Name & Address: ABC Standard Operating Procedure

Page 1 of 11
Department: Quality Assurance
TITLE: EMPLOYEE TRAINING IN PHARMA

SOP No.: Supersedes No.: Next Review

Issue date Effective date
NA date
Format No.:
CC No.: New
QA/001

1.0 PURPOSE

To ensure that all the employees have the knowledge and skills necessary to perform
there assigned duties and responsibilities consistent with the current Good
Manufacturing Practices (cGMP). 

2.0 SCOPE

This SOP is applicable to all the employees of Company.

3.0 RESPONSIBILITIES

All the department heads and Training Coordinator, QA Head shall be responsible for
training program in the factory.

4.0 REFERENCES

SOP-QA-001-04

5.0 DEFINITIONS

Qualified individual: An individual “who, by possession of a recognized degree,

certificate or professional standing, or who by extensive knowledge, training and
experience.

 On the job training: It is a form of training provided at the workplace.

6.0 PROCEDURE

6.1 REQUIREMENT OF TRAINING:

It is necessary that all the employees at the plant have an appropriate combination of
education, training and experience to enable them to perform their assigned functions.
Therefore a training program covering the following aspects shall be designed for all
the employees.
Prepared by: Checked by: Approved by:

Name: Name: Name:

Date: Date: Date:
Designation: Designation: Designation:Manager QA
 Name & Address: ABC Standard Operating Procedure
Page 2 of 11
Department: Quality Assurance
TITLE: EMPLOYEE TRAINING IN PHARMA

SOP No.: Supersedes No.: Next Review

Issue date Effective date
NA date
Format No.:
CC No.: New
QA/001

6.1.1 cGMP training shall be given as per the nature of job to all employees,
twice a year criterion.

6.1.2 In house qualified individuals and external faculty shall conduct training.
The trainer will make the training material (such as power point
presentation).

6.1.3 The HOD shall prepare ‘Identified Training needs and Schedule’ for
individual employee refer as per Annexure-I, III.

6.1.4 Training coordinator shall maintain employee training record and the
training given in the course of employment.

6.1.5 For every training coordinator shall maintain attendance record duly
signed by trainees.

6.1.6 Each training shall be concluded by written or verbal evaluation.

6.2 QUALIFICATION FOR TRAINERS:

6.2.1 The basic qualification for the trainer is compliance to one or more of the
following    criterion.

6.2.2 Necessary education with minimum 5 years of total experience in the

relevant field in which training is being imparted.

6.2.3 Good communication skills in both writing and oratory sound knowledge
in the relevant field.

6.2.4 Certified or qualified to impart training in the specific subject

6.2.5 Document Trainer qualification

6.3 TRAINING OF NEW RECRUITS:

Prepared by: Checked by: Approved by:

Name: Name: Name:

Date: Date: Date:
Designation: Designation: Designation:Manager QA
 Name & Address: ABC Standard Operating Procedure
Page 3 of 11
Department: Quality Assurance
TITLE: EMPLOYEE TRAINING IN PHARMA

SOP No.: Supersedes No.: Next Review

Issue date Effective date
NA date
Format No.:
CC No.: New
QA/001

6.3.1 INDUCTION PROGRAM:

6.3.1.1 Every new employee shall be given induction training with a view
to facilitate entry into the organization and to explain with the
systems and procedures applicable.

6.3.1.2 During the induction training all new employees shall be formally
inducted to the company. The Training Coordinator & HR and the
QA Heads shall be responsible for training the employees at this
stage.

6.3.1.3 During induction training, the employees shall receive instructions

in the   following areas as appropriate

a)      General GMP
b)      Good Documentation Practices
c)      Entry / Exit Procedure and controls
d)     Cross contamination & mix up
e)      Tablet and Capsule
f)       Ware housing
g)      Utilities & Planned Preventive Maintenance
h)      Quality Control 
i)        General Health and Industrial Safety
6.3.1.4 The induction training shall be carried out in accordance with the
schedule specified and the details of training imparted shall be
recorded by the training coordinator in ‘Induction Training’
record.

