Follow
1.0 OBJECTIVE
To confirm that the personnel performing the tests in IPQA and other documentations in Quality Assurance are adequately trained to produce reliable and accurate results within the specified parameters.
2.0 SCOPE
This procedure is applicable to IPQA officers to assure that the analysts are familiar with all tests, analytical techniques, calibration & documentation before starting their regular assigned job.
3.0 RESPONSIBILITY
3.1 Responsible Officer / Sr. Officer/ Manager in QA are responsible for carrying out the procedure and maintenance of records.
3.2 Overall responsibility for training, implementation & follow-up with the Head of Quality or his nominee.
4.0 ACCOUNTABILITY
4.1 Head of Quality.
5.0 PRECAUTIONS
5.1 Without certification of QA personnel, no one can involve in the assign job.
6.0 PROCEDURE
6.1 All QA personnel involved in the IPQA activity for intermediate and finished products shall be adequately trained for operation, cleaning, maintenance, calibration of instruments /equipments and other QA activities and same training shall be assessed and documented.
6.2 All the IPQA officer will be trained on the relevant SOPs by the Manager, QA and will be documented.
6.3 The responsible person for the QA personnel certification shall select the previously analysed in-process samples of intermediate and finished products for certification.
6.4 Samples of each test shall be coded as (S) and (T) for IPQA testing. A Fresh QA person shall perform tests on sample (T) and experienced IPQA person shall perform tests on sample (S). But depending on his/her experience the test number may vary.
6.5 The specified tests shall be carried out by the QA personnel following the approved SOPs and specifications for the sample / product.
6.6 The analytical findings shall be recorded in the prescribed format (Annexure-I).
6.7 Manager, QA shall review the results in comparison with the known values for the test carried out by approved QA personnel and forward to the Head of Quality for approval.
6.8 The acceptance criteria for the analytical results shall be as per the specifications.
6.9 Following IPQA test results will be considered for evaluation:
6.9.1 Tests for OSD unit:
• Weight variation.
• Disintegration.
• Hardness, Thickness and Diameter.
• Friability.
• Leak test.
6.9.2 Tests for MDI unit:
• Crimping strength test.
• Crimper height and Diameter.
• Weight variation.
6.10 The evaluation of QA personnel shall be based on his/her performance as indicated in the analytical results and acceptance criteria.
6.11 The QA personnel will be certified if the personnel can operate the IPQA instruments satisfactorily as per the SOPs and well trained on the documentation activities and the analytical results as reported by him/her during these evaluation studies fall within the established acceptance criteria.
6.12 Re-certification of the QA personnel shall be carried out once in five years.
