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1.0
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PURPOSE
To lay down a procedure to control planned and
unplanned deviations, that directly or indirectly impacts the quality
management system.
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2.0
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SCOPE
This SOP covers the deviation related to the
facility, manufacturing process, specifications, test procedures, documents
and containers closure system.
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3.0
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RESPONSIBILITY
Concerned Department Head
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4.0
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ACCOUNTABILITY
Head QA
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5.0
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PROCEDURE
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5.1
5.2
5.2.1
5.2.2
5.2.3
5.2.4
5.2.5
5.2.6
5.2.7
5.2.8
5.2.9
5.2.10
5.2.11
5.2.12
5.2.13
5.2.14
5.2.15
5.2.16
5.2.17
5.2.18
5.3
5.3.1
5.3.2
5.3.3
5.3.4
5.3.5
5.3.6
5.3.7
5.3.8
5.3.9
5.3.10
5.3.11
5.3.12
5.3.13
5.3.14
5.3.15
5.3.16
5.3.17
5.3.18
5.3.19
5.4
5.4.1
5.4.2
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Deviation may be
classified into two categories.
·
Planned
Deviation
·
Unplanned
Deviation (unforeseen deviations, non – conformances)
Planned Deviations
Any deviation in
manufacturing process / procedure / testing procedure / operating / calibrating
procedure, batch size, equipment,
operating environment or any other GMP critical process which is pre-planned
for the next coming batches, shall be known as planned deviation.
Such a
pre-planned deviation shall be taken / implemented only after pre-approval
from QA.
Such planned
deviations shall be properly documented, evaluated for its impact on product
quality and
Authorized by QA
in advance.
QA shall maintain
a logbook for the approved Planned & Unplanned deviations as per Annexure-I.
All planned
deviations shall be recorded as per Annexure- II.
The concerned
department officer / executive / head shall initiate the “Planned Deviation Report”
by documenting the following and signing
off;
a) Product
Name
b) Batch
Number
c) Batch
Size
d) Manufacturing
Date
e) Expiry
Date
f) Deviation related to (procedure, process,
equipment, standard, batch size etc.)
g) Deviation
details
h) Justification
/ Rationale
i) Supporting
Data
The department Head /Nominee shall review the
proposal for planned deviation, Justification given for its impact on the
product quality requirements, for feasibility of the deviation sign off in
the specified columns.
QA shall assign a unique number to each
planned deviation as follows;
The
report number for a planned deviation shall consist of ten (10) alphanumeric
characters
In the report number for planned deviation, the 1st,
2nd & 3rd characters ‘PDR’ stand for ‘Planned Deviation Report’. The 4th
character “/” is a forward slash. The 5th & 6th
characters represent the last two digits of the year .The 7th
character “/” is again a forward slash. The 8th, 9th
& 10th characters‘001’ are a sequential serial number.For
ex.For first planned deviation no is given as PDR/12/001.
Head QA shall assess the need for any additional
testing for quality monitoring of the Planned Deviation batches and document
the same.
Head QA shall approve / reject the Planned Deviation
with appropriate recommendations.
If approved, the deviation shall be applicable for a
defined number of batches or defined number of days, as mentioned
in the Planned Deviation Report.
After QA approval, the concerned department shall
implement the planned deviation and the observations and data generated shall
be documented.
QA shall review the implementation and make sure
that the recommendations are complied with quality profile of the batches
impacted by the deviation is studied and all the data is annexed with the
“Planned Deviation Report”.
The closure of the planned deviation shall be
responsibility of the concern Deptt. Head and QA Head. Recommendations may be
made during the review.
If the planned deviation in the process /
procedures, leads to improvement in the product quality / process / assurance
/ GMP, then the deviation / change can be made permanent by following the
change control procedure.
Finally, Tech. Director and QA Head shall sign off
the closure in the specified columns.
Unplanned
Deviations
While carrying out day-to-day activities, there are
chances of unplanned deviations (unforeseen
deviations) and events to occur. These deviations are unforeseen,
accidental and may be due to several reasons like;
a) Equipment failures / breakdowns / malfunctioning /
Process Failures
b) Power supply failures / interruptions
c) Accident / Mishap in the plant
e) Breakdown in support services / utilities
f) Documentation Failures
g) Analytical Failures / Errors
An unplanned deviation report (UDR) shall be raised
as a part of the approved system for handling of deviations at the time they
occur, in order to provide alerting production and quality department to
record the deviation and assess the impact and perform corrective action.
QA shall maintain a logbook for the approved
unplanned deviations as per Attachment-I.
All unplanned deviations shall be recorded as per
Attachment-II.
Operator on the job shall inform production
supervisor about the details of incident, resulting in deviation in the
process.
Production officer / executive shall fill the
details of the unplanned deviation in Report and forward the same to production head for his review,
assessment and comments.
Finally, the ‘Unplanned Deviation Report’ shall come
to QA for review and approval.
The numbering of unplanned deviation report shall be
done as follows;
The reference number for an unplanned deviation
report shall consist of ten (10) alphanumeric characters.
In the report number for planned
deviation, the 1st, 2nd & 3rd characters
‘UDR’ stand for ‘Unplanned Deviation
Report’. The 4th character “/” is a forward slash. The 5th & 6th characters
represent the last two digits of the year .The 7th character “/”
are again a forward slash. The 8th, 9th & 10th
characters‘001’ are a sequential serial number. For ex. For first planned
deviation no is given as UDR/12/001.
Head - QA & Head - Production shall assess
unplanned deviation for its impact on product quality. Details shall be
documented as per annexure .Head QA may recommend for performing any
additional studies, if required.
