SOP for Training of Personnel in Pharmaceutical Manufacturing Facility
1.0 OBJECTIVE:
To describe the procedure for Training of plant personnel to give assurance that they are properly trained as the quality of product is directly affected by action they take in their job. This assurance is built by having a laid down training procedure to ensure that each individual engaged in organization are qualified.
2.0 SCOPE:
This procedure applies to Internal and External training given to plant personnel.
3.0 RESPONSIBILITY:
3.1. Human Resources and Administration: Training Coordination/ Records keeping / organizing. Refer Annexure X.
3.2. Head of Department (HOD): Training to department personnel / To identify the training need, and do evaluation of Training.
3.3. Head of Quality Assurance (QA): To ensure compliance, to authorize the training need specified.
4.0 PROCEDURE:
Procedure of training of plant personnel is defined in following elements
4.1. Job Responsibility.
4.2. Specific training need to be identified for job.
4.3. Training plan to accomplish the training.
4.4. Qualified trainers to perform the training.
4.5. Types of training.
4.6. Training material.
4.7. Evaluation of effectiveness of the training.
4.8. Documentation and record keeping.
4.1 Job Responsibility:
4.1.1 A Job Responsibility shall define the job or role of the individual as per respective SOP.
4.2 Specific training need to be identified for job:
4.2.1. Training need for individual shall be identified based on educational qualification and experience through format as per annexure – XII. Same procedure shall be followed in case of inter department transfer of personnel.
4.2.2. Gap analysis to be done on basis of format as per annexure- XII and individual job responsibility issued by HOD and same shall be covered in training need identified for SOP’s (Annexure XIV).
4.2.3. Training needs to be identified covering all type of training as per annexure-VI for each employee. This is to be done during Induction and or before 31st March of every year for the period of April – March of next year.
4.2.4. On the basis of training need identified except need for SOP training, HR Department shall prepare specific training list of participants as per Annexure-XIII.
4.2.5. Schedule of SOP training shall be prepared by department Head as per annexure – XIV and original copy shall be retained with individual department and photocopy of the same shall be given to HRA and QA department.
4.2.6. Training need shall also be identified based on incident occurred.
4.2.7. In case when new employee join in between schedule year (April – March) the SOP schedule and other training schedule shall be prepared in line as above and put as sheet to the regular schedule. Which can be updated monthly basis.
4.3 Training plan to accomplish the Training:
4.3.1. Training plan for each individual consist of Training Calendar and schedule of SOP, whereas induction training plan for new recruit shall be scheduled as per annexure VIII.
4.4 Qualified Trainers to perform the Training:
4.4.1 The minimum requirement for trainers may include
4.4.1.1 Formal education
4.4.1.2 Train the trainer course
4.4.1.3 Experience in presenting training
4.4.1.4 Expertise on the subject matter.
4.4.2 Trainers / faculties shall have any suitable combination of the above mentioned requirement.
4.4.3 Consultant: Consultant is hired on basis of their education and experience. Consultants shall have sufficient education, training and experience or any combination their of. HA shall keep a record for Name, Address, Qualification and type of service they provide.
4.5 Type of Training:
4.5.1 Induction Training:
4.5.1.1 Whenever any new employee joins the organization, on completion of joining procedure, HR personnel shall give him / her first hand information regarding the company’s profile, group activities, services benefits, service rules, administrative rules, disciplinary rules, Basic safety, GMP and personal hygiene.
4.5.1.2 On completion of Organizational Introduction , HR Personnel shall take him/her for plant round and introduce with Department Heads by acknowledging the Induction Training Record as per Annexure-I.
4.5.1.3 The initial Training Period of a new employee shall be at least for ten days, as described in the Training Schedule (Annexure – VIII). Flow Chart is also given as Annexure – IX. Number of day’s requirement to be fixed by HRA person in consultation with respective HOD.
4.5.2 cGMP Training:
4.5.2.1 cGMP training shall be given as per the nature of job to all employees, twice a year.
