1. Purpose
Guarantee the effectiveness, reliability and timely supply of the reference substances used in the test.
2. Scope of application
The management of reference substances used in laboratories.
3. Responsibility
Laboratory technicians and reference substance administrators 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. Types of reference substances
6.1.1 The reference control substance, USP reference substance or instrument calibration sheet provided by GSK.
6.1.2 The reference substance of Chinese Pharmacopoeia.
6.1.3 Factory internal reference control substance.
6.1.4 Calibration sheets (products) for various instruments.
6.2. Purchase of reference substances
6.2.1. The benchmark reference substances used in product analysis should be applied to the headquarters by QC or directly purchased from USP and local drug testing agencies.
6.2.2. For the purchase of GSK internal reference substances, the QC supervisor shall apply regularly every month, and relevant personnel shall order. In addition to purchasing new reference substances, the analysis report of the original reference substance that needs to be updated should also be applied to the SB headquarters according to the requirements provided by the administrator of the reference substance. The reference control substances not provided by GSK shall be regularly applied for purchase by the QC procurement coordinator.
6.3. Receipt of reference substances
6.3.1. The reference substance should be strictly accounted for management, and each batch of each type of reference substance should establish a one-page reference substance receipt and use record form. When receiving a new reference substance, the administrator of the reference substance should immediately register relevant information on the registration form for receiving the reference substance (see Appendix 1).
6.3.2. When receiving a new reference substance or an updated analysis report, the manager of the reference substance should update the corresponding information in a timely manner, and send the updated reference substance update record to the laboratory, so as to ensure that the analysts can access accurate information. Such as reference substance number, inventory and expiration date, etc.
6.3.3. The benchmark reference substance received from GSK headquarters should be accompanied by relevant analysis certificates, which will be kept by the reference substance administrator.
6.4. Issuance of reference substances
6.4.1 When distributing the reference substance, the name of the product and the current batch number should be recognized clearly to avoid taking the wrong one.
6.4.2 QC is responsible for providing the required reference materials to the relevant departments of the company.
6.4.3 QC is only obliged to provide the reference control substances of our products to the local drug control institute.
6.5. Use of reference substances
6.5.1 Usually, when testing and determining the content of drugs according to the provisions of the Pharmacopoeia, a reference substance is required for comparison. During the inspection process, the drug and the reference substance should be tested under the same conditions, and the method of preparation and determination of the reference substance should be compared with that of the sample. The conditions used for each measurement were the same.
6.5.2 When unsealing a new reference substance, the user should fill in the "Reference Substance Unsealing Label" (see Appendix 2), indicate the date of unsealing, and stick it on the bottle of reference substance.
6.5.3 When taking the reference substance stored in the refrigerator, the desiccator cover should be opened when the temperature is the same as the room temperature, so as to prevent the moisture in the air from entering the reference substance.
6.5.4 The sample spoon used to take the reference substance should be clean to avoid any foreign matter and prevent cross-contamination. The sample spoon should be cleaned immediately after use.
6.5.5 For the reference substance after use, the original packaging should be sorted out immediately and put back to the original place in time to avoid confusion.
6.5.6 After each use of the reference substance, it should be recorded in time on the "Registration Form for Receiving and Using the Reference Substance" (see Appendix 1), including the date of use, the batch number of the reference substance, the amount taken, and the user, etc. The use records of reference substances should be clean and complete.
6.6. In case of any of the following situations, the reference substance manager should be reported in time
6.4.1 There are not many reference substances left.
6.4.2 A new reference substance is required.
6.4.3 The expiration date of the reference substance used is approaching.
6.4.4 Re-ordering is required if the number of reference substances decreases. (USP references require six months to order)
6.7. Storage of reference substances
6.5.1 The reference substance should be properly stored. Generally, the reference substance should be stored in a dark and heat-insulated place. The powdery reference substance should not be stored in a humid place. If special storage is required, specific requirements should be marked and regular inspections should be made. Storage: Unopened USP Reference Standard and raw materials used as reference were stored in a desiccator in the refrigerator (4oC).
6.5.2 The unsealed reference substance can be stored in a desiccator. The mouth of the bottle should be sealed tightly with a parafilm. The desiccant in the desiccator should be replaced after it starts to change color. The desiccator for the reference substance should not store other samples.
6.8. The label of the factory internal reference control substance:
The label should indicate the name of the reference substance, batch number, test date, expiration date, content value, water content, person who handled it, and person who approved it (see Appendix 3).
7. Reference
GMPcs-020
8. Distribution department
Quality Management Department
9. Revision history:
none
