Follow
1.0 OBJECTIVE : To confirm that the analysts performing the tests in Quality Control Laboratory (Company Name) are adequately trained to produce reliable and accurate results within the specified parameters.
2.0 SCOPE : This procedure is applicable to assure that the analysts are familiar with all tests, analytical techniques, calibration & documentation.
3.0 RESPONSIBILITY
3.1 Responsible Officer / Sr. Officer/Asst. Manager in the laboratory is responsible for carrying out the procedure and maintenance of records.
3.2 Overall responsibility for training, implementation & follow-up with the Head of QC or His/Her Nominee.
4.0 ACCOUNTABILITY
4.1 Head of Quality.
5.0 PRECAUTIONS
5.1 Without certification of analyst, no one can involve in the analysis.
6.0 PROCEDURE
6.1 Only certified analyst shall carry out the testing of materials and drug products.
6.2 All QC analyst involved in the testing of materials and drug products shall be adequately trained for operation, cleaning, maintenance and calibration of instruments /equipments and same training shall be assessed and documented.
6.3 The responsible person for the analyst certification shall collect samples of raw materials or finished products from two different batches those were tested by certified analyst (s) and released. The samples shall be from batches those are released within one month from the date of analyst validation study.
6.4 These samples of the two batches shall be coded as (A) and (B), and shall be given to the analyst under certification without disclosing the batch numbers of the samples.
6.5 The Analyst shall prepare three (3) samples (i.e. 3 preparations) from each coded sample following the approved testing procedure of the specific material or product and perform Assay analysis.
6.6 The specified tests must be carried out by the analyst following the approved test procedures and specifications for the material / product.
6.7 The analytical findings shall be recorded and the summary of results shall be entered in the prescribed format (Annexure-I).
6.8 Head of QC or his/her nominee shall review the results and compare the results obtained by the analyst under certification with that obtained by the certified/approved analyst.
6.9 The acceptance criteria for the analytical results shall depend upon the nature of tests carried out and the range provided in the specifications.
6.10 Following acceptance criteria shall be used for evaluation:
• For Assay by Spectrophotometry & HPLC: The results obtained by the analyst under certification shall not vary by more than 2.0% of that obtained by the certified/validated analyst.
• For Dissolution: The dissolution results obtained on 6 units by the analyst under certification shall not go beyond 5.0% of the maximum & minimum value over the results obtained by the certified/validated analyst. However, the results should be within the specification limit of the product.
6.11 The evaluation of analyst shall be based on his/her performance as indicated in the analytical results and acceptance criteria.
6.12 The analyst shall be certified if the analytical results as reported by him / her during these evaluation studies falls within the established acceptance criteria.
6.13 The certification of analyst shall be applicable to him / her only for carrying out those activities for which he / she is certified.
6.14 Re-certification of the analyst shall be carried out once in five years.
6.15 Re-certification shall be done through reviewing the performance & the training records of the analysts during the review period. Re-certification shall be done using Annexure-II (FQC/572).
6.16 During re-certification, if it is found that the analyst did the same personal error more than twice a year which resulted deviations/OOS or ATY results/incidences etc., his or her initial certification will be considered as not valid and the certification procedure will be repeated.
6.17 Certification program for the year, indicating the name of the analysts, tests/ instrument/equipment for which to be certified shall be prepared by the responsible Officer/Sr. Officer/Asst. Manager or His/Her nominee of QC at the beginning of the year.
