AC QA 004-01 (Deviation)

ALKEM
Laboratories Limited, Daman
(FOR RESTRICTED CIRCULATION ONLY)
STANDARD OPERATING PROCEDURE

DEPARTMENT : QUALITY ASSURANCE (QA)
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SOP No.:
AC/QA/004
Revision No.:
01
: QUALITY ASSURANCE
SUBJECT : DEVIATION MANAGEMENT AND CONTROL
Supersedes:
AC/QA/004-00
dt. 04.09.07
Effective Date:
Revision Due:
PREPARED BY
CHECKED BY
APPROVED BY
AUTHORIZED BY
Officer QA
Head of Department
Head Operations
Head QA
SIGNATURE
NAME
DATE
DESIGNATION
1.
OBJECTIVE :
1.1.
To lay down a procedure for managing and reporting of deviation, unexpected events and
incidents, and their investigation at Alkem Labs. Ltd. manufacturing plant in Amaliya, Daman.
1.2.
This Standard Operating Procedure defines key system requirements to ensure that there is a
consistent approach to investigations of unplanned deviations. Compliance with this SOP will
also ensure that each investigation is conducted properly and in a timely manner, that corrective
and preventive actions are implemented, and that tracking, follow-up and trending mechanisms
are employed to ensure compliance with GMPs.
2.
SCOPE :
2.1.
Any deviation from approved procedures must be clearly described and justified. This
procedure applies to unplanned deviations, other than:
2.1.1.
Laboratory chemistry and microbiology Out Of Specifications OOS, and other similar
laboratory unexpected results, such as Out Of Limit OOL, and Out of Trend OOT.
Laboratory Investigations may be handled under the Laboratory Investigations System.
They are covered in SOP for Out Of Specification (SOP No. AC/QC/010) and Handling
of Laboratory incidences (SOP No. AC/QC/093).
2.1.2.
Planned deviations. They are covered in SOP for Change Control Procedure (SOP No.
AC/QA/010) and are referred in that SOP as Temporary Change Control.
2.2.
This procedure is applicable to all unplanned deviations in all departments in Alkem Daman.
For example, but not limited to the Production, Quality Control, Quality Assurance, Engineering,
Personnel & Administration, Warehouse at Alkem Laboratories Limited, Amaliya, Daman.
ALKEM

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SOP No.:
AC/QA/004
Revision No.:
01
: QUALITY ASSURANCE
Supersedes:
AC/QA/004-00
dt. 04.09.07
Effective Date:
Revision Due:
PREPARED BY
CHECKED BY
APPROVED BY
AUTHORIZED BY
Officer QA
Head of Department
Head Operations
Head QA
SIGNATURE
NAME
DATE
DESIGNATION
2.3. Policy:
2.3.1. This SOP assures that deviations relating to the manufacturing and distribution of production
materials are thoroughly investigated and documented. These procedures include addressing
deviations that may occur in the production of development and validation batches.
2.3.2. These procedures address the following elements:
2.3.2.1. Identification of reportable events
2.3.2.2. Prompt communication of event and investigation to appropriate parties
2.3.2.3. Identification and responsibilities of the investigators
2.3.2.4. Root cause analysis
2.3.2.5. Evaluation of the impact on other processes, other batches and other facilities
2.3.2.6. Evaluation of quality and final disposition of the production materials
2.3.2.7. Steps of initial and subsequent investigations
2.3.2.8. Proper and timely documentation of investigation to include:
2.3.2.8.1.
Unique investigation report number
2.3.2.8.2.
Preparation, review and approval reports
2.3.2.8.3.
Time frame for reporting
2.3.2.8.4.
Development and implementation of corrective and preventive action(s)
2.3.2.8.5.
Periodic management review of investigation reports including:
2.3.2.8.6.
2.3.2.8.5.1.
Root cause analysis
2.3.2.8.5.2.
Status of corrective and preventive actions
2.3.2.8.5.3.
Effectiveness assessment of corrective actions
2.3.2.8.5.4.
Tracking and trending of deviations
The role of each Department in notification, investigation and resolution of

co-manufactured product deviations
ALKEM

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SOP No.:
AC/QA/004
Revision No.:
01
: QUALITY ASSURANCE
Supersedes:
AC/QA/004-00
dt. 04.09.07
Effective Date:
Revision Due:
PREPARED BY
CHECKED BY
APPROVED BY
AUTHORIZED BY
Officer QA
Head of Department
Head Operations
Head QA
SIGNATURE
NAME
DATE
DESIGNATION
2.3.2.8.7.
Conditions for continuing the processing of batches / production materials

under investigation, including Quality Assurance approval
2.3.2.8.8.
Controls to assure that the status of the production material(s) batch(es)

involved in an investigation is properly identified, and such items are
segregated (if required) as directed by Quality Assurance
2.3.2.8.9.
3.0
Record retention and storage
RESPONSIBILITY: Key Roles and Responsibilities

3.1
The following outlines the key roles and associated responsibilities within the investigation
process:
3.1.1
All Personnel
3.1.1.1 Identify and communicate Reportable Event(s).
3.1.1.2 Take Immediate Action(s).
3.2
Quality Assurance Unit

3.2.1
Approve appropriate immediate actions, including whether to stop or continue

processing.
3.3
3.2.2
Approve Investigation Reports.
3.2.3
Assign disposition.
Investigator/investigation Team
3.3.1
Conduct a thorough and timely investigation.
3.3.2
Involve subject matter experts (e.g., Technical Services, Engineering, Validation

experts, R&D, Regulatory Affairs), where appropriate.
ALKEM

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SOP No.:
AC/QA/004
Revision No.:
01
: QUALITY ASSURANCE
Supersedes:
AC/QA/004-00
dt. 04.09.07
Effective Date:
Revision Due:
PREPARED BY
CHECKED BY
APPROVED BY
AUTHORIZED BY
Officer QA
Head of Department
Head Operations
Head QA
SIGNATURE
NAME
DATE
DESIGNATION
3.4
3.5
3.6
Site Management
3.4.1
Assign adequate and qualified resources for investigations and commitment tracking.
3.4.2
Review Investigation Reports.
3.4.3
Ensure Commitments are completed.
Alkem Daman Site Quality Assurance Unit

3.5.1
Ensure effectiveness of corrective actions.
3.5.2
Measure the performance of the investigation process.
Senior Management / Division Management

