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SOP on Training

SOP on Training

  • Objective: To lay down a procedure to conduct training of working personnel at all levels and its evaluation.
  • Scope: This Standard Operating Procedure is applicable for training of personnel at Pharmaceuticals Company.
  • Responsibility
    • Head, QA or his/her designee for co-ordination on training of the personnel.
    • Head of every department shall ensure that each individual in his or her department has been imparted required training, which shall be relevant to the activities performed by the individual, as per this SOP.
    • Head of each department shall ensure compliance of this SOP and shall maintain training records annually.
    • Head of all department or his/her designee shall co-ordinate with Head QA for the preparation of cGMP Training Calendar in conjunction with other departments.
    • Induction training shall be initiated by HR personnel and technically induction training for new employees shall be done by QA personnel.
  • Accountability
    • Department Head & QA Head shall be accountable for implementation of this SOP.
  • Abbreviations and Definitions

cGMP                          :           Current Good Manufacturing Practices.

HR                              :           Human Resource

QA                              :           Quality Assurance

SOP                             :           Standard Operating Procedure

cGMP Training           :           Training pertaining to Current Good Manufacturing Practices which

are supposed to be followed at different stages of design, development and manufacturing of drug product. This type of training shall be given to all those who are directly or indirectly associated with the quality of the drug product. cGMP training shall also cover the safety aspects of the personnel engaged in manufacturing operations.

On the Job Training      :         This type of training is a departmental training which shall be imparted to all staff members whose functioning affects the productivity of various departments. The staff shall be trained with respect to his or her area of working in the department.

  • Procedure
    • Every employee of the organisation shall be trained on his / her area of operation prior to start the work. The training shall be imparted depending on the nature of job and responsibilities and the cGMP training is mandatory for each employee.
    • Training Plan
      • The training needs shall be based on the criticality of the operation performed by the employees working in different areas.
      • Departmental HOD shall identify the need of training for different levels. The training need identification shall be primarily based on the scope of cGMP and technical aspect related to the operational area.
      • At the start of calendar year concerned department shall prepare a Training Calendar which shall include the aspect of cGMP and Technical training.
      • The training calendar shall be approved by Head of concerned department and Head Quality Assurance. (Refer Annexure – I, Training Calendar).
      • As per training calendar, Concerned department Head shall confirm the date of training to QA personnel and plan the training accordingly.
      • On the identified training topic, trainer shall prepare the training materials.
      • All training records with training materials shall be submitted by concerned department personnel to QA documentation.
    • Selection of Trainer
      • Internal trainer from different departments shall be identified based on his / her qualification, communication / presentation skills, experience, knowledge and expertise or combination of thereof in the different areas of operation.
      • For class room training, identified trainer shall conduct pre-certification training on the identified topic based on his / her area of expertise, on the basis of training the trainer shall be evaluated and certified on parameters as detailed in Annexure – II (Refer Annexure – II, Trainer Evaluation Record).
      • QA personnel shall prepare list of internal trainers, which shall be approved by Head – Quality Assurance (Refer Annexure – III, Internal Trainer List). The list shall be updated as and when required.
      • Prior to start of the training the participants shall fill their attendance for all types of training (Refer Annexure –IV Training Attendance).

 

  • Types of Training

The types of training are divided in to two major categories as mentioned below:-

  • Internal Training
  • External Training
    • Internal Trainings: Internal training is the training which shall be conducted within the organisation by the in house faculty only. It is divided in to four main categories as mentioned below:
  • Induction Training
  • cGMP / Technical Training
  • On the Job Training
  • Refresher Training
    • Induction Training
      • Training which shall cover the overview of organisation, units, company policies and departments called induction training.
      • The induction training shall be imparted to every new employee, who joins the organisation.
      • Induction training shall be co-ordinated by HR & QA department.
      • Initial induction training is carried out by HR department, which cover topics like
      • Organisational Structure
      • Key personnel and organisation structure of various departments
      • Product range
      • HR policies e.g. shift timing, leave policy and other employee benefit policies.
      • After that QA personnel shall prepare the induction training schedule (Refer Annexure – V, Induction Training Schedule).
      • As per the induction training schedule, the new joinees shall go to applicable departments for the interaction with concerned HOD and

staff members.

  • HOD of various departments or his / her designee shall brief to the new joinee about their departmental structure, departmental functions.

