1.0
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OBJECTIVE:
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To
lay down the procedure for organizing and conducting training programs in the
factory for plant personnel.
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2.0
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SCOPE:
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This
SOP is applicable for all personnel at all levels at XYZ Pharmaceuticals
Ltd.,
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3.0
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RESPONSIBILITY:
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All
department heads and training coordinator for organizing, conducting and
assessing the trainees.
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HRD
Personnel for conducting induction training to all new recruits.
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Head – Quality Assurance
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4.0
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PROCEDURE:
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4.1
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Training
shall be given to all personnel in the production, Quality Assurances,
Quality Control, Engineering, Stores and Personnel departments.
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4.2
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The training needs of staff employee
shall be identified based on their activities by department heads and
consequently the training schedule cum card shall be
prepared. The Training schedule cum cards shall be prepared for individuals
or groups whose job responsibilities are similar.
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4.3
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For operators, the training schedule
cum-card shall be prepared group wise, based on the skill set
requirements.
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4.4
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Training schedule cum card shall be
prepared by the training coordinator and shall be checked by the department
head and approved by Head Quality Assurance.
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4.5
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Training program shall consist of
following five categories:
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4.6
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Human resources Department shall be
responsible for the induction program for the new recruits, which shall
include the overview of the organization and its general policies.
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4.7
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The quality Assurance department
shall be responsible for organizing and conducting cGMP / cGLP / cGDP / cGEP
/ cGWP training/awareness program through internal and external trainers.
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4.8
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The job related training shall be
given by the concerned department heads his designee or external trainers
having sufficient knowledge on the subject.
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4.9
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Safety training shall be conducted by
Engineering head, his designee or external trainers having sufficient
knowledge on the subject. The modules used to impart training for safety are
as per the list No..
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4.10
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For NCR related training, appropriate
training sessions shall be carried out and the same shall be recorded in
unscheduled training card. Any external training or SOP
revision training shall also be recorded in the similar way.
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4.11
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At the end of each month updated
unscheduled training card printout shall be taken &
maintained in the individual’s training file.
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4.12
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The mode of training shall be oral,
or through visual presentations or through self-reading prepared as modules.
The modules for the cGMP / cGLP / cGDP / cGEP / cGWP training are as per the
list No..
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4.13
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The trainees shall be evaluated
through written questionnaire or orally. If the evaluation score is less than
80%, the trainee shall be required to undergo retraining. The operators and
workers shall be evaluated orally only.
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4.14
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Retraining attempts shall be maximum
three times for each topic. If the candidate fails to qualify the retraining
in the all attempts, the concern HOD shall re-identify the training need or
need for change in job profile.
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4.15
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Department Head shall ensure that new
recruits are suitably trained for their work before assigning them with
independent activities. Each new recruit shall endorse the New Recruit
Induction/Training certificate after the successful
completion of the training program.
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4.16
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If the employee is on long leave
(more than 30 days) the employee shall undergo training basically on the
SOP’s related to the jobs performed
on his/her re-reporting. The schedule training missed by him/her shall also
be taken and all these shall be treated as unscheduled if the schedule month
passed away.
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4.17
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A Training Manual shall also be
prepared by the training coordinator which shall include the following but
not limited to:
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4.18
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Trainers shall be certified by
Head-QA based on the educational qualification and experience. A list of trainers shall be maintained as per list No..
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4.19
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All training activities shall be
recorded in the training format with required comments from the
trainees. There is no need for filling the training attendance sheet for the
induction training & on job training, which shall be held for the new
joinees.
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4.20
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At the end of the year, each employee
shall be evaluated through the long-term evaluation format and
any additional training requirements shall be identified for the individual
during such evaluation by the department head.
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4.21
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The frequency of the training program
is as follows:
NOTE: Schedule of the training
programs may be changed to suit work exigencies.
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4.22
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External trainings shall be
coordinated by Quality Assurances Department along with HRD and concerned
department. The training details shall also be recorded in the training
format. The trainees shall handover the training materials to
the training coordinator for reference.
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4.23
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Advanced technical training topics
shall be identified by the respective department heads from recent
publication, external training and Pharmacopoeial revisions. Such trainings
can be conducted through classroom training or issuing materials for reading.
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4.24
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The training records of all existing
employees shall be retained by Quality Assurance department. For resigned
employees, the training records shall be retained for a period of five years
after resignation.
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4.25
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Feedback forms shall be obtained
through “Feedback about Training program and Trainer/ Facility” only for the training programs conducted by external faculties.
