SOP For Storage and Use of Reagents & Chemicals

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Document No: Page No.
SOP/QC/055 SOP for Storage and Use of Reagents & Chemicals Page 1 of 4
Effective Date Revision Date
SOP for Storage and Use of Reagents & Chemicals
Prepared by： X X
Department Name Date
Checked by： Y Y
Approved by： Z Z
1. Purpose
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Title:
This procedure defines procedure to store and use of Reagents and Chemicals in Quality
Control
2. Scope
This procedure is applicable to for all chemical and reagents received in quality control.
Validity
This SOP is valid only until next revision date and if it bears control seal.
3. Responsibility
It will be the responsibility of the Quality Control supervisor to follow the procedure.
Quality assurance manager is responsible for SOP compliance.
4. Material and Equipment
None
5. Procedure:
6.1. 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.
6.2. 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.
6.3. The program should include the following kinds of training:
6.3.1. Orientation / general information for new and temporary employees.
6.3.2. GMP and GLP concepts and procedures.
6.3.3. Theoretical knowledge for job related training.
6.3.4. On the job training.
6.3.5. Safety.
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6.3.6. General Operations / procedures.

6.3.7. Outside seminars, conference etc.
6.4. 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.
6.4.1. 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.
6.5. Program
6.5.1. Conduct the training session by any of the following methods.
6.5.1.1. Lecture or presentation.
6.5.1.2. On job training.
6.5.1.3. Educational material / handouts.
6.5.1.4. Slide/tape/video presentation.
6.5.1.5. Computer program.
6.5.2. 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.
6.5.3. 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.
6.6. Evaluation Criteria
6.6.1. In case of questionnaires / individual discussion if candidates should score the
between (90 to 100%) marks. Evaluation counted Excellent performance.
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6.6.2. In case of questionnaires/ individual discussion if candidates should score the

between (80 to 90%) marks. Evaluation counted Very good performance.
between (70 to 80%) marks. Evaluation counted Better performance.
between (60 to 70%) marks. Evaluation counted Good performance.
between (50 to 60%) marks. Evaluation counted Average performance.
6.6.6. In case of questionnaires candidates do score below 50% marks. Evaluation
counted, provide retraining for candidates.
6.6.7. 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.
6.6.8. Retraining is necessary if the trainee scores less than 50% marks or does not
qualify for testing.
6.6.9. Frequency: As per schedule and whenever required.
Related: Organogram and Job Responsibilities in Pharmaceuticals

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