1. Purpose
This protocol provides detailed standard procedures for the preservation and destruction of samples.
2. Scope of application
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
none
5. Safety Precautions
none
6. Procedures
6.1 Storage of samples
6.1.1 Use the reserved sample card (see Appendix 1) and appropriate packaging to retain all the samples of raw and auxiliary materials used in normal production. The amount of reserved samples should be twice the amount of the full inspection. year, solvent samples can be kept for one year.
6.1.2 Use reserved sample cards and appropriate packaging to retain all samples sent for inspection during normal production (including: granules, plain tablets, coated tablets, ointments, solutions, etc.), and the reserved sample volume should be twice the full inspection volume. These samples can be retained until the batch of finished products is released.
6.1.3 Keep all the finished products packaged in normal production, the amount of reserved samples should be twice the amount of full inspection, the reserved form is the smallest market packaging of the product, and mark "retained samples for quality inspection" on the sample reserved card typeface. These samples should be retained until one year after the expiry date of the batch.
6.1.4 Keep all samples produced during abnormal production process, including samples provided by new suppliers, new product test samples, and samples taken during various verification processes, and save them according to the above regulations unless otherwise required.
6.1.5 More expensive samples can be reserved as appropriate.
6.2 Sample storage
6.2.1 Register all reserved samples (see Appendix 2).
6.2.2 Store all reserved samples on the sample rack in the sample storage room, store them in categories, and clearly mark them.
6.2.3 The sample storage room should be kept at 18oC~26oC, RH45~65% and monitored daily.
6.2.4 According to the different requirements of the samples, select a place or container with airtight, light-proof, airtight, dry, cooling and other properties to store the samples.
6.3 Use of samples
6.3.1 The samples taken should be registered, and the person taking the samples should record the date of taking, the name of the sample, the reason for use, the amount of use, etc. on the registration card for reserved samples (see Appendix 3).
6.4 Destruction of samples
6.4.1 The person in charge of sample storage should check the reserved samples at the beginning of each year according to the sample storage period. Submit the list of samples whose storage period has expired to the environmental protection and safety supervisor for approval by the QC supervisor.
6.4.2 The destruction of samples is jointly supervised by the supervisor of environmental protection and safety and the sample custodians.
7. Reference
none
8. Distribution department
Quality Assurance Department, Management Department
9. Modify history;
none