3.6.1
Provide Quality Assurance concurrence on facility/functional unit investigation reports,

when required.
4.0
ACCOUNTABILITY :
4.1
Head Quality assurance is accountable for Approval of Deviation, Implementation & Periodic
review of system.
5.0
PROCEDURE:
5.1
Definition:
Deviation includes but is not limited to any departure, difference, divergence, variation,
fluctuation, change, irregularity, abnormality, variance, or discrepancy from approved written
procedure - a nonconformity of SOP, systems and specifications. An incident may not be a
deviation. A deviation is a reportable event
An unplanned deviation is a deviation detected during the process
Minor Deviation (Non-Critical) a deviation unlikely to have a detectable impact on quality or
system capability
Major Deviation (Critical) a deviation that could have a significant impact on the quality or
system capability
ALKEM

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SOP No.:
AC/QA/004
Revision No.:
01
: QUALITY ASSURANCE
Supersedes:
AC/QA/004-00
dt. 04.09.07
Effective Date:
Revision Due:
PREPARED BY
CHECKED BY
APPROVED BY
AUTHORIZED BY
Officer QA
Head of Department
Head Operations
Head QA
SIGNATURE
NAME
DATE
DESIGNATION
OOF : Out of Frequency, the recalibration or revalidation are conducted exceed the planned
schedule.
OOA : Out of Alert level , the monitoring data exceed the trending
OOS : Out of Specification, the testing result are exceed the limit in specification
OOT : Out of Tolerance, the measurement result of equipment exceeds the accepted limit.
OOV : Out of Verification, using material before release
OEM : Out of Environment Monitoring
Root Cause is the most basic cause of a deviation and / or failure in a process, component
or product. An identified reason for the presence of a defect or problem, which if eliminated,
would prevent recurrence. A root cause of a consequence is any basic underlying cause that
was not in turn caused by more important underlying causes
5.2
A deviation investigation may be initiated upon review of information obtained from but not
limited to
5.2.1
annual reviews,
5.2.2
quality audit reports (including internal audits, third party customer audits and or
regulatory audits),
5.2.3
Quality Control results other than those handled by the OOS procedures, AC/QC/010,
5.2.4
Equipment-use logs,
5.2.5
Any other sources of quality data
5.2.6
Change in process parameter.
5.2.7
Change in process equipment
5.2.8
Yield
5.2.9
Change in quality attribute of Raw Material / Packaging Material / Finished product.
5.2.10 Change in manufacturing environment / storage conditions.

5.2.11 Any incident recorded during manufacturing and packing operation or any other
system.
ALKEM

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SOP No.:
AC/QA/004
Revision No.:
01
: QUALITY ASSURANCE
AC/QA/004-00
Supersedes:
dt. 04.09.07
Effective Date:
Revision Due:
PREPARED BY
CHECKED BY
APPROVED BY
AUTHORIZED BY
Officer QA
Head of Department
Head Operations
Head QA
SIGNATURE
NAME
DATE
DESIGNATION
5.2.12 Malfunctioning of equipment / utilities /

5.2.13 Metrology found to be out of calibration
5.2.14 Planned Preventive maintenance.
5.2.15 Vendor notification.
5.3 Deviation Categories examples
CATEGORY
Examples
Wrong version, unapproved document, data
5.3.1
Use of Documents
5.3.2
5.3.3
Procedures
Batch/Packaging
o
o
Step was not followed, step skipped.
Incoming
Events reported by Receiving Department
Record
5.3.4
Materials
Requiring
QA
including
Release
5.3.5
Sampling
5.3.6
Incoming Materials
Materials
5.3.7
Their Status
Process
damaged
or
incorrect
shipment,
missing
or
of
questionable label or documentation.

Damaged or incorrect shipment, incomplete
and
or incorrect documentation.
Incorrect or
unapproved
material
used,
questionable release.
Control
Parameters
5.3.8
Sampling
5.3.9
Material
Holding
and
Holding
Time
missing or incorrect.
Procedure not followed, not applicable.
Parameters not in control and/or not followed.
Improper sampling technique or frequency.

Sample identity mix- up.
Holding time or condition not met, incorrect
o
vessel used.
5.3.10
Conditions
Environmental
5.3.11
Controls
Calibration
Parameters
exceed
action
limits,
leak,
unauthorized entry.
Equipment out of calibration or tolerance, log
ALKEM

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SOP No.:
AC/QA/004
Revision No.:
01
: QUALITY ASSURANCE
AC/QA/004-00
Supersedes:
dt. 04.09.07
Effective Date:
Revision Due:
PREPARED BY
CHECKED BY
APPROVED BY
AUTHORIZED BY
Officer QA
Head of Department
Head Operations
Head QA
SIGNATURE
NAME
DATE
DESIGNATION
CATEGORY
5.3.12
Examples
or sticker missing.
Equipment
used.
5.3.13
5.3.14
5.3.15
Facility Issues
Yields
Quality
5.3.16
Data Entries
5.3.17
Signatures/Approv
o
o
o
Established yield or reconciliation is not met.

Failures, errors, reprocessing, re-inspection.
Calculation error, critical readings missed,
explanations inappropriate.
Inconsistent dates / initials, lack of, or
als
5.3.18
5.3.19
Equipment failure, incorrect equipment/area
Function/
inappropriate approvals.
Equipment or Area
Cleaning
Sterilization,
Sanitation
and
Line
Clearances
Validation related
Testing
5.3.21
Product
clearance
failure,
not
satisfactorily
cleaned, questionable housekeeping.

Failure
Events
5.3.20
Line
to
meet
validation/revalidation
requirements, non- validated equipment, unapproved protocol.

