SOP for Training Procedure for Quality Control

1.0 OBJECTIVE

To describe the procedure for Training procedure for QC persons.

2.0 SCOPE

This SOP is applicable for Training procedure for QC persons.

3.0 RESPONSIBILITY

Officer/ Executive - Quality Control

4.0 ACCOUNTABILITY

Manager – Quality Control

5.0 PROCEDURE

5.1 Procedure

5.1.1 Qualified individual, knowledgeable in the subject/ topic who is able to effectively communicate the information should conduct training. A person of supervisory or managerial cadre is most often required to give training.
5.1.2 Permanent and temporary employees must be trained and have basic knowledge and understanding of their job function. Experienced employees must also be trained for new or changed procedure in addition to the regular job.
5.1.3 The program should include the following kinds of training:
5.1.3.1 Orientation/ general information for new and temporary employees.
5.1.3.2 GMP and GLP concepts and procedures.
5.1.3.3 Theoretical knowledge for job-related training.
5.1.3.4 On the job training.
5.1.3.5 Safety.
5.1.3.6 General Operations / procedures.
5.1.3.7 Outside seminars, conference etc.
5.1.4 Training require to be imparted to the personnel should be decided in the month of December every year. A program is to be established for the entire subsequent year by the HOD and record as per format for training schedule. Depending upon the individual job requirement the areas of training to be imparted and goals of the training are to be decided by the HOD and QA/QC Manager.
5.1.5 Training should be on continuing basis and with sufficient frequency. It should include the topics to be covered, the people to attend and the approximate timing for each session. In some instances, it may be necessary to schedule the same topic more than once to ensure that all relevant employees attend.

5.2 Program

5.2.1 Conduct the training session by any of the following methods.
5.2.1.1 Lecture or presentation.
5.2.1.2 On job training.
5.2.1.3 Educational material / handouts.
5.2.1.4 Slide/tape/video presentation.
5.2.1.5 Computer program.
5.2.2 Evaluate effectiveness and training through questionnaires, performance indicators (e.g. parallel testing by trainer and trainee) direct observation or discussion / review with supervision for job competence.
5.2.3 Prepare a report containing the name of trainer, his designation, names of trainees, subjects covered, evaluation sheets, any raw data that may have been generated during the course of training, mark obtained by the trainee and comments of the trainer etc. as per Annexure – 1.

5.3 Evaluation Criteria

5.3.1 In case of questionnaires / individual discussion if candidates should score the between (90 to 100%) marks. Evaluation counted Excellent performance.
5.3.2 In case of questionnaires/ individual discussion if candidates should score the between (80 to 90%) marks. Evaluation counted Very good performance.
5.3.3 In case of questionnaires/ individual discussion if candidates should score the between (70 to 80%) marks. Evaluation counted Better performance.
5.3.4 In case of questionnaires/ individual discussion if candidates should score the between (60 to 70%) marks. Evaluation counted Good performance.
5.3.5 In case of questionnaires/ individual discussion if candidates should score the between (50 to 60%) marks. Evaluation counted Average performance.
5.3.6 In case of questionnaires candidates do score below 50% marks. Evaluation counted, provide retraining for candidates.
5.3.7 In case of parallel testing compare the results of trainer and trainee and if the results of trainee are found satisfactory then the trainee may be allowed to undertake the particular testing.
5.3.8 Retraining is necessary if the trainee scores less than 50% marks or does not qualify for testing.
5.3.9 Frequency: As per schedule and whenever required.
Related: Organogram and Job Responsibilities in Pharmaceuticals

6.0 ABBREVIATIONS

6.1 SOP - Standard Operating Procedure
6.2 No. - Number
6.3 QA - Quality Assurance
6.4 NA - Not Applicable
6.5 CCF - Change control format
6.6 QC - Quality Control

ANNEXURE-I

TRAINING RECORD

Title……………………………………………………………………………………………………..

Trainer Name ………………………..                                                Date……………………….

Sign. of Trainer………………………                                               From …………...to……….

Sr. No.	Name of the trainee	Department	Employ Sign.	Evaluation on the basis of Questionnaires/Discussion

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