| Department | Validation/Technical Services | Document no | VAL-075 | ||
| Prepared by: | Date: | Supersedes: | |||
| Checked by: | Date: | Date Issued: | |||
| Approved by: | Date: | Review Date: | |||
1.0 DOCUMENT OWNER
Validation / Technical Services Manager
2.0 PURPOSE
The objective of this Standard Operating Procedure is to describe the actions required to handle deviations encountered during validation studies.
3.0 SCOPE
This procedure applies to all deviations from approved validation and/or re-validation procedures during the course of a validation study.
Validation studies include: Process Validation (including Raw Material Evaluations) Cleaning Validation, Equipment Qualification, Computer Validation, Facility & Utility Validation, Analytical and Microbiological Method Validation and Method Transfers.
This procedure does not apply to deviations raised outside of an approved validation study.
4.0 RESPONSIBILITY \ BUSINESS RULES
It is the responsibility of all personnel performing validation studies to ensure that all deviations are documented as per this procedure. Specific responsibilities are as follows:
4.1 Deviation Author
The individual who prepares the deviation, and who is responsible for ensuring that an accurate and detailed description of the deviation has been created in compliance with all relevant procedures and that all supporting documentation is attached or properly referenced, or, where appropriate, that a Quality Assurance Report (QAR) – Deviation has been raised.
4.2 Protocol Reviewer
The protocol reviewer is responsible for ensuring that all deviations are documented and referenced and for ensuring that all resolved deviation has been completed satisfactorily.
4.3 System Owner
The System Owner is responsible for ensuring that the deviation and its resolution / justification is appropriate for the product/system being validated and its use.
4.4 Validation
Validation is responsible for ensuring that the deviation has been completed in accordance with validation requirements and guidelines, that all validation criteria have been met and that all deviations have been closed out as per this procedure.
Note: for analytical method validation, the Laboratory Systems/Technical Coordinator may approve for validation
4.5 Quality Assurance
Quality Assurance is responsible for ensuring that the deviation has been completed in accordance with all cGMP requirements and Quality guidelines and that the completed deviations do not impact product quality or data integrity.
5.0 PROCEDURE
5.1 Validation Deviations
A validation deviation is a planned or unplanned excursion from an expected result or approved procedure. When an actual result is different from the expected result or the procedure is changed from the authorised procedure whether planned or unplanned, or for any unexpected event, it is considered a deviation.
A critical deviation is a deviation as described above, which directly or indirectly results in compromise of the product, system or data integrity.
A non-critical deviation is a deviation as described above resulting from a misunderstanding of the requirement, function, or procedure, or an unexpected result or change to the procedure that does not impact the product, system or data integrity.
All deviations must be assessed to determine their impact on the following as required:
a. Product, system and data quality and integrity
b. Design, functional, or product specification
c. Protocol(s)
d. SOP’s
e. System documentation and Drawings
f. Testing already completed
g. Training programs
h. User requirements
i. Validation plan
Once the impact on these aspects have been determined, resolutions or justification shall be established and documented on a deviation form (for all deviations) and, for critical deviations, in a Quality Assurance Report – Deviation (QAR) (in addition to the deviation form.). Refer to appendix 1 for deviation form format.
A blank deviation form must be attached to each protocol and copied as required to record deviations. In general a separate form should be completed for each deviation, however related deviations may be grouped on one form. All completed deviation forms must be attached to the protocol.
A typographical error is not considered a deviation and may be hand corrected with an appropriate comment. All hand corrections to approved protocols must be counter signed by QA.
All completed deviation forms should be appended to the validation protocol. The deviation forms will be numbered sequentially and will be referenced in the protocol at the page where the unexpected result or change in procedure was recorded.
5.2 Types of Validation and Deviations
5.2.1 Process Validation
If a deviation occurs during process validation performed on a commercial batch, it must be assessed to determine if it is a critical or non-critical deviation as defined in section 5.1. If an in-process or final product result does not meet the release for sale or validation criteria or the process is different to expected, it is a critical deviation. At minimum the following should be considered in addition to the list in 4.1 when assessing the deviation.
a. In process specifications
b. Final product specifications
c. Registered process steps
d. Validation protocol requirements
If a deviation has been assessed as being a critical deviation, a QAR must be raised and a summary, with reference to the QAR, recorded on a deviation form and appended to the validation protocol.
A critical deviation raised during validation on a non-commercial batch does not require a QAR unless information generated during the validation is used to support any GMP process such as regulatory submissions or stability. The deviation should be summarised on the deviation form.
