The training
program shall comprise of following types of training:
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Ø Induction
Training
Ø Basic
GxP i.e. (GMP, GLP, GDP, GEP & GWP Etc.) training
Ø On Job
Training
Ø Scheduled
and Unscheduled Training
External
Training
Induction
Training:
All newly appointed employees shall undergo the
induction schedule for “Induction Schedule”.
Induction schedule shall be completed within 7 working
days of the employee
Head/Designee-HRD shall prepare the schedule by
mentioning the name of department Head/Designee, date of visiting the
department and introduce the new employee with respective department Head/Designee.
The induction training shall cover all the departments
as well as the department to which he or she belongs.
Head - HRD or
Designee shall explain the new employee at least the following (but not limited
to):
Ø Company
discipline, Benefits, Perks and welfare activity.
Ø First
Aid / Medical Policy
Ø Personal
Hygiene
Ø Leave
Policy
Entry
& Exit Procedure
During induction the department Heads / Designee shall
brief the procedures followed at their department / section explaining the
functions & role of their section / department.
On completion of the induction program employee shall
get the signs from all the department head and complete the induction format
and submit the same in HR department
GxP
(GMP, GLP, GDP, GEP & GWP Etc.) training:
GxP training shall be imparted during induction of the
new Joinees. Under this training, the
employee is imparted
training on Good
Practices in Production, Quality Control, Personnel, Sanitation and Hygiene, Good
Documentation Practice and QMS
System (Wherever Applicable) by concerned department.
GxP training shall be given to all employees (existing
and newly joined) those are directly or indirectly associated with the quality
of the drug product, cGMP training also cover the safety aspects of the
personnel engaged in manufacturing operation. During induction Concerned department
shall describe about GxP
Specimen
Signature of Employee:
The specimen signatures and initials of every employee
/ staff member of the company shall be taken after completion of induction
program.
After completion of induction program HR personnel
shall be responsible to introduced the newly join person to QA for specimen
signature.
These specimen signatures shall be documented
The specimen signature shall be maintained by QA
department.
The specimen signature and initials shall be added at
the time of new recruitment from time to time.
If any employee wants to change his signature he / she
should inform to QA personnel to take new signature in specimen signature log
book accordingly and old signature will be invalidated.
Job
Responsibilities:
Job Responsibilities shall be finalized, signed and
approved by the concern HOD after
Induction to the trainee
All Responsibilities shall be approved by department
head, Should be accepted by designee & acknowledged by HR and same shall be
retain in personal training file of employee / trainee.
Personnel are authorized to perform activities which
are listed in job responsibilities.
Job Responsibilities will be revised in case of
additional responsibility provided to employee or change in the designation or
yearly basis.
job Responsibilities will be given version number
Previous superseded Job Responsibilities shall also be
retained in personnel training file.
In case of additional responsibility to be given to
employee same procedure to be followed.
On completion of basic induction/GxP training,&
Job Responsibility concerned department head or his designee shall prepare
“Training Need Identification” for the new joinee.
On
job Training:
On job training shall be given based upon the Training
Need Identification of new employee.
Training Need
Identification for new joinee shall be
prepared by concerned department Head/Designee in consultation with Head QAD/ Designee on the basis
of individual's qualification,
experience, and the job
he/she is going to handle which
include departmental SOPs and relevant cross functional departmental SOPs
For the
new employee, Training
Need Identification / On job
training program shall be
governed for a period of approximately 7 working days or more
as decided by department Head.
During on job training, the person shall be trained on
actual area of working. This includes class
room training as well as shop floor training, adherence to
cGMP and procedure related to Safety,
Health and Environmental standards of
the working area, SOPs related to the equipment’s, instruments and working
area, Unit operations,
use and operation of equipment and instruments, change room practices etc.
Topics of training
for the training need identification (TNI) / On job training shall be
decided
by the
respective department Heads.
On job training takes place in a normal working
condition, using the actual tools, equipment, documents or materials that
trainees will use when fully trained. New joinee having
instrument/equipment/activity operational responsibility shall be trained
through on job training and same shall be recorded in “Training Attendance
Record”.
The SOPs for Operation of Equipment / Instrument /
Process / In-process checks etc. shall be explained by the Qualified Trainer of
concern department to operators / technician and checkers.
On Job Training shall be evaluated by the trainer
based on the satisfactory operation of task and evaluation shall be done based
on “Training Assessment Form”
The evaluation of the new entrance shall be done
either by written examination or questionnaires on the topic covered during
training to assess the level of competence and same shall be evaluated and
recorded.
Trainees questionnaire shall be assessed for the
satisfactory training, trainees who score less than 80 % marks shall be
considered unsatisfactory and retraining shall be imparted.
Questionnaires shall be prepared or set as per
certified trainer's assessment for the evaluation of trainee at the time of
conduction of training for the identified subject.
A certificate stating the declaration of the trainee
to carry out the assigned activities/test and/ or handling of the selected
equipment/instrument independently shall be issued based on technical and
training need identification.
Certificate is to be signed by the Department
Head/Designee and Head-QAD.
The date on which the certificate is signed by
Head-QAD is to be considered as effective date for that certification. After certification person shall be assigned for
his/her duties and responsibilities.
Evaluation:
Training Assessment Form
shall have the questionnaire in objective, True / False, Fill in blanks or
descriptive forms
The
Training Assessment Form shall be prepared in Hindi also for operators /
technicians if required.
The filled Training Assessment Form shall be checked
by trainer and checked Training Assessment Form shall be attached in personal
training file by trainee.
In case the new joinee scores less than 80% marks in
any of the SOP, he/she shall be re- trained for that SOP, Retraining will be
done in same way and shall be considered only twice.
In such cases evaluation shall be with different
questionnaire than that of previous questionnaire.
