Document Review

Current Good Manufacturing Practice (CGMP) documentation is a set of guidelines established by the United States Food and Drug Administration (FDA) that ensures the quality, safety, and efficacy of products throughout their manufacturing process. CGMP applies to the pharmaceutical, food and beverage, medical devices, and dietary supplement industries.

Documents will be reviewed at your facility and findings will be discussed with your staff. The review can be stand alone or part of an audit.

Proper documentation includes batch records, SOPs, calibration records, validation reports, and other cGMP-related documents. Well-maintained records provide evidence of compliance during inspections and help identify deviations or trends for continuous improvement. 

Training records indicate competence as well as compliance to requirements.

Send documents and records electronically and an online meeting will be scheduled to review the findings.