SOP for Training of Employees : Pharmaceutical Guidelines

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:
Sr. No.
Training Subject
Proposed Month For Training
Name of Employee
Emp.
Code
Designation

Remarks





























































  Prepared By:                                   Reviewed By:                                    Approved By:
Sign/Date                                        Sign/Date                                            Sign/Date


Annexure-2 
Training Plan

For Year:
S.
No.
Training
Subject
No. of
Train
Progm
Duration
Of
Training

Target
Group
Training
Faculty
No. of Training Programme







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





































































































































































































































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

Department / Location:                                                                  Period:
Sr. No.
Training Subject
Date/
Month
Time
Name of Faculty
No. of Participants
Venue





























































 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























































Annexure-6 
Training Summary Sheet 

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
























































































































































































Annexure-7 
Feed Back Form

TRAINING PROGRAMME:                                                             TRAINING AGENCY:

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:

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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Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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