SOP for Handling of Deviation

Objective

To lay down the investigation and control procedure for deviation, which can affect the quality of the product, to enable a suitable and prompt action.

Scope

This procedure applies to any deviations reported in any department at PharmaInfo Ltd.

Responsibility

Operating Manager for initiation, investigation, execution, and evaluation of deviation concerning its impact on product quality

Sr. Head- QA for approval and recommendations

Accountability

Sr. Head- QA/ Department - Head

Procedure

Deviations:

Planned Deviation: 

Planned deviations are those, that are planned before they happen or are executed or are observed as going to have occurred. These are preidentified and pre-approved with proper justification and cover a specified period or number of batches. Example: Calibration or validation delayed due to various reasons.

Unplanned Deviation:

The deviation, which is not, identifies when they occur and which is detected post occurrence. These deviations may be an uncontrolled event in the form of non-compliance with the designed system or procedure. This can be critical, major, or minor in nature due to failure of (but not limited to) machine, personnel, material, product quality, safety, efficacy, and regulatory compliance and appropriate actions to correct the impact of deviation.

Minor Deviation:

Deviation that does not have a direct impact on product safety, identity, strength, purity, quality, and processes involved in product manufacturing and testing. Example: Dealer sample wrongly printed with a price.

Major Deviation:

The deviation may have a significant impact on product safety, identity, strength, purity, quality, and process involved in product manufacturing and testing. Example: Manometer reading in the sampling booth crosses the action limit.

Critical Deviation:

Deviations have a direct impact on product safety, identity, strength, purity, and quality.

ALSO READ: Deviation Management - Pharmaceutical Industry

Handling of Deviation:

• Deviations shall be intimated to the quality assurance department by the initiator department immediately.
• Officer Quality or designee shall issue the “Deviation form” by assigning a deviation report no. and log the deviation in the “Deviation log”.
• Deviations shall be initiated for the following situations:

1. Human error
2. Malfunctioning of equipment or instrument
3. Deviation from any written procedure
4. Change in FIFO order for Raw materials packaging materials or finished goods.
5. Change of process steps/control limits.

• For all other deviations, the SOP for Change Control shall be followed.

Initiation of Deviation:

• The concerned department officer/executive/chemist shall fill in all the details regarding deviations like a Description of the event that caused the deviation, a Reference SOP/Document, a Description of the proposed deviation, and a Justification for the deviation.
• The concerned department head/designee shall review and write the comment on the product impact analysis likely to be caused by the Deviation.
• The Quality Head/Designee shall then review the Deviation jointly with the concerned Department Head/Designee and classify the Deviation.
• Specify the unique number of the Deviation as 

DN/YYYY/ZZZ

Where

DN: Deviation Number.

YYYY: Year (Like for the year 2022)

ZZZ: Sequential numbers like 001,002 ..... etc.

Planned Deviations (Planned Deviation Report)

• Any Deviation in the manufacturing process/procedure/testing procedure/ operating/calibrating procedure, batch size, equipment, operating environment, or any other GMP critical process that is pre-planned for the forthcoming batches, shall be known as planned deviation.
• Such a pre-planned deviation shall be taken/implemented only after pre-approval from HEAD QA
• Such planned deviations shall be properly documented, assessed/evaluated for their impact on product quality, and authorized by HEAD QA in advance.
• All planned deviations shall be recorded as per Annexure No. 1.
• QA shall maintain a logbook for the approved planned deviations as per Annexure No. 2.
• The concerned department shall initiate the Planned Deviation as per Annexure No.-1 and sign.
• The department Sr. Head and plant Head shall review the proposal for planned deviation, a justification for its potential impact on the product quality and compliance with regulatory requirements, for the necessity/feasibility of the deviation, and sign in the specified columns.
• QA shall assign a unique number to each planned deviation as follows;

1. The report number for a planned deviation shall consist of ten (10) alphanumeric characters.
2. For example, PDR/22/001 shall be assigned to the first planned deviation of the year 2022.

• Sr. Head QA shall review the planned deviation concerning the impact on product quality, necessity/feasibility of the deviation proposed, rationale/justification & compliance to cGMP / regulatory requirements, along with the adequacy of the supporting data attached.
• Sr. Head QA shall assess/recommend the need for any additional testing or document for quality monitoring of the Planned Deviation batches.
• Sr. Head QA shall approve/reject the Planned Deviation with appropriate recommendations.
• If approved, the deviation shall be applicable for a defined number of batches or a defined number of days, as mentioned in the Planned Deviation Report.
• After Head QA approval, the concerned department shall implement the planned deviation and the observations and data generated shall be documented.
• Head QA shall review the implementation and make sure that the recommendations have complied with the quality profile of the batch(es) impacted by the deviation (are) studied and that all the data is annexed with the “Planned Deviation Report Format” Annexure No.-1.
• If the plan leads to improvement in the product quality/process / GMP, then the deviation/change can be made permanent by the change control procedure.
• Finally, the Plant Head and QA Sr. Head shall sign and close the deviation.