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4.26
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To assess the technical and
presentation skills of the external faculty, feedback form shall be obtained
from the participants for the first program of the faculty. Evaluation shall
be done by Head-QA.
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4.27
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The contractor shall be responsible
to ensure that the contract workers are adequately trained in the basics of
GMP, personnel hygiene and safety prior to entry into the work premises. For
contractor worker QA and concerned department will impart verbal training on
cGMP module and specific job related training respectively. A pictorial may
be used for the same. A formal record to be maintained for the same
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4.28
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The training records shall be
preserved as follows:
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4.29
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The modules used for the imparting
training to the trainees shall be revised minimum at the end of two years or
as and when required for revision /updations of the guidelines.
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7.0
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ABBREVIATION (S) /DEFINITION (S) :
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cGLP
: Current Good Laboratory Practices
cGMP
: Current Good Manufacturing Practices
cGMP: current Good Manufacturing
Practice
cGLP : current Good Laboratory
Practice
cGDP : current Good Distribution
Practice
cGEP : current Good Engineering
Practice
cGWP : current Good Warehousing
Practice
HRD
: Human Resource Department
NCR : Non conformance Report
SOP : Standard Operating Procedure
QA : Quality Assurance
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QUALITY ASSUARANCE
Tuesday 6 January 2015
SOP for Training of Personnel in factory
Preparation, approval, distribution control, revision and destruction of Standard Operating Procedure (SOP)
SOP Approval
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Head Operations
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Head QA
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1.0
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OBJECTIVE:
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To
lay down a procedure for preparation, approval, distribution control,
revision and destruction of SOP.
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2.0
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SCOPE:
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The
scope of this document is to provide the guidelines for preparation and
approval of all Standard Operating Procedures prepared for activities related
to department function by concerned department personnel. It also explains
the distribution control, revision and destruction of these Standard
Operating Procedures including this procedure.
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3.0
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RESPONSIBILITY:
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Officer
/Executive – QA: For preparation and execution of the SOPs.
Manager
–QA: To ensure the compliance all SOPs.
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|||||
4.0
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PROCEDURE:
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|||||
4.1
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Preparation procedure:
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|||||
4.1.1
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The
format for the SOP structure is provided in Annexure – I.
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|||||
4.1.2
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Use
A4 size (Width: 8.27” and Height: 11.69” approximately) white paper.
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4.1.3
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Format
SOPs with the following margins. Top: 1.0”, Bottom: 0.5”,
Left : 1.0”, Right : 0.7”, Header : 0.7” and Footer :
0.7” approximately.
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4.1.4
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Prepare
SOPs “Arial” font with font size “12”
approximately.
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4.1.5
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Prepare
SOPs in a clear, unambiguous, easy to understand and easy to follow language.
SOP shall be prepared in draft form as required & printed with ‘’DRAFT’’
only .The draft copy shall be circulated for checking and shall be retained
upto approval.
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4.1.6
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All
SOPs prior to issue shall be checked and approved.
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4.1.7
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All
SOPs shall be prepared with following subheadings,
4..1.7.1
Objective
4..1.7.2
Scope
4..1.7.3
Responsibility
4..1.7.4
Procedure
4..1.7.5
Annexure(s)
4..1.7.6
Reference (s)
4..1.7.7
Abbreviation(s) /Definition (S)
4..1.7.8
Revision Card
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|||||
4.1.8
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The
following details as given under each of the above mentioned ( Step No. : 4.1.7
) subheadings shall be entered .
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|||||
4.1.8.1
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OBJECTIVE
State
the reason for writing the SOP. Restrict the reason to one sentence or
maximum two sentences statement, starting with the word “To”.
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4.1.8.2
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SCOPE
State
the scope to which this SOP shall be applicable for. The scope shall be
applicable for processes / equipment / policies/ particular section/site.
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4.1.8.3
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RESPONSIBILITY
State
the designation of the person who is competent enough / operating person
responsible for performing the job as described in SOP. Care must be taken to
ensure that preferably one to two persons are responsible for compliance of
SOP.
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4.1.8.4
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PROCEDURE
Give
in short, unambiguous sentences of the operating procedure, all checks to be
done, record to be maintained, frequency of various operations, etc. Give
special precautions, if any. SOP must not have long paragraphs but in short,
a few sentences paragraphs. Special instructions may be given as ‘ Note’ , ‘
Precautions’ etc.
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4.1.8.5
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ANNEXURE
(S)
Give the
Annexure (s) used in SOP
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4.1.8.6
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REFERENCE (S)
The references referred to prepare
the SOP/Document shall be mentioned under this heading without version no.