Testing not performed within established
timeframe, testing not performed

No pallet identification number on the pallet or
Identification Discrepancy
the pallet number cannot be found in the Warehouse

Management System.
Case / Carton / Label / Lot Identification - is
not present, is illegible, incomplete, or incorrect, or does not

properly identify the product or lot.
A lot number discrepancy either physical or
systemic between what is expected and what is received, or

what is on hand.
5.3.22
Mixed
Lots
on
More than one lot on a single pallet without
ALKEM

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SOP No.:
AC/QA/004
Revision No.:
01
: QUALITY ASSURANCE
Supersedes:
AC/QA/004-00
dt. 04.09.07
Effective Date:
Revision Due:
PREPARED BY
CHECKED BY
APPROVED BY
AUTHORIZED BY
Officer QA
Head of Department
Head Operations
Head QA
SIGNATURE
NAME
DATE
DESIGNATION
CATEGORY
Pallet
5.3.23
SOP Procedure
Examples
proper placard and separation.
Failure to execute - A SOP or job aid exists
but is not being followed.
5.3.24
Third Party
5.3.25
Vendor or
5.3.26
Supplier Issues
No SOP available.
o
o
Training - did not take place or was ineffective

Incorrect/Defective Packaging Supply Supplies that do not meet specifications.
Third Party Vendor Error - An error by Third
Party Vendor that effects product identity, safety, stability.
5.3.27
Lot Status issues
Transportation Error - An error made by a
carrier of our products.

Lot Status Discrepancy -The status of a lot is
not the same in all computer systems. A situation where the true
lots status is in question.
5.3.28
Improperly Placarded - Placards do not reflect
Mechanical
actual product status.

A mechanical event within the unit that results
Potential Product
in a possible GMP event.

Potential Product Defect - Product has an
Failure
5.3.29
Defect
event other than packaging and labelling.

Temperature Deviation -Temperature goes
outside of range for temperature storage class

5.4
Critical Deviation examples

- OOT , if the equipment related to the quality of product
- OEM, if monitoring is conducted during the process
ALKEM

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SOP No.:
AC/QA/004
Revision No.:
01
: QUALITY ASSURANCE
Supersedes:
AC/QA/004-00
dt. 04.09.07
Effective Date:
Revision Due:
PREPARED BY
CHECKED BY
APPROVED BY
AUTHORIZED BY
Officer QA
Head of Department
Head Operations
Head QA
SIGNATURE
NAME
DATE
DESIGNATION
- product deficiencies, nonconformity with the specification.

- manufacturing or processing performed using incorrect parameters,
- production or process operation was not performed in accordance with specification &
requirements
- stored the product at an unacceptable temperature,
- primary materials did not meet all required specifications,
- testing procedures was incorrectly performed,
- incorrect or missing information on label-packing
- product release prior to validation of process
- production equipment operating improperly or out of specifications
- date of re-calibration or validation out of date,
- secondary packaging did not meet all required specifications,
- product stored for excessive hold time,
- interruption of process e.g due to power or pressure outage,
- sanitation procedure performed incorrectly,
- environmental monitoring does not meet established specifications,
5.5
Non Critical Deviation examples

- OOF
- OOT, if the equipment not related to the quality
- OOA
- OOV
- OEM, if monitoring conducted not related to the product.
- cosmetic defect on materials
- supporting non-GMP process has incorrect parameters
- supporting non-GMP equipment operating improperly
ALKEM

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SOP No.:
AC/QA/004
Revision No.:
01
: QUALITY ASSURANCE
Supersedes:
AC/QA/004-00
dt. 04.09.07
Effective Date:
Revision Due:
PREPARED BY
CHECKED BY
APPROVED BY
AUTHORIZED BY
Officer QA
Head of Department
Head Operations
Head QA
SIGNATURE
NAME
DATE
DESIGNATION
5.6 Timing:
5.6.1
The Quality Assurance shall be notified and a unique tracking number shall be
assigned within one business day (the normal operating days for a facility at Daman or
functional unit (such as G-Block), typically Monday through Saturday) of the date that
the reportable event was detected:
5.6.2
The investigation report shall be completed and approved within 30 calendar days of
the initiation date, unless the Quality Assurance Unit approves an extension. The
initiation date is the date the unique tracking number is assigned. All extension
requests shall be justified and documented.
5.7 Amendments:
5.7.1
If a completed investigation requires an amendment, the Quality Assurance shall

determine the appropriate documentation including version control and approval
requirements.
5.7.2
The reason for the amendment and any additional supporting documentation shall be
included in the amended investigation.
5.7.3
An assessment shall be made of the potential impact any amendment has on

production materials / equipment / areas / processes / procedures.
5.8 Co-Manufacturing and Contract Manufacturing or Testing:

5.8.1
Investigations that involve contracted or co-manufactured product shall be handled by

this SOP unless otherwise defined in the Contract, Quality Agreement, or another
mechanism to ensure adequate investigation procedures are in place.
5.9 Investigation Team:

5.9.1
A multi-disciplinary approach shall be used for investigating an event, where

appropriate.
ALKEM

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SOP No.:
AC/QA/004
Revision No.:
01
: QUALITY ASSURANCE
Supersedes:
AC/QA/004-00
dt. 04.09.07
Effective Date:
Revision Due:
PREPARED BY
CHECKED BY
APPROVED BY
AUTHORIZED BY
Officer QA
Head of Department
Head Operations
Head QA
SIGNATURE
NAME
DATE
DESIGNATION
5.10System Linkages: Other SOPS or systems that may be relevant but are not limited to:
Subject
a) Change Control
b) Batch Record Release
Full title
Change Control Procedure
Batch record auditing for approval or rejection
SOP Number
AC/QA/010
AC/QA/036
c) Preventive Maintenance
d) Annual Product Review
e) Stability
f) Training
g) Materials Management
of batch.
Planned Preventive Maintenance,
Product Quality Review
Stability Studies
Plant personnel Training
Receipt, Identification, Storage and movement
A/EM/001
A/QA/009
AC/QC/001
AC/QA/003
A/WH/102
of Raw Materials (RM) and Packing Materials

h) Laboratory investigations
i) Corrective and Preventive action
(PM) in warehouse.
Reporting of Laboratory incident / Discrepancy
Handling of Corrective and preventive and
AC/QC/093
AC/QA/005
preventive action
j) Failure investigation
Failure investigation
AC/QA/006
k) Market Complaint
Handling of Market Complaint
AC/QA/008
5.11
All personnel who observes any deviation anywhere at any time must immediately report the
event in writing to the area supervisor / in-charge and Quality assurance.
5.12
Identifying and Reporting Events

5.12.1 A Reportable Event is any unplanned occurrence that may or may not affect the
identity, strength, quality, purity or safety of the material being produced or may affect
the validation of the equipment or process used to manufacture, store or distribute
product or regulatory filing conformance.
5.12.2 All reportable events must be documented (refer Annexure VIII), tracked, and trended.
5.12.3 All investigations start as reportable events, but not all reportable events become
investigations.
5.12.4 If a reportable event is triggered by information from another investigation(s), the
original investigation(s) shall be referenced.
ALKEM