If the Deviation does not affect product quality,
Head - QA shall allow further processing of the batch in question.
If there are likely chances of product quality
getting affected, Head - QA shall assess the impact on product quality before
allowing further processing of the batch.
Product may be “Quarantined” in sealed containers,
if required. Containers shall be labeled, indicating product name, Batch No.,
Manufacturing Date, Expiry Date & Batch size. The labeled containers
shall be kept in secured area under lock & key.
Head - QA along with the Head - Production &
Head - Maintenance (if required)shall investigate & find out the root
cause of the problem that resulted in the deviation.
Based on the investigation, corrective and
preventive action shall be planned to avoid any such reoccurrence and the
same shall be implemented.
QA shall review impact on product quality as
critical ,major or minor and decide upon the future course of action(s),
which could be:
a) Reprocessing or
b) Rejection of batch.
Reprocessed product shall be released only if the
Product meets all the approved specifications.
Both planned and unplanned approved deviations shall
be controlled by QA and the same shall be documented.
Closure of Deviation:
Finally, Head - QA shall close the deviation by
reviewing and assessing the impact of deviation on the quality of the
product.
Any data, comments, documents required to close the
deviation shall be recorded or attached to the deviation report.
Note: The planed deviation shall be implemented
after the approval of Q.A.
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6.0
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REFERENCES
SOP guideline by D.H. Shah
cGMP Guideline
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7.0
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ANNEXURES
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Annexure No.
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Title of Annexure
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Format No.
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Annexure
I
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PLANNED/UNPLANNED DEVIATION FORMATE
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QA/015/F01-03
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Annexure
II
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PLANNED/UNPLANNED
LOG BOOK
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QA/015/F02-03
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8.0
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ABBREVIATIONS
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Abbreviations
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Full Forms
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SOP
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Standard Operating
Procedure
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QA
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Quality Assurance
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UDR
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Unplanned Deviation Report
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PDR
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Planned Deviation Report
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9.0
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DISTRIBUTION
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Master Copy
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Quality Assurance
Department
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Controlled office Copy No. 1
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Quality Assurance Deptt.
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Controlled office Copy No. 2
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Production (Tablet) Deptt.
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Controlled office Copy No. 3
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Production (Liquid) Deptt
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Controlled office Copy No. 4
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Production (External)
Deptt
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Controlled office Copy No. 5
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Production (Soap) Deptt
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Controlled office Copy No.
6
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Head Ware house (External
Block)
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Controlled office Copy No.
7
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Head Ware house (Main
Block)
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Controlled office Copy No.
8
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Head Engineering Deptt.
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10.0
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REVISION
HISTORY
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S.No.
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Revision No.
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Effective
Date
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Reason for
Revision
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Details of
Change
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Authorized
By
(sign
& Date)
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Annexure I
PLANNED/UNPLANNED LOG BOOK
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S. No.
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Date
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UDR/PDR No.
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Details of Deviation
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Corrective Action Taken
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Preventive Action
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Deviation Authorized By
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Closing Date
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Closed By
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Remarks
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Annexure II
Planned/Unplanned Deviation Report
Date: ___________
1.0
Deviation Initiation Planned Unplanned
Deviation Initiation Planned Unplanned |
1.1
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Planned /Unplanned Deviation Report No.:
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________________ (to be assigned by QA)
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1.2
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Initiated By (department):
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_______________
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1.3
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Product Name: ___________
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Batch No.: _________
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Market: ___________
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1.4
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Batch Size: ______________
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Mfg. Date: _________
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Expiry Date: _______
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1.5
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Deviation related to:
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   Procedure, Process, Equipment 
Standard, Batch Size Others
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1.6
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Potential Impact On
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Quality, Yield, GMPs
Manufacturing Process, Others |
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1.7
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Deviation Details:
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1.8
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Justification / Rationale:
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1.9
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Attachments / Supporting Data (If any):
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Initiated
By
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Name
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Signature
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Date
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2.0
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Review by Department Head(Comments):
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Review by Concern
Department Head
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Name
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Signature
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Date
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3.0 QA Review / Approval
3.1.1 Any
additional studies required: Yes / No 
3.1.2 Stability Studies, Additional Quality Testing ,
Others
3.2 Quality Assurance
(comments): ___________________________________________________________________________________________________________________________________________________________________
3.3 Deviation: Approved
/ Rejected
3.4 The Deviation is limited to time / No. of Batches:
_________________________
Head - QA
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Name
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Signature
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Date
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Tech Director
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4.0 Implementation
of Deviation
4.1 Deviation implemented by
(department)_____________________________________________
4.2
Observations if any: _____________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________
4.3 Data Generated (If any):__________________________________________________________
____________________________________________________________________________________________________________________________________________________________________
4.4Quality Profile of batches
affected (If applicable):
__________________________________
__________________________________________________________________________________________________________________________________________________
Implemented By
Department Head
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Name
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Signature
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Date
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5.0 QA Review of
Implementation & Closure
5.1
QA comments: ________________________________________________________________
______________________________________________________________________________________________________________________________________________________
5.1.1 All
recommendations fulfilled: Yes / No
5.1.2 If No, Justification:
_______________________________________________________
______________________________________________________________________________________________________________________________________________________
5.1.3 Data generation
completed: Yes / No
5.1.4 If No, Justification:
__________________________________________________________
___________________________________________________________________________
5.1.5 Can the
Deviation/Change be made permanent through change control? Yes/
No
5.1.6 Remarks (If any):
________________________________________________________
_________________________________________________________________________________
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Closure
Approved By Production /QCHead
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Name
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Signature
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Date
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Closure
Approved By QA Head
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