SOP for Training of Personnel

1. OBJECTIVE
To lay down the procedure for training of personnel

2. SCOPE
This procedure is applicable for all employees working in Production, Quality Control, Quality Assurance, Warehouse, Engineering and other related areas at the company

3. RESPONSIBILITY
• Concerned Department Head: Training needs identification, Conduction of training and feedback.
• Training Co-coordinators: To coordinate training activities.

4. SAFETY INSTRUCTIONS
• N/A

5. PROCEDURE
5.1 Head production/ Deputy should ensure the completion of all batch documents before submitting to QA.
5.2 Training program for the personnel shall be divided into three main areas: Topics relevant to current Good Manufacturing Practices and Good Laboratory Practices.
5.3 On the Job Training (OJT) – Operational & Calibration training for equipment and Instrument, specific training for personnel working in clean areas or areas where sensitizing or hazardous materials are handled. On the job training need identification shall be suggested and implemented by the Head of Department. OJT training shall be assessed by ensuring the understanding by the trainees of the various actions and its importance. Written test assessment may not be followed / compulsory, in such cases.
5.4 Behavioral Training and training related to Safety, Health and environmental management.
5.5 All departments shall depute a person as training coordinator.
5.6 Department head along shall identify the training needs of the employee once in a year.
5.7 All departments shall send training need identification form to HR department and QA department for review and approval.
5.8 HR department and QA department shall make a list of in-house faculties. For workmen, the syllabus will be covered in interactive sessions, especially topics that are related in the day to day work.
5.9 HR department shall prepare annual training plan.
5.10 HR department shall prepare a monthly training schedule.
5.11 Training attendance records shall be maintained.
5.12 Training summary sheet shall be maintained for each employee.
5.13 Feedback from shall be filled by all attendees.
5.14 A written assessment shall be taken by concerned department head/designee.
5.15 Employees who score less than 50 % marks or C grade, a retraining shall be given to them.
5.16 In case of external training, HR department shall take the feedback from the participant(s).
5.17 List of employees sent for external training along with evaluation details will be sent to HR to record in individual files.
5.18 Induction training shall be provided by HR department to all new joiners.
5.19 Training on new SOP shall be given by Dept. Head/Designee to departmental personnel before implementations of a new SOP. Whenever an SOP shall be revised training on revised SOP shall also be carried out. SOP training record shall be maintained.

6. RELATED DOCUMENTS

Training Schedule – Annex-I
Training Documents Format – Annex-II

7. DISTRIBUTION INDEX
Original Copy will be retained by Quality Assurance Department.

DISTRIBUTION INDEX
Distributed To Copy No. Received By/Date
Quality Control Department 01 ,
Production Department 01 ,
Warehouses 01 ,

8. ABBREVIATIONS
Q.A Quality Assurance Department
OJT On the Job Training
HR Human Resources

9. REVISION HISTORY

Revision No. Issue Date Supersedes Reason of Change / Description
          Revision No.              Dated     
00 10/08/2022 00                            N/A First Version

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Pharmaceutical Services

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