Monitor Supplier Specification Changes to Maintain GMP Compliance

Stay Alert to Specification Changes from Your Suppliers

Remember: Suppliers must inform you of any specification changes. GMP requires evaluating and approving updated specs before material use.

Why This Matters in GMP

Raw materials, excipients, and packaging components are all governed by predefined specifications that ensure compatibility with the product and manufacturing process. If a supplier modifies specifications (e.g., particle size, grade, impurity limits), these changes can impact process performance or product quality. GMP demands that such changes be reviewed, approved, and where necessary, trigger requalification or validation. Failure to detect and manage supplier changes may result in deviation, batch rejection, or customer complaints. Ongoing oversight ensures that your manufacturing system remains robust and aligned with incoming material quality.

Also Read: Quarantine Returned Goods with Clear Identification Labels

Regulatory and Compliance Implications

FDA 21 CFR Part 211.84 and 211.100 require incoming materials to meet specifications approved by QA. EU GMP Chapter 5 and WHO GMP mandate formal change control systems and supplier quality agreements. Schedule M requires written communication from suppliers about any change. Auditors evaluate vendor qualification files, change notification records, and response actions. Overlooking supplier modifications is considered a systemic failure and may attract regulatory observations for lack of supply chain control and quality assurance oversight.

Implementation Best Practices

Include change notification clauses in quality agreements with all suppliers.
Assign QA personnel to review all incoming specifications and change alerts.
Trigger internal change control processes for evaluation, risk assessment, and requalification.
Maintain a specification history log for all approved raw materials and packaging components.
Conduct periodic supplier audits to confirm their adherence to change control processes.

Also Read: Maintain Clear Segregation Between Different Product Families in GMP

Regulatory References

FDA 21 CFR Part 211.84 – Testing and Approval of Components
FDA 21 CFR Part 211.100 – Written Procedures; Deviations
EU GMP Chapter 5 – Supplier Qualification and Material Control
WHO GMP – Specification Review and Change Management
Schedule M – Supplier Specification Compliance and Notifications