1/1/2021 SOP for Training of Employees : Pharmaceutical Guidelines

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SOP for Training of Employees

Standard operating procedure for training of newly joined employees in pharmaceutical company and training plan for all departments.

1.0 PURPOSE
To define the procedure for the training of personnel.

2.0 SCOPE
This procedure is applicable to all employees working in Production, Quality Control, Quality Assurance, Warehouse, Engineering and other related
areas at the company.

3.0 RESPONSIBILITY
Concerned Department Head or Designee: Training needs identification, Conduction of training and feedback.
Training Co-coordinators: To co ordinate training activities.

4.0 ACCOUNTABILITY
HR Head / Designee: Review of Training Plan, Schedule and co ordination of training programmes.
Site Quality Head: Implementation and Compliance and approval of training programmes.

5.0 PROCEDURE
5.1 Training programme for the personnel shall be divided into three main areas:
5.1.1 Topics relevant to current Good Manufacturing Practices and Good Laboratory Practices.
5.1.2 On the Job Training (OJT) - Operational & Calibration training for equipment and Instrument, specific training for personnel working in clean
areas or areas where sensitizing or hazardous materials are handled. On the job training need identification shall be suggested and implemented by
the Head of Department. OJT training shall be assessed by ensuring the understanding by the trainees of the various actions and its importance.
Written test assessment may not be followed / compulsory, in such cases.
5.1.3 Behavioral Training and training related to Safety, Health and environmental management.
5.2 All departments shall depute a person as training coordinator.
5.3 Department head along shall identify the training needs of the employee once in a year as per Annexure-1.
5.4 All departments shall send training need identification form to HR department and QA department for review and approval.
5.5 HR department and QA department shall make a list of in-house faculties as per Annexure-2.
5.6 For workmen, the syllabus will be covered in interactive sessions, especially topics that are related in the day to day work.
5.7 HR department shall prepare annual training plan as per Annexure-3.
5.8 HR department shall prepare a monthly training schedule as per Annexure-4.
5.9 Training attendance records shall be maintained as per Annexure-5.
5.10 Training summary sheet shall be maintained for each employee as per Annexure-6.
5.11 Feed back form shall be filled by all attendees as per Annexure-7.
5.12 A written assessment shall be taken by concerned department head/designee as per Annexure-8.
5.13 Employees who score less than 50 % marks or C grade, a retraining shall be given to them.
5.1413 In case of external training, HR department shall take the feedback from the participant(s).
5.15 List of employees sent for external training along with evaluation details will be sent to HR to record in individual files.
5.16 Induction training shall be provided by HR department to all new joiners.
5.17 Training on new SOP shall be given by Dept. Head/Designee to departmental personnel before implementations of a new SOP. Whenever an
SOP shall be revised training on revised SOP shall also be carried out. SOP training record shall be maintained as per Annexure-9.

6.0 ABBREVIATIONS
6.1 QA: Quality Assurance
6.2 SOP: Standard Operating Procedure
6.3 OJT: On Job Training
6.4 cGMP: Current Good Manufacturing Practice

Annexure-1
Training Need Identification
Department:
Proposed Month Name of Emp.
Sr. No. Training Subject Designation Remarks
For Training Employee Code

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1/1/2021 SOP for Training of Employees : Pharmaceutical Guidelines

Prepared By: Reviewed By: Approved By:

Sign/Date Sign/Date Sign/Date

Annexure-2
Training Plan

For Year:
S. Training No. of Duration Target Training No. of Training Programme
No. Subject Train Of Group Faculty
Progm Training

Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec

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1/1/2021 SOP for Training of Employees : Pharmaceutical Guidelines

Prepared By: Reviewed By: Approved By:

Sign/Date Sign/Date Sign/Date

Annexure-3
List of In House Faculties

Sr. No. Training Subject Name of Faculty Employee Code Department

Prepared By: Reviewed By: Approved By:

Sign/Date Sign/Date Sign/Date

Annexure – 4
Training Schedule

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1/1/2021 SOP for Training of Employees : Pharmaceutical Guidelines

Department / Location: Period:

Date/
Sr. No. Training Subject Time Name of Faculty No. of Participants Venue
Month

Prepared By: Reviewed By: Approved By:

Sign/Date Sign/Date Sign/Date

Annexure-5
Training Attendance Record

Subject:
Faculty:
Signature: Date:
Venue:

Sr. No. Participants Name Employee No. Department Participants Signature

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1/1/2021 SOP for Training of Employees : Pharmaceutical Guidelines

Annexure-6
Training Summary Sheet

Name: ____________________
Date of Joining: Employee No.:
Designation: Department:
Date:
Sr No Subject Date of Duration Faculty/ Venue Grade Date Sign
Training Agency

Annexure-7
Feed Back Form

TRAINING PROGRAMME: TRAINING AGENCY:

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1/1/2021 SOP for Training of Employees : Pharmaceutical Guidelines

DT. FROM: TO: FACULTY/ IES:

____________________________________________________________________________________________

1. YOUR RATING OF THE COURSE

EXCELLENT VERY GOOD GOOD AVERAGE
PROGRAMME CONTENTS O O O O
PROGRAMME COVERAGE O O O O
PROGRAMME DURATION O O O O
BENEFITS EXPECTED O O O O
RELEVANCY TO YOUR WORK O O O O
PRESENTATION BY THE FACULTY
1. O O O O
2. O O O O
3. O O O O
READING MATERIAL (IF GIVEN) O O O O

2. THE SESSION I LIKED THE MOST: (PLEASE GIVE REASONS)

______________________________________________________________________________________________________________________
______________________________________________________________________________________________________________________
_____________________________________________________________

3. PLEASE SUMMARISE WHAT YOU LEARNT FROM THE PROGRAMME:

______________________________________________________________________________________________________________________
______________________________________________________________________________________________________________________
_____________________________________________________________

4. HOW DO YOU PROPOSE TO UTILISE THE TRAINING INPUTS IN YOUR PRESENT WORK SITUATION ( SET SPECIFIC GOALS AS FOR AS
POSSIBLE)
______________________________________________________________________________________________________________________
______________________________________________________________________________________________________________________
__________

5. POST TRAINING SUPPORT REQUIRED :

FROM WHOME : DESCRIPTION :
______________________________________________________________________________________________________________________
______________________________________________________________________________________________________________________
__________

6. ANY OTHER FEEDBACK YOU WOULD LIKE TO SHARE, ABOUT THE PROGRAMME:
______________________________________________________________________________________________________________________
______________________________________________________________________________________________________________________
__________

NAME : EMP. NO.:

Annexure-8
Written Assessment Test Records

Name : _____________________ Date : ________________

Designation : _____________________ Department: ________________
Computer No: ____________________ Assessed By : ________________
Ref. Topic : _____________________
Total Marks: Marks obtained:

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1/1/2021 SOP for Training of Employees : Pharmaceutical Guidelines

Sr.No Question Answer Marks

Remarks:-
Grade obtained from the written Assessment Test Records
More than 80 % = A+
Between 70 % to 80 % = A
Between 50 % to 70 % = B
Less than 50 % =C.

Annexure-9
SOP Training Sheet

Title of SOP: ___________________________________ SOP No.:__________________

Effective Date: _______________ Department: _______________
Trainer: ____________________
S. No. Name Designation Signature & Date Feedback by Trainee
(Satisfactory/
Not Satisfactory
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3.
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1/1/2021 SOP for Training of Employees : Pharmaceutical Guidelines

Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceuti
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