1.0
OBJECTIVE:
To lay down
the procedure for control of deviations when introduced for systems, process,
materials, product, procedure or man material movement from current
specification.
2.0
SCOPE:
This sop is applicable to all the
deviations occurring in manufacturing and testing and also arising from
malfunctioning of equipment at -------------
3.0
RESPONSIBILITY:
3.1
Each affected department is responsible for
initiation of deviation report.
3.2
Concerned Section Head
of the Department is responsible for investigation, identifying root cause and
placing corrective action & preventive action.
3.3
QA is responsible for review and approval of the
deviation report.
4.0
ACCOUNTABILITY:
4.1
Department
Head / Head - Quality Assurance shall be accountable for the compliance of SOP.
5.0
PROCEDURE:
5.1
Any departure from ongoing approved and
established procedures such as SOPs, STP, Process, Systems, standards and
protocols etc.
5.2 Deviations shall be categorized in Minor & Major deviations depending upon the nature of deviation & extent of direct or indirect impact on the quality systems & product quality.
5.3
Deviation may
be classified as Unplanned Deviation
or Planned Deviation.
5.3.1
Unplanned
Deviation may occur due to human error, Malfunctioning or breakdown of equipment
or equipment failures, Utility or service failure or breakdown, power supply
failures/ interruptions, Accident/ Mishap in the plant, any other unforeseen situation. It can also be observed on shop
floor i.e. during processing for e.g. Temperature of the area has gone out of
limit. At that time Department In
charge shall forward the Deviation Control Form to QA Head.
5.3.2
Planned
Deviations are those which are planned prior to execution. Planned Deviation
may be carried out only for quality improvements, yield improvement,
safety reasons, better GMPs or Marketing requirements.
Implementation of the planned deviation shall be done only after it is
authorized by Production Head and QA Head.
5.4
The Quality
Assurance department classifies the deviation as follow:
5.4.1
CRITICAL DEVIATION: A functional deviation i.e. deviation which is certain to Cause
failure of product to fulfill its intended procedure.
5.4.2
MAJOR DEVIATION: A deviation that may cause failure of product to fulfill its intended purpose.
5.4.3
MINOR DEVIATION: Deviation that may not prevent the product from fulfills its intended
purpose.
5.5
In case the
deviation is critical nature it’s rejected straight away and same is sent back
to head of department concerned.
5.6
If required,
the deviation initiator and department head with Quality Assurance or Quality
Control, along with any other department complete any agreed actions required
to evaluate the impact of deviation.
5.7
The deviation
shall be assessed by the quality assurance, and include consideration of any batches
of product, intermediate or components which may be affected from a standpoint
of patient safety or regulatory compliance.
5.8
Decision by
above group is taken based on following i.e. past history i.e.
5.8.1
Stability
studies on retention samples in products, having same or similar deviation etc.
5.8.2
Evaluation on
the impact of deviation is based on the present scenario with retention to product,
its specifications, process difficulties etc.
5.9
The
Production Head must ensure that there are no deviation approved in the
established processes, procedure and standards under normal operating
conditions. In case if any deviation occurs, it shall be immediately (24 hour) brought
to the notice of QA Head for immediate appropriate action taken. The stage
of operation, nature of deviation and the reason for deviation shall be
recorded in the deviation report. No deviation shall be permitted from
pharmacopoeia and other regulatory specifications.
5.10
Once the
impact of deviation is evaluated and accepted, the Document Issuance Requisition
shall be approved by applicable Department Head or his designee and authorized
by QA Head or his designee.
5.11
QA Officer /
Executive shall receive the request for deviation form in Document Issuance
Requisition Format No. F/QA-013-01 duly signed with reason for the issuance.
5.12
After the
authorization of requisition by QA Head or his designee, submit the request to quality
assurance officer/executive shall allocate the unique requisition number as per
following procedure.
The Document Issuance requisition shall be numbered as – PD/@@/XXYYY
Where PD indicates the type of deviation (i.e. PD indicates for Planed
deviation & UD indicates for unplanned deviation).
@@ indicates the name of the Originating department.
