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Deviation : Any unwanted event that represents a departure from approved processes or procedures or instruction or specification or established standard or from what is required. Deviations can occur during manufacturing, packing, sampling and testing of drug products.

Examples of Deviations:

Temperature and RH of area goes out of limit during manufacturing, Typographical error observed in approved documents, Standard operating procedure not followed, Breakdown of equipment, Spillage of material during unloading, Instrument calibration results goes out of limit etc.

Critical deviation: A Critical Deviation is an unplanned event that affects a quality attributes a critical process parameter, an equipment or instrument critical for process control and has an immediate patient safety risk, life threatening situations. 

Major deviation: A Major Deviation is an unplanned event that potentially affects a product’s quality, safety or efficacy or its ability to meet specification, or regulatory or documentation requirements which may not have direct impact on patient.

Minor deviation: A Minor deviation is an unplanned event that potentially has GMP impact (e.g. an event affecting a utility, equipment, materials, components environment or documentation) but does not affect product quality and / or the physical state of the product, intermediate or component, or its labeling .

Observer or Initiator : The person identifying the occurrence of deviation shall be termed as observer and the person initiating the documentation of deviation in deviation form shall be termed as Initiator.  

Corrective action : An action taken to eliminate the cause of the existing deviation , incident or problem in order to prevent its recurrence (occurring again).

Preventive action: An action taken to eliminate the cause of potential deviation, incident or problem in order to prevent its occurrence (an incident or event) .

Requirements :

Each deviation related to a batch production, to materials used during processing, to test procedures, to warehouse/ storage and transport conditions, to re calibration / re-qualification activity or to the rejection of a defective product, etc., must be identified, evaluated, investigated and documented, it may be for commercial batch or regulatory dossier preparation batches (e.g. scale up / tech transfer / pre-exhibit / exhibit / registration etc.).

The person identifying the deviation shall immediately inform to supervisor and department head and QA after discovery of any deviation.

Necessary immediate actions must be taken in consultation with QA and department head to avoid the recurrence of observed deviation.

The deviation form for reporting all types of the deviations shall be initiated and investigated immediately.

Deviation shall be notified to the concern department and QA for review, evaluation and logging within one working day after occurrence.

Each deviation must initiate appropriate corrective and preventive actions as necessary.

All deviations shall be closed within 30 calendar days. If not closed, then fill the deviation extension form justifying the delay. Each extension (maximum two) shall be allowed for next 30 days only.

Trending of the deviations shall be done on Quarterly basis.

All products related deviations (critical, major, and minor) having impact on product quality, safety, and efficacy, validated status of process & equipment shall be circulated to the customer/Qualified Person/Marketing Authorization Holder for notification and approval.

deviations shall be sent to CQA for approval if required

Procedure :

A person identifying the deviation (observer) shall inform to initiator for documenting the deviation details in the deviation form with the description of the deviation, Batch no. / A. R. No., name of the product / Material. date, time and other details related to deviation as per deviation form

Observer/Initiator shall take immediate actions in consultation with QA and head of responsible department to contain the deviation.

Initiator shall address all immediate actions taken in deviation form and shall analyze the risk and evaluate impact of deviation in consultation with HOD of responsible department and subsequently mention it in the deviation form . After completion of details initiator shall submit deviation form to QA for review, evaluation and login.

The products intended for the regulatory dossier preparation / submission purpose; the overall risk as a concept must be considered differently for the following reasons like Products considered at the development stage, Product knowledge is under development phase and the products are not intended for commercial purpose at this stage till approved by the respective regulatory authorities.

Wherever applicable, quality risk assessment shall be performed for suspected product defects, potential impact on other batches or on other products etc.

QA shall review & evaluate details of deviation mentioned in deviation for correctness & completeness along with the immediate actions taken, risk & impact assessment of deviation and supporting documents (if any). Additional supportive data and documents can be requested from responsible department for evaluation.

After review and evaluation, QA shall assign unique reference number to the deviation form and update the deviation number in the deviation log book.

After evaluation of details mentioned in deviation form, risk, impact assessment of deviation, QA shall categorize the deviation in to Critical, major or minor as per nature of deviation.

