1.0
|
PURPOSE
To lay down a procedure for training of plant personal (Staff and personal).
|
2.0
|
SCOPE
The scope of this document is to provide the guidelines for trainings to be given to plant personnel
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3.0
|
RESPONSIBILITY
Training Coordinator (HR – Personnel)
Deptt. Head of Respective Area
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4.0
|
ACCOUNTABILITY
Head of the Respective Department
Head Quality Assurance
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5.0
5.1
5.1.1
5.1.2
5.1.3
5.1.4
5.2
5.2.1
5.2.2
5.2.3
5.2.4
5.3
5.3.1
5.3.2
5.3.3
5.3.4
5.3.5
5.3.6
5.3.7
5.3.8
5.3.9
5.3.10
5.3.11
5.3.12
5.3.13
5.4
5.4.1
5.4.2
5.5
5.5.1
5.5.2
5.5.3
5.5.4
5.5.5
5.5.6
5.5.7
5.5.8
5.5.9
\
5.5.10
5.6
5.6.1
5.6.2
5.6.3
5.6.4
5.6.5
5.6.6
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PROCEDURE
Different types of the Training Shall be as follows:
Induction Training:
Training given to the new comer at the time of joining the organization for awareness of organization and organization personnel is termed as Induction Training.
cGMP Training : Training given to a candidate for cGMP awareness.
Job Related Training: Training given to a candidate at the shop floor or at the work place or at training hall by means of SOP training is termed as Job Related Training.
4 External or others training :Training given to a candidate outside the plant location is termed as External Training.
Procedure of Induction Training :
Whenever a new candidate is join the organization, on completion of joining procedure, HR –Personnel shall give him/her first hand information regarding the company’s profile, group activities, service benefits, service rules, administrative rules, disciplinary rules and personnel hygiene.
Executive – Human Resource & Administration shall take him / her for plant round to acquaint to plant as well as plant personnel.
On completion of plant round, individual introduction shall be given by plant personnel regarding him / her department and activity handled by him / her by acknowledging the “Induction Training Record” as per Annexure – I .
On completion individual introduction, the person shall be instructed to go to department head (for which department he / she is selected) for further training.
Procedure for Job Related Training:
On completion of Induction Training department head and or section head or his / her deputy will give job training to new candidate regarding his future work profile.
For the refreshment of the subject (e.g. SOP, cGMP Modules) “Training Calendar” shall be prepared by concern Deptt. Head as per Annexure – II.
Quality Assurance Head shall approve the “Training Calendar”.
Concerned department shall conduct training program on the scheduled date ± 3 days.
On the day of training, candidates will be gathered at the decided venue and all candidates shall fill “Training
Attendance Form” for the particular training program as per Annexure – III.
Trainer shall give training in English / Hindi language to all candidates. Along with Training material
(if applicable).
On completion of training effectiveness of training shall evaluate in term of understanding of course material
by the examination.
The examination shall be done by questionnaire or through viva voice by asking the relevant question about the subject (as applicable) as per Annexure – IV.
To qualify training for each participant shall gets minimum 80% marks or satisfy the trainer through viva voice.
If any employee fails to meets these criteria retrain the same within 15 days. If employee fails again give
the training at least thrice within 15 days. If again fail the remove the employee for that particular job and allot any other job with the consultation of Tech.Director, HR & QA head & concern department Head.
In case candidate is experienced (one or more year in pharmaceutical company on same subject), self reading will be done by the experienced employee and training record will be mentioned.
All the training related documents shall be maintain & kept in Quality assurance department.
Arrange alternative arrangement of training for the personnel on leave.
Trainer
The personnel who reviewed or approved the procedure are qualified trainer for the training of other employee.
Any trained personnel (s) for a procedure may be a trainer for training to other employee.
Procedure for cGMP Training:
For GMP training, QA department shall plan the same at least once in a year.
For the refreshment of the subject “Training Calendar” shall be prepared by Quality Assurance Deptt.
Quality Assurance Head shall approve the “Training Calendar”.
Training shall conduct on the scheduled date ± 3 days.
The HOD of participants shall be informed for training.
On the day of training, candidates will be gathered at the decided venue and all candidates shall fill “Training
Attendance Form” for the particular training program as per Annexure – III.
On completion of training effectiveness of training shall evaluate in term of understanding of course material
by the examination.
The examination shall be done by questionnaire or through viva voice by asking the relevant question about the subject (as applicable) as per Annexure – IV.
