Deviation management process
Purpose
To
lay down the procedure to ensure deviation is identified, reported, assessed,
investigated and appropriate CAPA has been taken to prevent reoccurrence of
deviation.
Procedure
Definition
A
deviation is a departure from established GMP standards or approved
requirements, specification and standard operating procedure resulting in
non-conforming material and/or processes or unusual and unexplained events
which may or may not have the potential impact on product quality, system
integrity or personal safety.
Deviation
can be classified in two types:
Planned Deviation
Un-Planned Deviation
Planned
Deviation:
These
are the deviations that are described and pre-approved deviations from the
current operational document/system for a specific period of time or number of
batches. Planned deviation shall be initiated if established system, procedure
or process is under alteration and it is necessary to have data for observation
prior to proceed for permanent change.
Example
of Planned Deviations (But not limited to):
Finished goods release for next stage
without complete analysis.
Change in batch size for a fixed
number of batches.
Change in vendor of raw material
(Excipients), packaging materials.
Change in process parameters for a
fixed number of batches.
Unplanned
Deviation:
Unplanned
Deviations can be explained as any aberrations that come across on account of
some unforeseen reasons. These are the deviations which are discovered after it
occurs and are accidental.
Example
of Unplanned Deviations (But not Limited to):
Unintentional deviation during any
stage of manufacturing and packing process (from receipt to dispatch).
Interruption of ongoing process due to
breakdowns during any stage of manufacturing (from receipt to dispatch).
Power failure that may lead to impact on
process and quality attribute of product or system.
Wrong / missed revision number on the
document.
Accident / Mishap.
Wrong / missed entries in executed
documents.
Unknowingly missed schedule of
Calibration / Qualification / Validation.
Mix-ups / Spillage.
Any Non-conformances identified at any
stage of GMP activity.
Categorization
of Deviation:
Deviation
shall be categorized as follows:
Critical
Major
Minor
Critical
Deviation:
Any
deviation that affects the quality of product or has substantial potential to
have an adverse impact on the safety, quality or purity of product.
Major
Deviation:
Any
deviation which occurred during execution of an activity, which may or may not
have impact on the strength, identity, safety, purity and quality of the
product.
Minor
Deviation:
Any
deviation which occurred during execution of an activity which may not have
direct impact on strength, identity, safety, purity and quality of the product.
Initiation
of Deviation:
- The deviation identified by any personnel shall be reported to his concerned department Head/ Designee and QA.
- Unplanned deviation shall be initiated within 24 hours / next working day from the time of non-conformance.
- Executive/Designee QAD shall issue ‘Deviation Form’ on the basis of request of originating department and enter the details in the form.
- The deviation shall be logged by Executive/Designee-QAD in “Deviation Logbook” .
Handling
of Planned Deviation:
- A planned deviation shall be initiated when a decision is made to deviate a certain approved procedure for specific period of time or number of batches. All planned deviations shall be properly documented, assessed/evaluated for impact on product quality and authorized by QA.
- Originator / Initiating department shall provide the details (Description, Reason/ justification/Period for which planned deviation is requested) of planned deviation in deviation form.
- Originator shall also attach documents, in support of justification provided for the proposed deviation if required.
- Head Initiating department in consultation with Executive/Designee-QAD shall carryout the Impact assessment of the deviation on quality of material/product/system/documentation or any other.
- Based on the impact analysis and evaluation of the planned deviation Executive/Designee-QAD shall perform the risk assessment for the deviation and shall select the relevant departments which are impacted by deviation. Initiating department shall send the deviation form to head/designee of all other relevant departments for their comments.
- After receipt of comments, Executive/Designee-QAD shall review the comments of all departments and classify the deviation as major, minor or critical based on the impact / risk assessment and shall give reason for same in Deviation Form.
- Executive/Designee-QAD shall recommend the action plan/CAPA to be implemented based on the impacted system, process and documents due to deviation and shall record the same in deviation form.
- Executive/Designee-QAD shall forward the deviation to Head QAD along with supporting documents to approve/reject the deviation with appropriate recommendation.
- Head/Designee-QAD shall review the proposal for planned deviation, justification given for its potential impact on the product quality, classification, action plan/CAPA, supporting documents, comments from other corporate functions and compliance to regulatory requirements for feasibility of the deviation. Head/Designee-QAD shall approve the deviation proposal if found satisfactory.
