GAP ANALYSIS
A Gap Analysis is used for the purpose of determining whether your company (or your contractor) is ready to submit their Site License (SL) or Drug Establishment (DEL) application, or ready for a QA Audit / QA Inspection.
When we perform a Gap Analysis, our approach is client-focused, versus just "going by the book". We do not inspect the QA program just to meet the regulations, but also to ensure the documents and processes are streamlined to provide the most efficient Quality Management System (QMS) possible.
We perform an audit on your SOPs / forms / checklists/ facilities by using our highly detailed Internal Quality Audit checklists, which are continually updated / refined
This provides a quick snapshot of the overall status of your QA program in relation to GMP. The Gap Analysis is much less involved than a thorough internal/3rd party audit. However, it is more “targeted” towards identifying those specific areas in which a Critical Nonconformance can do the most damage (i.e. having to delay the official inspection). Thus, the GAP analysis allows the company to identify those areas which are most critical to its operations and which problems should then be prioritized and addressed first.
The purpose of the Gap Analysis is to assess your firm’s progress towards Quality Assurance readiness:
- what is compliant —or close to compliant
- what requires amendments / revisions / further details
- what is missing or has critical non-conformances
We achieve this by:
- Providing an overall evaluation of each of the applicable sections of the QMS
- Making suggestions as part of your firm’s Continual Improvement Process (CIP) and Risk Management programs
- Providing fine-tuning suggestions in order to reduce unnecessary paperwork and increase regulatory efficiency
- Identifying where the time and resources could be better prioritized for the future (many times, it has been found that an outside point of view can provide a more objective evaluation and fresh perspectives)
- Identifying which areas of the QA program should be tackled before other areas — ones that have a higher potential to impact product or service quality, and ones that might take longer to accomplish since they involve requesting information from outside suppliers or contractors
- Identifying whether the procedures, checklists, forms, and any other quality records are of appropriate format (before the rest of them are prepared/revised)
- Identifying whether the procedures are of sufficient detail (or too much detail) for the operators to follow
- Identifying whether/where the processes can be streamlined to reduce the potential for conflicts with other SOPs and reduce redundancies (can the number of QC test parameters be reduced for each batch of finished product or raw material, yet still comply with the regulations?)
- To help prioritize the QA program either by sales, by volume, by process, by product category, or by a combination of these
We can perform a GAP analysis of your entire premises or focus solely on one area of your operations, as required.
We can draw your attention to areas that the inspectors may have concerns about/deem deficient.
Please refer to the audit section of the website for a more detailed overview of our audit services.