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SOP No.:
AC/QA/004
Revision No.:
01
: QUALITY ASSURANCE
Supersedes:
AC/QA/004-00
dt. 04.09.07
Effective Date:
Revision Due:
PREPARED BY
CHECKED BY
APPROVED BY
AUTHORIZED BY
Officer QA
Head of Department
Head Operations
Head QA
SIGNATURE
NAME
DATE
DESIGNATION
5.12.5 Event shall be reported in pre-numbered format (Refer Annexure VII) having 6 digit as
XYNNNN where,
5.12.5.1
X represent the block code as follows :
5.12.5.1.1 C representing the deviation in Cephalosporin block,

5.12.5.1.2 B for Beta lactam,
5.12.5.1.3 G for General block,
5.12.5.1.4 E for Engineering,
5.12.5.1.5 W for Warehouse,
5.12.5.1.6 Q for QA / QC and
5.12.5.1.7 O for others which include any other department along with IT and
Human resources Department.
5.12.5.2
Y represents Last digit for the year (i.e. 8 for 2008) and NNNN
represents a serial number starting from 0001.
5.12.6 Event Information Slip shall contain the following information:

5.12.6.1
Originating Department
5.12.6.2
Slip Number
5.12.6.3
Date of detection
5.12.6.4
Product / Material name(s)
5.12.6.5
Product / Material Code
5.12.6.6
Batch or lot number(s) / A. R. Number.
5.12.6.7
Stage of Manufacturing
5.12.6.8
All affected items such as but not limited to:

5.12.6.8.1
Facility
5.12.6.8.2
System
5.12.6.8.3
Equipment
5.12.6.8.4
Components
ALKEM

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SOP No.:
AC/QA/004
Revision No.:
01
: QUALITY ASSURANCE
Supersedes:
AC/QA/004-00
dt. 04.09.07
Effective Date:
Revision Due:
PREPARED BY
CHECKED BY
APPROVED BY
AUTHORIZED BY
Officer QA
Head of Department
Head Operations
Head QA
SIGNATURE
NAME
DATE
DESIGNATION
5.12.6.8.5
Product
5.12.6.8.6
others
5.12.6.9
Description of the event including how and where detected
5.12.6.10
Person who reported the event
5.12.6.11
Immediate actions taken
5.12.6.12
Linkage to Deviation, as applicable
5.12.7 A database in the form of a register (Refer Annexure VIII) shall be maintained for
tracking the status of each reported event including. The register will comprise the
following information, but not limited to:
5.13
5.12.7.1
Date of event
5.12.7.2
Serial number of the event
5.12.7.3
Origination Department
5.12.7.4
Identity of product
5.12.7.4.1
Facility
5.12.7.4.2
System
5.12.7.4.3
Equipment
5.12.7.4.4
Components
5.12.7.4.5
Product
5.12.7.4.6
others
5.12.7.5
Event category (Reportable only / Deviation).
5.12.7.6
Remarks.
Immediate Action(s):
5.13.1 The following actions shall occur within one business day, but not necessarily in the
listed order.
5.13.1.1
Notify a Supervisor by Event information Slip (Refer annexure VII).
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SOP No.:
AC/QA/004
Revision No.:
01
: QUALITY ASSURANCE
Supersedes:
AC/QA/004-00
dt. 04.09.07
Effective Date:
Revision Due:
PREPARED BY
CHECKED BY
APPROVED BY
AUTHORIZED BY
Officer QA
Head of Department
Head Operations
Head QA
SIGNATURE
NAME
DATE
DESIGNATION
5.13.1.2
Supervisor shall inform block QA.
5.13.1.3
Supervisor and Block Quality Assurance will evaluate the event and take
decision on category of event i.e.
5.13.1.3.1
Reportable only, or
5.13.1.3.2
Deviation.
5.13.1.4
If event is decided as deviation then initiating department shall obtain the

format for Deviation Record from Document Cell in QA.
5.13.1.5
QA will assign 9 digit control number as DX / YY / ZZZ. Where,
5.13.1.5.1
The first character shall be D representing Deviations.
5.13.1.5.2
The second character X is code for originating department as

follows:
5.13.1.5.2.1 C representing the deviation in Cephalosporin block,

5.13.1.5.2.2 B for Beta lactam,
5.13.1.5.2.3 G for General block,
5.13.1.5.2.4 E for Engineering,
5.13.1.5.2.5 W for Warehouse,
5.13.1.5.2.6 Q for QA / QC and
5.13.1.5.2.7 O for others which include any other department along
with IT and Human resources Department.
5.13.1.5.3
The third characters shall be /.
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SOP No.:
AC/QA/004
Revision No.:
01
: QUALITY ASSURANCE
Supersedes:
AC/QA/004-00
dt. 04.09.07
Effective Date:
Revision Due:
PREPARED BY
CHECKED BY
APPROVED BY
AUTHORIZED BY
Officer QA
Head of Department
Head Operations
Head QA
SIGNATURE
NAME
DATE
DESIGNATION
5.13.1.5.4
The forth and fifth character YY shall represent the year like 08
for year 2008.
5.13.1.5.5
The sixth character shall be /.
5.13.1.5.6
Finally seventh, eighth and ninth character ZZZ shall be serial

number of deviation starting from 001 to 999 for each department.
5.13.1.5.7
Example : DC / 08 / 001 is first deviation for year 2008 in

Cephalosporin block.
5.13.2 Perform an initial assessment of the scope and impact.

