Handling of Deviations SOP
Any non-conformance /disobedience in written approved procedures (like standard operating procedure, standard test procedure, BMR, etc.) of the quality system in the organization is called deviation.
SILVER SULPHADIAZINE AND CHLORHEXIDINE CREAM
Objective of Deviations :
To describe a procedure for handling deviations that may occur during the execution of various activities in written procedures in the facility.
Scope:
This Standard Operating Procedure shall apply to all the departments responsible for carrying out activities related to the manufacture of the product, in the formulation plant of (Pharmaceutical Company Name).
Responsibility
Personnel of the concerned department shall be responsible to notify immediately their respective superiors when any deviation occurs or is noticed.
Head-Regulatory Affairs or his/her designee shall be responsible for facilitating prior notification or intimation to the regulatory authority if the deviation has an impact on the concerned regulatory submissions.
The head of the concerned department or his/her designee, and the Head-Quality Assurance or his/her designee of the respective location shall be responsible for the implementation and compliance of this SOP.
Accountability
QA Head shall be accountable for the implementation of this SOP
Abbreviations and Definitions
- BMR: Batch manufacturing record; a controlled regulated copy, which comprises the recordings against the manufacture of a batch.
- PDR: Planned deviation report
- UDR: Unplanned deviation report
- cGMP: Current good manufacturing practices
- BPR: Batch packing record
- ICH: International conference on harmonization
Written Procedures:
Written procedures are the approved and controlled documents that are followed for the execution of various activities performed in the organization viz., Batch Manufacturing Records detailing manufacturing and packaging procedures, Standard Operating Procedures (SOPs), and Standard Testing Procedures (STPs). General Test Procedures and various protocols followed for the execution of validation studies, stability studies, etc.
Deviation:
Any non-conformance /disobedience in written approved procedures of quality system in the organization.
Or
We have any written procedure like standard operating procedure, standard test procedure, BMR, etc., and works against this, then it is called deviation. It means deviation from any written procedure that we have implemented.
Critical Deviation:
The deviation is likely to or will have a significant impact on critical attributes of the product.
For example,
- Manufacturing instructions are not followed,
- Wrong batch details are printed,
- SOPs or methods of testing not followed during analysis etc.
Major Deviation:
The deviation could or may have a significant impact on the critical attributes of the product.
For example
- The raw material is received in a damaged container,
- Manometer readings in the sampling booth crossed the action limits, etc.
Minor Deviation:
The deviation is unlikely to have a detectable impact on critical attributes of the product.
For example:
- Line Clearance is not taken from QA,
- Physician samples are wrongly printed with price, etc.
Critical Attribute:
A critical attribute defines the product and contributes to safety, identity, purity, strength, or quality. Critical attributes are usually detectable during product testing.
Unplanned Deviation:
An accidental or unanticipated non-conformance or deviation observed or noticed during or after the execution of an activity. An unplanned deviation can be critical major or minor.
For example:
Deviation in failure of the procedure, utility, material, equipment, or any system occurs. We can consider it as any change from the previous or our written procedure.
Planned Deviation:
Any deliberate or intentional non-conformance or deviation Planned before the execution of an activity, which is to be undertaken following documented, justifiable, and approved rationale. No critical or major deviation, which has the potential to alter the quality of the product, shall be planned.
For example
Calibration or validation is not carried out as per schedule due to delays for various reasons.
Deviation Recording Procedure:
Deviations may be classified into the following two categories:
Planned Deviation
Unplanned Deviation
Unplanned & Planned deviations shall be sub-classified based on their impact on product quality in critical, major, or minor.
Planned Deviation (Planned Deviation Report)
Any departure from established and approved procedures observed or noticed before the execution of an activity, such as SOPs, STPs, processes, systems, standards, and protocols, which is done under compulsion or for continuous quality improvement programs will be categorized as planned deviation.
No critical or major planned deviation shall be allowed, that has the potential to alter the quality of the product, only minor deviations shall be allowed.
Such a planned deviation shall be taken/implemented only after proper evaluation, risk assessment, and pre-approval from Quality Assurance.
Such planned deviation shall be properly reported, assessed/evaluated for its impact on product quality, process performance, or GMPs.
