ARCO PHARMA PVT. LTD.
Plot No. 94/B, Survey No. 104/A/1, Pappdy Industrial Estate, Village: Dhowali,
Vasai (West), Dist. Palghar, Maharashtra - 401201
MASTER COPY STAMP CONTROLLED COPY STAMP
STANDARD OPERATING PROCEDURE
SOP No. : AP/QA/SOP-010 Effective Date :
TITLE : DEVIATION CONTROL
Revision No. : 00 Next Review :
Superseded : None Page No. : 1 of 16
1.0 OBJECTIVE
1.1 This SOP defines the procedure for Identification, Record and Control of Deviations that
directly or indirectly may affect final quality characteristics of the product.
2.0 SCOPE
2.1 This SOP is applicable for all kind of deviations at Arco Pharmaceuticals Pvt. Ltd.
3.0 REFERENCE
3.1 IN-HOUSE
4.0 DISTRIBUTION LIST
4.1 Quality Assurance Department
4.2 Quality Control Department
4.3 Production Department
4.4 Packing Department
4.5 Store department
4.6 Engineering Department
4.7 Personal & Administration Department
5.0 ANNEXURES
Prepared By Checked By Approved BY
Name &
Designation
Sign & Date
F/QAD-001/01
ARCO PHARMA PVT. LTD.
Plot No. 94/B, Survey No. 104/A/1, Pappdy Industrial Estate, Village: Dhowali,
Vasai (West), Dist. Palghar, Maharashtra - 401201
MASTER COPY STAMP CONTROLLED COPY STAMP
STANDARD OPERATING PROCEDURE
SOP No. : AP/QA/SOP-010 Effective Date :
TITLE : DEVIATION CONTROL
Revision No. : 00 Next Review :
Superseded : None Page No. : 2 of 16
5.1 F/QAD-010/01 : Deviation Form.
5.2 F/QAD-010/02 : Deviation Log Book.
5.3 F/QAD-010/03 : Trend of Deviation.
5.4 F/QAD-010/04 : Extended Review Deviation.
5.5 F/QAD-010/05 : Evaluation of Repetitive Deviation.
5.6 F/QAD-010/06 : Flow Chart for Deviation.
6.0 RESPONSIBILITY
6.1 Originating Department : Reporting of the Deviation, filling the related information of deviation,
Investigation of deviation.
6.2 Head Originating Dept. : Root Cause / Justification for the deviation & comments
6.3 Head QA or Designee : Review of Root Cause / Justification, Impact Analysis, Comment &
Approval / Rejection of Deviation.
6.4 Executive / Officer QA : Maintain the Deviation Log Record, Assigning the deviation No.,
Closure of Deviation.
6.5 Impacted Department : To assess the impact with respect to their functional responsibilities.
7.0 PROCEDRE
7.1 Definition:
Prepared By Checked By Approved BY
Name &
Designation
Sign & Date
F/QAD-001/01
ARCO PHARMA PVT. LTD.
Plot No. 94/B, Survey No. 104/A/1, Pappdy Industrial Estate, Village: Dhowali,
Vasai (West), Dist. Palghar, Maharashtra - 401201
MASTER COPY STAMP CONTROLLED COPY STAMP
STANDARD OPERATING PROCEDURE
SOP No. : AP/QA/SOP-010 Effective Date :
TITLE : DEVIATION CONTROL
Revision No. : 00 Next Review :
Superseded : None Page No. : 3 of 16
Any planned or unplanned departure from an approved instruction or established standard
is a deviation.
7.2 An “unplanned deviation” is an unexpected event that results in a departure from
approved procedure, document, or specification. It is usually discovered after the
occurrence.
7.2.1 Sudden changes in the temperature in the manufacturing area or temperature /
humidity in dispensing area.
7.2.2 Yield less than the standard limits or less than normal expected limit.
7.3 A “Planned Deviation” is a proposed departure to any approved procedure, document
or specification prior to execution.
7.3.1 Use of different packing / raw material code other than the specified in the specification.
7.3.2 Use of different machine / equipment of same principle.
7.4 Minor Deviation – Any Planned / Unplanned departure from any established standard
which may not have any impact upon the identity, quality, purity, stability, physical
Prepared By Checked By Approved BY
Name &
Designation
Sign & Date
F/QAD-001/01
ARCO PHARMA PVT. LTD.
Plot No. 94/B, Survey No. 104/A/1, Pappdy Industrial Estate, Village: Dhowali,
Vasai (West), Dist. Palghar, Maharashtra - 401201
MASTER COPY STAMP CONTROLLED COPY STAMP
STANDARD OPERATING PROCEDURE
SOP No. : AP/QA/SOP-010 Effective Date :
TITLE : DEVIATION CONTROL
Revision No. : 00 Next Review :
Superseded : None Page No. : 4 of 16
characteristics and efficacy of the product or process is a minor deviation.
