Service overview
We audit your quality system and manufacturing against 21 CFR Part 820 and FD&C Act guidance, and help close the gaps before FDA inspections.
Why this service matters
- The FDA enforces 21 CFR Part 820 for medical devices and FD&C Act guidance for cosmetics.
- Compliance needs robust quality systems, controlled manufacturing and thorough documentation.
- Non-compliance can lead to warning letters, import refusals and recalls.
GMP Facility Audits & Compliance Assessments
We audit your manufacturing, packaging and distribution to assess GMP readiness and identify compliance gaps.
- Gap analysis reports with actionable recommendations
- Pre-inspection audits to prepare for FDA reviews
- Corrective action planning for identified deficiencies
Good Manufacturing Practice for Medical Devices & Cosmetics
GMP Documentation Development & Review
Accurate documentation is essential for demonstrating GMP compliance during FDA inspections and audits.
- Review of batch records and manufacturing reports for accuracy
- Quality management system (QMS) documentation for medical devices
- Document control systems to maintain version accuracy
Quality Control & Assurance Programme Implementation
We help you establish quality control (QC) and quality assurance (QA) systems that support product safety and consistency.
- QA systems for process validation and equipment calibration
- In-process inspections for real-time quality monitoring
- Deviation and non-conformance management procedures
Supplier Qualification & Supply Chain Compliance
We qualify and audit suppliers and third-party manufacturers against the GMP standards they must meet.
- Audits for contract manufacturers and raw material suppliers
- Ongoing performance monitoring and compliance reviews
- Document verification for supplier certifications and approvals
Employee Training & GMP Awareness Programmes
Our tailored GMP training covers regulatory requirements and best practice for your employees.
- GMP fundamentals training for all operational staff
- Refresher training sessions to ensure up-to-date knowledge
- Certification programmes to document employee competency
FDA Inspection Preparation & Post-Inspection Support
We help you prepare for FDA inspections and respond to any findings.
- Mock FDA inspections to identify potential compliance risks
- Remediation strategies to address inspection findings
- Post-inspection compliance monitoring for ongoing readiness
Ongoing compliance support
Time-Saving
Targeted audits show where to focus, avoiding unnecessary changes to your operations.
Regulatory Assurance
Quality systems and documentation reviewed against 21 CFR Part 820 requirements.
Peace of Mind
Reduce the risk of warning letters, import refusals and recalls.
What you'll need
GMP work starts from your quality system as it is today.
- QMS documentationYour quality management system documents.
- Batch and manufacturing recordsReports to review for accuracy.
- Supplier certificationsFor contract manufacturers and raw material suppliers.
- Previous inspection findingsSo remediation can be planned.
Official sources
- 21 CFR Part 807: Establishment Registration and Device Listing (eCFR)
- 21 CFR Part 807 Subpart E: Premarket Notification (510(k)) (eCFR)
- 21 CFR Part 820: Quality Management System Regulation (eCFR)
- Device Registration and Listing (FDA)
- Premarket Notification 510(k) (FDA)
- 21 CFR Part 701: Cosmetic Labeling (eCFR)
- Modernization of Cosmetics Regulation Act of 2022 (FDA)