Unplanned Deviations (Unplanned Deviation Report)

• While carrying out day-to-day activities, there are chances of unplanned deviations (unforeseen deviations) and events to occur. These deviations are unforeseen, and accidental, and may be due to several reasons like;

1. Equipment failures/breakdowns/malfunctioning / Process Failures.
2. Power supply failures/interruptions.
3. Accident / Mishap in the plant.
4. Breakdown in support services/utilities.
5. Documentation Failures.
6. Analytical Failures/errors.
7. Any other unforeseen situation.

• An unplanned deviation report (UDR) shall be raised as a part of the approved system for handling deviations at the time they occur, to provide a mechanism for alerting the production and quality department to record the deviation assess the impact, and perform corrective action.
• All unplanned deviations shall be recorded as per Annexure No. 3.
• Head QA shall maintain a logbook of the approved unplanned deviations as per Annexure No. 3.
• The operator on the job shall inform the production supervisor about the details of the incident, resulting in a deviation in the process.
• The concerned officer/executive shall fill in the details of the unplanned deviation in Annexure No. 2 and forward the same to the department Sr. Head for his review, assessment, and comments.
• Finally, the ‘Unplanned Deviation Report’ shall come to the Head QA for review and approval.
• Head QA shall issue the deviation report number as given;

1. The reference number for an unplanned deviation report shall consist of ten (10) alphanumeric characters.
2. For example, UDR/22/001 shall be assigned to the first unplanned deviation of the year 2022.

• Sr. Head - QA shall assess unplanned deviation for its impact on product quality.
• Sr. Head QA may recommend performing any additional studies if required.
• If the Deviation does not affect product quality, Sr. Head QA shall allow further processing of the batch in question.
• If there are likely chances of product quality getting affected, Sr. Head QA shall assess the impact on product quality before allowing further processing of the batch.
• The product may be kept in Quarantine in sealed containers if required. Containers shall be labeled, indicating product name, Batch No., Manufacturing Date, Expiry Date, and batch size.
• Sr. Head QA along with the Head of Production and head of maintenance shall investigate & find out the root cause of unplanned deviation.
• Based on the investigation, corrective and preventive action shall be implemented to avoid any such reoccurrence.

ALSO READ: What is Root Cause Analysis (RCA) in Pharmaceuticals?

• If required, Research & Development (R&D) shall be consulted by Head QA to review the impact on product quality and decide upon the future course of action(s), which could be:

1. Reprocessing or
2. Rejection of batch.

• Based on R&D advice Head QA shall inform to plant Sr. Head / Head Production for reprocessing or rejection.
• Reprocessed batch shall be kept on stability studies as per ICH Guidelines, in case of major rework.
• The reprocessed products shall be released only if the Product meets all the approved specifications.
• QA Executive shall review stability data at scheduled intervals to decide further course of action.
• Finally, Sr. Head of QA shall close the deviation by reviewing and assessing the impact of deviation on the quality of the product.
• Both planned and unplanned approved deviations shall be controlled by QA and the same shall be documented in the respective BMR also.
• Any data, comments, or documents required to close the deviation (e.g. stability data) shall be recorded or attached to the deviation report.

Evaluation of proposed deviation:

• The Quality Head/Designee shall evaluate the proposed deviation along with the concerned Department Head/Designee and other personnel, as may be required to analyze the effect of deviation in their respective work area and on the product quality and safety.
• Based on the recommendations of the above evaluation, the Quality Head/Designee shall give approval / non-approval for the proposed deviation.
• In case the proposed deviation is not approved, it shall be informed to the initiating department and the deviation shall be canceled.

Risk Assessment:

• Based on the investigation of Deviation, the concerned Department Head/Designee along with the Quality Head/Designee shall review the risk assessment and update the same as necessary.
• The Quality Head/Designee shall then approve the Risk Assessment.
• Quality Head/Designee may initiate necessary corrective action(s) and/or corrective action(s) based on the investigation of Deviation.

Closure of Deviation:

• The Quality Head/Designee shall review the action and close out the deviation after obtaining satisfactory results. Deviation shall be closed within 30 working days, if not closed within the target completion date. The initiating department head shall give proper justification for the same and a timeline for the closing of deviation. Photocopy of the required documents shall be attached with the deviation form by initiating departments.
• Deviation related to the product shall be closed before the release of the batch. Once the Corrective action(s) shall be agreed upon, the deviation report shall be closed.

Deviation log:

• After approval of deviation, the Quality Executive/designee shall update After approval of deviation, the QA designee shall update the “Deviation log” as per the “Deviation log” with status and maintained in the Quality department.
• The deviation log shall be maintained as per calendar year.

Annexure

Annexure-1: Planned Deviation Report

Annexure-2: Planned Deviation Logbook

Annexure-3: Unplanned Deviation Report

Annexure-4: Unplanned Deviation Logbook

Abbreviations

SOP - Standard Operating Procedure

QA - Quality Assurance

ICH - International Conference on Harmonization

BMR - Batch Manufacturing Record

CAPA - Corrective & Preventive action

PDR - Planned Deviation Report

UDR - Unplanned Deviation Report

Revision History

Nil

ALSO READ: SOP for Handling of Out of Trend (OOT)