Regulatory ComplianceRegulatory ComplianceRegulatory Compliance
Regulatory Compliance - HomeRegulatory Compliance - AboutRegulatory Compliance - CapabilitiesRegulatory Compliance - ServicesRegulatory Compliance - ContactRegulatory Compliance - Sitemap

Audits

CGMP Pro consultants perform a variety of audits to help you determine where you or your prospective vendor stand in regards to CGMP regulatory compliance. Some of our clients find it helpful to have a third party audit potential vendors so that they may concentrate on other aspects of their business, with confidence that the evaluation report will give a fair assessment of that potential associate.

Pre-inspection CGMP Assessment: Let us take an unbiased look at your operations before the FDA comes, and identify potential problems that may need to be addressed. It is far better to have a consultant make a regulatory compliance assessment in time to make appropriate corrections, than to have a problem with FDA. In addition, you may have identified an area that you are concerned about; our consultants can assess this concern and offer an opinion on it, and offer solutions if warranted.

Gap analysis: Our consultants will look for areas that are lacking something that might offer problems from a CGMP view. This may be necessary SOPs have not been drafted, or procedures lacking details or frequency etc. We look for the completeness of your procedures, documents, documentation, and identify items that have been overlooked or are missing.

Regulatory Compliance

Compliance assessment: This is one of our strongest abilities. We assess how well your operations meet the regulatory compliance expectations of the CGMPs, and offer recommendations on what needs improvement to be considered within regulatory compliance standards. We also let you know what areas we consider to be in good order.

Vendor audits: We are able to make a fair and quick assessment of the potential vendor’s regulatory compliance status and their ability to meet CGMPs in their operations as they manufacture the component or API you are interested in purchasing.