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Desk Audit: GMP Records and Documentation
Product Review
Guided. Managed. Prepared.
This desk audit is a comprehensive product review carried out in a manner consistent with FDA inspectional expectations. It is distinct from the full-scope mock inspection and concentrates on a single product and its associated records to assess compliance, identify gaps, and support inspection readiness.
This review includes evaluation of the following GMP documentation and controls:
- Specifications (raw material, in-process, and finished)
- Product formulas
- Master Manufacturing Record (MMR)
- Batch Record (BR)
- Testing and monitoring plans
- Quality roles and responsibilities
- Label and labeling compliance
Where applicable, the review also addresses vendor qualification, Foreign Supplier Verification Programs (FSVP), and laboratory qualifications. Findings are summarized with clear observations and practical, risk-based recommendations to support corrective actions and system improvements.
If you are feeling overwhelmed or unsure where to start, a focused product review can provide clarity and a practical path forward.
FDA GMP-Required Written Procedures
In addition to the product review, we also provide a thorough assessment of your GMP required written procedures to evaluate alignment with FDA expectations.
During an FDA inspection, investigators may request approximately 30 written procedures based on FDA investigator training, applicable GMP regulations, and the relevant Compliance Program. We will review these procedures appropriate to your needs, including whether they are written, established, and adequate to support compliance and inspection readiness.
Our review focuses on identifying gaps, assessing regulatory risk, and providing practical recommendations to strengthen your documentation and quality system.
Manufacturing Records Review
Clear, accurate, and complete documentation is the cornerstone of FDA compliance. We provide structured, objective manufacturing record review to ensure that your quality, regulatory, and operational documents align with dietary supplement GMP requirements, applicable labeling regulations, and industry best practices.
Document gaps are among the most frequent reasons for FDA Form 483 Observations. A focused manufacturing record review can identify issues early, reduce the risk of repeat observations, and support a robust, sustainable compliance foundation.
The most common review requests include one or more of the following:
- Master Manufacturing Records (MMR), including verification of required elements and adequacy.
- Batch Records assessed against regulatory requirements for more than 15 elements
- Certificates of Analysis ( CoAs)
- Testing and Monitoring Plans
- Release and disposition documentation
- Review of Standard Operating Procedures (SOPs) related to manufacturing and quality operations
- Supplier Qualification Programs
- Recall procedures
Additional records may be reviewed based on product type, process complexity, and regulatory risk.