The document no/ SOP no and title shall be mention.
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4.1.8.7
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ABBREVIATION (S) /
DEFINITION (S)
State
the Abbreviation(s) used in SOP or State
the Definition of necessary phrases and words present in SOP.
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4.1.8.8
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REVISION CARD
State serial no., revision no.,
revision date, details of revision and reason(s) for revision, reference
change control No.
The revision card shall note the
history of revision and be part of the master copy to be circulated as per
requirement.
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4.1.9
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Each
SOP shall have a header and footer with the following details.
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4.1.9.1
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ITEM – I:
Header of the all pages
will have the word “Restricted Circulation” on the top right
hand side corner, above the header.
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4.1.9.2
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ITEM – II:
Name
of the company with address of the site and logo of the company.
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|||||
4.1.9.3
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ITEM – III:
STANDARD OPERATING PROCEDURE
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4.1.9.4
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ITEM – IV:
Department,
Mention respective department for
which the SOP is being written or who has major responsibility to accomplish
the job / tasks.
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4.1.9.5
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ITEM- V:
SOP
No., Mention a unique number to each SOP. First seven
characters shall be consider as SOP number and last three characters( 8th
, 9th &10th) shall be consider as sop version
number or revision number, broken down as follows ;
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XXX
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/
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XXX
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-
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XX
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First three characters
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4th character
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5th, to 7th
character
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8th Character
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9th & 10th
character
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Department Code*
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Forward Slash
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Serial No.
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Hyphen
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Revision No.
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( ‘X’ In capital
alphabetic letters)
The
First ( 1st ) three
characters are letters of the alphabet denoting the
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|||||
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“Department Code (alphabetic)” for which SOP is being written for
as per annexure IV.
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Ø
4th
character denotes ”/ “ (Forward Slash).
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Ø
5th,
6th and 7th character denotes “serial number of SOP” (A
three-digit number starting serially from 001).
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Ø
8th
character denotes “- ’’(hyphen).
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Ø
9th
& 10th character denotes “Revision No.” If any new SOP is written, it will be
numbered as “00”. The next revision will be numbered as “01”.
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4.1.9.6
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ITEM- VI:
Title,
Mention the title of the SOP for which it is being prepared.
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4.1.9.7
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ITEM – VII:
Supersedes,
Mention previous
revision number. Write “Nil”, if the new SOP is written.
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4.1.9.8
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ITEM – VIII:
Issue Date,
Mention the month
& year when this SOP is issued to the respective department.
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4.1.9.9
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ITEM – IX:
Effective Date,
Mention the month
& year when this SOP is scheduled to be effective and the SOP shall be
effective after training of this SOP.
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4.1.9.10
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ITEM – X:
Review Date;
Mention the month
& year for review of SOPs.
(Two years from the effective date),
SOPs Shall be reviewed during this month. However any change in SOP, can be
brought on need basis. It will require
a revision and re-issuance of the same as and when the change is implemented.
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4.1.9.11
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ITEM – XI:
Page No., Mention the running page number
followed by the total page number (CURRENT PAGE of TOTAL NUMBER OF
PAGES).For example page no. 4 of 5 , 5 of 5.
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4.1.9.12
|
ITEM – XII:
SOP approval: On first page of SOP below the
header approval Signature
·
Approved
by: shall be signed by Operational Head and QA Head
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4.1.9.13
|
ITEM – XIII:
Each
SOP footer shall have following details:
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·
Prepared by : shall be signed by a
person responsible for executing the SOP.
·
Reviewed by: Shall be signed by Head
Of Department or his designee, and From QA who review the SOP and format.
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Each signatory shall sign in blue pen and
put the date of signature.
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4.1.10
|
Each signature column
shall mention the designation of the person, signature & date of
signatory & name of the signatory.
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4.1.11
|
Quality
Assurance department shall take photocopy of same SOP and distribute it as
per the following Distribution and Control Procedure.
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4.2
|
Distribution and Control Procedure:
|
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4.2.1
|
After
receiving the soft copy of SOP from the concern department. Documentation
cell person shall review the documents for its accuracy and adequacy such as
but not limited to:
·
Format & Format No.