Codes for individual department shall be as follows –
|
Sr. no. |
Department |
Code No. |
|
0.1 |
Quality Assurance |
QA |
|
2.0 |
Quality Control |
QC |
|
3.0 |
Engineering |
EG |
|
4.0 |
Personnel &
Administration |
PA |
|
5.0 |
Production |
PD |
|
6.0 |
Ware house (RM/PM) |
WH |
|
7.0 |
Finished Goods |
FG |
XX- Year of deviation like 18 for the current year,
YYY – Serial Number of the deviation
5.13
Each
deviation report shall be filled as per the Format No. F/QA-011-01 issued from
QA and recorded in Log book Format No.: F/QA-011-02. In case of Loan License
Party’s/QA Third party if required, the deviation report is filled in the form
provided by the respective Party.
5.14
Planned
deviation shall be previously approved by the other departments concerned with
the deviation for e.g. Production, Quality Control, Warehouse, Maintenance,
Personnel and Administration, Accounts, Marketing or the Quality Assurance
Department of Loan Licence/QA Third party if applicable, Quality Head and QA
Head whereas unplanned deviation shall be brought into their notice and
approval shall be taken.
5.15
If in any
case deviation not closed timely then give the reason and justification for
extension date of deviation extension period as per format number F/QA-011-01.
5.16
QA Head shall
review the deviation and shall evaluate its impact on the product quality
attributes in consultation with Production manager.
5.17
If the
deviation does not affect product quality, QA Head shall allow further
processing of the batch in question.
5.18
If there are
likely chances of product quality getting affected, QA Head shall not allow
further processing of the batch. Product shall be “quarantined” in sealed
container. Container shall be labeled, indicating product name, Batch number,
manufacturing date. The labeled containers shall be kept in secured area under
lock & key.
5.19
The QA Head
along with the Production manager & maintenance manager shall investigate
& find out the root cause of the problem that results in the process
deviation. Based on the root cause, preventive action plan to avoid
reoccurrence shall be decided & implemented. In case of unplanned deviation
and comments including the steps to avoid such deviations in future shall be
recorded in the Deviation Control Form. In case of unplanned deviation copy of
investigation report shall be attached and for planned deviation
justification shall be provided.
5.20
The report shall be forwarded to quality
assurance head /designee. After reviewing
the nature of deviation and its impact on product quality, identity,
strength and purity shall decide upon the future course of action(s), which
could be
5.20.1 Reprocessing
or
5.20.2 Rejection
of batch
5.21
QA Head shall inform Plant Head/ Production
Head regarding the disposition of the batch under deviation and also shall
decide about the requirement of carrying out any additional test, controls,
sampling and stability studies.
5.22
Reprocessing product shall be released only if
the product meets all its approved specifications. Past experience on similar deviations or past
validation data shall be referred for taking the decision.
5.23
Based on the above review QA Head shall give
their recommendation including the steps to avoid such deviation in future and
additional testing of the product if required. The results of studies carried
out in support of process validation or any past incidences of similar nature
may be used for taking the decision on deviation under consideration.
5.24
After getting the decision from QA Dept it
will be reflected on the format number F/QA/013-02. The approved photocopy of
the Deviation Control Form shall be filed in the respective Batch Manufacturing
Record and the original copy shall be retained by the QA Head in Deviation
Control Form File. In case if a deviation is recurring with respect to some
material, which may affect more than one production batches, photocopies shall
be filed in every Batch Manufacturing Records of the other affected batches.
5.25
After implementation of corrective action / preventive
action as per the deviation QA person verified the result of effectiveness of
the result. Impact of Deviation shall be assessed and compliance ensured with
aspect to various recommendations made in the Deviation Control Form. Then only
QA Head/designee shall finally close out the deviation .All investigation shall
be completed within a time period of 30 days except if approval /data waiting
from the party.
5.26
Every
Deviation Control Form shall be approved/ rejected and closed within a time
frame of 30 days after investigation except in cases where decision is pending
from party.
5.27
Repetition of same type of deviation should be
recorded and take the corrective action.
5.28
Review the
Deviations log book on yearly basis with a goal to look for trends as common
problems as per Annexure number A/QA-011-05.
Inform to QA Head about review findings.
5.29
Any
amendments to systems, documents or operating procedures arising out of the
recommendations for corrective and preventive actions shall be done according
to the sop for ‘Change Control’.
5.30
Acceptance Criteria:
Every Change Control Form
should be closed within its specified time period after final authorization.
5.31
Frequency: As per requirement.