5.13.3 An event that has significant impact and presents a potential compliance risk, as
defined by the facility / functional unit procedures, shall be reported to the Quality
Assurance immediately, defined as within one calendar day.
5.13.4 Identify any immediate action that may be necessary to isolate the event to limit any
adverse effect such as, but not limited to:
5.13.4.1
production materials
5.13.4.2
Equipment
5.13.4.3
Areas
5.13.4.4
Processes
5.13.4.5
procedures,
5.13.4.6
Discontinue processing: Resumption or continuation of GMP-related

activities requires approval from Quality Unit.
5.13.4.7
Quarantine the production

5.13.4.7.1
Materials
5.13.4.7.2
equipment
5.13.4.7.3
Areas
5.13.4.7.4
Processes
5.13.4.7.5
Procedures
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AREA
SOP No.:
AC/QA/004
Revision No.:
01
: QUALITY ASSURANCE
Supersedes:
AC/QA/004-00
dt. 04.09.07
Effective Date:
Revision Due:
PREPARED BY
CHECKED BY
APPROVED BY
AUTHORIZED BY
Officer QA
Head of Department
Head Operations
Head QA
SIGNATURE
NAME
DATE
DESIGNATION
5.13.4.8
If the process cannot be stopped, the IPQA in-charge and Production

in-charge can take a decision on continuing the process until the next
stage, after assessing the impact of deviation on product quality and
taking immediate corrective action(s). However, the Head of QA shall
make the final decision on batch disposition after reviewing the
deviation and other related documents.
5.13.5 Assess the potential need for a Market Alert or other Regulatory Notification and if
required, contact Senior Management in Alkem HQ.
5.13.6 Link the reportable event involving production materials to Batch Record Review and
Release System.
5.14
Classification of Deviation: The Quality Assurance shall have the final authority to determine
if an investigation is necessary for each deviation.
5.14.1 Reportable Only - These events have minimal or no impact on production materials /
equipment / areas / processes / procedures and are limited in nature. The event and
circumstances surrounding that event shall be considered when determining if an
investigation is required. The rationale for not investigating a reportable event shall be
documented. Reportable only events may include:
5.14.1.1 Minor Batch Record or documentation errors not affecting the integrity of
data.
5.14.1.2 Repeat event(s) for which the root cause is known and for which corrective /
preventative actions have been identified, but implementation has not been
completed. The repeat event must be linked to the original investigation.
5.14.1.3 Events for which the root cause is known and for which the actions required
to address these events are governed by appropriate facility / functional unit
procedures.
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SOP No.:
AC/QA/004
Revision No.:
01
: QUALITY ASSURANCE
Supersedes:
AC/QA/004-00
dt. 04.09.07
Effective Date:
Revision Due:
PREPARED BY
CHECKED BY
APPROVED BY
AUTHORIZED BY
Officer QA
Head of Department
Head Operations
Head QA
SIGNATURE
NAME
DATE
DESIGNATION
5.14.1.4 If trending indicates that the frequency of the reportable event is repetitive
(as defined by facility / functional unit procedures), the need for performing
an investigation shall be evaluated.
5.14.2 Deviations that Require Investigation
5.14.2.1 All deviations that are not classified as reportable only" shall be investigated.
5.14.2.2 An investigation shall be conducted when the frequency of similar "reportable
only" events is determined to be unacceptable (e.g.. exceeds pre-established
limits). The scope of the event must be assessed to determine whether the
event is isolated or if a pattern exists (refer annexure V). Data for a sufficient
period of time or number of batches / lots must be reviewed to identify any
similar or identical events that may be indicative of a trend or a common root
cause. The number of batches / lots and / or the time period will vary
depending on the reported event.
5.14.2.3 If after the initiation of the investigation, it is determined that no investigation
was warranted, the investigation may be closed in the tracking system.
Closure of the investigation shall require documented rationale that is
approved by the responsible functional area management and the Quality
Assurance.
5.14.3 The Investigation - The Quality Assurance shall approve the documented rationale for
continued use of production materials / equipment / areas / processes / procedures
impacted by the investigation.
5.14.4 The functional unit management shall assign resources needed to perform the
investigation, including an investigator/ investigation team. Unless otherwise directed
personnel from the department along with IPQA person shall jointly investigate the root
cause of deviation.
5.14.5 A due date for completion for each investigation shall be established.
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SOP No.:
AC/QA/004
Revision No.:
01
: QUALITY ASSURANCE
Supersedes:
AC/QA/004-00
dt. 04.09.07
Effective Date:
Revision Due:
PREPARED BY
CHECKED BY
APPROVED BY
AUTHORIZED BY
Officer QA
Head of Department
Head Operations
Head QA
SIGNATURE
NAME
DATE
DESIGNATION
5.14.6 The investigation report shall be completed and approved within 30 calendar days of
the initiation date, unless the Quality Assurance approves an extension. The initiation
date is the date the unique tracking number is assigned. All extension requests shall be
justified and documented.
5.14.7 The functional unit shall define how investigations are addressed that exceeds the due
date.
5.14.8 The investigation report shall
5.14.8.1 Assess the likely implication of deviation on existing process / activity /
product / parameters etc.
5.14.8.2 Define the steps taken to resolve the deviation (correction) and suggested
corrective action for the current stage
5.14.8.3 QA shall review the investigation and then shall forward the deviation form to
other concern department, if required.
5.14.8.4 After getting comments from other concern department the deviation form
shall be forwarded to Head Operations for review and comments.
5.14.8.5 The deviation form shall then be forwarded to Head Quality Assurance who
shall evaluate the deviation and decides the approval / Rejection.
5.14.8.6 All deviations need correction, corrective action and or preventative action
depending on the category. The QA head shall approve the degree of the
CAPA system based on category of deviation. All deviations deemed to be
critical for quality of product, system or may pose a compliance risk, shall use
CAPA as outlined in the SOP no. AC / QA / 005.
5.14.8.7 The QA-in-charge shall ensure implementation of the corrective actions after
evaluation and approval of the deviation form by Head Quality Assurance.
5.14.8.8 On completion of the corrective activity the deviation shall be closed by the
QA.
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SOP No.:
AC/QA/004
Revision No.:
01
: QUALITY ASSURANCE
Supersedes:
AC/QA/004-00
dt. 04.09.07
Effective Date:
Revision Due:
PREPARED BY
CHECKED BY
APPROVED BY
AUTHORIZED BY
Officer QA
Head of Department
Head Operations
Head QA
SIGNATURE
NAME
DATE
DESIGNATION
5.15The Investigator or investigation team :

5.15.1 Define the extent or range of impact by identifying all production materials / equipment /
areas / processes, etc., that may be involved. The evaluation shall include analysis of
other batches of the same product, other products that may have been affected, and
similar occurrences.
5.15.2 Document the rationale for the exclusion/inclusion of production materials / equipment /
areas / processes, etc.
5.15.3 Continually re-assess the scope throughout the investigation based on new information
/ data collected.
5.16
Root Cause Analysis