7.4.1 Use of stereo height of 1.5 mm instead of 1.25 mm.
7.4.2 Use of different type secondary and tertiary packing material code e.g. plain carton / shipper.
7.4.3 SOP not made effective within 30 days.
7.4.4 Change in plan at the time of packing.
7.4.5 Use of 5 ply shipper instead of 7 ply shipper.
7.5 Major Deviation – Any departure from any established standard which may have an impact
upon the identity, quality, purity, stability, physical characteristics, and efficacy of the product
or process is major deviation.
7.5.1 Dust /powder observed adhered to clean accessories.
7.5.2 Use of different machine/equipment of different principle.
7.5.3 Equipment breakdown during activity running.
7.5.4 Average weight of Tablet is out of limit.
Prepared By Checked By Approved BY
Name &
Designation
Sign & Date
F/QAD-001/01
ARCO PHARMA PVT. LTD.
Plot No. 94/B, Survey No. 104/A/1, Pappdy Industrial Estate, Village: Dhowali,
Vasai (West), Dist. Palghar, Maharashtra - 401201
MASTER COPY STAMP CONTROLLED COPY STAMP
STANDARD OPERATING PROCEDURE
SOP No. : AP/QA/SOP-010 Effective Date :
TITLE : DEVIATION CONTROL
Revision No. : 00 Next Review :
Superseded : None Page No. : 5 of 16
7.5.5 Less tablet in Blister / Strip or less blisters / strips in carton or less cartons in shipper.
7.5.6 Wrong status labeling.
7.5.7 In both the case originating department shall initiate the deviation by filling the Deviation Form
(Refer F/QAD-010/01) and shall provide all information related to the impacted activity in the
deviation form.
7.6 Repetitive deviation :
A deviation which has an occurrence of three times is called as a repetitive deviation. These
repetitive deviation shall be evaluated in Evaluation of Repetitive Deviation ( Refer F/QAD-
010/05).
7.7 Reporting and Logging :
7.7.1 An unplanned deviation shall be reported within 24 hours of being reported by any personnel.
7.7.2 A planned deviation should be evaluated by carrying out impact assessment before being
proposed by originating department.
Prepared By Checked By Approved BY
Name &
Designation
Sign & Date
F/QAD-001/01
ARCO PHARMA PVT. LTD.
Plot No. 94/B, Survey No. 104/A/1, Pappdy Industrial Estate, Village: Dhowali,
Vasai (West), Dist. Palghar, Maharashtra - 401201
MASTER COPY STAMP CONTROLLED COPY STAMP
STANDARD OPERATING PROCEDURE
SOP No. : AP/QA/SOP-010 Effective Date :
TITLE : DEVIATION CONTROL
Revision No. : 00 Next Review :
Superseded : None Page No. : 6 of 16
7.7.3 A permanent change can be implemented for repetitive deviations as per the SOP for change
control (Refer AP/QA/SOP-012).
7.8 Immediate Action:
7.8.1 For an unplanned deviation, immediate action shall be taken by QA and record the same in
Deviation Form ( Refer F/QAD-010/01) by selecting either ‘Stop Activity’ or ‘continue activity’
in the ‘Immediate Action’ section and same shall be informed to originating department head
through head QA for investigation.
7.8.2 If required the originating Department Head along with Quality Assurance should suggest any
additional immediate action.
7.9 Investigation and Impact Assessment:
7.9.1 The originating Department Head and Quality Assurance shall review the details filled by the
person originating the deviation form and if required asks for more details.
7.9.2 The originating Department Head and Quality Assurance shall investigate the deviation and
write the details in the remaining part of the justification for the planned deviation /
investigation of unplanned deviation.
Prepared By Checked By Approved BY
Name &
Designation
Sign & Date
F/QAD-001/01
ARCO PHARMA PVT. LTD.
Plot No. 94/B, Survey No. 104/A/1, Pappdy Industrial Estate, Village: Dhowali,
Vasai (West), Dist. Palghar, Maharashtra - 401201
MASTER COPY STAMP CONTROLLED COPY STAMP
STANDARD OPERATING PROCEDURE
SOP No. : AP/QA/SOP-010 Effective Date :
TITLE : DEVIATION CONTROL
Revision No. : 00 Next Review :
Superseded : None Page No. : 7 of 16
7.9.3 Investigation should be done according to the sequence of events taken place and should
clearly state the stepwise course of events that led to the deviation.
