• OBJECTIVE
  • To lay down the procedure for training of the personnel through Training Information Management System (TRIMS).

 

  • RESPONSIBILITY
  • Department Head: shall be responsible to ensure the training of employees.
  • Quality Assurance In-charge: shall be responsible to ensure that training is imparted to all concerned as per this SOP.
  • Training Coordinator: shall be responsible for preparation of Induction, Refresher training Schedules and to maintain the training records.
  • System Administrator: shall be responsible to allot TRIMS User ID and Password to the new employees.
  • Section In charge: shall be responsible for the completion of training activities of the team members in TRIMS.

 

  • PROCEDURE
  • Training shall be imparted to all the personnel working in Production, QC, QA, Stores  and Engineering department through Training Information Management System [TRIMS].
  • Training is imparted based on the following categories;
  • cGMP / GLP Training:
    • cGMP training usually comprises of topics like cGMP orientation, 21 CFR Part 210 & 211, EU and other Regulatory guidelines etc.
    • cGMP / GLP training shall be conducted periodically every year to the employees wherever applicable.
    • Training Co-ordinator shall be responsible for organizing and conducting cGMP, GLP awareness Programs.
  • Job related training (SOPs):
    • Training on Job related SOPs shall be imparted to all concerned as per the Induction and refresher schedule. Whenever a new SOP is made or the existing SOP is revised, training shall be imparted to all concerned through TRIMS.
    • Department head/In charges, with appropriate training skills and having adequate knowledge shall be responsible to impart on the job training.
  • Safety Training:
    • Safety training shall be conducted annually as per the schedule.
    • EHS (Environment, Health and Safety,) In-charge/External agency shall be responsible to organize such training to all the employees of the plant.
    • Safety Training shall also covers the EMS training to the concerned person.
  • Specific Training:
    • Specific training in response to Market complaints / Out Of Specifications / Process Non conformances / Material Non Conformances/Audit observations shall be imparted to all the personnel involved in that activity.

Note: Job responsibilities of the person shall be revised if the personnel commit repeated errors for more than 5 times.

