1/31/2017 SOPforTrainingProcedureforQualityControl:PharmaceuticalGuidelines

SOPforTrainingProcedureforQualityControl
Standard operating procedure of training procedure for personnel working in Quality Control.
1.0 OBJECTIVE
To describe the procedure for Training procedure for QC persons.
2.0 SCOPE
This SOP is applicableforTraining procedure for QC persons.
3.0 RESPONSIBILITY
Officer/ Executive Quality Control
4.0ACCOUNTABILITY
Manager Quality Control
5.0PROCEDURE
5.1Procedure
5.1.1Qualified individual, knowledgeable in the subject / topic who is able to effectively communicate the information should conduct training. A person o
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 regular job.
5.1.3The 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 shouldscore 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 allowe
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
ANNEXUREI
TRAINING RECORD
Title..
Trainer Name .. Date.
Sign. of Trainer From ...to.

http://www.pharmaguideline.com/2011/04/sopfortrainingprocedureforqc.html 1/2
1/31/2017 SOPforTrainingProcedureforQualityControl:PharmaceuticalGuidelines
Sr. No. Name of the trainee Department Employ Evaluation on the basis
Sign. of
Questionnaires/Discussi
on

Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widelyread pharmaceutical
blog since 2008. Signup for the free email updates for your daily dose of pharmaceutical tips.
Need Help: Ask Question
Online

http://www.pharmaguideline.com/2011/04/sopfortrainingprocedureforqc.html 2/2