5.16.1 Data Collection
5.16.1.1 Identify and collect data / information that are relevant to defining and
investigating the event
5.16.1.2 Collect and document input from support functions (e.g., Subject Matter
Experts, etc.), when appropriate.
5.16.1.3 Assess and document probable cause(s) for the event; identify and collect
data to confirm / invalidate those causes.
5.16.1.4 The analysis of data shall provide the basis for subsequent data / information
collection and review, as well as for conducting root cause analysis.
5.16.2 Data Analysis
5.16.2.1 Analyze factual data, records and other relevant documentation to
determine:
5.16.2.1.1 if the impact and scope (other production materials / equipment /
areas / processes / procedures) of the reported event have been
fully defined.
5.16.2.1.2 if the event is related to other similar events or part of a trend.
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SOP No.:
AC/QA/004
Revision No.:
01
: QUALITY ASSURANCE
Supersedes:
AC/QA/004-00
dt. 04.09.07
Effective Date:
Revision Due:
PREPARED BY
CHECKED BY
APPROVED BY
AUTHORIZED BY
Officer QA
Head of Department
Head Operations
Head QA
SIGNATURE
NAME
DATE
DESIGNATION
5.16.2.1.3 if any additional data or information is needed.

5.16.2.1.4 the probable root cause(s).
5.16.2.1.5 potential corrective / preventive action(s).
5.16.2.2 Establish the basis for subsequent data / information collection and conduct
preliminary root cause analysis.
5.16.2.3 If the analysis does not identify any clear-cut root cause, or if all probable
root causes have been eliminated, the need for further analysis shall be
evaluated.
5.16.2.4 Ensure that the data fully supports the root cause(s) determination, lot /
batch impact and conclusion(s) of the investigation.
5.16.2.5 Document all activities performed and conclusions made during data
analysis.
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SOP No.:
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Revision No.:
01
: QUALITY ASSURANCE
Supersedes:
AC/QA/004-00
dt. 04.09.07
Effective Date:
Revision Due:
PREPARED BY
CHECKED BY
APPROVED BY
AUTHORIZED BY
Officer QA
Head of Department
Head Operations
Head QA
SIGNATURE
NAME
DATE
DESIGNATION
5.16.3 Root Cause(s) Determination

5.16.3.1 Assess probable cause(s) for the event and disqualify those not supported
by data.
5.16.3.2 Analyze the remaining probable root cause(s) to identify those which are
best supported by the data.
5.16.3.3 Challenge the most probable root cause(s) to ensure all relevant data
supports conclusions, confirming the root cause(s), wherever appropriate.
Perform additional data collection and analysis, if necessary.
5.16.3.4 Document all activities performed and conclusions made during root cause
analysis even when no definitive root cause(s) can be identified.
5.16.3.5 Classify the root cause(s) for purposes of documenting and trending.
5.17
Corrective and Preventive Actions

5.17.1 Actions taken to correct the event under investigation are corrective. Actions that
address the underlying root cause and are implemented to minimize or eliminate
recurrence are preventive.
5.17.2 More than one corrective / preventative action may be necessary to address the
identified root cause (s) and other contributing factors.
5.17.3 Determine the appropriate corrective/preventative action(s) by:
5.17.3.1 Identifying possible actions that may remediate the root cause(s) for the
observed event.
5.17.3.2 Analyzing each possible action.
5.17.3.3 Challenging each action to ensure that the root causers) were addressed.
5.17.4 Identify and document the specific corrective/preventive action(s) 'that shall occur:
5.17.4.1 Prior to the closure of the investigation.
5.17.4.2 After file closure of the investigation and prior to further processing or the
resumption of GMP-related activities. Systems must be in place, including
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SOP No.:
AC/QA/004
Revision No.:
01
: QUALITY ASSURANCE
Supersedes:
AC/QA/004-00
dt. 04.09.07
Effective Date:
Revision Due:
PREPARED BY
CHECKED BY
APPROVED BY
AUTHORIZED BY
Officer QA
Head of Department
Head Operations
Head QA
SIGNATURE
NAME
DATE
DESIGNATION
the need to notify affected departments, to ensure that any production

materials / equipment / areas / processes/procedures that have been
isolated / quarantined / placed on hold are not used prior to release or return
to service.
5.17.4.3 As a future action that requires a longer time to implement and does not
require completion prior to further processing or the resumption of GMPrelated activities associated with the investigation.
5.17.4.4 Determine target due date for completion, conditions, and responsible
person assignment for implementing corrective / preventive action(s).
5.17.4.5 Identify corrective / preventive actions that extend beyond the closure of the
investigation and enter them into the functional units commitment tracking
system. These commitments shall:
5.17.4.5.1 be well defined.
5.17.4.5.2 include a due date for completion.
5.17.4.5.3 identify the responsible individual.
5.17.4.5.4 obtain concurrence, if required, from affected functional units
Subject Matter Experts.
5.18
Recommendation for Disposition

5.18.1 The investigator/investigation team shall determine the fate of the item, batch etc (eg
reject, rework, quarantine, release) :
5.18.1.1 recommend disposition of the affected production / material / equipment /
areas / Processes / procedures.
5.18.1.2 document the recommendation and the rationale.
5.19
Investigation Report
5.19.1 The results of the investigation shall be documented in a clear, comprehensive report
that shall include, but is not limited to:
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SOP No.:
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Revision No.:
01
: QUALITY ASSURANCE
Supersedes:
AC/QA/004-00
dt. 04.09.07
Effective Date:
Revision Due:
PREPARED BY
CHECKED BY
APPROVED BY
AUTHORIZED BY
Officer QA
Head of Department
Head Operations
Head QA
SIGNATURE
NAME
DATE
DESIGNATION
5.19.1.1
Description of the unplanned deviation:
5.19.1.2
Define the event.
5.19.1.3
Record immediate actions taken.
5.19.1.4
Investigation into probable root causes:
5.19.1.5
Data collection
5.19.1.6
Data Analysis
5.19.1.7
Probable root causes considered
5.19.1.8
Other production materials/ equipment/ areas/ processes/ procedures

possibly affected:
5.19.1.9
Scope and impact

5.19.1.9.1
Impact of other similar events or failures
5.19.1.10 Conclusion about root cause:

5.19.1.10.1 Identify the most probable root cause(s), including the
rationale for selecting the most probable root cause(s).
5.19.1.11 The rationale for eliminating other probable root causes
5.19.1.12 Corrective / Preventive action(s)
5.19.1.13 Actions taken and commitments
5.19.1.14 Recommendation for disposition related to the investigation:
5.19.1.15 Decisions and rationale
5.19.2 All supporting documentation shall be either referenced in or attached to the
Investigation Report providing a logical presentation of the facts.
5.19.3 Author(s) / investigator(s) shall ensure that the report is complete and the most current
version is circulated for review and approval.
5.20
Review and Approval of the Investigation Report

