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 the training personnel at Pharmaceuticals Companies.
Responsibility
Head, QA, or his/her designee for coordination on the training of the personnel.
The head of every department shall ensure that each individual in his or her department has imparted the required training, which shall be relevant to the activities performed by the individual, as per this SOP.
The head of each department shall ensure compliance with this SOP and shall maintain training records annually.
The head of all departments or his/her designee shall coordinate with Head QA for the preparation of the 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 the 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 products. 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 work in the department.
Procedure
Every employee of the organization shall be trained in his / her area of operation prior to starting the work. The training shall be imparted depending on the nature of the 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 for 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 the calendar year, the concerned department shall prepare a Training Calendar which shall include the aspect of cGMP and Technical training.
The training calendar shall be approved by the Head of the concerned department and the Head of Quality Assurance. (Refer to Annexure – I, Training Calendar).
As per the training calendar, the Concerned department Head shall confirm the date of training to QA personnel and plan the training accordingly.
On the identified training topic, the 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 trainers 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 classroom training, the 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 a list of internal trainers, which shall be approved by the Head – of Quality Assurance (Refer to Annexure – III, Internal Trainer List). The list shall be updated as and when required.
Prior to the start of the training, the participants shall fill in their attendance for all types of training (Refer to Annexure –IV Training Attendance).
Types of Training
The types of training are divided into two major categories as mentioned below:-
Internal Training
External Training
Internal Training: Internal training is the training that shall be conducted within the organization by the in-house faculty only. It is divided into four main categories as mentioned below:
Induction Training
cGMP / Technical Training
On-the-Job Training
Refresher Training
Induction Training
Training that shall cover the overview of the organization, units, company policies, and departments is called induction training.
The induction training shall be imparted to every new employee, who joins the organization.
Induction training shall be coordinated by HR & QA department.
Initial induction training is carried out by the HR department, which covers topics like
Organizational Structure
Key personnel and organizational 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 to Annexure – V, Induction Training Schedule).
As per the induction training schedule, the new joiners shall go to applicable departments for the interaction with concerned HOD and
staff members.
HOD of various departments or his / her designee shall brief the new joinee about their departmental structure, and departmental functions.
cGMP / Technical Training
cGMP training covers various aspects of current Good Manufacturing Practices as per different regulatory guidelines.
Technical training is training which is designed to develop specific and cross-functional skills and to update 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 are 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 classroom training.
Different training sessions shall be conducted for Level – 1, Level – 2, and Level – 3 employees. The level 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 program.
On-the-Job Training
On-the-job training shall include training in the concerned and cross-functional departments of the new employees and others as identified.
On-the-job training shall be imparted to all the new joined 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 the 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 the 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 another 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 (HODs or above) shall be based on their self-read out of existing sops & all as per their prior fixed job description. After self-read out, they shall maintain their 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 are identified.
Refresher training shall be carried out as per the ongoing training calendar, and whenever there is a procedural change or revision in the SOP.
External Training: External Training is training that is imparted by persons from other sites, locations, and persons from outside of organizations. It shall be conducted as and when required.
The selection of an External Trainer for in-house training shall be done with the consent of the concerned HOD and HOD Quality Assurance. The selection of a 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 programs and identification of the employees for training shall be done by the concerned HOD.
After attending the training program at outside it shall be recorded in the external training record (Refer to 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 operations 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
The HR department in consultation with HOD identifies the Behavioural Training needs of employees (Refer Annexure – VIII, Training Need Identification).
Evaluation of Training
Feedback from each participant shall be taken at the end of each training session. (Refer to Annexure XII , Training Feedback Form)
Training evaluation shall be done by the trainer.
The evaluation shall be conducted for each type of training except the external training by the means of a Questionnaire through a written test to check the effectiveness of the training program (Refer Annexure – IX, Training Evaluation Questionnaire).
The questionnaire shall include questions related to the training topic and the questions shall be of objective types as well.
If the score mark is less than 80%, then the employee shall be retrained & re-evaluated.
Evaluation of re-training shall be done and the same shall be recorded in the 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
A representative from the respective department shall coordinate with the 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.
The staff Training card of each employee shall be maintained by QA Dept. (Refer to Annexure – X, Staff Training Card).
If any employee leaves the organization 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 to 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
Annexure-I
Specimen Format for Training Calendar
Department: ___________For the year: _________Date of Preparation: ________
- Topics
- Faculty
- Month
- 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.
Training Stages
- Preparation of training Module
- Use of Picture Presentation in module
- Addition of case study; If applicable
- Reference to other guidelines related to the topic for reference to the trainees
- Module write-up in bullet point, not in the paragraph
- Presentation skills
- Communication Skills
- Confidence in delivering the topic details
Evaluation: Satisfactory / Not Satisfactory
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
- 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
- The topic of Training
- Document No
- 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:
HR & Admin.
- Induction Manual
- Brief about the Presentation of the film
- Brief about Organization Structure
- Product range
- Basic HR Policies
- Employees Entitlement / Payments
- Joining formalities
- Welcome & Introduction by respective HODs
- Security
- Housekeeping
Warehouse
- Role & Responsibility of Stores & Warehouse Deptt.
- Concept of Engineering Stores, RM Stores, PM Stores/BSR
- Finished Goods Dispatch
- Material Handling
Engineering
- Role & Responsibility of Engineering. Dept.
- Concept of GEP
- Type of utilities
Quality Control
- Role & Responsibility of QC Deptt.
- Concept & Significance of GLP
Quality Assurance
- 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
Information Technology
- Role & Responsibility of IT
- Computer Management
- Mail ID
Annexure-VI
On the Job Training Record
- Name of Trainee
- Department
- Date of Joining
- Designation
- Subjects
- Discipline: Shift Schedule, timings for Tea, Lunch, etc.Other (Specify)
- Sanitization & Hygiene: General Housekeeping Procedure (specify the SOP No.)
General
- Gowning /de-gowning
- Different sections 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)
Equipment
Utilities and Services (specify)
Departmental SOPs (Specify SOP series)
Cross-functional SOPs (Other dept.) – (Specify SOP series)
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:
- Sign / Date:
Annexure-VIII
Training Need Identification
- Date of identification
- Reason for identification of Training
- Type of Training required and details of training
- The department responsible for Training
- Employee (s) identified for training
1. ___________Dept. ____________ 2. ___________Dept.____________
- Trainer Details: 1. _______________________Dept.____________________
- Planned Date of TrainingComments by Concern HOD
- Comments by HR (Applicable for Behavioral training)
- Comments by Head QA
- Date of Training
- Sign of Trainer (s):
Annexure-XII
Training Feedback Form
Venue:_______________________Date:________________________
Your feedback will help us to improve the future training program so please try to be objective and frank in your statements.
- How do you rate the program as a learning experience? (indicate by tick mark)
(a) Very thought Provoking (b) Good learning experience (c) Partially gainful (d) Not clear at all
- What do you think was the objective of the program?
2. Which part of the program appealed to you the most?
3. Which part of the program was not clear to you?
4. What important points have you gained from the program?
- Write down the points most relevant to your day-to-day work.
- Give your suggestions as to how the program 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
- Name of Employee
- Employee code no.
- Designation
- Date of Leaving
- Due date of destruction
- Approval of HOD
- Destruction Done
