1. Purpose
Quality inspection methods and quality standards describe the evaluation of raw and auxiliary materials (including process water), packaging materials (including labels), semi-finished products (intermediates), and finished products, as well as the methods and limits that should be implemented. These standards and methods are regularly checked. review to ensure their completeness, accuracy and professionalism.
2. Scope of application
Formulation and review of quality inspection methods and quality standards for raw and auxiliary materials, packaging materials, semi-finished products (intermediates), and finished products.
3. Responsibility
QC supervisor, QA supervisor
4. Definition
none
5. Safety Precautions
none
6. Procedures:
6.1. The quality standard is formulated by the quality control department, approved by the QC supervisor, approved by the manager of the quality assurance department, signed and issued, and implemented according to the specified date. The numbering principle is article number/version number.
6.2. Every 3 years, the QC supervisor and QA supervisor shall review the existing methods and standards in order to decide whether they need to be revised. If they need to be revised, the revised methods and standards should be submitted to the manager of the quality assurance department for approval.
6.3. If the company headquarters or the drug administration department have updated regulations on these methods and standards, corresponding revisions should be made at any time.
6.4. All changes in quality standards and inspection methods must be approved by the process technology change procedure in SOPRCM011.
6.5. The effective date should be indicated on the inspection method and quality standard. If there is any modification, the revised date should be noted and signed by the manager of the quality assurance department to be valid.
6.6. The established inspection methods and quality standards shall be implemented immediately after they are approved.
6.7. After the new version of quality standards and inspection methods takes effect, the original text will be withdrawn by the Quality Assurance Department.
6.8. The discarded test methods and original quality standards should be archived and kept by the Quality Assurance Department.
7. Reference
SOPRCM011
8. Distribution department
Quality Assurance Department
9. Revision history:
none