 

  • cGMP / Technical Training
    • cGMP training covers various aspects of current Good Manufacturing Practices as per different regulatory guidelines.
    • Technical training is the training which is designed to develop specific and cross functional skill and to update the technical knowledge.
    • The internal cGMP training shall be conducted at least once in three months or as and when required.
    • Technical training shall be conducted as per Calendar or whenever needs identified.
    • cGMP at Induction training shall be mandatory for all new joinees within a month of joining.
    • The cGMP at induction training shall be conducted by trainer as class room training.
    • Different training sessions shall be conducted for Level – 1, Level – 2 and Level – 3 employees. The levels details are as follows:
      • Level – 1 : Includes from Asst. staff and above
      • Level – 2 : Supervisor and Machine Operators
      • Level – 3 : Workmen and Housekeeping staff.
    • The scope of cGMP / Technical training includes but not limited to the following topics:
    • Basic cGMP aspects of Different regulatory agencies.
    • Other as identified during the routine operation.
    • If required, the training material used by the trainer shall be distributed, after the training, to the employees attending the training programme.
  • On the Job Training
    • On the job training shall include the training in the concerned and cross functional departments of the new employees and other as identified.
    • On the job training shall be imparted to all the new joinee by the concerned HOD or his / her designee related to the area of operation. This training program shall include the training related to the specific aspects of an individual’s role including use of equipment, unit operations, safety norms to be followed and adherence to cGMP (Refer Annexure – VI, On the Job Training Record).
    • The mode of imparting training shall be through Standard Operating Procedures, Cleaning Procedures, Operating Instructions, Preventive Maintenance Procedures and Practical Assessment wherever possible.
    • After successful completion of On the Job Training, Trainees shall be certified, duly signed by Concerned HOD (Refer Annexure – VI, On the Job Training Record).
    • Training on the required SOP to the operator / worker shall be imparted by the concerned area in- charge.
    • After approval of any new / revised SOP the training shall be imparted by the concerned user department to concerned persons before implementation of the SOP.
    • If any employee is transferred from one area of operation to other area of operation within the department, training on related SOPs shall be imparted to the employee.
    • If the revision of the SOP is done without any change, then training on the SOP is not required.
    • Routine training of SOP shall be imparted to the employees as and when required due to some non-conformance or customer complaints.

Note: On job training of senior personnel (HOD’s or above) shall be based on their self-read out of existing SOP’s & all as per their prior fixed job description. After self-read out they shall maintain their on job training record accordingly.

  • Refresher Training
    • All employees shall undergo Refresher training on the procedures of their respective functions and related or cross functional department processes, wherever needs identified.
    • Refresher training shall be carried out as per ongoing training calendar, and whenever there is a procedural change or revision in the SOP.
  • External Training: The External Training is a training which is imparted by the persons from another sites, locations and persons from outside of organizations. It shall be conducted as and when required.
  • The selection of External Trainer for in house training shall be done with the consent of concerned HOD and HOD Quality Assurance. The selection of trainer shall be primarily based on his Experience, Qualification, Skills and Expertise on the training topics.
  • The external training program shall be identified by the concerned HOD and information shall be sent to HR or his / her designee.
  • Selection of outside training program and identification of the employees for training shall be done by concerned HOD.
  • After attending the training program at outside it shall be recorded in the external training record (Refer Annexure –VII, External Training Record)
  • Training Needs Identification
    • Specific Training

This shall be identified by the concerned HOD on the basis of Market Complaints received, any Non Conformance observed during Internal Audits or routine operation or PMS review and also if the feedback received from the concerned employees (Refer Annexure – VIII, Training Need Identification) is not satisfactory or etc.

  • Behavioural Training

HR department in consultation with HOD identifies the Behavioural Training needs for employees (Refer Annexure – VIII, Training Need Identification).

