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Regulations on quality assurance management of pharmaceutical factories
1 Management function:

In order to ensure the accuracy and reliability of inspection results, the original records of quality inspectors must meet the requirements of standardization.

2 management content and requirements:

2. 1 The quality inspector must issue the inspection report timely and accurately according to the specified inspection time. In case of special circumstances, it is necessary to report the decision in time.

2.2 All records shall be filled in in a true, effective, timely and earnest manner.

2.3 Records shall be clearly identifiable. Pencils and red pens are not allowed. Shall not be torn or altered at will. Do not modify them with a knife or eraser.

2.4 If it is really necessary to make corrections, it shall meet the requirements and sign the full name. But you can only modify three places on a page at most.

2.5 The original records and inspection reports must be rechecked three times. First, the chemist himself rechecks them correctly, and the rechecker signs them. Finally, they are effectively issued after being rechecked and stamped by the person in charge.

2.6 All products must be fully inspected according to the quality system, and missed inspection or less inspection is not allowed.

2.7 The auditor may refuse to review the original records or reports that do not meet the requirements. The auditor is responsible for content calculation errors, and the tester is responsible for inspection errors.

2.8 The name and quantity unit shall be filled in as required, and shall not be abbreviated or omitted.