  • External Training:
    • External training shall be coordinated by Head–QA along with Training coordinator. The training details and feed back shall be recorded in TRIMS.
    • A copy of the training materials shall be handed over to the Training coordinator for reference.
  • Advanced Technical Training:
    • Advanced Technical Training topics shall be identified by the respective department head from recent publications, external training attended or pharmacopeial revisions.
    • Training coordinator shall coordinate the activity and impart the training in TRIMS through Course sessions by Document Review / Content delivery.
  • Training program shall comprise of
    • Induction Training Program for new employees.
    • Refresher Training Program for all the existing employees.
  • Induction Training Program for new recruits.
    • Training Coordinator shall enter the details of the new employee in the Employee Master list.
    • TRIMS User ID & Password shall be allotted to the Trainee by the System administrator .
    • After completion of Induction training, the trainee shall sign on the “ELECTRONIC DOCUMENTS & RECORDS CONFIDENTIALITY DECLARATION”(Annexure-3)
  • Initiation of induction Course Session:
    • Based on the Job responsibility as per SOP  the trainee, the Training Coordinator shall prepare the Training Schedule Cum Card as per Annexure – 4.
    • Induction Course for the new employee shall be initiated in TRIMS .
  • Response to the Induction Course Invitation:
    • Trainees shall operate the Course Manager Module in TRIMS .
    • Trainees shall respond to the course invitation for the course initiated by Training coordinator.
  • Responding to the Question paper:
    • Trainees shall respond to the question paper as per the course invitation.
  • Evaluation of Induction training:
    • Immediate Evaluation
      • Immediate evaluation of the personnel shall be conducted after each training session by questionnaire.
      • If the score is less than 70%, re-training shall be imparted.
      • The counseling of incorrect answers shall be recorded manually on the evaluation sheet.
  • Shop Floor Evaluation
    • Training coordinator shall initiate Shop Floor Evaluation for the new trainees after the completion of Induction training.
    • Shop floor Evaluation shall be carried out by concerned supervisor as per Shop floor Evaluation Template.
    • Three types of templates shall be used for the Shop Floor Evaluation.
      • Shop Floor Evaluation for Production (Annexure-11)
      • Shop Floor Evaluation for Manufacturing Assurance (Annexure-13)
      • Shop Floor Evaluation for Engineering (Annexure-12)
    • The Evaluation template shall be categorized as Excellent, Good, Average and Poor.
  • Refresher Training Program:
  • Initiation of Refresher Training Course:
    • Training Coordinator shall prepare a General Training Schedule and Department Specific Schedule for the entire year in the month of December (Annexure – 1) for all the existing employees in consultation with the respective department head.
    • The schedule shall include the Name of the Topic; Month proposed and the probable groups of the participants.
    • General Training Schedule shall be approved by the QA-In charge and authorized by Head QA.
    • Department wise yearly schedule shall be approved by the concerned department head and authorized by QA In-charge.
    • Training Coordinator shall also prepare the departmental wise monthly training plan as per the yearly schedule and the same shall be approved by QA in charge (Annexure – 2).
    • Training coordinator shall register each training program through TRIMS with respect to the scheduled training activities. Training coordinator shall register the documents through document manager.
    • Depending upon the Job responsibilities (as per Annexure -5), all the employees shall be arranged into Groups. (Refer to the Annexure 15)
    • Refresher Training courses are prepared as per the schedule.
    • Group Training Plan shall be proposed by selecting the refresher course and Refresh Trainee subgroup.
    • Training coordinator shall plan the Course session as per schedule and initiate start and end date of training.
    • The course session shall be sent for approval of the concerned department head.
    • On approval of the course Session by the department head, the trainees shall receive the course invitation.
  • Response to the Refresher course sessions:
    • Each trainee shall log in through his/her ID in TRIMS and shall open the Course Manager Module.
    • The trainee shall accept the session & submit the acceptance.
  • Formation of a Batch:
    • Training coordinator shall form batch for Refresh training programs.
  • Preparation of Question Paper
    • After the batch formation, Training Coordinator shall prepare the Question paper from the question bank.
    • “Topic Based” type of questions shall be entered and the number of questions required also shall be mentioned.
    • Qualifying marks shall be entered so as to obtain minimum of 70% and the details are submitted.
  • Recording Attendance:
    • Training coordinator shall record the attendance of trainees.
    • The batch name for recording the attendance shall be selected and planned.
  • Responding to the Refresher Course Question Paper:
    • Each trainee shall respond to the questions and submit it for evaluation in TRIMS.
  • Evaluation of Refresher training program:
  • Immediate Evaluation:
    • The evaluator shall evaluate the questions and on submission of the evaluated answer paper, the system shall generate a certificate stating the Qualification status of the employee.
    • An immediate evaluation format (as per Annexure –9) shall be generated by the system stating the percentage of trainee. If it is above 70% then the trainee shall be qualified.
  • Long term Evaluation:
    • Long Term Evaluation shall be carried out by concerned supervisor as per Long Term Evaluation Template.(Annexure -10)
  • All the existing employees shall be periodically evaluated once in 6 months (in January & July).
  • The Evaluation template shall be categorized as Excellent, Good, Average and Poor.
  • Training Manual shall be prepared by the Training coordinator, which comprises the following, but not limited to:
    • Identification of Trainers
    • Training modules
    • Training Categories
    • of groups for training
    • Method of Training and Evaluation
    • Method of recording
  • Training manual shall be approved by the QA In-charge and authorized by Head QA.
  • The mode of training shall be either oral or visual such as videos, Slides, Pictorial diagrams.

Note: Training shall be given orally in Vernacular Language wherever applicable.

  • Training Formats:
    • Training formats shall be in the form of
      • General Training Schedule for the Year.(Annexure – 1)
      • Monthly Training Plan cum Report.(Annexure – 2)
      • Electronic documents and records confidentiality declaration(Annexure – 3)
      • Training Schedule Cum Card.(Annexure – 4)
      • Job Responsibilities.(Annexure – 5)
      • Training Format (Annexure – 6)
      • Question Bank Report.(Annexure – 7)
      • Evaluation Sheet (Annexure – 8)
      • Immediate Evaluation Sheet.(Annexure – 9)
      • Long Term Evaluation Template.(Annexure – 10)
      • Shop Floor Evaluation Template ( Production)(Annexure – 11)
      • Shop Floor Evaluation Template (Engineering)(Annexure – 12)
      • Shop Floor Evaluation Template (Manufacturing Assurance)(Annexure – 13)
      • Training Certificate.(Annexure – 14)
      • Group Wise User Report (Annexure – 15)

Note: The trainees who fail to understand the training shall not fill the questionnaire and shall be given re training.

  • Records:
    • Training records shall be maintained by the Documentation Cell.
    • Employee training record shall contain:
      • Job responsibilities.
      • Induction Training:
        • Training schedule cum card
        • Electronic documents and records confidentiality declaration
        • Training Formats.
        • Evaluation Sheet.
        • Training certificate.
  • Individual Training status report.