7.9.4 Based on the investigation and impact assessment, Head Quality Assurance shall categories
the deviation as major or minor.
7.9.5 Root cause analysis shall be carried out for all major unplanned deviation, by originating
Department Head and Quality Assurance and copy of the root cause analysis shall be
attached to the deviation form.
7.9.6 If a batch /batches are affected, impact of deviation shall be assessed on product quality
before releasing batch /batches to the market. This decision shall be made by the Head
Quality Assurance and shall be recorded in the final review of the deviation.
7.9.7 Deviation shall be intimated to other department to check the impact of deviation on their
departmental procedure. The concerned departments shall be identified by QA.
7.9.8 The comments from other department shall be recorded in the ‘Comments’ section of the
deviation form.
7.10 Recommendation of CAPA:
Prepared By Checked By Approved BY
Name &
Designation
Sign & Date
F/QAD-001/01
ARCO PHARMA PVT. LTD.
Plot No. 94/B, Survey No. 104/A/1, Pappdy Industrial Estate, Village: Dhowali,
Vasai (West), Dist. Palghar, Maharashtra - 401201
MASTER COPY STAMP CONTROLLED COPY STAMP
STANDARD OPERATING PROCEDURE
SOP No. : AP/QA/SOP-010 Effective Date :
TITLE : DEVIATION CONTROL
Revision No. : 00 Next Review :
Superseded : None Page No. : 8 of 16
7.10.1 After receipt of comments from various Department Heads, the Originating
Department Head along with other Department Heads in coordination with Quality Assurance
Head (Head – Quality) shall evaluate the need and recommended areas of the corrective and
preventive action along with the assessment of the impact of CAPA. Justify if CAPA is not
required.
7.10.2 The originating Department Head and Quality Assurance should propose CAPA as per the
CAPA SOP (Refer AP/QA/SOP-015) after Logging the Deviation in CAPA log. The reference
CAPA No. Should be recorded in the deviation form.
7.10.3 In case of unplanned major deviation related to product, CAPA and Deviation shall be closed
before release for sale and distribution.
7.11 Approval / Rejection of Deviation:
7.11.1 The deviation control form and recommended CAPA and its impact assessment shall be
reviewed for adequacy by Head Quality Assurance and Head Quality. If any more actions
recommended, the same shall be updated in the impact assessment and recommended
CAPA and the ‘Approval or rejection’ shall be done by Head Quality Assurance (Head –
Quality) in the Approval or Rejection section of deviation form.
Prepared By Checked By Approved BY
Name &
Designation
Sign & Date
F/QAD-001/01
ARCO PHARMA PVT. LTD.
Plot No. 94/B, Survey No. 104/A/1, Pappdy Industrial Estate, Village: Dhowali,
Vasai (West), Dist. Palghar, Maharashtra - 401201
MASTER COPY STAMP CONTROLLED COPY STAMP
STANDARD OPERATING PROCEDURE
SOP No. : AP/QA/SOP-010 Effective Date :
TITLE : DEVIATION CONTROL
Revision No. : 00 Next Review :
Superseded : None Page No. : 9 of 16
7.11.2 Wherever applicable approval from Regulatory Affairs shall be taken and recorded in
Approval/Rejection section. The applicability of these shall be decided by Head Quality
Assurance.
7.11.3 Any major deviation related to product for regulated or non regulated market or any deviation
required customer approval shall be communicated to regulatory affairs or marketing.
7.11.4 Regulatory Affairs / Marketing shall decide for need of customer approval and shall record
their comment in comment section and tick mark on required or Not Required comment.
7.11.5 The PL (Product License) / MA (Marketing Authorization) Holder will evaluate the deviation
and after reviewing the impact shall report back to regulatory affairs / marketing.
7.11.6 Based on comments received from PL / MA Holder, regulatory affairs / marketing shall record
their comment in Deviation Form (Refer F/QAD-010/01) and communicate to head quality
assurance through e-mail or fax.
7.11.7 All data related to the deviation should be attached to the deviation form. All the E-mails /
faxes / communications related to the deviation form and recorded in the attachments section
of deviation form.
Prepared By Checked By Approved BY
Name &
Designation
Sign & Date
F/QAD-001/01
ARCO PHARMA PVT. LTD.
