OM MEGASHREE PHARMACEUTICAL PVT.

LTD
JUGEDI, CHITWAN

Document Number Revision Effective Date

1.0 INTRODUCTION
Pharmaceutical Ltd. recognizes the importance of formalized training programs to impart training to all
employees of various levels.

This “Training Manual” is prepared at the beginning of calendar year to enhance the effectiveness of
training procedure existing in the company.

Training Manual includes the various Types of training and cGMP training schedules for each
department, which identifies the name of the topic, targeted audience & trainer to conduct the training
in all organized manner.

Departmental training schedules are prepared by concerned departmental head in coordination with
the head – QA, keeping in mind the background of training needs.

“SOP” training is not included in the Manual, since it will be covered in the change management system,
via a separate SOP. Whenever a new SOP is made (or) existing SOPs is revised, the respective dept.
personnel are trained to make them familiar with the activities mentioned in the SOPs to make them
effective.

2.0 OBJECTIVE

To ensure that all the employees working in Pharmaceutical Ltd., are capable to perform the duties as
per the cGMP, SOPs and procedures and each employee of Pharmaceutical Ltd., shall improve the
relevant knowledge, expertise and to consolidate the same to discharge their duties effectively. cGMP
advises that appropriate training is required to perform the jobs effectively, which in turn helps in
maintaining the quality system.
OM MEGASHREE PHARMACEUTICAL PVT. LTD
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3.0 SCOPE

This procedure applies for training of all levels of employees and permanent workers, working in

Pharmaceutical Ltd.

4.0 RESPONSIBILITIES

Departmental heads are responsible to ensure that the training programs are conducted as per the
schedule in respective departments.

Personnel & administration department is responsible to coordinate with the trainer, trainee and
departmental heads and to monitor the schedules, to organize the trainings and to keep the training
records, department wise and individually.

Trainer should prepare / refer the (training) course material and a questionnaire will be prepared for
each topic in consultation with the departmental heads / seniors.

After completion of each session, trainer should evaluate feedback. If some body needs retraining it
should be organized in coordination with the personnel and administrative department.

Each trainee should sign in their departmental training log after attending the training program.

Each employee is responsible to attend the training / retraining as per the schedule communicated to
him.

QA shall verify whether the Training program is carried out as per the schedule during their audits.
 OM MEGASHREE PHARMACEUTICAL PVT. LTD
JUGEDI, CHITWAN

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5.0 PROCEDURE

TYPES OF TRAINING:

5.1 Induction training

5.2 On job training

5.3 GMP training (Interim),

5.4 External training

MANUAL PREPARATION:

 Individual Departmental Schedules of training topics are prepared by the respective departmental heads,
reviewed by Executive – Production, which is Approved by QA and Authorized by Plant Head and then
included in the training Manual.

 The schedules are prepared by departmental head in consultation with Executive – Production, Q.A , Q.C
identifying the training needs of personnel in respective departments in connection with WHO-GMP
system. By including individual departmental schedules besides the coverage of other kind of topics a
training Manual shall be compiled by Q.A.

 A training Manual for the next calendar year may be prepared in the month of March or in advance as
appropriate.

 Training Manual should be approved by Q.A and Authorized by Plant Head prior to issuance and
implementation.
 OM MEGASHREE PHARMACEUTICAL PVT. LTD
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 A copy of the training Manual shall be issued to personnel dept and Personnel Department will circulate a
copy of the departmental training schedules to the respective head of departments.

 A master copy of training Manual shall be retained at Q.A and controlled copy circulated to Executive – P &
A.

5.1 Induction training

(Chemists, Officer, Executives & Above)

Each new employee from supervisory and above will be given induction training in the following aspects:

 Introduction about the company’s code of conduct and job responsibilities.

 Personal hygiene, dos & don’ts.

 Importance of GMP and its compliance, key elements of GMP and GLP (Good laboratory practices) as
appropriate.

 An induction program will be arranged by Executive – Production, where the new person will be made
familiar with the contact people in each dept. and the activities that are being carried out in those
departments.

Induction training (workman / Workmen)

Each new employee will be given induction training in the following aspects by Executive – Production.

 Introduction about the company.

 Definition of GMP, its importance and basic rules of GMP.

 OM MEGASHREE PHARMACEUTICAL PVT. LTD
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 Personal hygiene, personal up keepment at the work place and gowning procedures.

 Briefing about their job responsibilities.

Evaluation of Induction training

 Evaluation of induction training will be done by oral questioning and interactive sessions; hence no
specific evaluation will be done. Mainly this training is to make the employees familiar with the
organization and their job roles / requirements in brief and to know the preliminary information about
the organization and the contact personnel.

5.2 “On the job” training:

 The topics will be selected on the basis of training needs related to the job by department Heads
periodically. The training will be conducted “on the job” at the work places like manufacturing floor and in
the Q.C lab etc (In brief at the work place.)

 If required, classroom sessions will be also conducted to impart the knowledge about the theory as
decided by the department Head (trainer).

 Training on relevant process equipment/analytical instruments, manufacturing process steps and

detailed procedure to operate the same equipment/ instruments to be practically demonstrated /
explained. Other procedures shall also be practically explained on the job as applicable.

