GMP Document |
两个中心Title: Standard Operation Procedure for Review and Relea of Materials | Drafted by: Date夏至未至经典语录 | Document No.: SOP-QU-02-001-00 |
Reviewed by: Date | Effective Date: |
钟表馆Approved by: Date | Page: 1 / 2 |
Issuing Department: Quality Department | Distributed to: Quality Department |
Copies: 01 |
Reasons for change |
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1. Purpo: To establish the standard operation procedure for review and relea of materials, standardize the relea of materials, and avoid the occurrence of quality accident.
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2. Applicable Scope: The procedure is applicable to review and relea of materials.
3. Responsibilities: QA supervisor and QA inspector shall be responsible for implementation of the procedure.
4. Contents:
4.1 QA inspector and QA supervisor shall be responsible for review and relea of materials.
4.2 Contents of review before relea of materials
4.2.1 Sentinel procurement: The material supplier shall be the ntinel procurement unit approved by the enterpri.
4.2.2 The materials shall be qualified in the initial inspection, and the records shall be complete and correct.
4.2.3 The approved operation procedure shall be executed in sampling, and the sampling sheet shall be complete and correct.
4.2.4 The approved inspection procedure shall be executed in inspection.
4.2.5 According to “Inspection Requisition”, check whether all records are consistent, and whether the name, lot number and quantity in lot inspection record are consistent with the “Inspection Requisition”.
4.2.6 According to quality standard, check one by one whether the lab test result conforms to the quality standard and check the operator’s signature/date, and the signature/date of the checker or the person in charge.
4.2.7 The inspection report contents shall be accurate and complete.
4.3 Procedure for review and relea of materials
4.2.1 QA inspector checks the sampling sheet, “Inspection Requisition” of materials, supplier’s lab report/ certificate of conformity, and inspection report, and according to the qualification inspection report of materials issued by lab, review that the material supplier shall be the supplier qualified in auditing.
4.2.2 QA inspector shall issue the “Certificate of Conformity” and “Material Review and Relea Sheet”;
4.2.3 After they are approved by QA lab supervisor, QA inspector shall issue them and the qualification inspection report of material to the warehou, and the materials are approved to be relead for u.
4.3 QA inspector shall supervi the warehou personnel to paste the certificate of conformity on the package of material (one for each lot). The warehou shall decide the issue of materials according to “Inspection Report”, “Material Review and Relea Sheet” and “Certificate of Conformity”.
5. Keeping and Management of Relevant Records: “Certificate of Conformity” will be discarded as the outer package of material is discarded, and will not be saved; “Material Review and Relea Sheet” shall be prerved in warehou, and managed by warehou keeper.
6. Supplementary Provisions:
List of Supporting Records of the Document
No. | Record Name | Record No. | Remarks |
1 | Certificate of Conformity | SOP-QU-02-001-R-02-00 | |
2 | Material Review and Relea Sheet | SOP-QU-02-001-R-02-00 | |
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List of Reference Records of the Document
No. | 幼儿园工作反思 Record Name | Record No. | 高丝美 Remarks | 深切缅怀
1 | Inspection Requisition | SMP-QU-02-013-R-02-00 | |
2 | Material Inspection Report | SMP-QU-02-013-R-07-00 | |
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7. The document is drafted by QA, reviewed by QA supervisor, and approved by Quality Department head.
