Standard Operating Procedure of Training of Personnel in Pharmaceuticals is describe in this post.
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1. Purpose:
1.1. The purpose of this SOP is to describe the procedure for training of the personnel working under cGMP environment at Pharmaceuticals.
2. Scope:
2.1. The scope of this SOP pertains to all the persons working at Pharmaceuticals.
3. Responsibility:
3.1. It is the responsibility of departmental heads to follow this SOP as it is written.
3.2. It is the responsibility of QA to ensure that all employees have been trained and qualified in their respective job functions, regulatory and compliance procedures and safety regulations.
3.3. It is the responsibility of QA to review and update this procedure as necessary and to ensure its compliance.
4. Definitions:
4.1. Orientation Training: Training of new employees, covering Company general rules, job description, cGMP concepts, safety regulations etc.
4.2. Document Training: Document training is conducted by QAD. Managers / supervisors or an author can also conduct document training.
4.3. Task Training: Tasks training refers to particular methodology or process training and applies in laboratory and production areas.
4.4. Proficiency Training: Training by experience of at least one more years at any particular discipline.
4.5. Equipment Training: Equipment training refers to operation of equipment.
5. Procedure:
5.1. Orientation Training (General cGMP Training)
5.1.1. All the new employees at Pharmaceuticals. have to complete orientation training which includes the following, depending upon the nature of the job responsibility of the person:
(1) General Company Policies and Regulations
(2) cGMP requirements and documentations
(3) Personnel hygiene
(4) Procedures for Gowning and De-gowning
(5) Job descriptions
5.1.2. HR department intimates to QAD and arrange the orientation training for the newly appointed employees.
5.1.3. QA Department conducts the training in different stages considering the job requirements of the trainee.
5.1.4. At the end of training, trainer gives a questioner to all the participants about the training.
5.1.5. Name and signature of the trainee are recorded on Training Participants List.
5.1.6. Trainer signs the Training Participants List and forwards it to QA for record keeping.
5.1.7. QA maintains the training record in Training Record File.
5.2. On-Job Training
5.2.1. Department heads identify the training needs of the employees working under their supervision.
5.2.2. On-Job training includes both task training and equipment training.
5.2.3. The trainee observes the trainer, while performing a task or operating equipment and follow the instructions to understand it.
5.2.4. The trainee performs the same task or operation thrice under the supervision of the trainer.
5.2.5. The trainer must observe the trainee performance during task execution.
5.2.6. The trainer evaluates the trainee's performance. The evaluation is done on the basis of consistency in the performance.
5.2.7. Upon successful completion of training, trainer gives the approval that the trainee is now qualified to perform the particular task independently.
5.2.8. The trainer and trainee complete the Training Record Form after training and topic of training should be written on form.
5.2.9. QA keeps the training record of employees.
5.2.10. Fill the separate training forms, incase multi disciplinary training is given (for more than one equipment/task).
5.3. Document Training
5.3.1. Document training is done either by QC/QA/ Production or other departmental head, or designee.
5.3.2. QA/QC/Production informs trainee/s about the training venue, time and makes necessary arrangement for the training.
5.3.3. The trainer and trainee discuss the document in detail, addressing all the relevant issues and questions of the trainee.
5.3.4. At the end of training, trainer gives a questioner to all the participants about the document.
5.3.5. Name and signature of the trainee/s are recorded on Training Participants List.
5.3.6. Trainee fills the Training Record Form, at the end of training.
5.3.7. Trainer signs the Training Participants List and forwards it to QA for record.
5.3.8. QA keeps the training Form in Training Record File.
NOTE: The trainee's signature indicates that he/she fully understand the content of the document on which training is given.
5.4. Schedule Training
5.4.1. Department heads make a schedule for cGMP routine trainings according to the requirements of their working areas.
5.4.2. The schedule trainings are conducted at least on quarterly basis.
5.4.3. The training schedule for all the departments must be approved by QA on yearly basis, Training Schedule.
5.4.4. Trainers arrange the training at the schedule date and inform the trainee/s about the time and venue of training.
5.4.5. Name and signature of the trainee are recorded on Training Participants List
5.4.6. Trainer signs the Training Participants List and forwards it to QA for record.
5.4.7. QA maintains the record of the training in Training Record File.
5.5. Out-Source Training (External Training)
5.5.1. Pharmaceuticals arranges out-source training for its employees, whenever required, to improve their competency in the job.
5.5.2. QA keeps the record of Out-source trainings.
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