4.5.3 On Job Training:
4.5.3.1 The Head of the department / designee shall be responsible to train the new employee on concerned SOPs and related documentation before placing them on the job.
4.5.3.2 The Head of the Department shall provide on-the-job training to the new employee by engaging them with a trained person. In Quality Control department the new analyst / any analyst before taking any analysis / new analysis job on different instrument is subjected to certification as per the sop on Certification of Analyst.
4.5.3.3 Technical training and SOP training programs shall be evaluated through oral or written questionnaire (Refer Annexure – V) immediately after the training.
4.5.3.4 Training coordinator in HR department shall be responsible for maintaining the individual training file and evaluation forms.
4.5.3.5 The criteria for trainee to qualify in respective questionnaire shall be 80%. In case the trainee scores below 80%, retraining shall be provided. The questionnaire shall be prepared by trainer as per his/her understanding. Questionnaire can be prepared as per Annexure-V but not compulsory, trainer can give their own questionnaire also.
4.5.3.6 The Head of the Department shall ensure that the new employees have acquired, necessary training before they are given independent charge of the activities assigned to them. The above activities shall be recorded in ‘Training Certificate’ which shall be certified by Head QA. (Annexure – II).
4.5.3.7 Relevant SOP training shall be given to all employees in the department by Head of the Department or his designee. A SOP Study Record (As per Annexure – XI) wherever required will also be filled up by a new employee while joining / and regular employee based on required SOPs as per his / her job responsibilities. This shall be logged in the training log book (Annexure III), and evaluation may be done, if required.
4.5.3.8 Based on the training plan, the training coordinator in HR department shall organize the training program and communicate to the participants and maintain records thereof.
4.5.4 External Training:
External Training shall be defined as any training conducted by any consultant hired by Corporate HRA at the location or outside the location.
4.5.4.1 Corporate Human Resource & Administration shall receive the brochure from the different Consultants or from the plant location and contact the same for techno-commercial discussion.
4.5.4.2 On the basis of the techno-commercial discussion, Corporate Human Resource & Administration department shall finalize the training program.
4.5.4.3 HRA department with consultation of all department heads shall prepare candidate list for training program.
4.5.4.4 Corporate Human Resource and Administration department shall circulate the date and venue of training program in advance.
4.5.4.5 Training methodology and Evaluation shall completely depend upon the Trainer. Certification to the participants may or may not be given.
4.5.4.6 When candidates come back to the plant location, they are supposed to give a copy of training material to Personnel and Administration department along with “Training Program Feedback Form” As per annexure VII. Based on Feedback, further program may be arranged, if required.
4.5.5 Safety and First Aid Training:
4.5.5.1 Need based training on Safety & First Aid shall be given periodically by either in house trainer or from outside agency.
4.5.6 Miscellaneous Training:
4.5.6.1 This shall be organized by manufacturer or external party and recorded as per parties’ material only.
4.6 Training Material:
4.6.1 Training material shall be clear and well organized. It shall contain stated subject objectives. Any Training material shall be in compliance with cGMP, Company policy and guidelines procedures.
4.7 Evaluation of the Effectiveness of the Training:
4.7.1 cGMP and SOP related training shall be evaluated on basis of question and answer. It may be based on other tools like case study, discussion or other appropriate ways. In question answer seeking a percentage on correct answer where 80% and above is considered as qualifying marks.
4.7.2 Evaluation shall be performed after training. In case retraining on SOPs / cGMP as part of schedule training written evaluation can be done if required.
4.7.3 After retraining on subject like SOP, cGMP (either need based or incidental), conducted then each and every pages of evaluation shall be stamp as “RE-TRAINING”. The scheduled periodic retraining of the SOP shall be given and evaluation of the same is not compulsory.
