STANDARD OPERATING PROCEDURE FOR TRAINING OF PERSONNEL | SOP FOR TRAINING OF PERSONNEL

1.0 OBJECTIVE

1.1 To lay down a standard procedure for training on current Good Laboratory Practices (cGLP), Standard operating procedures, and General training for employees in order to create and update self-awareness, improve working skills, and overcoming of their identified deficiencies (if any) of employees.

2.0 SCOPE

2.1 This SOP shall be applicable to training procedures that come into practice at the time of routine training of all employees working in the Department of Quality Assurance (QAD) and Animal House Facility (AHF).

3.0 RESPONSIBILITY

3.1 Head- QA

3.2 QA Personnel (QAP)

3.3 Head- AHF

4.0 DEFINITIONS

4.1 Nil

5.0 PROCEDURE

5.1 Employees shall undergo a concerted training program based on defined/revised job responsibilities. Training programs fall under the following categories:

5.1.1 Internal training program

5.1.1.1 Induction training program for new employees

5.1.1.2 On-the-job training program

5.1.2 External training program

5.2 Internal training program

5.2.1 Induction training program for new employees

5.2.1.1 QA department shall organize the induction training program for the new joiner.

5.2.1.2 The new joiner shall be briefed about the organization's policy, facility & systems and introduced to every department as per the induction training program and this activity shall be recorded in a format no.: F……………. titled as ‘Induction training Record’ which shall be maintained by the QA department. A copy of the same shall go to the personal file of individual trainees.

5.2.1.3 The new joiner shall go to different departments and acquaint knowledge about the work and the system. The new joint shall go through the relevant standard operating procedures, STPs, Logbooks, etc. of the related departments.

5.2.2 On-the-job training program

5.2.2.1 Provide the training as per SOP for the training of personnel, SOP number SOP………. (Current version).

5.2.2.2 The Head of the department is responsible for organizing the on-job training for each individual. On-job training is based on Standard Operating Procedures/Standard Testing Procedures, Job rotation, new procedures/policies implementation, purchase of new equipment, nonconformities/deviations, safety procedures, and other work instructions related to the job.

5.2.2.3 In case of revision in SOPs, related personnel will be given training for the revised version before the implementation of the revised version.

5.2.2.4 The requirement and frequency of on-job training for all are assigned by the head of the department as per individual job requirements in format F……………. titled as ‘Training calendar for the year-____’ and the same shall be handed over to QA department. In case of any interim training planned (which has not been mentioned in the training calendar) a fresh format F…………….. shall be filled and circulated to the concerned department/s.

5.2.2.5 head of each department shall keep a copy of the ‘Training calendar for the year-____’

5.2.2.6 On-job training is effectively carried out with the help of lectures based on
seminars, presentations, and a practical demonstration of the operation or experiments as applicable.

5.2.2.7 Approved trainer of respective department listed in Annexure no.: A…………….. shall conduct the training and shall make attendance record as per Format No.: F…………….. titled as ‘Training attendance record’.

5.2.2.8 In case of addition or deletion of approved trainer the list shall be updated within one week of change.

5.2.2.9 After training trainer shall evaluate the trainees through questionnaires in Format No.: F………………………… titled as ‘Post-training evaluation questionnaires’.

5.2.2.10 Questions for assessment shall be written/typed in advance by the trainer and the required number of photocopies shall be taken.

5.2.2.11After completion of training all questionnaires shall be assessed and grading shall be assigned by the trainer.

5.2.2.12 Grading and retraining need assessment shall be carried out on the basis of marks obtained as per Table 1 below:

Table – 1
Competency Evaluation Rating
RATING	GRADE
above 80%	Excellent
71%-80%	Good
61%-70%	Average
Below 60%	Poor

5.2.2.13 Trainer shall complete the Training attendance record & Post training evaluation questionnaires and the same shall be handed over to the QA department. In the case of oral/mock tests, the trainer shall fill grading without any questionnaires. A copy of the Training attendance record format shall go to the personal file of all attendees.

5.2.2.14 QA Department shall coordinate the training program activities and ensures necessary documentation by all personnel.

5.2.2.15 All Individuals shall maintain and update the index of their all training in a format no. F…………………… entitled ‘Individual training record’ in their Personal file.

5.3 External Training

5.3.1 Employees will also be deputed for external training programs for special training in their work-related areas as and when required and records shall be maintained as per above discussed formats.

5.4 Requirements of Trainer

5.4.1 Trainer shall be having sound technical & practical knowledge of the subject in which he is going to give training.

5.4.2 Usually the trainer is qualified & has previous experience in the concerned field.

5.4.3 Trainer can be the immediate supervisor, executives of the concerned department, or department head / QA / external as applicable.

5.4.4 Apart from the subject knowledge a trainer must also have good interpersonal & communication skills.

5.4.5 Internal Trainers are trained from time to time by the department head / QA based on the requirement or undergo external training.

6.0 ENCLOSURES

6.1 Formats

Sr. No.	Format Title	Format No.	No. of pages
	Induction training Record	F……………………	01
	Training calendar for the year-___	F……………………	01
	Training attendance record	F……………………	01
	Post-training evaluation questionnaires	F……………………	02
	Individual training record	F……………………	01

6.2

Annexures

Sr. No.	Annexure Title	Annexures No.	No. of pages
1.	List of approved trainers	F……………………	01

7.0 ABBREVIATIONS

7.1 SOP- Standard Operating Procedure

7.2 QAD- Department of Quality Assurance

7.3 AHF- Animal House Facility

8.0 REFERENCES

8.1 In-house

9.0 REVISION HISTORY

9.1 Nil


                                                                   END OF DOCUMENT


Enable GingerCannot connect to Ginger Check your internet connection
or reload the browserDisable in this text fieldEditEdit in GingerEdit in Ginger×

SHARE

Owner

Hi. I’m Writer of Researchsop.com. ’ ’ Please share these SOPs to all concern pharma people for their development. I like to fullfill the need of curious people. These things inspire me to make things looks better.

• 
• 
• 
• 
•