experienced by the patient. Excipient manufacturing process control and distribution is the area of control traditionally covered by GMPs, auditing, quality-control testing, information-sharing, and supply-chain security.

As part of developing the TEC process, IPEC has identified some areas that are not fully covered by current IPEC guidelines and programs. The following sections of this article provide some details related to IPEC's plans in this regard.

Validation versus process capability. Validation is one of the most commonly misunderstood issues that comes up during pharmaceutical company audits of their supplier's excipient manufacturing facilities. Pharmaceutical company auditors often ask excipient manufacturers for their validation data on the manufacturing or cleaning process and do not always get the information they are looking for because excipient manufacturers do not always have formal validation studies compiled in the manner typical of the pharmaceutical industry. In many cases, the problem is tied to the terminology rather than an actual issue of control.

Excipient manufacturers typically have a huge amount of process-capability data that is essentially the same type of data that a pharmaceutical company would call "validation data," but it is often stored in sophisticated large-scale computerized process-control systems in a different format from that usually used by the pharmaceutical industry. Sometimes, due to terminology differences during the audit, the excipient company doesn't realize that this information is what the pharmaceutical auditor needs. Process-capability data can, however, provide appropriate excipient control and, in many cases, can provide information far beyond what is typically obtained in pharmaceutical validation studies.

To address this common misunderstanding, IPEC is drafting an Excipient Validation Guide which will clarify how validation studies should be handled for excipients. This guide will help excipient manufacturers convert their process capability data into useable information that will provide pharmaceutical users with a better understanding of how the excipient processes are controlled. Ideally, this guideline will lead to fewer unnecessary observations during audits of excipient manufacturing operations and help excipient manufacturers better understand what type of validation or process-capability information they should have in place.


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