4.8 Documentation and Record Keeping:
4.8.1 At the start of the training the required details shall be filled in the ‘Training Logbook’ (Annexure – III).
4.8.2 Participants shall enter name, employee code and sign in the Training Logbook. At the end of the training programme, concerned trainer shall write summary of training in training logbook, which consist topic and major points of training with sign./date. Training Logbook shall be maintained department wise separately.
4.8.3 After completion of training HR Department shall update the training History Card (Annexure – IV) in the every alternate month. Training History Card shall be maintained Employee wise.
4.8.4 The training records shall be preserved with the HR department till the employee is in services of the organization.
4.8.5 When an employee leaves the company, his / her training records shall be stamped as ‘OBSOLETE for Reference Only’ and preserved till 5 years from the date of leaving from the organization.
4.8.6 All the training record of individual shall remain in custody of HRA.
5.0 ANNEXURE:
Annexure – I Induction Training Record
Annexure – II Training Certificate
Annexure – III Training Log Book
Annexure – IV Training History Card
Annexure – V Training Questionnaire
Annexure – VI Training Need Identification
Annexure – VII Training Feedback Form
Annexure – VIII Schedule for Induction Training
Annexure – IX New Recruit Training Flow Chart [Not provided here]
Annexure – X Responsibility of Training coordinator
Annexure – XI SOP Study Record
Annexure – XII Individual functional details
Annexure – XIII List of Participants for Specific Training
Annexure – XIV Schedule of SOP Training
Annexure-I Induction Training Record
Name
Designation
Department
Date of Joining
Plant Round Taken (YES / NO)
Sr. No.
Name of Head of the Department / Designee
Department
Date
From (time)
To (time)
Signature
Annexure-II TRAINING CERTIFICATE
Induction Training:
1. Induction Training Given as per Schedule – Yes / No
2. Organization Introduction Given through slide show – Yes / No
3. HR Manual was discussed by Personnel Department with the new entrant – Yes / No
4. Explained Quality Policy – Yes / No
5. Others – Yes / No
Factory Orientations:
1. Taken for a plant visit – Yes/ No
2. Explained systems and policies and do’s & don’ts – Yes/ No
3. Organization structure explained – Yes/ No
4. Safety aspects explained – Yes/ No
5. cGMP Booklet given for study – Yes/ No
On the job training program:
1. Job Responsibility allocated by Head of the department – Yes / No
2. Self Certification of SOPs read and Department Manual Studied – Yes / No
3. Operations explained on the job – Yes / No
4. Department structure explained – Yes / No
5. Training Need Identified – Yes / No
Certified that the new recruit Mr./Ms. —————— is trained sufficiently to take up Independent charge.
Signature of the Employee
Head HR
Head of the Department
Head -QA
Annexure – III TRAINING LOG BOOK
TOPIC:
Date:
Time:
Trainers Name:
Designation:
Dept.:
S. No.
Name of the Employee:
Emp. Code:
Sign/Date:
Summary:
Annexure -IV Training History Card
Name of Employee:
Employee No:
Name of Dept.:
Designation:
Work Place:
Sr. No.
Topic of Training
Date of Training
Name of Trainer
Annexure – V Training Questionnaire
Name of Candidate:
Designation:
Employee No.:
Department:
Group:
Training Date:
Training Duration From : To:
Trainer (Faculty):
Training Location:
Training Subject:
Total Marks:
Marks Obtained:
Qualifying Marks:
QUESTIONS:
Signature of Trainee
Remarks:
Qualified/ Not Qualified
Signature of Trainer
Put ‘√’ mark whichever applicable
Annexure – VI: Training Need Identification
Year:
DEPARTMENT:
Sr. N.
Employee Name
Emp. No.
Compulsory Trainings [Tick mark required training]
1: c GMP
2: Personnel Hygiene
3: SOPs Optional
4: First Aid
5: 5S (House Keeping)
6: Safety
7: Computer Training (Basic)
8: Computer Training (Advance)
9: Leadership Development
10: Supervisory Excellence
11: Basic English Course
12: Executive Excellence
13: Attitudinal & Behavioral
14: Total Quality Management
15: Train the Trainer
16: Stress Management
17: Team Effectiveness
18: Business Presentation
19: Effective Communication
Department Head:
QA Head:
Annexure – VII Training Feedback Form
Name:
Designation:
Department:
Employee No.:
Training Subject:
Trainer (Faculty):
Venue:
Duration of Program
From To Days / Hours
Please give us your unbiased opinion to improve the training program in future.
