PERSONNEL TRAINING,
People in an organization are the main resource and has more value and importance than other resources like facilities, equipment and materials, provided these people are trained and trained appropriately to carry out their assigned task.
A trained person generally has the knowledge, skill and attitude relevant to their job and that too in the appropriate level.
We must understand the three main words and their perspective.
Training
Education
development
Training may also be defined as the acquisition of technology which permits employees to perform their present jobs to standards.
It involves human performance on the job, the employee is presently doing or is being hired to do.
2. INTRODUCTION OF PERSONNEL
W.H.O. guidelines on Good Manufacturing Practices
(G.M.P. ) very appropriately mention this in operating
remark about personnel – it says, “the establishment and
maintenance of a satisfactory system of quality assurance
and the correct manufacture and control of pharmaceutical
products and active ingredients rely upon people.”
For this reason there must be sufficient qualified
personnel to carry out all the tasks for which the
manufacturer is responsible.
All personnel should be aware of GMP.
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3. INTRODUCTION OF TRAINING
People in an organization are the main resource and has more value
and importance than other resources like facilities, equipment and
materials, provided these people are trained and trained
appropriately to carry out their assigned task.
A trained person generally has the knowledge, skill and attitude
relevant to their job and that too in the appropriate level.
We must understand the three main words and their perspective.
a) Training
b) Education
c) development
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4. DEFINATION OF TRAINING
Training may also be defined as the acquisition of
technology which permits employees to perform their
present jobs to standards.
It involves human performance on the job, the employee
is presently doing or is being hired to do.
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5. NEED OF TRAINING
To induce an awareness in the employees towards the
concept of cGMP.
To generate a feeling of high performance through
contribution by both employees and management.
To make the person proficient in their duties.
To manage safe, healthy and trouble free
environment in the production department.
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6. CONT……
To demonstrate about cleanliness, general hygiene
and personnel health.
To develop the communication and technical skills in
the employee.
To demonstrate about handling and storage of drug
products.
To ensures the use of safety measures in case of
emergency. 6
7. TYPES OF TRAINING
1. Induction Programme.
2. On Job Training (OJT).
3. Class Room Training (CRT).
4. Outside Training
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8. INDUCTION PROGRAM
The induction training is a type of training given to
the newly joined employee in the industry to make
him familiar with the new working environment.
It usually occurs on the first day and includes
background on the industry, its policies and
procedures for the well being of ultimate consumer.
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9. PROCEDURE
This training is conducted by the HRD department through the
quality assurance department.
Issue Company’s general information manual to the new
employee for reading.
Prepare one day induction programme schedule of employee on
the date of joining.
Advice new employee to work as per the induction program
and to make a report on induction training taken.
Evaluate an employee by respective HOD and Head-QA on the
basis of induction training imparted and report submitted by
him.
Upon satisfactory report from the departmental Head ,provide
the on job training to related area.
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10. ON JOB TRAINING
On job training is to be carried out after
successful completion of induction training
and is provided to each employee of the
company.
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11. PROCEDURE
Head of Department shall prepare a list of topics for
training in the department.
On the basis of recruitment of new employee decide
topics of the training to be imparted.
Prepare a schedule for completion of training to be
imparted.
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12. CLASS ROOM TRAINING
An annual training calendar shall be prepared on
topics identified by various departments.
Decide the faculty to conduct the CRT. Faculty may
be from the company or outside viz Expert,
Consultant, etc.
Collect the Literature of training module for each
topic for CRT from the Faculty.
Circulate the Authorized Training Circular to
intimate the concerned persons.
Keep a record for CRT conducted.
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13. OUTSIDE TRAINING
When a new equipment or instrument is introduced
in the particular organization then a person is
selected for out side training where the facility is
available.
The HOD is nominate the name of an employee for
outside training.
Based upon the information available from HOD,
send intimation to HRD, Head – Plant Operation and
Head – Quality Assurance and it shall be authorized
by President – Technical Operations. 13
14. TRAINING CALENDER
The cGMP training calendar mainly covers the
following topics.
a). Good Manufacturing Practices
b). Good Laboratory Practices
c). Good Warehouse Practices
d). Good Engineering Practices
e). SOP familiarization
f). HRD related topics like effective supervision,
developing communication skill, motivation,
leadership and teamwork.
g). Computer Awareness
h). Quality Tools
i). Safety related issues 14
15. EVALUATION
On completion of each training it has been
evaluated by preparing a set of question Paper.
A Qualifying marks has been decided.
If the trainee does not Qualify the Qualifying marks
then he is been again given the retraining.
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16. RETRAINING
If the trainee does not Qualify the Qualifying marks
then he is been again given the retraining.
Head – Quality Assurance and Head –HRD
prepares the list of employees, which requires
retraining.
Prepare a report on the feedback from employee's
on retraining.
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17. TRAINING RECORD
Identification of training needs.
Name of the course and its content.
Name of the trainer.
Name of the trainee.
Venue of the training.
Date and time of the training.
Record of evaluation.
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18. REFERENCES
1) Current Good Manufacturing Practices for
pharmaceuticals by Manohar A Potdar, Pg no-
1-11.
2) Good manufacturing practices, P.P. Sharma.
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