1. Purpose
Provide standard operating procedures for the calibration of internal reference substances in the factory, thereby ensuring the reliability of internal reference substances.
2. Scope of application
Calibration of the laboratory to the factory's internal reference control.
3. Responsible person
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
Ref.stdreferencestandard, reference substance.
5. Safety Precautions
none
6. Procedures
6.1 Take recent raw materials that have passed the test and have been approved.
6.2 The principle of setting up the batch number is
6.2.1 The internal reference reference substance is SXXXX (year) XX (month) XX (serial number), such as the first batch of reference reference substance calibrated in May 1999, its batch number is: S19990501
6.2.2 Where the headquarters provides or the USP and CP reference substances are still subject to the original batch number, they will not be arranged separately.
6.3 Calibrate with the method specified in the Pharmacopoeia reference substance or GSK reference substance to determine the purity. Use a dedicated reference substance calibration table (see Appendix 1, Appendix 2).
6.4 Calibration implements double review system. After the first calibration person calibrates, the second calibration person will independently review the calibration. If there are no special circumstances, the relative deviation between a single person is 50% of the corresponding method specified in the test method of raw and auxiliary materials, and the relative standard deviation between two people is the same as the standard deviation specified for raw and auxiliary materials.
6.5 Calculation of content value
6.5.1 Take the average value of all measurement results (dry product). If two methods are used for measurement, the relative standard deviation of the two measurement results should be <0.5%. If it exceeds, the average calculation cannot be performed and the measurement should be repeated.
6.5.2 If the average content is greater than 100%, it can be considered as 100% pure and marked on the packaging bottle.
6.5.3 If it is lower than 100%, such as 99.2%, record the average content on the packaging bottle, and make purity correction when calculating the sample when using the reference substance each time.
6.5.4 The purity of the internal reference control substance is generally not less than 99.0%.
6.6 Record keeping
6.6.1 The relevant information of the calibrated product and the reference product should be recorded on the reference product calibration table (I).
6.6.2 Record the data of each calibration test on the reference substance calibration form (II), and have the signatures of the calibrators and approvers.
6.7 Determination of validity period
6.7.1 The valid period is six months after the first use of the raw material has been tested and approved.
6.7.2 After six months, the remaining reference substance should be redone for content analysis and moisture determination. If the test is satisfactory, another six-month validity period will be given.
6.7.3 After one year, the reference substance can no longer be used.
6.7.4 If it is still necessary to use this raw material as a reference substance in the future, it can be given a one-time validity period of one year after passing the test.
7. Reference
"CHINA Standard Operating Procedures for Drug Inspection"
8. Distribution department
Quality Assurance Department
9. Revision history:
none
