SOP FOR IPQA INSTRUMENTS IN PHARMA

By evaluating the tests for weight variation, hardness, and friability, for example, IPQA Instruments in Pharma assess the test results from in-process tests carried out in the production areas or laboratory for compliance with established sampling and testing protocols, analytical methods, and specifications. While tableting or encapsulating, these tests might be run every fifteen or thirty minutes. All testing must follow cGMP guidelines. Some of the in-process testing plans, including techniques and requirements, may be included in the drug application. The inspection must verify that the in-process tests were carried out in accordance with the plan’s instructions and that the outcomes conformed to requirements. It’s also important to evaluate the laboratory work for the more involved tests. The techniques utilised for in-process testing and release testing may be different. The specifications for the in-process tests may typically be more stringent regardless of whether the procedures are the same or different. A product with an assay release specification of 90.0%–110.0% may have an in-process blend limit of 95.0%–105.0%. The tests conducted in IPQA Instruments in Pharma might not be the same as the tests conducted at release. For instance, a company might do dissolution testing as a release test but disintegration testing as an in-process test. The same formulation/process should produce consistent in-process test results both within and between batches (including development or exhibit batches). If not, anticipate seeing scientific evidence to support the variation..

1. SOP for Operation and calibration of Moisture Analyzer (Sartorius)
2. SOP for Operation and Cleaning of Vernier caliper
3. SOP for Operation and Cleaning of Leak test apparatus
4. SOP for Operation and calibration of Moisture Analyzer (Sartorius)
5. SOP for Cleaning, Operation and calibration of Disintegration test apparatus (Electrolab)
6. SOP for Cleaning, Operation & Calibration of Analytical Weighing Balance
7. SOP for SOP for Action Plan during failure of In-process Check
8. SOP for In Process checks
9. SOP for Inprocess control during manufacturing
10. SOP for Inprocess Control on the Packing Line
11. SOP for In-Process Sampling
12. SOP for IPQC During Packing
13. SOP for Line Clearance
14. SOP for Operation, Cleaning, Calibration and Verification of Weighing Balance
15. SOP for Operation and Calibration of Tablet Tester
16. SOP for Operation and calibration of Tap Density Tester
17. SOP for Operation and Calibration of Vernier Caliper
18. SOP for Operation, Calibration and cleaning of pH meter
19. SOP for Operation & Calibration of Tablet Hardness Tester