Please tick (Yes) against your unbiased answer.
Describe your learning point from the program:
Do you think this training is useful for you? Yes/ No
In what way this program will increase your effectiveness at work?
Do you feel that the duration was sufficient? Yes/ No
No, the duration period should be of ___________________
Other Observations
Methodology of training was (Very Good/Good/ Average/Poor)
Training Material Circulated was (Very Good/Good/ Average/Poor)
Practical demonstration (if related) was (Very Good/Good/ Average/Poor)
Any other suggestion (if any) Please specify.
Date:
Signature of Trainee
Annexure – VIII SCHEDULE FOR INDUCTION TRAINING
Name of Employee:
Department:
The following is a general guideline on training plan but not limited to:
Brief introduction of [Company name] by means of corporate CD.
Brief introduction of [Company name]by means of plant CD and presentation on [Company name].
Brief introduction of cGMP / Safety / Personnel Hygiene / HR Policies (providing notes on above subjects).
Issue booklet of cGMP.
Plant round with HR person.
Introduction with all department heads.
Handover to departmental head.
Issue of job responsibility.
Introductory reading of cGMP.
Issue of copy of SOPs and Department Manual.
Reading and understanding of Job Related SOPs. And Department manual Evaluation Certification.
On job demonstration of SOP by superior.
Starting of the job under supervision of superiors.
Certification from superiors for independent working OR
Recommendation for retraining (if required).
Dept. Head Sign./ Date
HRA Dept. Sign./ Date
Annexure – X: Responsibility of Training Coordinator
1. Providing information to the new employee regarding company profile, policy and benefits etc.
2. Introduce new employees with other working members.
3. Updating the training card employee wise, maintaining and preserving training records.
4. Arrange schedule for training of an employees periodically.
5. Prepare list of candidates requiring need based training.
6. Preparation of Training calendar.
7. Prepare list of candidates for external training.
8. Preparation of Induction training schedule in consultation with the department Head.
Annexure – XI SOP Study Record
SOP STUDIED BY :-
NAME
DATE OF JOINING
EMPLOYEE NO.
DESIGNATION
DEPARTMENT
SECTION
PERIOD FOR SOP STUDY
FROM
TO
SR. NO.
NAME OF SOP
SOP No
SELF CERTIFICATION*
I HAVE READ THE ABOVE LISTED SOPs & UNDERSTOOD THE SAME.
NAME OF EMPLOYEE :-
SIGN OF EMPLOYEE :-
DATE :-
* Understood does not indicate that you have memorized all the contents of SOPs.
Annexure – XII Individual Functional Details
Name:
Date:
Department:
Post Applied
Details of previous organization/ Section:
Last Designation:
Qualification:
Experience:
Exposure on Machine / Equipment:
Sr. No.
Name of the Machine / Equipment
Type
Used for
Exposure in department section:
Section Name
Type of job handled
Duration
Any other (Misc.) details:
I Mr./Ms _______________________________, here by declare that the details given above are correct to best of my knowledge.
______________
Signature / Date
Annexure – XIII List of Participants for Specific Training
Title of the training:
Sr. No.
Name of the Employee
Employee No.
Department
Compiled By (HRA):
Sign. / Date
Approved By (QA):
Sign. / Date
Annexure – XIV Schedule of SOP Training
Department:
Part A
Sr. No.
Name of the Employee
SOP No. Considered for Training
Part B
Schedule on SOP training
Sr. No.
Month
Number of SOP considered for Training
Prepared By
HOD (Sign./Date)
Approved By
QA (Sign./Date)