  • Evaluation of Training
    • Feedback from each participants shall be taken at the end of the each training session. (Refer Annexure XII , Training Feedback Form)
    • Training evaluation shall be done by trainer.
    • The evaluation shall be conducted for each type of training except the external training by the means of Questionnaire through written test to check the effectiveness of training program (Refer Annexure – IX, Training Evaluation Questionnaire).
    • The questionnaire shall include questions related to training topic and the questions shall be of objective types as well.
    • If the scored marked is less than 80%, then the employee shall be retrained & re-evaluated.
    • Evaluation of re-training shall be done and same shall be recorded in training record.
    • A person shall be allowed to work in the respective area after successful re-evaluation.
  • Documentation
    • The documentation of different types of training shall be done by the departments as mentioned below:
    • Induction / Behavioural Training :           HR & QA Department
    • On the Job Training :           Concerned Department
    • cGMP Training :           Quality Assurance Department
    • Technical Training :           Concerned & QA Department
    • External Training :           QA Department
    • Refresher Training :           Concerned Department
    • Representative from respective department shall coordinate with QA dept. for conducting any training and maintaining the record of the same. All the training relevant documents shall be submitted to QA Deptt. for final storage.
    • Staff Training card of each employee shall be maintained by QA Dept. (Refer Annexure – X, Staff Training Card).
    • If any employee leaves the organisation then his / her training records shall be maintained for a minimum period of two years from the date of relieving of the employee. Subsequently the records shall be destroyed and recorded (Refer Annexure – XI, Training Record Destruction).
  • Forms and Records (Annexures)
    • Specimen Format for Training Calendar – Annexure-I
    • Trainer Evaluation Record – Annexure-II
    • Internal Trainer List -Annexure-III
    • Training Attendance Sheet – Annexure-IV
    • Induction Training Schedule – Annexure-V
    • On the Job Training Record-  Annexure-VI
    • External Training Record – Annexure-VII
    • Training Need Identification – Annexure-VIII
    • Specimen format for Training Evaluation Questionnaire – Annexure-IX
    • Staff Training Card – Annexure-X
    • Training record destruction – Annexure-XI
    • Training feedback form – Annexure-XII
  • Distribution
    • Master copy       –     Quality Assurance
    • Controlled copies –     Quality Assurance, Production, Quality Control, Stores, Engineering, & Human Resource Development
  • History
Date   Revision Number                Reason for Revision
00 New SOP

 

 

Annexure-I

Specimen Format for Training Calendar

Department: _________________      For the year: __________   Date of Preparation: _______________

S. No. Topics Month
Faculty January Feb. March April May June July August Sep. Oct. Nov. Dec.
                             

Annexure-II

Trainer Evaluation Record

 

Name of the trainer   Topic of Presentation  
Designation   Date of presentation  
Department   Time duration From……hrs. to …….hrs.
Sr. No. Training  Stages *Evaluation Remarks
Satisfactory Not Satisfactory
1.0 Preparation of training Module
2.0 Use of Picture Presentation in module
3.0 Addition of case study; If applicable
4.0 Reference to other guidelines related to topic for reference to the trainees
5.0 Module write up in bullet point not in the paragraph
6.0 Presentation skills
7.0 Communication Skills
8.0 Confidence in delivering the topic details
* Mark Tick Mark whichever is applicable

Based on the evaluation…………………………………….has been qualified as an Internal trainer on

the basis of his / her skills, education & expertise.

 

 

Annexure-III

Internal Trainer List

Date of Preparation:   ________________

 

S. No. Name Department Designation Area of Expertise
         
         

 

 Annexure-IV

Training Attendance Sheet

Training Date: ____________

Type of Training: cGMP / Technical / On the Job / Specific / External / Refresher/ Re-training/ Behavioral/SOP

(Tick whichever is applicable)

Training Topic   :

Training Session:

Name of Trainer:

Time                     :     From………hrs. to ……..hrs.                Venue:

   S.No. Name of Trainee Employee code no. Designation Department Signature of Trainee
           
           

 

Annexure-IX

Specimen format for Training Evaluation Questionnaire

Topic of Training                  :    

 

Document No.                       :

(In case of Document Training)

Type of Training                   :

 

Revision No.

 

Name of the Employee          :

 

Department    :

 

 

Total Marks                           :

 

Time               :           ……Minutes                             

 

Q.1    Write questionnaires…..?

 

 

Employee Code No.   Trainee Sign. / Date  
Marks Scored   Evaluation Qualified / Retraining Required
Trainer Name   Trainer Sign. / Date  

 (Qualification mark is NLT 80 % of Total Marks)          

 Annexure-V

Induction Training Schedule

Name of New Joinee   Department  
Date of Joining   Designation  

Prepared By (HR Dept.):                                                                                        Sign & Date: 

Date Time Department To Understand Responsibility Sign.
From To
HR

&

Admin.