Note: Refresher training format and certificates are updated in TRIMS and print out for the same shall be taken out whenever required.

  • Training schedule cum cards of the employees who have resigned shall be stored for a period of 5 years from the date of resignation.

 

  • ABBREVIATIONS
  • TRIMS – Training Information Management System.
  • cGMP – Current Good Manufacturing Practices.
  • GTP       – Group Training Plan.
  • cGLP – Current Good Laboratory Practices.
  • SOP – Standard Operating Procedure.
  • QC – Quality Control.
  • QA – Quality Assurance.
  • ID             – Identification.

 

  • REFERENCES:

Nil

  • ANNEXURES:
  • Annexure – 1 General Training Schedule for the Year.
  • Annexure – 2 Monthly Training Plan cum Report.
  • Annexure – 3 Electronic documents and records confidentiality declaration
  • Annexure – 4 Training Schedule Cum Card.
  • Annexure – 5 Job Responsibilities.
  • Annexure – 6 Training Format
  • Annexure – 7 Question Bank Report.
  • Annexure – 8 Evaluation Sheet
  • Annexure – 9 Immediate Evaluation Sheet.
  • Annexure – 10 Long Term Evaluation Template.
  • Annexure – 11 Shop Floor Evaluation Template (Production)
  • Annexure – 12 Shop Floor Evaluation Template (Engineering)
  • Annexure – 13 Shop Floor Evaluation Template (Manufacturing Assurance)
  • Annexure – 14 Training Certificate.
  • Annexure – 15 Group Wise User Report.

 

                                                               Annexure – 1

GENERAL TRAINING SCHEDULE FOR THE YEAR – _______

S.NO
Topic
Module / SOP NO.Proposed MonthParticipantsCompletion Date
 
    
 
   
 
   
Prepared by                                          Approved by                                         Authorized by

(Sign & Date)                                             (Sign & Date)                                                      (Sign & Date)                              

Training Coordinator                            Head-QA                                                QA In charge

 

                                                                     Annexure – 2

MONTHLY TRAINING PLAN CUM REPORT

                                                                                                                                   Period: ———-  to——— 

S. No.Training for Dept.Topic NameSOP No.Reason for TrainingDate of Course InitiationCourse Invitation PeriodDate Of TrainingQuestionnaire Response PeriodDate of EvaluationTraining Completion Status
           
           
           
Make appropriate changes in case of rescheduling
Prepared by:                                                                                      Approved By

(Sign & Date)                                                                                                    (Sign & Date)

Training Coordinator                                                                                       QA In charge

 

      Annexure-3

ELECTRONIC DOCUMENTS & RECORDS CONFIDENTIALITY DECLARATION

I, Mr. / Ms. _________________________________________ Employee Code ________, am willing to abide by the electronic documents and records policy requirements listed below.

  1. I will be responsible for maintaining the confidentiality of the User Identification Codes, Passwords and Electronic Signatures of various software that I will be entrusted in my sphere of work.
  2. I will complete my assignments in the software without delegating to any other person, unless it is required by the procedures or due to my unavailability / absence.
  3. I will not try to falsify or use any other person’s User Identification Code, Password or Electronic Signatures.
  4. I will immediately intimate the System Administrator to block my User Account if I lose or forget my password or when my password is compromised.
  5. I will lock the computer systems with password before leaving my work station.
  6. I will not make any disclosure or reproduction or sharing of the electronic records to which I have access to.
  7. I hereby certify that my electronic password and signature is a legally binding equivalent of my handwritten signature.

 

Signature of the Employee

Date:

 

                                                                                  Annexure – 4

                                                              TRAINING SCHEDULE CUM CARD

NAME                        :                                                                YEAR                       :                                                                                                                                                                                                                                  

DESIGNATION          :                                                              QUALIFICATION      :                                                                                                                                                                                                                                    DEPARTMENT          :                                                              EXPERIENCE                        :                                                                                                                                                                                                                                               

S. No
Topic of Training
Jan.
Feb.Mar.AprilMayJuneJulyAug.Sep.Oct.Nov.Dec.
1
           
2
           
3
           
4
           
Note:a)         Mark the probable month of the course   

b)         After completion of training tick (ü  ) and enter  the date to indicate that training was conducted,

c)          Make appropriate changes in case of  rescheduling

 

Prepared by                                              Approved by                            Authorized by                                                                                                                                                                                                                                                                                                                            
Training Coordinator                            Head of the Department              In charge QA

 