5.20.1 Alkem Facility or at Functional Unit level management
5.20.2 The Quality Assurance shall be the final approval signature.
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SOP No.:
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Revision No.:
01
: QUALITY ASSURANCE
AC/QA/004-00
Supersedes:
dt. 04.09.07
Effective Date:
Revision Due:
PREPARED BY
CHECKED BY
APPROVED BY
AUTHORIZED BY
Officer QA
Head of Department
Head Operations
Head QA
SIGNATURE
NAME
DATE
DESIGNATION
5.20.3 Reviewers and approvers shall ensure that the investigation is clear, identifies the
scope, depth, root cause and appropriate corrective/preventive actions. Points to
consider may include:
5.20.3.1 Documentation package complete including attachments/ references as
applicable.
5.20.3.2 Compliance to GMP.
5.20.3.3 Appropriate regulatory input obtained.
5.20.3.4 Applicable root causes properly investigated.
5.20.3.5 Most probable root cause chosen based on supporting data and sound
scientific reasoning.
5.20.3.6 Appropriateness,
adequacy
and
timeliness
of
actions
taken-and
recommended.
5.20.3.7 Appropriate personnel included in the review and a process.
5.20.4 Reviewers and approvers shall ensure that the information presented in the
investigation is clear and has the appropriate scope and depth.
5.20.5 Reviewers and approvers shall document agreement with the facts as presented.
5.21
Alkem Senior Management and HQ Management Concurrence

5.21.1 In the case where critical deviations are logged, or where heavy capital expense is
required, the investigation report shall be completed and approved by the Alkem top
management before forwarding for information to HQ.
5.21.2 The final disposition can be determined before HQ is informed.
5.22
Investigation Report Closure

5.22.1 An investigation shall be closed in the investigation tracking system when:
5.22.1.1 the investigation report is approved.
5.22.1.2 all pertinent information for investigation trending is entered into the
investigation database.
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SOP No.:
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Revision No.:
01
: QUALITY ASSURANCE
Supersedes:
AC/QA/004-00
dt. 04.09.07
Effective Date:
Revision Due:
PREPARED BY
CHECKED BY
APPROVED BY
AUTHORIZED BY
Officer QA
Head of Department
Head Operations
Head QA
SIGNATURE
NAME
DATE
DESIGNATION
5.22.1.3 all commitments are entered into the commitment tracking system.
5.22.1.4 Corrective / preventive actions that were required to be completed prior to
the investigation closure have been completed.
5.22.2 Final Disposition
5.22.2.1 Final disposition decision related to production materials / equipment /
areas/processes/procedures shall be documented and justified by Quality
Assurance.
5.22.2.2 Disposition actions (e.g. reject. release, return to service) shall be taken
when relevant investigations are completed and closed.
5.23
Commitment Tracking
5.23.1 A system is required for entering and tracking commitments. This system shall track, at
a minimum, the commitment, the responsible individuals, the investigation number, due
date, and completion date.
5.23.2 The Quality Assurance shall approve changes to commitments.
5.23.3 The functional unit procedures shall define the approval process for changing due
dates and/or responsible persons and for verifying the completion of commitments.
5.23.4 The facility/functional unit shall determine the content, frequency of issuance and
distribution of periodic status reports of open and overdue commitments.
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Revision No.:
01
: QUALITY ASSURANCE
AC/QA/004-00
Supersedes:
dt. 04.09.07
Effective Date:
Revision Due:
PREPARED BY
CHECKED BY
APPROVED BY
AUTHORIZED BY
Officer QA
Head of Department
Head Operations
Head QA
SIGNATURE
NAME
DATE
DESIGNATION
5.24
Metrics
5.24.1 There shall be a system for tracking and reporting metrics, including, but not limited to,
the status of all open and any overdue investigations and commitments.
5.24.2 The frequency of reporting metrics shall be on a regular predetermined basis (at least
annual)
5.24.3 The Alkem Daman top management as the GMP Committee shall review metric reports
to:
5.24.3.1 identify
any
actions
needed
to
improve
timeliness
of
completing
investigations.
5.24.3.2 determine the effectiveness of corrective and preventive actions.
5.24.3.3 measure the performance of the investigation process.
5.25
Trending
5.25.1 A trend is a pattern that indicates a change in the expected frequency or occurrence.
5.25.2 There shall be trend analysis of deviations and investigation data including:
5.25.2.1 Event category
5.25.2.2 Root Cause category
5.25.2.3 Functional Area category (e.g., C-Block, B-Block, Quality Assurance, etc.)
5.25.3 Quality Assurance shall carry out trend analysis for all the deviations in the whole year
at the beginning of the next year as per the Trend Analysis of Deviation format as per
Annexure V.
5.25.4 A copy of the trend analysis shall be forwarded to Regulatory compliance, Head
Quality Assurance, and Head Operations.
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SOP No.:
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Revision No.:
01
: QUALITY ASSURANCE
Supersedes:
AC/QA/004-00
dt. 04.09.07
Effective Date:
Revision Due:
PREPARED BY
CHECKED BY
APPROVED BY
AUTHORIZED BY
Officer QA
Head of Department
Head Operations
Head QA
SIGNATURE
NAME
DATE
DESIGNATION
5.26
Record Retention:
5.26.1 Investigation reports shall be included or referenced in all related batch records or
applicable reports.
5.26.2 The record retention for all closed investigation reports shall be not less than 7 years,
or as otherwise agreed wit the regulatory body concerned.
5.26.3 Investigation reports shall be stored in a secure and easily retrievable manner.
5.26.4 Maintain all Deviation records in a separate register for tracking as per Annexure III.
6.0 TRAINING:
6.1 Training: All personnel involved in the investigation process (from identifying an event through
record retention) shall be properly trained to perform assigned tasks.
7.0 DISTRIBUTION:
Certified Copy No. 1
: Head of Department Cephalosporin Block
: Head of Department General Block
: Head of Department Beta-Lactam Block
: Head of Department Engineering
: Head of Department Warehouse (General Block)
: Head of Department Personnel & HRD
: Head of Department Quality Control B block
: Head of Department Quality Control
: Head Operations
: IPQA In charge (Cephalosporin Block)
: IPQA In charge (Beta-Lactam Block)
: IPQA -- In charge ( General Block)
: In charge PM QC
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SOP No.:
AC/QA/004
Revision No.:
01
: QUALITY ASSURANCE
Supersedes:
AC/QA/004-00
dt. 04.09.07
Effective Date:
Revision Due:
PREPARED BY
CHECKED BY
APPROVED BY
AUTHORIZED BY
Officer QA
Head of Department
Head Operations
Head QA
SIGNATURE
NAME
DATE
DESIGNATION
: Head of Department Warehouse (B Block)
: In charge IT Department
: In charge Microbiology Lab (Central QC)
: In charge Microbiology Lab (B Block QC).
: Head RA Department.
: Head CQA.
: Head FnD.
: Head ADL.
Original Copy
: Head Quality Assurance
8.0 ANNEXURE :
9.0
Annexure I
Deviation Record.
Annexure II
Deviation Control Register
Annexure III
Flow chart
Annexure IV
Trend Analysis of Deviations
Annexure V
Example Training Initial Assessment of the Scope
Annexure VI
Example Training Data Collection
Annexure VII
Event Intimation Slip
Annexure VIII
Event Intimation Record Register
REFERENCE:
Nil
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SOP No.:
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Revision No.:
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: QUALITY ASSURANCE
AC/QA/004-00
Supersedes:
dt. 04.09.07
Effective Date:
Revision Due:
PREPARED BY
CHECKED BY
APPROVED BY
AUTHORIZED BY
Officer QA
Head of Department
Head Operations
Head QA
SIGNATURE
NAME
DATE
DESIGNATION
10.0 REVISION HISTORY :

