1. Purpose
Provide a standard operating procedure for what to do when assay results do not meet specified limits.
2. Scope of application
chemical testing laboratory
3. Responsibility
Laboratory technicians should strictly follow the operating procedures, and the QC supervisor is responsible for supervising the implementation of the procedures.
4. Definition
OOS: Out-of-specification, does not meet the set standards. Refers to the results of chemical analysis or microbiological testing used to determine the disposition of a product or material for human use that does not meet established specifications or limits.
Multiple OOS: Non-compliant test results found in more than one batch of product or raw material.
5. Safety Precautions
Laboratory technicians should strictly abide by the testing procedures and wear protective glasses and gloves.
6. Procedures (see flowchart in Appendix 1)
6.1. When the test results do not meet the specified limits, the Tester should immediately report to the laboratory supervisor, and together check the test process according to the contents specified in Appendix 2. If the reason is clear, it should be corrected immediately, and the operator should retest. If the reason is unknown, find out possible problems and errors, and formulate a retest plan.
6.2. According to the re-inspection plan, re-inspect by the operator himself, or by another person.
6.3. Compare the retest result with the first result. If the two results are the same, fill in the abnormal result report form and report to the quality assurance manager, and re-sample for re-test. If the two results are different, conduct an internal inspection with the supervisor to find out the reason, and appoint another person to re-inspect, and if the result meets the requirements, it will be judged as qualified. If the results still do not meet the specified limits, report to the Quality Assurance Manager and re-sample for re-testing.
6.4. After receiving the abnormal result report, QC will take another sample and pay attention to check the sampling process and sample storage conditions. After receiving the sample, the assay will re-sample the sample. If the results meet the requirements, and the sampling process and sample storage conditions meet the requirements, it is judged as qualified. If it still does not meet the requirements, a non-conformity report will be issued and reported to the manager of the quality management department.
6.5. When the microbiological test results are inconsistent with the regulations, it should be reported to the laboratory supervisor immediately, and the contents specified in Appendix 3 should be followed.
6.6. When the number of bacterial colonies and mold (yeast) colonies exceeds the stipulations under the microbial limit of the variety for the first time, it should be randomly sampled from the same batch of samples, retested twice, and the average value of the three results should be reported.
6.7. When control bacteria or other pathogenic bacteria are detected in various preparations, the result of one detection shall prevail, and no sampling shall be performed for retesting, that is, the test product shall be judged as unqualified.
6.8. The number of days required to complete the above investigation process (signed by supervisor, estimated reasons, and includes complete and approved re-examination of provided documents) shall not exceed 5 working days.
6.9. All samples, test products, reagents, and solutions should be kept until the end of the investigation (except for reagents/solutions that cannot be used due to degradation). Procedures and facilities for safe storage and segregated storage of special solutions need to be in place.
6.10. When there is no confirmed laboratory reason for OOS, report to the manager of the quality assurance department and fill out the first part of the "Expanded scope of OOS investigation notice" (see Appendix 4) and submit it to the QA department to organize relevant departments for further investigation investigation.
6.11. After the relevant departments complete the investigation according to the requirements of the "Expanded OOS Investigation Notice", the managers of the relevant departments discuss the measures to be taken and implement them after obtaining approval.
6.12. After effective measures are implemented, the implementing department shall fill in the "Expanded OOS Investigation Report" (see Appendix 5). The report shall include the following contents:
6.12.1 Point out the production process, equipment and facilities that lead to OOS.
6.12.2 Describe the measures taken in detail.
6.12.3 Indicate all changes that occur during the process of taking measures. Changes that fall within the scope of change control must be applied for, and changes can only be made after the application.
6.12.4 If the problematic batches are reworked/readded, relevant records shall be attached after the report.
6.12.5 requires that the entire investigation, including the investigation of the laboratory and the extended scope, should be completed within 10 working days. For those that cannot be completed on schedule (with justified reasons), an interim report is also required.
6.13 For the abnormal fluctuations that occur during the experiment, but the results are still within the limit, after the experiment operator reports to the laboratory supervisor, conduct an investigation according to the above OOS requirements, and fill in the investigation report as required.
7. Reference
GMPCS-019
Pharmacopoeia of the People's Republic of CHINA 2000 Edition
8. Distribution department
Quality Assurance Department, Operation Department, Material Department, Engineering Department
9. Revision history:
none
