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Supplier Audit · Pro

Raw Materials Supplier GMP Compliance Audit Checklist

Evaluate raw materials suppliers against GMP requirements, facility standards, equipment calibration, and documentation compliance with this audit checklist.

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Raw Materials Supplier GMP & Documentation Compliance Audit Checklist

Audit Reference / Report Number

· · ·

Audit Date

· · ·

Lead Auditor Name

· · ·

Submit

The Raw Materials Supplier GMP & Documentation Compliance Audit Checklist is a comprehensive tool designed to help quality assurance teams, compliance officers, and procurement professionals systematically assess supplier facilities against Good Manufacturing Practice standards. It captures critical audit details including auditor information, supplier contacts, audit type, and raw material categories.

This checklist covers all key GMP compliance areas including facility cleanliness, pest control programs, equipment calibration and qualification, raw material receiving and quarantine procedures, and in-process manufacturing controls. Each area is evaluated using a standardized rating scale, ensuring consistent and objective assessments across multiple supplier visits.

Whether you operate in pharmaceuticals, food manufacturing, cosmetics, or any regulated industry, this template helps you maintain supply chain integrity, identify compliance gaps, and generate audit-ready reports. Streamline your supplier qualification process and reduce regulatory risk with a structured, digital audit workflow.

4 Pages

45 Questions

~15min To complete

Free No credit card needed

Field types Likert Scale ×19 Long Text ×5 Short Text ×3 Date ×3 Dropdown ×3 Full Name ×2 Email ×2 Signature ×2 Address Phone Multiple Choice Star Rating Yes / No File Upload

Questions in this template

Free template

The exact questions included — customize any of them to fit your needs.

Page 1 Audit Overview & Supplier Information 12 questions

Audit Overview & Supplier Information

1 Audit Reference / Report Number * Short Text

2 Audit Date * Date

3 Lead Auditor Name * Full Name

4 Lead Auditor Email * Email

5 Additional Auditor(s) Short Text

6 Supplier / Company Name * Short Text

7 Supplier Facility Address * Address

8 Supplier Contact Person * Full Name

9 Supplier Contact Phone * Phone

10 Supplier Contact Email * Email

11 Audit Type * Dropdown

12 Raw Material Category Supplied * Dropdown

Page 2 GMP Compliance Assessment 11 questions

GMP Compliance Assessment

Evaluate the supplier's facility and operations against applicable Good Manufacturing Practice (GMP) requirements. Rate each area using the scale provided.

1 Facility cleanliness and housekeeping standards * Likert Scale

2 Pest control and environmental monitoring programs * Likert Scale

3 Equipment calibration, maintenance, and qualification * Likert Scale

4 Raw material receiving, sampling, and quarantine procedures * Likert Scale

5 In-process controls and manufacturing procedures * Likert Scale

6 Storage conditions and warehouse management (temperature, humidity, segregation) * Likert Scale

7 Personnel hygiene, gowning, and training programs * Likert Scale

8 Cross-contamination prevention and cleaning validation * Likert Scale

9 Water systems and utilities qualification * Likert Scale

10 Quality control laboratory practices and instrument calibration * Likert Scale

11 GMP Observations & Findings — Detail any non-conformances or noteworthy observations Long Text

Page 3 Documentation & Quality System Review 11 questions

Documentation & Quality System Review

Assess the supplier's documentation practices, quality management system, and regulatory compliance records.

1 Batch manufacturing and packaging records completeness and accuracy * Likert Scale

2 Certificate of Analysis (CoA) accuracy and traceability * Likert Scale

3 Standard Operating Procedures (SOPs) — current, approved, and accessible * Likert Scale

4 Change control and deviation management system * Likert Scale

5 CAPA (Corrective and Preventive Action) effectiveness and timeliness * Likert Scale

6 Complaint handling and recall readiness procedures * Likert Scale

7 Supplier qualification and sub-supplier management * Likert Scale

8 Stability studies and shelf-life / retest date documentation * Likert Scale

9 Regulatory filings, certifications, and audit history (e.g., FDA, ISO, FSSC) * Likert Scale

10 Key documentation verified during audit Multiple Choice

11 Documentation Deficiencies — Describe any gaps, missing records, or data integrity concerns Long Text

Page 4 Audit Summary & Disposition 11 questions

Audit Summary & Disposition

1 Overall Audit Classification * Dropdown

2 Overall Supplier GMP Compliance Rating (1–5 Stars) * Star Rating

3 Summary of Critical and Major Findings * Long Text

4 Required Corrective Actions & Deadlines (CAPA Plan) * Long Text

5 CAPA Response Due Date * Date

6 Is a follow-up or re-audit required? * Yes / No

7 Planned Follow-Up Audit Date Date

8 Attach Supporting Evidence (photos, documents, checklists) File Upload

9 Additional Auditor Comments or Recommendations Long Text

10 Lead Auditor Signature * Signature

11 Supplier Representative Signature * Signature

How to use this template

Click "Use This Template Free" to open it in the FormBuilder editor. From there you can add, remove, or reorder fields with drag-and-drop, switch themes for instant restyling, add your logo, configure email notifications, and set your success message. When ready, publish with a unique link and start collecting responses immediately.