Plot No. 94/B, Survey No. 104/A/1, Pappdy Industrial Estate, Village: Dhowali,
Vasai (West), Dist. Palghar, Maharashtra - 401201
MASTER COPY STAMP CONTROLLED COPY STAMP
STANDARD OPERATING PROCEDURE
SOP No. : AP/QA/SOP-010 Effective Date :
TITLE : DEVIATION CONTROL
Revision No. : 00 Next Review :
Superseded : None Page No. : 10 of 16
7.11.8 If any planned deviation is rejected, it should be termed as ‘cancelled’ and same should be
updated in the remarks column in the deviation log book (Refer F/QAD-010/02) and close out
date column of CAPA log, wherever applicable.
7.12 Final Review and Closeout of deviation:
7.12.1 The immediate action and final immediate action (if any) shall be implemented by the
originating department after approval of the deviation.
7.12.2 The Head Quality Assurance shall coordinate and evaluate the implementation of immediate
action and additional immediate action (if any) and decide for the close out of the deviation.
7.12.3 For major deviation close out period shall be 30 days from logging the deviation and for minor
deviations, the close out period shall be 15 days. Any close out exceeding this period shall be
recorded as extended in the remarks section in the deviation log book ( Refer F/QAD-010/02)
and should undergo a review process as per Extended Review Deviation (Refer F/QAD-
010/04)
7.12.4 For deviations where root cause /investigation is not completed within the period specified,
justification for not closing out, the status should be mentioned as 1 st review. Incase the
deviation exceeds 30 days of 1st review ,the further status and action should be mentioned in
the 2nd review giving justification for not closing out. Further if investigation is not completed
Prepared By Checked By Approved BY
Name &
Designation
Sign & Date
F/QAD-001/01
ARCO PHARMA PVT. LTD.
Plot No. 94/B, Survey No. 104/A/1, Pappdy Industrial Estate, Village: Dhowali,
Vasai (West), Dist. Palghar, Maharashtra - 401201
MASTER COPY STAMP CONTROLLED COPY STAMP
STANDARD OPERATING PROCEDURE
SOP No. : AP/QA/SOP-010 Effective Date :
TITLE : DEVIATION CONTROL
Revision No. : 00 Next Review :
Superseded : None Page No. : 11 of 16
within 30 days of 2nd review, then the status and further action should be mentioned in 3 rd
review giving justification for not closing out .Further if investigation is not completed within 30
days of 3rd review then it should be reported to Head Quality for further advice.
7.12.5 If the deviation is closed out at 1 st review or 2nd review and does not require any further
actions, then the further review can be mentioned as not applicable.
7.12.6 Close out date should be entered in the deviation form by Head Quality with signature after
final review of the deviation and close out comment. The same should be recorded in the
deviation.
7.13 If the deviation is not ‘closed’ within six months then the Originating Department Head, along
with Quality Assurance in coordination with Head – Quality shall evaluate the justification
/investigation with the impact assessment and after final review of deviation by head quality
assurance, head quality shall be decide for the close out of deviation.
7.14 Implementation of CAPA and CAPA Closeout:
7.14.1 Head Quality Assurance shall coordinate for completion of all the recommended corrective
and preventive actions relevant and ensure the completion of all the recommended actions
prior to close out of the CAPA as per CAPA SOP (Refer AP/QA/SOP-015).
Prepared By Checked By Approved BY
Name &
Designation
Sign & Date
F/QAD-001/01
ARCO PHARMA PVT. LTD.
Plot No. 94/B, Survey No. 104/A/1, Pappdy Industrial Estate, Village: Dhowali,
Vasai (West), Dist. Palghar, Maharashtra - 401201
MASTER COPY STAMP CONTROLLED COPY STAMP
STANDARD OPERATING PROCEDURE
SOP No. : AP/QA/SOP-010 Effective Date :
TITLE : DEVIATION CONTROL
Revision No. : 00 Next Review :
Superseded : None Page No. : 12 of 16
7.14.2 CAPA closeout shall be entered in the deviation log book (Refer F/QAD-010/02).
7.14.3 On Implementation & completion of CAPA, it should be again communicated with PL / MA
Holder if deviation occurrence notification given to them earlier.
7.15 Review and Trending:
7.15.1 The deviation related to batches shall be reviewed before the release and shall be recorded in
the batch document.
7.15.2 Monthly log shall be reviewed within first 15 working days of subsequent month for accuracy,
completeness of data, close out of deviations and close out of CAPA by Quality Assurance
and should be signed in the reviewed by section with date provided on each page of the
deviation log book (Refer F/QAD-010/02).
7.15.3 A review of all major / minor product related deviations should be done during the Annual
Product Quality Review (Refer AP/QA/SOP-016).
7.15.4 Trending of deviation should be done graphically on six monthly basis for major and minor,
planned and unplanned deviations as per the Trend of Deviation (Refer F/QAD-010/03).
