SOP FOR TAINING IN PHARMA

Purpose: The purpose of this standard operating procedure is to lay down the

procedure for effective training of personnel working at the site. in order to ensure
that all employee receives appropriate training which would enhance their
knowledge, experience, skill, expertisation, ability, and behavior to execute their
appropriate duties and responsibilities in such a manner so as to provide Assurance
that the drug product has the safety identify strength quality and purity that it
purports.

Scope:
This procedure is applicable to all the employees of the company involved in
manufacturing, processing, packing, testing for holding of the drug products
for commercial distribution for stability or as an exhibit batch for submission
with a regulatory filling. this standard operating procedure (Training of
personnel) is also applied to all maintenance, other Support Service personal
and management associates assigned to a cGMP facility for working on the
cGMP system at the plant.

Responsibility:

 P and A Head shall be responsible for providing induction training to all

recruits.
 Concerned department head/Designee/approved trainer Shall impart training
on the relevant activity of the department.
 The concerned department head shall be responsible for the identification of
the training date of the individual depending on the activity he or she will
perform.
 The concerned department head shall be responsible to ensure that all
personal working in the respective department is trained and how the
expertise to work in their own function.
 Quality Assurance head designee shall be responsible to impart training
related to cGMP.
  QA head and plant Head shall be responsible for the selection of external
facilities to import training when the need arises.
 Site QA head shall be responsible to certify the qualified trainer.
 Each employee shall receive training in the particular operation that he or she
performs.
 Training in current good manufacturing practice, good distribution practice
and shall be conducted by QA head/designee on a continuing basis (at least
once in a year)so as to ensure that employee remains familiar with current
requirement applicable to them.
 A person envolve in activity of manufacturing and quality area must be
educated and well trained to ensure the quality and safety of products.
 Effective training programs shall be essential to ensure that the employee has
the knowledge and skills they need to perform their jobs.
Definition:

Training: is a continuous instructional process that enhances the employee

with competency in knowledge experience behavior and necessary skill to
perform assigned Job responsibility so as to achieve the required organization
goal.
Training calendar: The training calendar is a document prepared by every
department listing the SOP/cGMP/quality system and other training that shall
be given in the entire year to the individual department as per their training
needs and identification. based on the on-job for refresher training the
document is to be prepared by the officer/executive of the concerned
department checked by the Head of concerned department and approved by
the Head QA.
the master copy of the training calendar of All the departments shall be
submitted to QA and a control copy of the same shall be issued to the
respective department.

Approved trainer: the approved trainer is an employee from any of the

departments who have adequate knowledge of subject, qualification,
experience, training skill and designated for development and conducting
training related to function and operation.
Trainee: the trainee is an employee from any of the departments who
undergoes training for a particular job function.
Evaluator: The evaluator is an employee from the concerned department
who checks the questionnaires. the trainer himself may also be the evaluator.
GMP training: the continual and product training of personal to maintain their
level of the GMP regulation and current topics that are affecting the
manufacturing, processing, packing, testing, holding and distribution of drug
products.
Good distribution practice: Good distribution practice (GDP) is the part of
quality assurance which ensure that the quality of medicinal products is
maintained throughout all stage of the supply chain from the site of the
manufacturer to supply medicinal product to the public.
Training aids: any material item document procedure presentation used for
imparting training and evaluating training effectiveness.
Standard operating procedure training: the training of personnel on written
procedure either new, revised or updated procedure as per its applicability to
the specific individuals working in the department.
Training matrix: it is a guidance document which lists all the SOPs/ topic on
which training is required to the individual of a particular department. the
document shall display for every department, topics which shall be covered
under training and those which are are irrelevant through inappropriate
legend. the document shall be prepared as a stand-alone document and shall
be identified through the inappropriate number which includes the revision
number. the document shall be revised or annexed wherever a new
requirement is introduced to the department or when job responsibilities have
been changed.
External training: all training which is presented by external faculties, who
are experts in their own field, includes attending a seminar, consultant,
training, conference and professional organization meeting.
Training assessment record: the written evaluation of training
understanding of the training which will be related to their job responsibilities,
a master copy of his training assessment record shall be submitted to QA
Head and a control copy of the same shall be issued to respective
departments on request.