SOP on Employee’s Training
Objective: the objective of the training is to render all categories of employees competent enough to deliver their duties in an effective way.
Scope: The policy applies to the training of all employees involved in the manufacture and quality control of drug products.
Responsibilities: The management is responsible for ensuring that the persons employed in the company have an appropriate training.
Materials and Equipment: As required.
Procedure: Training covers the principle of GMP, duties and responsibilities of personnel, importance of cleanliness in the working area and personnel hygiene. Training is given at the time of recruitment to all the new employees and repeated with sufficient frequency, as per the program to ensure that all the employees remain familiar with cGMP.
Schedule: Training is provided to all personnel in different phases. The training needs are determined and accordingly training programs are prepared.
The training is imparted to the following categories of personnel:
-Managers
Senior Chemist
Asstt. Chemist
Workers / Operators
The training programs are conducted in the following way –
– Lectures
– Demonstrations
– On Job Training
– Awareness Programs
Training may be imparted individually or in group.
Unannounced training program may be conducted.
Records: it is the Quality Assurance Manager’s responsibility to document each training program and maintain the records.