Quality Monitoring at Contractors
- Published on: Oct 27, 2017
For contractors not previously used to manufacture, supply, test and/or distribute sponsors materials/products, the QA representative of the Lead Site shall:
- Agree the QA contacts between sponsor and the contractor;
- Share the principles included in this Procedure and the criteria for certification (see Section 5.3.2) with the contractor;
- Audit the contractor with reference to the activities to be included in the Quality Assurance Agreement;
- Develop with the contractor a Quality Assurance Agreement and either approve the Agreement on behalf of sponsor or identify the person
- who shall approve on behalf of sponsor:
- If required, develop with the contractor a GMP improvement plan to address any deficiencies highlighted during the earlier assessment; and
- Agree the process for monitoring progress and maintaining regular contact with the contractor for QA issues.
For contractors previously established to carry out similar activities for the sponsors products, the Lead Site will assist the Quality Assurance Agreement Co-ordination Site in updating the Quality Assurance Agreement and other information mentioned above to include the needs of the additional material/product to be manufactured by the contractor.
The Lead site, in consultation with the Quality Assurance Agreement Co-ordination Site, shall agree with the contractor how links will be maintained between the contractor and sponsors QA processes, such as:
Manufacturing Change Management Process (MCM);
- Dossier Management group to maintain the currency and accuracy of CMC Dossier for internationally sourced or internationally marketed products(s);
- Labelling changes;
- The commercial stability testing program, including timely Out of Specification (OOS) reporting and periodic data reporting;
- Product Defect, Customer Complaints and Product Recall procedures;
- Annual Product Reviews
- Sponsors Legal Affairs shall review any new Quality Assurance Agreement Quality Assurance Agreements shall be reviewed also by the Toll Manufacturing Manager in Supply and Manufacturing to eliminate conflicts with respect to tolling arrangements.
210 SOPs, 197 GMP Manuals, 64 Templates, 30 Training modules, 167 Forms. Additional documents included each month. All written and updated by GMP experts. Checkout sample previews. Access to exclusive content for an affordable fee.
Related Posts
Good Practice for Container Closure Integrity for Sterile Drug Products
Pharmaceutical sampling procedures for non-sterile products
Basic cleaning and sanitation practices in Pharmaceuticals