 Trainer shall write the remark that participants were “trained”, head of department review shall be carried
out and review comments shall be recorded in the same format.
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 On job training shall be documented only in the format “Department Training Log”.

 Schedules are prepared by head of department for on job training and the same will be complied to make
the employees pertinent to their relevant jobs that they carried out.

5.3 GMP Training:

 GMP training schedules are prepared as part of training Manual by each dept. Head, reviewed by Manager
– HR, Approved by Manager- Q.A and Authorized by Plant Head.

 Training sessions shall be conducted by the respective department Heads as per the schedules and
necessary evaluation shall be done at the end of the training session, which shall be documented in the
training logs and training cards and brief summary is recorded in the on the job training format.

Evaluation of GMP training:

 The effectiveness of the training will be evaluated for GMP training.

 Trainees will be assessed by written test (objective questionnaire) / oral as appropriate depending on
the training topic.

 The understanding about the topic on which participant was trained will be assessed by the percentage
of marks obtained. The trainee should obtain more than 80% Marks. The trainee who scores less than
80% will be retrained. Suitable method of departments can adopted for oral assessments.
 OM MEGASHREE PHARMACEUTICAL PVT. LTD
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5.4 External training:

External training will be imparted to chemists, Officers / Executives and other personnel based on the
needs. Normally following training topics are covered under this training.

 cGMP (current Good Manufacturing Practice).

 GLP (Good Laboratory Practice).

 Validations.

 Regulatory aspects.

 Other topics as appropriate.

External training shall be recorded in the individual training cards, no specific formats /Logs are
maintained for this kind of training. Training evaluation record shall be maintained.

6.0 TRAINING RECORD:

6.1 All the employees training details are recorded in Training Card maintained at
Human Resource department and in the respective “Log Book” for Training. .
6.2 Training needs shall be identified by the respective department heads, before preparation of
schedules to be included in subsequent calendar year training Manual.

6.3 All the training related formats are specified in the Annexure. Each training shall be recorded as in
the Annexure as Indicated below.

7.0 MODEL DOCUMENTS / FORMATS:

OM MEGASHREE PHARMACEUTICAL PVT. LTD
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7.1 Annexure – I: Induction Training Format.

7.2 Annexure – II: GMP / On job Department Training Log.

7.3 Annexure – III: GMP/ On Job Training Report Format.

7.4 Annexure – IV: Employee Training Card.

ANNEXURE-I

INDUCTION TRAINING FORMAT

Issued By: Topic: INDUCTION TRAINING

(Executive – P & A)

Name of the Employee: Designation:

Dept: Date of joining:

Remarks After training by Executive – P & A

OM MEGASHREE PHARMACEUTICAL PVT. LTD
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Remarks After training by Head - Q.A

Conducted By Sign Date

1.

2.

Note:-One form shall be filled for each employee

After Induction training program, Details shall be recorded in the following form.
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ANNEXURE-II

GMP / ON JOB DEPARTMENT TRAINING LOG

Name Of Trainer: Date:

Designation

Location: Duration of Training:

Title Of Training

Topics Covered

S. No. Name Of Employee Designation Department Employee Signature Trainer Sign

ANNEXURE-III

GMP/ ON JOB TRAINING REPORT FORMAT

OM MEGASHREE PHARMACEUTICAL PVT. LTD
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Issued By: Sign : Date : Dept :

Head - Q.A

Topic: Date :

Demonstration / Explaining / Counselling / Class room training

( which ever it appropriate)

OM MEGASHREE PHARMACEUTICAL PVT. LTD
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Brief description/ Review:

Type of Evaluation Written / Oral

OM MEGASHREE PHARMACEUTICAL PVT. LTD
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Trainer Name: Sign

ANNEXURE – IV

EMPLOYEE TRAINING CARD

NAME : DATE OF JOINING:

DEPARTMENT : DESIGNATION:

SR Date of Topic Mode of Mode of Sign of Remarks Name & Sign of

Training training Evaluation Employee by Sign of Dept.
No. Trainer Trainer Head

Written / Written /
Oral Oral

Written / Written /
Oral Oral

Written / Written /
Oral Oral

Written / Written /
Oral Oral
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Written / Written /
Oral Oral

Written / Written /
Oral Oral

Written / Written /
Oral Oral

Written / Written /
Oral Oral

All kinds of training programs attended by the participant shall be recorded in the following format.
These formats are maintained one individually for the each employee.
OM MEGASHREE PHARMACEUTICAL PVT. LTD
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8.0 Training Course Material

Training course material should be prepared / referred for each training class or relevant SOP
Procedures, Quality Manuals, Quality Policy and instructions ICH guidelines.

9.0 Training Feedback and evaluation

Training feedback should be obtained after conducting classroom training & Questionnaire evaluation
shall be done as appropriate.

Evaluation should be done as per the respective SOP.

10.0 Individual department training: Individual Department Training Schedule is as per the list.

10.1 Production

10.2 Stores

10.3 Engineering

10.4 Quality Control

10.5 Personnel

10.6 Quality Assurance

OM MEGASHREE PHARMACEUTICAL PVT. LTD
JUGEDI, CHITWAN

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