Revision
Number
Effective Date
Revision details
Reason for Revision
1.Change in Annexure
2.Formatting as per SOP for
04
22.12.2006
SOP
For more clarity and traceability.
3.Change in point no.5.2
To meet the regulatory requirement.
4.Addition of point 5.5.5

5. Addition of point no. 5.21
05
17.05.2007
00
04.09.2007
Inclusion
of
Definition
of
Deviation.
SOP
number
changed
A/QA/007 to AC/QA/004.
Annexure
III
Note
from
of
autorisation deleted
Time limit for closure of deviation
added.
Point number 5.5 added
Annexure I modified
For better clarity

Due to change in SOP for SOP
To be covered under change control
SOP.
For better tracking.
To define scope of SOP more
precisely.
To make more user friendly. Root
cuase
analysis
assessment added.
and
impact
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SOP No.:
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Revision No.:
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: QUALITY ASSURANCE
AC/QA/004-00
Supersedes:
dt. 04.09.07
Effective Date:
Revision Due:
PREPARED BY
CHECKED BY
APPROVED BY
AUTHORIZED BY
Officer QA
Head of Department
Head Operations
Head QA
SIGNATURE
NAME
DATE
DESIGNATION
Revision
Number
01
Effective Date
Revision details
Reason for Revision

For
Redrafted in totality
better
understanding
and
effective follow of SOP.
Correlated SOP with different

systems
such
as
Market
complaint, change control CAPA,

failure investigation etc.
For effective linkage between the

documents.

AC QA 004-01 (Deviation)

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(FOR RESTRICTED CIRCULATION ONLY)

STANDARD OPERATING PROCEDURE

SUBJECT : DEVIATION MANAGEMENT AND CONTROL

(FOR RESTRICTED CIRCULATION ONLY)

STANDARD OPERATING PROCEDURE

SUBJECT : DEVIATION MANAGEMENT AND CONTROL

Unique investigation report number

Preparation, review and approval reports

Time frame for reporting

Development and implementation of corrective and preventive action(s)

Periodic management review of investigation reports including:

Root cause analysis

Status of corrective and preventive actions

Effectiveness assessment of corrective actions

Tracking and trending of deviations

The role of each Department in notification, investigation and resolution of

(FOR RESTRICTED CIRCULATION ONLY)

STANDARD OPERATING PROCEDURE

SUBJECT : DEVIATION MANAGEMENT AND CONTROL

Conditions for continuing the processing of batches / production materials

Controls to assure that the status of the production material(s) batch(es)

Record retention and storage

RESPONSIBILITY: Key Roles and Responsibilities

Quality Assurance Unit

Approve appropriate immediate actions, including whether to stop or continue

Approve Investigation Reports.

Conduct a thorough and timely investigation.

Involve subject matter experts (e.g., Technical Services, Engineering, Validation

(FOR RESTRICTED CIRCULATION ONLY)

STANDARD OPERATING PROCEDURE

SUBJECT : DEVIATION MANAGEMENT AND CONTROL

Review Investigation Reports.

Ensure Commitments are completed.

Alkem Daman Site Quality Assurance Unit

Ensure effectiveness of corrective actions.

Measure the performance of the investigation process.

Senior Management / Division Management

Provide Quality Assurance concurrence on facility/functional unit investigation reports,

(FOR RESTRICTED CIRCULATION ONLY)

STANDARD OPERATING PROCEDURE

SUBJECT : DEVIATION MANAGEMENT AND CONTROL

Any other sources of quality data

Change in process parameter.

Change in process equipment

Change in quality attribute of Raw Material / Packaging Material / Finished product.

5.2.10 Change in manufacturing environment / storage conditions.

(FOR RESTRICTED CIRCULATION ONLY)

STANDARD OPERATING PROCEDURE

SUBJECT : DEVIATION MANAGEMENT AND CONTROL

5.2.12 Malfunctioning of equipment / utilities /

Step was not followed, step skipped.

Events reported by Receiving Department

questionable label or documentation.

Parameters not in control and/or not followed.

Improper sampling technique or frequency.

(FOR RESTRICTED CIRCULATION ONLY)

STANDARD OPERATING PROCEDURE

SUBJECT : DEVIATION MANAGEMENT AND CONTROL

Established yield or reconciliation is not met.

Equipment failure, incorrect equipment/area