·
Page Numbering
·
Typographical errors
·
Compliances with Change control
·
Other affected documents
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4.2.2
|
Documentation
cell person shall take the printout and stamp as “Originated By” with red
colour ink on left bottom of first pages and put the signature/date. This
hard copy shall be forwarded to concern department for signature.
|
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4.2.3
|
After
approval of SOP training shall be imparted if required before SOP is scheduled to be effective.
|
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4.2.4
|
Quality Assurance department shall
keep all approved SOPs (Master Copy in safe custody).
|
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4.2.5
|
The
Quality Assurance department shall stamp the SOPs as described below using
the standard stamps as given in Annexure – II.
|
||
4.2.6
|
Original
copy shall be stamped as “MASTER COPY” in red ink on the front top right hand
side corner of all the pages. The annexures in the SOP shall be also stamped
with “Approved” stamp in red ink on the top left corner.
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4.2.7
|
Quality
Assurance department shall photocopy the “MASTER COPY” and stamp as
“CONTROLLED COPY / DEPT. CODE NO.” in red ink on the front centre bottom side
of all the pages. It shall be signed by Quality Assurance person controlling
the SOPs or nominated person and allot a specific number to each department.
Department code No. is allotted to various departments is as per annexure IV.
|
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4.2.8
|
Quality Assurance department shall control distribution
of all SOPs. The details of distribution will be entered in “Document
Distribution Record” as per SOP QAD/005.
|
||
4.2.9
|
For
displaying on the site, photocopy of “MASTER COPY’’ shall be taken and
stamped as “REFERENCE COPY / DEPT. CODE NO.” in green ink on the bottom right
hand side corner of all the pages and It shall be signed by Quality Assurance
person. Number of reference copy issued to department shall be recorded in
the “Document
Distribution Record” as per SOP QAD/005.
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4.2.10
|
Any
photocopy of SOP(s) required by external agencies other than regulatory /
statuary / legal authorities shall be issued based on request and shall be
approved by Head – QA. Quality Assurance Department will issue a photocopy of
“MASTER COPY’’ stamped as “UNCONTROLLED COPY” in black ink at the bottom
right hand side corner on all the pages.
|
||
4.3
|
Revision Procedure:
|
4.3.1
|
Revision
of SOP shall be done at any time on need basis. It shall be reviewed at the
end of two years from the effective date. The SOP’s change shall follow the
steps as detailed in the change control system as per SOP QAD/030
|
4.3.2
|
SOP
to be reviewed, all “CONTROLLED COPY” and “REFERENCE COPY” shall be returned
to Quality Assurance department, and will be entered in the “Document
Distribution Record” as per SOP QAD/005.
|
4.3.3
|
Quality
Assurance Department shall ensure reconciliation and destroy the controlled
and reference copies received from different departments and enter in the “Document
Distribution Record” as per SOP QAD/005.
|
4.3.4
|
The old “MASTER COPY” maintained in the
Quality Assurance department shall be stamped “OBSOLETE” in red ink and
stored / archived for history purpose.
|
4.3.5
|
Serial No., revision No., revision
date, details of revision and reason of revision, reference change control no
for revision of of SOP shall be clearly mentioned in
the last item of the SOP. i.e. revision card.
|
4.3.6
|
If
there is no change in text of SOP, stamp “REVIEWED BY / DATE’’ and ‘’NEXT
REVIEW DATE” in red ink at the bottom left hand side corner of all the pages
of “MASTER COPY” shall be put. However, this will not limit the change in SOP, if
required.
|
4.3.7
|
The
revised SOPs shall once again go through the same procedure of approval,
authorization and distribution control as mentioned earlier.
|
4.4
|
Destruction procedure:
|
4.4.1
|
Retrieved copies of SOP shall be destroyed by any one of
the following methods.
1.
Shredding
2.
Incineration
Quality
Assurance department shall supervise this activity.
|
|
Note :
Ø
The SOP shall be translated to local language
whenever required.
Ø
The list of SOP for local language shall be
prepared.
Ø
If any
English SOP changes, the same version of local language shall be changed at
same time.
Ø
The SOP shall be prepared based on reference,
such as pharmacopoeia or manufacturer recommendation or specific guidelines
as applicable.
Ø
The index of SOP shall be revised every 3
months if any changes of SOPs or before any regulatory audit, if required.
Only last version copy of the index shall be kept in archival.
Ø
The index of SOP shall be controlled as per
point no. 4.2.
Ø
No person shall make changes to the SOP
without authorization, and any change must be approved before implementation.
|
7.0
|
ABBREVIATION (S) /DEFINITION (S) :
|
|
|
Dept. : Department
FG : Finished Goods
PM : Packing Material
QA : Quality Assurance
QC : Quality Control
RM : Raw Material
SOP : Standard Operating Procedure
|
|
Note: Any additional information /
attachment can be given as per requirement of SOP.
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