- If deviation is not approved, Head/Designee-QAD shall discuss with Head of originating department and document the details of discussion including the reason for rejection in the deviation form.
- The Action plan/CAPA shall be implemented by originating department and the effectiveness of implementation shall be monitored by originating department and QA.
- If the planned deviation in the process/procedures leads to improvement in the product quality/process/GMP then the deviation/change can be made permanent by following the change control procedure as per current version of SOP of Change Control.
- Handling of Unplanned Deviations:
- Originator/Initiating department shall provide the details (Description, Reason, prescribed and deviated parameter) of unplanned deviation in deviation form. The details of the material/product/batches affected due to occurring of deviation shall be provided in deviation form.
- Based on the nature of deviation the Initiator shall take the immediate action in consultation with Head department / QA or stoppage of the activity and further actions to be taken.
- Head of Originating department and QA shall carry out the investigation for all unplanned deviations whether minor, major or critical to identify the root cause, based on which corrective and preventive measures shall be identified, implemented.
- Appropriate tools shall be used to identify the root cause such as Ishikawa diagram, Brain storming and 5 Why.
- Head of Initiating department and QA shall carry out impact assessment of the deviation on manufacturing activities such as material/product/batches quality.
- Based on the impact, risk analysis and evaluation of the unplanned deviation QA shall select the relevant departments which are impacted by deviation. initiating department shall send the deviation form to head/designee of all other relevant departments for their comments.
- After receipt of comments, Executive/Designee-QAD shall review the comments of all departments and classify the deviation as major, minor or critical based on the impact / risk assessment and shall give reason for same in Deviation Form.
- In case of non-quality impacting deviations the risk assessment may not be performed if approved by Head QA with justification.
- Based on the investigation of the deviation, Root cause analysis & Risk Assessment, CAPA shall be recommended by Executive/Designee-QAD for minor, major and critical deviations to prevent the recurrence of deviation.
- Executive/Designee-QAD shall forward the deviation to Head QA along with supporting documents.
- Head QA shall review the deviation, justification given for its potential impact on the product quality, classification, CAPA, supporting documents, comments from relevant comments and compliance to regulatory requirements for feasibility of the deviation. Head/Designee-QAD shall approve the deviation if found satisfactory.
- Based on the impact of deviation on product quality, Head QA shall take the decision for future course of actions of product which can be reprocessing or disposition of the batch and shall record the same in deviation form.
- After the approval of deviation by Head QA, the initiating department shall execute the CAPA.
- The CAPA shall be implemented by originating department and the effectiveness of implementation shall be monitored by originating department and QA.
- Closure of Deviation:
- Originating department Head/Designee along with QA shall be responsible for closing of deviation.
- All deviation shall be closed within 30 working days after approval of the deviation. If closure of deviation requires more than 30 days, “Extension of Deviation” shall be issued by QA.
- Head of Originating department shall provide the justification, required extension period with requested targeted date and shall forward to QA department.
- Extended period for closing of deviation is of 30 days on the basis of request for “Extension of Deviation”. The time extension for deviation investigation and close out is permitted for two times with appropriate justification.
- QA shall verify the current implementation status of the proposed CAPA during closer verification.
- Head/Designee-QAD shall close Deviation by referring originating CAPAs with the Deviation form.
- Head/Designee-QAD shall monitor, verify & close originating CAPAs individually.
- In case the need for keeping deviation open for closure of originating CAPAs, identified during approval of CAPA plan, the deviation form shall be closed after successful closure of all identified CAPAs.
- In case of batch / material specific deviation, release of batch / material shall be done after closure of the deviation.
Documentation:
- Deviation form & supporting data with related communication shall be maintained at QA department.
- Photocopy of deviation form shall be enclosed with the respective affected document for reference purpose. Reference number of deviation shall be mentioned in the affected document wherever applicable.
Trending
of Deviation:
- QA shall carry out trend analysis of all deviation to assess re occurrence of deviations. The trend shall also include the review of effectiveness of CAPA.
- QA shall carry out trend analysis on quarterly basis as per “Trend Analysis Report”. This trend analysis shall be completed within 15 days for quarterly review, after completion of review period.
- QA Head shall review and approve the trend analysis with comments if any.
- During review the open deviations shall be listed and monitored for closure.
- Product specific deviation & CAPA implemented shall be covered in product quality review.
