SOP for Training of Employees | Pharmaguideline
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  • Apr 17, 2021

    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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    2 comments: Post Yours! Read Comment Policy ▼

    1. Very useful Could you please publish SOP for DeDusting of Materials received

      ReplyDelete
    2. A crisp document up to the point.

      ReplyDelete

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