6.0
LIST OF
ANNEXURE AND FORMATS:
|
Sr. No. |
Title of Format |
Format No. |
|
01 |
Deviation Form |
F/QA-011-01 |
|
02 |
Deviation
Control Log |
F/QA-011-02 |
|
03 |
Planned
deviation flow chart |
F/QA-011-03 |
|
04 |
Un-Planned
deviation flow chart |
F/QA-011-04 |
|
05 |
Trending of
Deviation |
F/QA-011-05 |
7.0
REFERENCE:
7.1
SOP-QA-001
7.2
F/QA-001-01
7.3
SOP-QA-014
8.0
REVISION HISTORY:
|
Sr. No. |
Date |
Reason for Revision |
Revision No |
|
1.
|
31/10/2018 |
New SOP |
R0 |
|
2.
|
31/10/2020 |
Schedule Revision |
R1 |
9.0
ABBREVIATIONS:
|
Sr. No |
Abbreviations |
Details |
|
01 |
GMP |
Good manufacturing practice |
|
02 |
EHS |
Environmental Health And Safety |
|
03 |
QA |
Quality assurance |
|
04 |
DEPT. |
Department |
|
05 |
SOP |
Standard operating procedure |
END OF DOCUMENT
DEVIATION FORM NO.: ________________________ DATE:
______________________
(To
be filled by QA dept.)
Short
Description of Deviation:
|
DEVIATION OCCURRED IN : (Put
a tick mark) □ Man □ Mother Environment □
Material □ Method □
Machine □ Measurement |
TYPE OF DEVIATION. (Put
a tick mark) □ Planned □ Unplanned
|
|
DETAILS :
|
|
DESCRIPTION OF THE DEVIATION : DESCRIPTION OF STANDARD PRACTICE: |
IMPACT ASSESSMENT:
|
(Initiator Name, Sign
& Date) (HOD/Designee
Name, Sign & Date) (Initiating Department)
(Initiating Department) |
|
OTHER AFFECTED DEPARTMENTS COMMENT / APPROVAL (As Applicable)
: |
||
|
DEPARTMENT |
COMMENTS / APPROVAL |
SIGN. / DATE |
|
Production |
|
|
|
Quality Control |
|
|
|
Warehouse |
|
|
|
Maintenance |
|
|
|
Personnel and Administration |
|
|
|
Account |
|
|
|
Marketing |
|
|
|
QA of Loan licensee |
|
|
|
Any Other department |
|
|
Number of Repeated Deviation in last Six Months: _____________________________________________
(To be filled by QA)
|
Critical Deviation A functional deviation i.e.
deviation which is certain to cause failure of product to fulfill its intended procedure |
Major Deviation A deviation that may cause
failure of product to fulfill its intended purpose |
Minor Deviation Deviation that may not
prevent the product from fulfill its intended purpose |
|
|
|
|
INITIATION APPROVAL FOR DEVIATION:
|
DEPARTMENT |
NAME |
DESIGNATION |
REMARK
(APPROVED/ REJECTED/MORE
INFORMATION) |
SIGN /
DATE |
|
QUALITY
ASSURANCE HEAD/ DESIGNEE |
|
|
|
|
|
INVESTIGATION FOR DEVIATION : By
QA and Dept. Head (Attach
extra sheet) Root Cause: Prepared by : Date : Reviewed by
:
Date:- |
|
Reason and Justification for Extension Date of the Deviation (If
applicable): REASON AND JUSTIFICATION FOR DELAY: TENTATIVE EXTENSION DATE: ____________________ INITIATOR NAME SIGN/DATE:
________________________________________
COMMENT/APPROVAL FROM QA: QA HOD/DESIGNEE NAME, SIGN &
DATE:_______________________________ |
|
QUALITY
ASSURANCE REVIEW : (Additional work required, if any)
Reviewed By
Sign/Date |
CLOSURE OF THE DEVIATION:
The
approved deviation have been implemented /not implemented satisfactory. The
deviation can be closed.
Close
out date of the deviation after evaluation: _____________________
|
DEPARTMENT |
NAME |
DESIGNATION |
REMARK (CAPA NO.
if required) |
SIGN /
DATE |
|
QUALITY
ASSURANCE HEAD/DESIGNEE |
|
|
|
|
|
Deviation
Req. No. |
Date |
Initiating
Dept. |
Deviation
Req. by (Sign/Date) |
Description
of Deviation |
Material/Product
name (if applicable) |
Conclusion
(Approved / Rejected) |
Initial approval
by Sign /date |
Close Out Date after confirmation |
Final
authorization Sign /date |
Remark |
|
|
Item/Product Name |
Batch No/ A.R. NO |
||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
No comments:
Post a Comment
Pharmaceutical guideline only