7.16 Maintaining of Document:
Prepared By Checked By Approved BY
Name &
Designation
Sign & Date
F/QAD-001/01
ARCO PHARMA PVT. LTD.
Plot No. 94/B, Survey No. 104/A/1, Pappdy Industrial Estate, Village: Dhowali,
Vasai (West), Dist. Palghar, Maharashtra - 401201
MASTER COPY STAMP CONTROLLED COPY STAMP
STANDARD OPERATING PROCEDURE
SOP No. : AP/QA/SOP-010 Effective Date :
TITLE : DEVIATION CONTROL
Revision No. : 00 Next Review :
Superseded : None Page No. : 13 of 16
7.16.1 The original copy of the deviation form and the deviation log shall be maintained by Quality
Assurance.
7.16.2 Supporting data for deviation, investigation and corrective and preventive actions should be
attached to the deviation form.
7.16.3 A photocopy of the deviations occurred related to product/batch shall be kept along with the
respective batch document after completion of investigation and immediate corrective action.
7.16.4 Based on the review of trend Quality Assurance shall indentify repetitive deviations. The
repetitive deviations shall be evaluated and a corrective/ preventive action shall be initiated.
7.16.5 The originating department shall fill the details of Deviation Form (Refer F/QAD-010/01) along
with Approved Process and deviation.
7.16.6 The Quality Assurance shall log the deviation in Deviation Log Book (Refer F/QAD-010/02)
and assign the deviation No. as mentioned below.
7.16.7 The Deviation No. shall consist of twelve characters.
For Example: DV / XX / NNN / YY
Where, DV indicates Deviation
Prepared By Checked By Approved BY
Name &
Designation
Sign & Date
F/QAD-001/01
ARCO PHARMA PVT. LTD.
Plot No. 94/B, Survey No. 104/A/1, Pappdy Industrial Estate, Village: Dhowali,
Vasai (West), Dist. Palghar, Maharashtra - 401201
MASTER COPY STAMP CONTROLLED COPY STAMP
STANDARD OPERATING PROCEDURE
SOP No. : AP/QA/SOP-010 Effective Date :
TITLE : DEVIATION CONTROL
Revision No. : 00 Next Review :
Superseded : None Page No. : 14 of 16
XX indicates the Department code
NNN indicates the sequential number (e.g. 001, 002….etc.)
YY indicates calendar year (e.g. ‘19’ for 2019)
Example: for production it should be DV/PD/001/19 – First deviation occurred in
Production department of Arco Pharmaceuticals Pvt. Ltd. for the year 2019
7.16.8 For unplanned deviations, where the root cause cannot be found evidently, deviation to be
extended to CAPA for further investigations.
7.16.9 Note: Deviation affecting the process or system of any specific area e.g. Production block,
Quality (Quality Control and Quality Assurance), Engineering and P & A department, shall be
logged in the deviation log book ( Refer F/QAD-010/02).
7.16.10 Department Codes
Production : PD
Quality Control : QC
Engineering : EG
Prepared By Checked By Approved BY
Name &
Designation
Sign & Date
F/QAD-001/01
ARCO PHARMA PVT. LTD.
Plot No. 94/B, Survey No. 104/A/1, Pappdy Industrial Estate, Village: Dhowali,
Vasai (West), Dist. Palghar, Maharashtra - 401201
MASTER COPY STAMP CONTROLLED COPY STAMP
STANDARD OPERATING PROCEDURE
SOP No. : AP/QA/SOP-010 Effective Date :
TITLE : DEVIATION CONTROL
Revision No. : 00 Next Review :
Superseded : None Page No. : 15 of 16
Stores : ST
P & A Department : PA
Quality Assurance : QA
7.17 The trend shall be prepared as per Trend of Deviation ( Refer F/QAD-010/03) based on the
Nature of deviations.
Prepared By Checked By Approved BY
Name &
Designation
Sign & Date
F/QAD-001/01
ARCO PHARMA PVT. LTD.
Plot No. 94/B, Survey No. 104/A/1, Pappdy Industrial Estate, Village: Dhowali,
Vasai (West), Dist. Palghar, Maharashtra - 401201
MASTER COPY STAMP CONTROLLED COPY STAMP
STANDARD OPERATING PROCEDURE
SOP No. : AP/QA/SOP-010 Effective Date :
TITLE : DEVIATION CONTROL
Revision No. : 00 Next Review :
Superseded : None Page No. : 16 of 16
8.0 CHANGE HISTORY
Revision No. Reason for Revision Superseded No.
00 New SOP None
9.0 END OF DOCUMENT
Prepared By Checked By Approved BY
Name &
Designation
Sign & Date
F/QAD-001/01