Any personnel from the concerned department shall initiate the “Planned Deviation Format” by detailing the reason for the deviation.
The department head shall review the proposal of planned deviation, a justification for its potential impact on the product quality, and compliance with regulatory requirements for the necessity/feasibility of the deviation, by providing supporting data.
After review by the concerned Head of the department, the proposal shall be forwarded to the Plant Head.
After review by Plant Head, the proposal shall be forwarded to QA for review and approval.
QA shall assign a unique number to each planned deviation as follows:
The numbering system for a planned deviation shall consist of ten (10) alphanumeric characters.
For example, PDR/24/001 shall be assigned to the first planned deviation of the year 2024.
- In the above-planned deviation report number, the 1st, 2nd & 3rd characters ‘PDR’ stand for ‘Planned Deviation Report’.
- The 4th character “/” is a forward slash.
- The 5th & 6th characters ‘24’ represent the last two digits of the year 2024.
- The 7th character “/” is again a forward slash.
- The 8th, 9th & 10th characters ‘001’ represent a sequential number.
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.
Head QA shall assess the requirement for any additional testing or checks for quality monitoring of the Planned Deviation and documents for the same.
QA shall consult Regulatory Affairs, where applicable, for any planned deviation before providing approval. The RA may provide inputs as necessary based on GMP and regulatory requirements.
Head QA shall approve/reject the Planned Deviation with appropriate recommendations.
If approved, the deviation shall be applicable for a defined number of batch (es) or a defined number of days as mentioned in the Planned Deviation Report.
After QA approval, the concerned department shall implement the planned deviation and the observations and data generated shall be documented.
QA shall review the implementation and documented data obtained from respective departments to ensure that the recommendations comply with a quality profile of the batch (es) impacted by the deviation. This data shall support the “Planned Deviation Report”.
The closure of planned deviation shall be the responsibility of the Department Head and Head-QA.
If the deviation is related to the batch that is for sale, then the batch shall be released only after QA approval and closure of deviation.
Recommendations may be conferred during the review.
If the planned deviation in the process/procedures leads to improvement in the product quality/process/assurance / GMP, then the deviation/change can be made permanent by following the change control procedure (SOP on change control procedure).
In conclusion, the Head of the concerned department and the Head of QA shall close out the deviation.
QA shall maintain a logbook for the approved planned deviations.
Unplanned Deviation (Unplanned Deviation Report)
While carrying out day-to-day activities, there is a probability of unplanned deviations (unforeseen deviations) occurring. Such unexpected events may be related to any procedures, processes, systems, equipment, and utilities. These deviations may occur for many reasons, such as the following (not all-inclusive):
- Equipment failure / Breakdown / Malfunctioning.
- Power supply failure/interruption.
- Accident in the plant.
- Breakdown in support services/utilities.
- Documentation Errors
- Laboratory failure / Error.
An unplanned deviation report (UDR) shall be initiated as a part of the approved system for handling deviations, to provide a mechanism for ensuring the recording of the deviation and assessing the impact on product quality. If required, corrective and preventive action shall be performed to ensure product quality.
The user department shall request the issuance of an unplanned deviation Format to the Quality Assurance department through an Issuance form.
Any individual on the job shall inform the concerned department supervisor regarding the occurrence of deviation and details of initial observations.
The concerned department personnel shall fill in the details of the unplanned deviation along with cause and investigation details and forward the same to the department head for review, assessment, and comments.
While reviewing, the concerned head of the department shall incorporate corrective and preventive action based on assessment. Then the ‘Unplanned Deviation Report’ shall be forwarded to the Plant Head for review.
Then ‘The unplanned Deviation report will be submitted to the QA for review and approval.
QA shall assign a unique number to each unplanned deviation report as follows;
The reference number for an unplanned deviation report shall consist of ten (10) alphanumeric characters.
For example, UDR/24/001 shall be assigned to the first unplanned deviation of the year 2024.
- In the above-unplanned deviation report number, the 1st, 2nd & 3rd characters ‘UDR’ stands for ‘Unplanned Deviation Report’.
- The 4th character “/” is a forward slash.