In case the trainee didn’t qualify the passing
criteria even after two retraining and getting scores less than 80% marks in
any of the SOP, then it should be investigated and provide the training related to other work.
Scheduled
and Unscheduled Training
In-house training shall be arranged for existing staff
to upgrade their knowledge and skills to familiarize with the principle of new instruments,
new equipment, process, methods and new dosage forms etc. and same shall be
recorded in “Training Attendance Record”.
Unscheduled
trainings shall be imparted and same shall be recorded in “Training Attendance
Record” as and when required in case of following changes may be considered but
not limited to:
Ø Change
in the nature of job and responsibilities
Ø Whenever
a change shall be made in the SOP / STP/ Specifications or whenever
SOP/STP/Specifications shall be revised due to any revision of system.
Ø Whenever
the method of operation and analysis changes.
Ø Whenever
any changes are made in the operating parameters or change in
any operational
procedure, cleaning procedures.
Ø Changes
required due to regulatory requirements.
Ø Changes
in master protocol and new protocols.
In
case of internal audit findings complaints and other foreseen or unforeseen
reasons.
External
Training:
External trainings (in plant or outside plant) shall
be organized if required
Head-QAD/HRD or Designee shall share the training
program to all concerned departments as and whenever required.
Head HRD/Designee shall make arrangements of external
training.
Department Head shall nominate the name of trainees
for scheduled external training.
After completion of external training, trainees shall
fill the External Trainer Feedback Form to check the effectiveness of training
and further decision
Head HRD/Designee shall review the External Trainer
Feedback Form and same shall be retain in personal training file of
employee/trainee.
The employees, who shall get external training from outside
the plant shall conduct internal training program.
Training
Schedule:
All the Department Heads/ Designee shall prepare
Training Schedule \ on half yearly basis i.e. Jan.-June & July- Dec.)
General Annual
training Schedule shall be prepared by QA Which must contain the GMP and
cultural trainings related to all department and shall be imparted by all
concerned HODs & tracked by HR in training schedule.
Un controlled copy of training schedule shall be
submitted to HR department for monitoring and ensure the training of each
department.
Department shall provide the trainings to the employee
as per training schedule with information to HR and cross functional department
if required and same shall be recorded in “Training Attendance Record”.
After completion of training, training attendance
sheet and evaluated training assessment form shall be enclosed in personal
training file by the trainee and shall update the Employee Training Record.
All the trainings as per schedule shall be completed
in specified time period (±3 Working days) and if the people not attend the
training due to some reason training shall be imparted individually and same
shall be recorded in Employee Training Record. In case training not imparted on
agreed time Deviation shall be raised.
Department head shall ensure the compliance of the
training schedule.
Qualification
of Trainer:
Training shall be conducted by qualified trainer only.
The trainers shall have good understanding of
respective subject/ training topic to ensure the understanding of topic/
subject.
The trainers shall be
nominated by the head of department based on at least the following but not
limited to:
Ø Subject
Matter Expert
Ø Skills on preparation and delivery of training
modules and Good communication skills.
Ø Section
Head of respective SOP shall be the trainer.
Ø Employee
who prepared the SOP.
Ø Head –QA
or Approver of SOP.
Ø Employee
obtaining 100% marks in a SOP qualifies trainer criteria for that SOP.
Person
has five or more years of experience in similar field & qualifies the
training.
Certificate of qualified trainer shall be approved by
department head and authorized by Head QAD and these certificates shall be
maintained with their respective training file.
A list of qualified trainer shall be prepared by
concerned department head and shall be kept in department file.
General
Training Program for contractual employees/ workmen and service provider:
Basic GMP , safety
training shall be imparted by the
HR-Person in vernacular language verbally at the joining of new contract
employee with respect to Good Manufacturing
Practices, Do's and Don’ts,
Sanitization, Hygiene and Entry &
Exit Procedure for the change
rooms and same shall be recorded.
Contract/temporary worker should not be the part of
training need identification/On
Job Training.
Authorized HRD Personal shall conduct the abbreviated
GMP training program for contractual employee.
Service provider shall be accompanied by company
personnel. Service provider shall
include those parties who are performing activities like calibration,
maintenance, filter cleaning, HVAC validation, Painting or civil works, Pest
Control etc., this list is not a comprehensive list by itself. Before
initiating any activity, service provider shall be instructed by HR department
regarding basic norms of GMP, hygiene, safety and entry and exit procedure etc.
Training
for Department heads and top management team:
Department head who joined in the company shall be
inducted by the HRD personal for all relevant cross functional department
heads.
Induction shall be documented as per “Induction
Training”
After induction program the employee shall be inducted
within the department.
Before starting of the job employee shall read the
company policies / applicable procedures & department SOP’s. Same shall be
documented by himself as per “Employee Training Record”
Evaluation of this training shall not be done.
After induction and training procedure Job
Responsibilities for the employee is prepared by HRD in co-ordination with
concern heads or top management.
Documentation
and Controlling:
Personal training file of each employee shall be
prepared by each department, for new joining.
Training file shall
contain the following but not limited to:
Ø Training
Need identification.
Ø Certificate
of Trainee
Ø Employee
Training Record.
Ø Training
Assessment Form, if any.
Ø Training
Attendance Record, if any.
Ø Job Responsibility.
Ø Certificate
of Qualified Trainer, (if any).
Records
of External Training (if any).
Concerned department head shall be responsible for
ensuring & Tracking the training
file of individual for the implementation
& evaluation as recorded by individual employee.
The training file of the employee shall be kept in the
respective department.
These training file shall be updated by the employee
during or after training session.
Personal training file of each employee of concerned
department shall be submitted to QA department on yearly basis i.e. end of the
year month (December).
After relieving the job, one copy of the relieving
letter shall be attached with personal training file.
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