GMP Gap Assessments
IPEA offers a comprehensive evaluation of an excipient manufacturer or distributor for conformance to the current Joint IPEC-PQG Good Manufacturing Practices Guide for Pharmaceutical Excipients or the current IPEC Good Distribution Practices Guide for Pharmaceutical Excipients respectively, and makes recommendations for improvement. The guides can be downloaded for free at the IPEC Store.
To request an Excipient GMP gap assessment:
Please contact the IPEA office at 703-351-5266 or by email at firstname.lastname@example.org.
Information will need to be provided about the scope of the assessment needs, such as the number and type of excipients to be assessed at the site. IPEA will then develop a cost estimate based upon the assessment scope. A typical gap assessment requires two days on-site plus ½ day to prepare the report. The duration of a distributor gap assessment depends upon the nature of the activities conducted at the distributor site. The gap assessor will develop a site assessment plan and begin with a site tour followed by interviews and review of procedures and instructions. The inspection and document review will cover the appropriate contents of the GMP or GDP audit guide. The visit will conclude with a presentation of opportunities for improvement and recommendations. The Gap Assessor will prepare a report of improvement opportunities and recommended enhancements.
The gap assessment report will contain the following:
- Summary of the site visit
Summary of Findings categorized as follows:
i. Improvement needed
ii. Improvement suggestedL
- List of personnel in attendance
Detailed discussion of enhancements
i. Detailed description of the observations
ii. Description of suggested enhancement