If a deviation has been assessed as being a non-critical deviation, a deviation form will be raised and all appropriate paperwork attached.
5.2.2 Cleaning Validation
If a deviation occurs during cleaning validation, it must be assessed to determine if it is a critical or non-critical deviation for the subsequent product following cleaning as defined in section 5.1. If a result does not meet the cleaning validation criteria, it is a critical deviation.
If a deviation has been assessed as being a critical deviation, a QAR must be raised and a summary, with reference to the QAR attached to a deviation form and appended to the validation protocol. The batch affected must be the subsequent batch to the cleaning procedure and not the batch prior to cleaning.
A critical deviation raised during cleaning validation followed by a non-commercial batch does not require a QAR unless information generated during the validation is used to support any GMP process such as regulatory submissions or stability. The deviation should be summarised on the deviation form.
A non-critical deviation should be completed as per section 5.2.1.
5.2.3 Equipment, Utilities, Computer Systems, Analytical and Microbiological Method Validation
As these systems have validation completed prior to product manufacture or use in a production environment, all deviations, critical or non-critical do not require a QAR. All deviations should be recorded on a deviation form only as per section 5.2.1.
5.3 Deviation Requirements
5.3.1 Deviation Form
Deviation Forms must, at a minimum, contain the following information:
5.3.1.1 Deviation Report Number:
The deviation number is a unique sequential number for each deviation in a protocol and is used to reference from the test to the deviation.
5.3.1.2 Test Script/Test Procedure Number:
The section of the protocol/procedure where the deviation occurred must be referenced in the deviation form for traceability back to the test.
5.3.1.3 Description of Deviation:
The description of the deviation concisely and clearly details the deviation from the protocol/procedure. There should be sufficient information in this section to allow the approvers a clear understanding of the actual results/requirements versus the required results/requirements. This section should not contain any information on resolution or justification of the failure. The person who raised the deviation must initial and date this section.
5.3.1.4 Type of Deviation (Critical/Non-Critical):
The type of deviation must be defined by circling the classification on the form. Define the type of deviation as per the definition in section 5.1. If the deviation requires a change control, QAR or commitment, the number should be referenced in this section.
5.3.1.5 Deviation Close Out
A deviation may be closed out by resolution and retesting, if required, or by justification for acceptance of the deviation:
5.3.1.5.1 Resolution:
The resolutions section should be completed only if the deviation has been resolved and should detail the resolution and any retesting required on the resolution. Any retesting should be attached to the deviation form.
The resolution section should indicate if the deviation resolution has been accepted and must be initial and dated by the person completing the deviation.
5.3.1.5.2 Justification for Acceptance of Deviation
If the deviation cannot be resolved or does not require resolution but is still considered acceptable a justification for acceptance of the deviation must be detailed in this section. The justification should be clear and concise and provide enough information to allow approvers a full understanding of the deviation and its acceptance including corrective actions. The justification section should indicate if the deviation has been accepted and must be signed by the person completing the deviation.
In general if resolved, a justification is not required and likewise if justified, resolution is not required. In some situations resolution is not required prior to release of the equipment/system/product e.g. a drawing update for equipment. In this case a justification for delaying the resolution must be documented. The commitment should be referenced in the deviation form and the validation report detailing the responsible person and timeline for resolution. If a change is required as a result of a deviation, the change control number should be reference on the deviation form.
5.3.1.6 Deviation Approval
All deviations must be approved by:
– System Owner (Name, Signature and Date)
– Validation (Name, Signature and Date)
– Quality Assurance. (Name, Signature and Date)
The approvers should be the same as those persons approving the report or protocol or their delegate.
For traceability purposes, each deviation will also have a page number that is used to record the number of sheets as part of the deviation including any attachments.
Deviation approval does not need to wait until the validation is complete and a report generated but should be obtained as close as possible to the occurrence of the deviation so a decision on the deviation status and any retest requirements can be made by the relevant approvers.
5.3.2 Deviation Log
The deviation log is an index of deviations. The deviation log should contain the following information:
a. Deviation Number
b. Test Number
c. Deviation description (Title of deviation)
d. Critical or Non-Critical
e. Initial and Date or person entering the deviation
5.4 Deviation Reporting
The deviation should be referenced in the deviation section of the validation report and its affect on the process, system or data integrity determined.
The validation report conclusion should summarise what affect the deviation(s) had upon the system/process/product integrity.
6.0 DEFINITIONS / ACRONYMS
| QAR | Quality Assurance Reporting (Deviation) |
7.0 REFERENCES
None
8.0 SUMMARY OF CHANGES
| Version # | Revision History |
| VAL 075 | New |