6.3.1.5 At the end of the induction training, the evaluation shall be done
as per ‘Induction Questionnaire’.

6.3.1.6 After completion of the induction training, department head shall

Prepared by: Checked by: Approved by:

Name: Name: Name:

Date: Date: Date:
Designation: Designation: Designation:Manager QA
 Name & Address: ABC Standard Operating Procedure
Page 4 of 11
Department: Quality Assurance
TITLE: EMPLOYEE TRAINING IN PHARMA

SOP No.: Supersedes No.: Next Review

Issue date Effective date
NA date
Format No.:
CC No.: New
QA/001

prepare “Identified Training needs and Schedule” for the new

employee and copy of the same is with department head.

6.3.1.7 The questionnaire related to topics mentioned in “Identified

Training needs and Schedule”. Induction training refer
Annexure-III, General GMP: Printed copy available with QA
along with questionnaire, QA SOP (Critical) questionnaire if
require with QA department, Departmental SOP questionnaire if
require with respected department.

6.3.2 EVALUATION

6.3.2.1 The effectiveness of training shall be evaluated by written test or

by verbal evaluation. Trainee shall write the answers in the
stipulated time period or can answer verbally

6.3.2.2 Trainer shall evaluate the trainee based on the marks scored by
him/her. The details of evaluation shall be recorded in ‘Training
Evaluation Sheet’.

Criteria for Grades

evaluation

100% Excellent

> 90%   Very good

80-90%   Satisfactory

< 80%       Poor and Retraining

required

6.3.2.3 All the training evaluation sheets should be reviewed and signed
Prepared by: Checked by: Approved by:

Name: Name: Name:

Date: Date: Date:
Designation: Designation: Designation:Manager QA
 Name & Address: ABC Standard Operating Procedure
Page 5 of 11
Department: Quality Assurance
TITLE: EMPLOYEE TRAINING IN PHARMA

SOP No.: Supersedes No.: Next Review

Issue date Effective date
NA date
Format No.:
CC No.: New
QA/001

by QA personnel.

6.3.2.4 Unsuccessful employees (< 80%) shall be retrained immediately.

6.3.3 ON THE JOB TRAINING

6.3.3.1 After completion of induction and orientation programme new

employee shall be sent to respective departments for under going
on job training.

6.3.3.2 Initially the senior technical personnel would explain the

procedure, step involved, precautions to be taken and would
perform the activity with new recruit observing

6.3.3.3 After minimum three of such sessions or as and when trainer is

confident of new recruit’s performance, the new recruit would
perform the activity under the observation of senior technical
personnel.

6.3.3.4 Only successful employee shall be allowed to perform his

assigned duties and responsibilities.

6.3.3.5 On job training shall be documented.

6.3.4 EVALUATION

6.3.4.1 Refer point no. 6.3.2 for Evaluation Criteria.

Note: For on the job training (Standard Operating Procedure) Evaluation

criteria shall be not less than 100 %

6.4 TRAINING IN THE COURSE OF EMPLOYMENT:

6.4.1 In-house training or training from outside faculties including seminars

shall be organized as per the training plan / card. For any training outside

Prepared by: Checked by: Approved by:

Name: Name: Name:

Date: Date: Date:
Designation: Designation: Designation:Manager QA
 Name & Address: ABC Standard Operating Procedure
Page 6 of 11
Department: Quality Assurance
TITLE: EMPLOYEE TRAINING IN PHARMA

SOP No.: Supersedes No.: Next Review

Issue date Effective date
NA date
Format No.:
CC No.: New
QA/001

the scope of training card shall be given by external faculty or

consultancy by training institution and shall be recorded in as per
Annexure-II.

6.4.2 In addition to the training imparted based on the “Identified Training

needs and Schedule” shall be given in the event of following:

a) Introduction of new Quality Assurance SOP

b) Revision of SOP

c) Observations of Audits

d) Explanation of incidence

e) Sharing investigation finding

6.4.3 The details of training programme conducted shall be recorded in

‘Training Record’. Refer the as per Annexure-II.

6.4.4 The details of training given as recorded in the Training Record

Annexure-III and the training Evaluation result record shall be posted in
the format as per Annexure-II.

6.4.5 Training Record as per Annexure-II shall be filed in a separate file for
training imparted in the course of employment.

6.4.6 As and when required the personnel shall be sent for attending training
programme conducted by external training institutions, manufacturers of
machineries, equipment, etc.

6.4.7 The individual after attending the external training shall submit the
training report along with hand out & documents received during training
to QA for record.