                                                                              Annexure – 5

Job Responsibility
Employee Name 
Employee Code 
Designation 
Department 
Qualification 
Previous Experience 
Revision no 
Job Description
Reporting To 
Authorized Deputy  
Employee Sign & DateReporting To Sign & DateApproved By Dept. Head Sign & Date
  

 

Annexure – 6

Training Format

 

 

 

 
Session                        
Date 
Time 
 Name Of the   Trainer  
S.NoName of the ParticipantDesignationDepartment
    
    
    
    

Annexure – 7

                                                               Question Bank Report

Topic Name 
Subject Name 
Category Name 
List of Questions
S. No.QuestionQuestion TypeMarks
1   
Ans   
2   
Ans   
3   
Ans   
4   
Ans   
5   
Ans   

Annexure – 8

Evaluation Sheet

Trainee Name 
Designation 
Department 
Batch Name 
Course Name 
Evaluator 
Acquired Marks 
Acquired Percentage 
Maximum Marks 
Qualify Marks 
Result 
Question Paper
S. NoQuestions and AnswersMarks
1  
Ans  
2  
Ans  
3  
Ans  
4  
Ans  
5  
Ans  

Annexure – 9

Immediate Evaluation Sheet

Name of the Trainee   
Trainee Code       
Designation   
Department  
Type of Training  
Training is given on following topics and he/she secured 100%
List of Topics :
Sr.No.Topic Name
1 
2 
3 
 

                                                                                Annexure – 10

                                                                           Long Term Evaluation

Trainee Name 
Designation 
Department 
Course Name 
Date 
S. NoQuestionsResponse
1Whether the person is Personally Hygienic 
2Whether the employee strictly following Entry and Exit Procedures 
3Whether the employee is following Good Manufacturing Practices 
4Whether the employee is following Safety Precautions 
5Whether the employee is following critical SOPS 
6Whether the employee is performing Jobs as per SOPS 
7Whether the employee is keeping things neatly 
8Whether the employee is keeping records for every activity 
9Whether the employee is updating records timely and accurately 
10Whether the employee is doing sufficient checks to avoid mix ups and errors 

                                                                       Annexure – 11

                                                     EVALUATION TEMPLATE – PRODUCTION

                                                                Shop Floor Evaluation

Trainee Name 
Designation 
Department 
Course Name 
Session Duration 
Machine 
S. NoQuestionsResponse
1Whether the person is able to understand all instructions given in BPRR/BPAR & work accordingly 
2Whether the person is able to operate the machine independently 
3Whether the person is well conversant with all SOPS related to the operation 
4Whether the person  is following all the safety  precautions and security checks of the machine 
5Whether the person is following proper cleaning procedure 

                                                                           Annexure – 12

                                                     EVALUATION TEMPLATE – ENGINEERING

                                                                        Shop Floor Evaluation

Trainee Name 
Designation 
Department 
Course Name 
Session Duration 
Machine 
S. NoQuestionsResponse
1Whether the person is able to perform break down maintenance as per SOP 
2Whether the person is performing preventive maintenance as per preventive maintenance schedule. 
3Whether the person is able to perform preventive maintenance of the machine independently 
4Whether the person is monitoring environmental conditions as per SOP 
5Whether the person is following all safety precautions 

                                                                             Annexure – 13

                                          SHOP FLOOR EVALUATION TEMPLATE – MANUFACTURING ASSURANCE

                                                                        Shop Floor Evaluation

Trainee Name 
Designation 
Department 
Course Name 
Session Duration 
Machine 
S. NoQuestionsResponse
1Whether the person is aware of checks to be carried out during dispensing 
2Whether the person is following line clearance procedures as per SOP and instructions in BPRR/BPAR 
3Whether the person is able to handle all inprocess equipments. 
4Whether the person can carry out all inprocess tests independently at frequency mentioned in BPRR/BPAR and record results correctly in the BPRR/BPAR 
5Whether the person is executing documentation controls and supervisory controls at all his assigned responsibilities. 

Annexure – 14

Training Certificate

Name of the Trainee 
Department   
Designation 
Name of the Course  
Duration of Course  
Type Of Training 
Training is given on following topics: 
S.No.Topic Name
1 
  
  
Percentage Secured :       %
 

 

                                                                              Annexure-15

                                                                        GroupWise User Report

                                                               SUB GROUP WISE USER LIST

Group 
S. No.Sub Group Name
  
S. No.Employee NameDesignationDepartmentImmediate Supervisor
     
     
     
S. No.Sub Group Name
     
S. No.Employee NameDesignationDepartmentImmediate Supervisor