QA shall also check whether similar type of deviation was happened in past one year.

Investigation of Critical, major deviations and minor deviations which are repetitive in nature shall be performed using investigation report and deviations which are minor in nature or deviations having obvious or known root cause, investigation shall be performed as per deviation approval form .

The responsible department head/designee shall initiate the investigation as per the SOP for Investigations as applicable, considering history & trending, root cause evaluation, risk and impact assessment and comments from other departments within the site along with QA department.

The cross functional investigation team shall be formed for the investigation of deviations and shall consist of Head of the department or designee where deviation has occurred and members with sufficient knowledge on current matter for investigation.

The investigators must have appropriate knowledge and training to perform an investigation.

The team shall include members (depend upon nature and Applicability) from QA, QC, Manufacturing, Packaging, Regulatory, Engineering, Safety and Warehouse etc.  

The tools like Ishikawa diagram analysis (fish bone diagram), 5 why’s, fault tree analysis (FTA) failure mode and effects analysis (FMEA), Flow charts, Process flow etc. shall also be used for detection of the root cause, if necessary.

If actual root cause is not identified, potential root cause shall be identified based on history of repetitive deviation, deviation trends, vendor assessment, scientific knowledge and actions shall be taken to prevent the potential from occurring.

Investigations where human error is suspected or identified as a root cause shall be justified. The procedural or systems based errors must be thoroughly reviewed before concluding for human errors.

Responsible department along with QA shall evaluate the following information (but not limited to) for the impact / risk  assessment for the deviation as mention below: 

Scope of the deviation – batch affected (both in-process and previously released).

Potential quality impact.

Trends relating to (but limited to) similar products, materials, equipment and testing processes, product complaints, previous deviations, annual product reviews, and /or returned goods etc. where appropriate. 

A review of similar causes.

Regulatory commitment impact.

Other batches potentially affected.

Market actions (i.e. recall etc).

Investigation of critical deviations shall be completed within 15 working days & investigation of major deviations shall be completed within 20 working days and investigation of minor deviations shall be completed within 30 working days from the day of deviation occurrence.

The deviations (wherever applicable) shall be communicated to the customer / QP / MAH immediately after the completion of the investigations as per timelines mentioned .

Depending on the impact assessment / risk assessment, identified root cause, and comment received from various sources, CAPAs shall be defined by responsible department head in consultation with QA.

Based on the investigation results and derivation of CAPAs, Quality Assurance shall determine the disposition of the affected material/product as applicable.

The final evaluation of root cause, CAPAs and the conclusion of the investigation shall be performed by head QA/designee and shall be recorded in the investigation report.

Appropriate CAPA’s shall be identified and subsequently logged into CAPA log book and the deviation report shall be closed.

QA shall check the implementation and completion of the corrective and preventive action and update the Log book.

The implemented corrective & preventive actions shall be monitored periodically for its effectiveness as per SOP for CAPA management.

At the time of batch release, QA representative shall ensure that the investigation for the deviations is carried out and closed.

QA shall review the deviation logbook after every month to identify the open deviation report and follow- up for the same with respective responsible department & HODs.

All deviations shall be timely reviewed to close within 30 calendar days of occurrence of deviation & Justification for delay in closure shall be filled by the responsible department in case deviation is not closed in 30 days .

Only two extensions, of 30 days each, shall be allowed for Investigation & deviation closure, if failed to complete the activities after two extensions, then QRA shall be prepared by responsible department.

Periodic review of deviation system or Trending of deviation shall be conducted quarterly to check the effectiveness of deviation system and shall be documented . Periodic review shall include (but not limited to) total no. of deviations during review period as per category (e.g.  Critical, Major and minor), as per department, as per nature of deviation (e.g. Product related, Process related, equipment related, calibration validation failure, testing related etc.), no of repeat deviations (e.g. as per nature and as per root cause etc). 

The trending or Periodic review of deviation system shall include Department wise classification of deviation, Category wise,Type wise, Review of similar root cause,Review of previous open, Summary and conclusion etc.

Deviation Approval form Attached for Reference

Flow chart for Deviation :

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