To qualify training for each participant shall gets minimum 80% marks or satisfy the trainer through viva voice.
Arrange alternative arrangement of training for the personnel on leave.
Procedure for External Training:
Human Resource and Administration shall receive the brochure from the different faculties or from the plant location and contact the same for techno – commercial discussion and finalize the training program.
Training details shall be sent to concern Department for selection of candidates for the training program.
Human Resource and Administration department with consultation of all department heads shall prepare candidates list for training program and forward to Tech Director for approval.
After Approval Human Resource and Administration department shall circulate the date and venue of training program to all concern Deptt. in advanced.
All candidates shall attend the training program at announced date and venue.
When all candidates will come back to the plant location, they are supposed to give a material to concern department.
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6.0
|
REFERENCES
cGMP Guideline
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7.0
|
ANNEXURES
|
Annexure No.
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Title of Annexure
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Format No.
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Annexure I
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INDUCTION TRAINING RECORD
|
QA/002/F01-00
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Annexure II
|
TRAINING CALANDER
|
QA/002/F02-03
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Annexure III
|
TRAINING ATTENDANCE FORM
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QA/002/F03-03
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Annexure IV
|
TRAINING QUESTIONNAIRE EVALUATION RECORD
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QA/002/F04-00
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8.0
|
ABBREVIATIONS
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Abbreviations
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Full Forms
|
|||||||
SOP
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Standard Operating Procedure
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|||||||
QA
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Quality Assurance
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|||||||
NA
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Not Applicable
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|||||||
GMP
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Good Manufacturing Practices
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|||||||
HOD
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Head Of Department
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|||||||
9.0
|
DISTRIBUTION
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|||||||
Master Copy
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Quality Assurance Department
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|||||||
Controlled office Copy No. 1
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Quality Assurance Deptt.
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|||||||
Controlled office Copy No. 2
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Quality Control Deptt.
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|||||||
Controlled office Copy No. 3
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Production (Tablet) Deptt.
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|||||||
Controlled office Copy No. 4
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Production (Liquid) Deptt
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|||||||
Controlled office Copy No. 5
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Production (Lotion) Deptt
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|||||||
Controlled office Copy No. 6
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Production (Soap) Deptt
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|||||||
Controlled office Copy No. 7
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Head Personnel & Administration
|
|||||||
Controlled office Copy No. 8
|
Ware house Dept.(Main Block)
|
|||||||
Controlled office Copy No. 9
|
Ware house Dept.( External Block)
|
|||||||
Controlled office Copy No. 10
|
Head Engineering
|
|||||||
10.0
|
REVISION HISTORY
|
|||||||
S.No.
|
Revision No.
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Effective Date
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Reason for Revision
|
Details of Change
|
Authorized By
(sign & Date)
|
|||
Annexure I
INDUCTION TRAINING RECORD
|
Name :
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Designation :
|
Department :
|
Date of Joining :
|
Duration of Training : From To
Date :
|
Plant Round taken : From To
Date :
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Sr.No.
|
Name of Key Person
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Designation
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Department
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Date
|
Time
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Signature
|
|
From
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To
|
||||||
Annexure II
TRAINING CALANDER
Department : Year: Date of Preparation:
S.No.
|
Topics
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Month
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|||||||||||
Jan
|
Feb
|
Mar
|
Apr
|
May
|
Jun
|
July
|
Aug
|
Sep
|
Oct
|
Nov
|
Dec
|
||
Prepared By Approved By
Annexure III
TRAINING ATTENDANCE FORM
Type of Training: cGMP/Technical/On the Job/Specific/External/Refresher/Retraining/Behavioral
(Tick whichever is applicable)
Training Topic: Training Session:
Name of Trainer: From--------- hrs. to------------hrs.
Venue: Training Date:
Sr. No.
|
Name of Participant
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Employee Code
|
Designation
|
Department
|
Remarks
|
ANNEXURE – IV
TRAINING QUESTIONNAIRE EVALUATION RECORD
|
||||||
Subject of the Training Program :
|
||||||
Document No. :
|
||||||
Trainer (Faculty) :
|
||||||
Department :
|
||||||
Date of the Training :
|
||||||
Minimum Qualifying Marks :
|
||||||
Sr. No.
|
Participants Name
|
Emp. Code
|
Total Marks
|
Marks Obtained
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(%)
|
Results
|
Remarks: Above mentioned candidate is qualifying / not qualifying training examination. So, re-training is
required / no required.
Date: Signature of Trainer:
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