- The 5th & 6th characters ‘24’ represent the last two digits of the year 2024.
- The 7th character “/” is again a forward slash.
- The 8th, 9th & 10th characters ‘001’ are sequential numbers.
QA shall maintain a logbook for unplanned deviations.
The filled form shall be forwarded to the QA head after review by the QA.
Head – QA & Head – concerned department shall assess unplanned deviation for its impact on product quality. Details shall be documented.
Head QA may recommend performing any additional studies if required.
If the deviation does not affect product quality, the Head – of QA shall allow further processing of the batch in question.
If product quality is probably getting affected, the Head – QA shall assess the impact on product quality before allowing further processing of the batch.
Product may be “Quarantined” in sealed containers if required. Containers shall be labeled, indicating product name, Batch No., Manufacturing Date, Expiry Date & Batch size. The labeled containers shall be kept in the secured quarantine area.
Head – QA along with the Head of the concerned department shall investigate & find out the root cause of the problem that resulted in the deviation as per SOP on CAPA.
Based on the investigation, the proposed corrective and preventive action shall be taken to avoid any such reoccurrence and the same shall be implemented.
If required Formulation Research & Development (FR&D) shall be consulted by QA to review the impact on product quality and decide upon the future course of action(s).
Closure of Deviation
In conclusion, the Head – of QA shall close the deviation by reviewing and assessing the impact of deviation on the quality of the product.
Any supporting data and comments required to close the deviation (e.g.stability data) shall be recorded or attached to the deviation report.
The timeline for the closure of deviation (planned or unplanned) shall be not more than 30 working days. If required, an extension should be taken.
Both planned and unplanned approved deviations shall be controlled by QA and the same shall be documented in the respective BMR also.
(Note: The planned deviation shall be implemented after the approval of QA).
Forms and Records (Annexures)
- Planned Deviation Report – Annexure-I
- Unplanned Deviation Report – Annexure-II
- Logbook for Planned/Unplanned Deviation Reports – Annexure-III
Distribution
- Master Copy- Quality Assurance
- Controlled Copies -Engineering, Human Resources, Production, Quality Assurance, Quality Control, Regulatory Affairs, Warehouse
Annexure – I
Planned Deviation Report
Review by Department Head (Comments):
Review by Plant Head(Comments):
QA Review / Approval and QA Comments:
- Comments received from QP attached: Yes /No / NA
- Any additional studies required: Yes / No
- Stability Studies, Additional Quality Testing, Others
- Deviation: Approved/ Rejected
- The Planned Deviation is limited to time / No. of Batches
- Implementation of Deviation
- Deviation implemented by (Department)
- Observations (If any)
- Data Generated (If any)
- Quality Profile of batches affected (If applicable)
- Implemented By the Department Head
- QA Review of Implementation & Closure
- QA comments: ___All recommendations fulfilled: Yes /No
- If No, Justification
- Data generation completed: Yes / No
- If No, Justification
- Can the Deviation/Change be made permanent through change control? Yes/No
- Affected batch can be released? Yes/No
- Closure Approved By Department Head / Nominee
- Closure Approved By Head-QA/ Nominee
Annexure – II
Unplanned Deviation Report
Date of Deviation Initiation
Unplanned Deviation Report No. (to be assigned by QA)
Deviation Reported By (Department)
Product Name/ Batch No./Market
Batch Size/Mfg. Date/Expiry Date
Deviation related to Procedure/Process/Equipment/Standard/Batch Size/Others( If any) specifies:
Potential Impact On Quality/ Yield/GMPs/Manufacturing Process/Others ( If any) specify :
Deviation Details
Cause for Déviation
Investigation Details
Proposed Corrective Action
Proposed Preventive Action
Initiated By
Review by Department Head (Comments):
Review by Plant Head(Comments):
QA Review for implementation of CAPA (Comments)
Details of any additional studies Required / Performed
Review & Deviation Closure by Head – QA (Comments)
Annexure -III
Log Book for Planned/Unplanned Deviation Reports Contains
Date
PDR/UDR No.
Deviation Related to
Initiated By & Deptt.
Expected date for Implementation
Approved/ Rejected
Closed out on(sign/date)
