Training SOP

SOP for Training of Employees in Pharma | Training SOP in Pharmaceutical Industry |

Training SOP covers below points:
- Induction training
- Departmental Induction training
- Identification of training needs
- Training method
  - Classroom training
  - Interactive and participative/ external training
- Induction Training format
- Training Calendar format

1.0 OBJECTIVE :

To describe the procedure for conducting training of operating personnel at all levels for improving the morale, delegation and competency.

2.0 SCOPE :

This SOP shall be applicable to all the personnel including helpers, operators, officers, executives and managers.

3.0 RESPONSIBILITY :

Human Resource department is responsible for Induction training of the new recruit. The record of the same is maintained by Human Resource department.
Concerned Head/Deputy of the department is responsible for the Departmental Induction training of new recruit. HOD is also responsible to ensure that the every employee of the department should attend the training program (On Job as well as Class Room Training) as per Training Calendar.
Quality Assurance department is responsible for complete implementation of this SOP.
Quality Assurance Head/Deputy shall monitor and fulfill the training needs.

4.0 ACCOUNTABILITY:

Q.A. Head

5.0 PROCEDURE :

5.1 INDUCTION TRAINING:

Induction training is co-ordinated by Human Resource department.
The Human Resource department Officer/ Executive hand over the Induction Training Form (Refer Annexure 01) & Feedback of Induction Training (Refer Annexure 02) to new recruit after filling the Name, Designation, Department and Date of Joining.
Human Resource Head / Deputy give the Induction training to new recruit explaining in brief regarding the policies of Organization (eg. Quality Policy) and other basic information like Products, Departments, Number of Staff and workers, building layout/structure, market/customer etc. with rule and regulations of the organization and also Safety, Housekeeping and Personal Hygiene aspects.
The Human Resource Officer / Executive then takes the new recruit to plant visit as a part of introduction to Head / Deputy for GMP awareness and also to understand the working atmosphere of all the departments.
HOD of Individual department describes / explain the working style, procedures and systems of the department with do’s and don’ts and then enter detail in the Induction Training Form like Name of trainer, sign and Date with remark under the head of Individual department.
After completion of the plant visit, the Human Resource Officer / Executive introduce the new recruit to HOD of the department in which he/she is recruited and maintain the Induction Training Form in the respective Employee’s file in human resource department.
Induction training of the new recruit should be completed within 5 days after its appointment, which depends on earlier exposure of new recruit.

5.2 DEPARTMENTAL INDUCTION TRAINING:

Departmental Induction training is provided by department Head / Deputy.
On job training is also the part of Induction training for new recruit.
HOD of individual department is responsible for training of the new recruit on GMP / GLP aspects, concerned SOPs and related documentation before placing them on the job.
HOD first explains in brief the job responsibilities allocated to the new recruit and also explain him/her the process/system of the department.
All relevant SOPs of the department are provided to read and if he / she not understand anything, explain whenever required.
All relevant documents and records related to his / her job responsibilities which have to be maintained regularly are to be explained by HOD.
The HOD shall ensure that the new recruit has acquired necessary training and experience before giving him / her independent charge of the activities assigned to them.
HOD handover the independent charge of the activities to the new recruit under the supervision of the HOD or the senior person.

5.3 IDENTIFICATION OF TRAINING NEEDS:

The HOD of all departments is responsible for the need based training.
Each department head will identify the generic and specific need to develop the competency. This is based on educational qualification and past experience. The training needs will be identified as “Awareness” or “competence.” “Awareness” denotes the understanding and knowledge of the subject and “competence” denotes the capability of the person to carry out the task with skill and knowledge appropriating the job.
The generic and specific need of each employee will be identified by department head and recorded in the format.

5.4 TRAINING METHODS:

CLASS ROOM TRAINING:
- This training is imparted by senior employee of company or outside expert faculty. The venue is decided as per situation.
- It is a conventional method of training in which the trainer by virtue of knowledge and expertise will impart the training on the subjects, Standard operating procedures, review of standard operating procedures, Standard testing procedures, General Testing Procedures, and Good Documentation practices and other related issue on working of company etc.
- Based on the Training Calendars, the training coordinator of Quality Assurance department shall organize the training program and communicate to respective Trainers and participants.
- Training is provided by the qualified trainers or the HOD / Deputy of the individual department who have the good knowledge regarding the training topic.
- Evaluate the performance of each trainee through oral or written questionnaires immediately after training through Training Evaluation Form (Refer Annexure 06), whenever specific training is given.
- All participants of the training program shall enter the Topic, Name of Trainee, Sign and Date, Date of Training and Name of Trainer in Training Evaluation Form and Solve the Question paper.
- The criteria for the qualification in respective questionnaire shall be 60%. In case trainee scores below the 60%, retraining shall be provided.
- Quality Assurance training coordinator shall be responsible for maintaining the Training File and evaluation forms.
- Quality Assurance department shall maintain training record of all employees working in the plant. The training record of the individual employee is maintained through the “Training Summary of Employee” (Refer Annexure 07) for the Calendar year. The training records shall be preserved with the Quality Assurance department for 5 years minimum.
- Quality Assurance training coordinator issue “Training Attendance Sheet” (Refer Annexure 05) for each training. Quality Assurance Training Coordinator attend the training and record the details like Date of Training, Time of Training, Name of the Trainer, Designation of the Trainer, Topics / Topic No. of the Training and Type of Training. He/ She also marks the appropriate mode of the Training.
- Sr. No. , Name of Trainee, Department, Designation with Sign and Date is filled by the employee who attends the training.
- After completion of training, Trainer writes his / her Name with Sign and Date.
- At the end of the calendar year Quality Assurance Head carry out the review of the Training documents on the basis of the Training Log Book and Training Summary of Employee.
- The Q.A. department shall prepare the annual “Training Calendar” for the year for training on the key topics.
- The training calendar shall include the following:
  - Good Manufacturing Practices
  - Good Laboratory Practices
  - Good Documentation Practices
  - Good Warehouse Practices
  - Quality Management Systems
  - Market Complaints
  - Self inspections
  - Validation/ Qualification
  - Calibrations
  - Water System
  - HVAC System
  - Housekeeping and Personal Hygiene
  - Schedule M and U of Drugs and Cosmetics Rules 1945
  - Standard Operating Procedures
  - Specific operations, job functions and skills.
  - Audit findings, discrepancy reports and regulatory findings audits, follow ups and Compliances.
  - Self Inspection, Development, Cost Control Management/ Executive effectiveness.
- Evaluation of the effectiveness of the training programme shall be done by the trainer based on the questionnaire.
INTERACTIVE AND PARTICIPATIVE/ EXTERNAL TRAINING:
Includes seminars, workshops, conferences, presentations, demonstrations, lectures, case studs, group discussions, group training programme, exhibition etc.
External training is given to the employee as per their training needs identified by head of the department and approved by Head Q.A. Employees are sent for external training to be conducted by experts in respective area on GMP compliances, Good Documentation Practices, Stability study, personality development, safety, cost, new technology etc. On the completion of the training the employee who has attended the training programme shall submit training report along with literature given.

6.0 ABBREVIATIONS:

Abbreviation	Expanded form
SOP	Standard Operating Procedure
Q.A.	Quality Assurance
GMP	Good Manufacturing Practice

7.0 ANNEXURES:

Annexure No.	Title
01	Induction Training Form
02	Feedback of Induction Training
03	Training Calendar
04	Training Log Book
05	Training Attendance Sheet
06	Training Evaluation Form
07	Training Summary of Employee
08	Format for Training Acknowledgement