 Induction Manual

Brief about Torque Group/Presentation of film

Brief about Organization Structure

Product range

Basic HR Policies

Employees Entitlement / Payments

Joining formalities

Welcome & Introduction by respective HODs

Security

House keeping

   
 

 

 

Warehouse

Role & Responsibility of Stores & Warehouse Deptt.

Concept of Engineering Stores, RM Stores, PM Stores/BSR

Finished Goods Dispatch

Material Handling

 

Date Time Department To Understand Responsibility Sign.
From To
Engineering Role & Responsibility of Engineering. Dept.

Concept of GEP

Type of utilities

   
QC Role & Responsibility of QC Deptt.

Concept & Significance of GLP

   
QA Role & Responsibility of QA Deptt.

Concept of GMP

SOP & other Documentation & Validation Processes

Production Role & Responsibility of Production Deptt.

Brief about the layout of the Site Plan

Documentation in Production Dept.

Process flow of Dosage forms

Brief about mfg. of various dosage forms

        IT Role & Responsibility of IT

Computer Management

Mail ID

Plant Head Discussion & Feedback

Summing up

 Checked by (QA Dept.)                                                                    Approved by: (Head – QA)                     

 Sign / Date:                                                                                                                Sign / Date:

 

Annexure-VI

On the Job Training Record

Name of Trainee    Department  
Date of Joining    Designation  

 

S. No. Subjects *Training required Responsibility Date No. of Days Trainer
From To
1 Discipline :

Shift Schedule, timings for Tea, Lunch etc.

Other (Specify)

           
2 Sanitization & Hygiene :

General Housekeeping Procedure                              (specify the SOP No.)

           
3 General

·   Gowning /de-gowning

·   Different section in the department

·   Man & Material Movement

·   Process Flow  and Briefing

·   Safety in the department

·   Briefing on the Departmental procedures

·   In – Process checks (if applicable)

·   Instruments used for In – Process checks

·   Others (Specify)

           
4 Equipments            
5 Utilities and Services (specify)            
6 Departmental SOPs (Specify SOP series)            
7 Cross functional SOPs (Other dept.) – (Specify SOP series)            
8 cGMP Training            

Tick Mark whichever is required.

 

This is to certify that…………………………has successfully completed On the Job Training from dated …………………….. to …………………………His / Her Training evaluation was found satisfactory.

 

Deptt. Head (Date & Sign.)________________

 

Annexure-VII

External Training Record

Name   Training Date  
Department   Training Topic  
Designation   Trainer Details  
Venue  
Key learning:

(if required attached more blank pages)

 

 

Sign / Date:    

Annexure-VIII

Training Need Identification

Date of identification  
Reason for identification of Training  
Type of Training required and details of training  
Department responsible for Training  
Employee (s) identified for training                                        
1. _______________Dept. ____________ 2. ____________________Dept.____________

 

Trainer Details: 1. _______________________________________Dept.____________________

2. _______________________________________Dept.____________________

Planned Date of Training  
Comments by Concern HOD:                                                                         

 

Sign:                                                                                                                                 Date :

Comments  by  HR (Applicable for Behavioral training):

                          

Sign:                                                                                                                                 Date :

Comments by Head QA :

 

Sign :                                                                                                                               Date :

Date of Training  
Sign of Trainer (s) :                                                                                                       Date :

Annexure-XII

Training Feedback Form

Venue:                                                                                                             Date:

 

Your feedback will help us to improve the future training programme so please try to be objective and frank in your statements.

 

  1. How do you rate the programme as a learning experience? (indicate by tick mark)

 

Very thought Provoking                                             Good learning experience

Partially gainful                                                     Not clear at all

  1. What do you think was the objective of the program?

2.Which part of the program appealed you the most?

3. Which part of the programme was not clear to you?             ­­­­­­­­­

4.What important points have you gained from the programme?

  1. Write down the points most relevant to your day to day work?
  1. Give your suggestions as to how the programme could be improved?

________________________________________________________________________________

Name & Signature                                                                                              Designation & Dept.

 

 

Annexure-X

Staff Training Card

 

Sr. No. Date of Training Training Topic Employee Sign. Trainer Name Training Hrs. Cumulative Training Hrs.

 

Annexure-XI

Training record destruction

Sr. No Name of Employee Employee code no. Dept. Designation Date of Leaving Due date of destruction Approval of Concern HOD Destruction Done Remarks
 On by  

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About Pharmaceutical Guidanace

Mr. Shiv Kumar is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 14 years of rich experience in pharmaceutical field. During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube

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