STANDARD OPERATING PROCEDURE TRAINING AND QUALIFICATION OF QUALITY CONTROL PERSONNEL.

STANDARD OPERATING PROCEDURE

SUBJECT:                      TRAINING AND QUALIFICATION OF QUALITY CONTROL PERSONNEL.

DEPARTMENT           : QA SOP NO.                      : Page No                       : Effective Date             : Next Review                : Version No                  :

1.0       OBJECTIVE: 

To lay down a procedure for qualifying quality control personnel.

2.0       SCOPE: 

This standard operating procedure covers training and qualification of all laboratory technical personnel.

3.0       PROCEDURE:

3.1              Training shall be conducted by a QC executive / the head and the effectives of the training

shall evaluated through oral questions. The trainee shall be considered as trained only

after qualifies as per the acceptance criteria given in the questionnaire.

3.2              Details of the above training shall be recorded in individual’s training card.

3.3              Based on the category to which the analyst belongs (“with prior experience/ without prior experience”), as per the discussion with the head of the department, the tests in which the analyst shall be trained and qualified depending on the job responsibilities shall be identified.

3.4              The qualification of the analyst on relevant analytical techniques shall be carried out as per annexure -1 attached and for Non Complex analytical techniques shall be carried out as per annexure -2 attached.

3.5              The trainer shall record key points of the analytical technique in the analyst qualification record during the above training.

3.6              The effectiveness of training shall be assessed through a oral questionnaire. The trainee shall be considered as trainee only after the trainee qualifies as per the acceptance criteria.

3.7                 In the analyst register, the trainer shall summarize the observation analyst is qualified or not qualified.

3.8              If not qualified, then relevant steps indicated in the flow chart attached shall be followed.

3.9              The details of the analytical techniques in which the analyst is trained and qualified shall be recorded in the analyst qualification record. as per annexure -3 attached.

3.10          The analyst shall perform the test as per the STP/Specification/GTP, under the supervision of trainer and the qualification shall be verified as per the acceptance criteria as per annexure -4 attached.

3.11          The trainer shall use the checklist provided as per annexure -5 attached, verify whether the analyst undergoing qualification performs all unit operations as per the standard procedure/requirement.

3.12          In case the analyst is found not following correct unit operations while performing the analysis on a pre approved sample, the test shall be repeated completely or only those steps where the unit operations was not correctly followed and all details shall be recorded in the analyst qualification register without raising a non quality impacting incident report.

3.13          For each analytical technique, the details such as name of the analytical technique, product/material name, batch/lot number. A.R.No. of the previous analysis shall be recorded in the analyst qualification register.

3.14           The details of analysis shall be recorded in the qualification sheets/ Records of analysis in case the qualification is performed on routine samples. The AR.No. of the sample being analyzed shall also be recorded in the analyst qualification register as a reference.

3.15          The trainer shall review analytical results and consider the analyst as qualified, if the result of the test performed is complying with the acceptance criteria.

3.16          In case the analyst is being qualified on routine sample, if the sample fails to meet the specification limits an OOS shall be raised.

3.17          OOS investigation shall be conducted as detailed in the SOP.

3.18          Head of the department or his designee shall review the data of technique for which the analyst is under qualification and provide comments as qualified or not qualified in analyst qualification register.

3.19          If the analyst is qualified for a analytical technique listed in a group of analyst qualification record, shall be considered as qualified for other analytical techniques listed in the same group.

3.20             The details of analytical techniques in which the analyst is qualified shall be recorded in the analyst qualification record.

3.21          For Microbial Analyst qualification : The following tests will be conducted to qualify the

  Trainee microbiologist.

Tests	Acceptance criteria
TBC	Shall comply with specification. Both the results should be within 30 cfu/ml or gm difference.
TFC	Shall comply with Specification.
Pathogens	Shall comply with Specification.
Water Analysis	Shall comply with Specification.

3.22          3.22  For Packing material analyst qualification : The following tests will be conducted to qualify the Trainee.

Pack Materials	Tests	Acceptance criteria
Labels Cartons Shippers	Dimensions Grammage Colour Text matter	To comply Specifications.
Bottles	Various Dimensions	To comply Specifications.

4.0       FREQUENCY: As and when analyst qualification is done.

5.0       RESPONSIBILITY: Departmental Head/ Tranee.

6.0       REVIEW GUIDE:  Analyst qualification record.

7.0       ANNEXURE: 1.Flow chart.

                                    2. Non complex analytical techniques for qualification of analysis.

                                    3. Analyst qualification record.

                                    4. Complex analytical techniques for qualification of analysts.

                                    5. Checklist for the analytical qualification

8.0       SOPs DISTRIBUTION:

            This SOP shall be distributed to following Departments:

Name of the Department	Master Copy	Circulatory Copy
QA/QC	√	√
Production	X	√
Warehouse	X	√
General	X	x
Maintenance	X	x