Prepared by: Checked by: Approved by:

Name: Name: Name:

Date: Date: Date:
Designation: Designation: Designation:Manager QA
 Name & Address: ABC Standard Operating Procedure
Page 7 of 11
Department: Quality Assurance
TITLE: EMPLOYEE TRAINING IN PHARMA

SOP No.: Supersedes No.: Next Review

Issue date Effective date
NA date
Format No.:
CC No.: New
QA/001

6.5 SELF TRAINING RECORD

6.5.1 Details of all the training Programmes attended by trainees shall be

entered in training record (Annexure-II) and photocopy of the same to be
filed in Individual Training Record.

6.5.2 Individual training schedule for complete year to be prepared and enter in
Individual training schedule record. (Annexure-III)

6.5.3 The following details shall be entered in the training record,

a) Topic

b) Trainer

c) Date, Time, From, To, Duration

d) Venue

e) Mode of training

f) Details of participants

g) Trainer, Name, Sign, Date

h) Reviewed by (Training co-ordinator) Name, Sign, Date

6.5.4 A file for each employee shall be maintained with all the details of
schedules, training records and evaluation sheets.

Prepared by: Checked by: Approved by:

Name: Name: Name:

Date: Date: Date:
Designation: Designation: Designation:Manager QA
 Name & Address: ABC Standard Operating Procedure
Page 8 of 11
Department: Quality Assurance
TITLE: EMPLOYEE TRAINING IN PHARMA

SOP No.: Supersedes No.: Next Review

Issue date Effective date
NA date
Format No.:
CC No.: New
QA/001

7.0 ATTACHMENTS

No. Title Format No.

1 Annexure-I: Identification of training needs.
2 Annexure-II: Training attendance sheet.
3 Annexure- III: Training Calendar

8.0 ABBREVIATIONS

Abbreviation Full Form

CC Change control
No. Number
QA Quality Assurance
SOP Standard Operating Procedure
HR&A  Human Resource and Administration
QCD Quality Control Department
No. Number
c-GMP Current Good Manufacturing Practice
HOD Head of Department

9.0 CHANGE HISTORY

Effective Date Version Reason for Changes

00

Prepared by: Checked by: Approved by:

Name: Name: Name:

Date: Date: Date:
Designation: Designation: Designation:Manager QA
 Name & Address: ABC Standard Operating Procedure
Page 9 of 11
Department: Quality Assurance
TITLE: EMPLOYEE TRAINING IN PHARMA

SOP No.: Supersedes No.: Next Review

Issue date Effective date
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Format No.:
CC No.: New
QA/001

ANNEXURES-1

Identification of training needs

Sr.No Training Proposed Name of Emp.Cod Designation Remarks

Subject Month of Employe e
training e

Prepared By: Reviewed By: Approved By:

Sign/Date Sign/Date Sign/Date

Prepared by: Checked by: Approved by:

Name: Name: Name:

Date: Date: Date:
Designation: Designation: Designation:Manager QA
 Name & Address: ABC Standard Operating Procedure
Page 10 of 11
Department: Quality Assurance
TITLE: EMPLOYEE TRAINING IN PHARMA

SOP No.: Supersedes No.: Next Review

Issue date Effective date
NA date
Format No.:
CC No.: New
QA/001

ANNEXURES-II

Training attendance sheet

Subject:
Faculty:
Signature:
Venue: Date:

Sr.No Partcipant Employee Department Participant Signature

s Name No.

Prepared By: Reviewed By: Approved By:

Sign/Date Sign/Date Sign/Date

Prepared by: Checked by: Approved by:

Name: Name: Name:

Date: Date: Date:
Designation: Designation: Designation:Manager QA
 Name & Address: ABC Standard Operating Procedure
Page 11 of 11
Department: Quality Assurance
TITLE: EMPLOYEE TRAINING IN PHARMA

SOP No.: Supersedes No.: Next Review

Issue date Effective date
NA date
Format No.:
CC No.: New
QA/001

ANNEXURES-III

Training Calendar

Name:
Date of Joining:
Designation:
Date: Employee No:
Department:

Sr.No Subject Date of Duration Faculty/ Venue Grade Date Sign

Training Agency

Prepared By: Reviewed By: Approved By:

Sign/Date Sign/Date Sign/Date

Prepared by: Checked by: Approved by:

Name: Name: Name:

Date: Date: Date:
Designation: Designation: Designation:Manager QA