Information & Training. | Product & Process Validation.
The Validation Report. The Qualification Report.
A validation / qualification report should contain the following elements:Purpose: A description of the purpose for the validation / qualification report.
Background information: Reference to where the report resides within the overall validation program, and reference to the Master Validation Plan (where the report is a component within a validation program or where a MVP exists). The justification for performing the report. Other information may be provided in a brief format which can help the reviewer establish the basis for the report. Also details on the overall validation / qualification which is leading to the need for the report.
Responsibilities: Identify and define the roles and responsibilities of the various individuals inputting into the validation or qualification. For example, details on who will draft the report, who will perform data collection, who will approve the report.
Acceptance Criteria: Information on the pre-defined acceptance criteria, which will have been established in advance of performing the validation / qualification.
Results obtained: Details of the data obtained. The results should not be interpreted, amended in any way. Interpretation will occur on the next section. Here the objective is to record the factual data as obtained.
Analysis of the results: The results versus the pre-determined acceptance criteria are now analyzed. Ideally, the results should clearly confirm the meeting of acceptance criteria. However, some level of interpretation may be necessary. In this latter situation, justification will be necessary to explain any potential deviation from the acceptance criteria.
Deviations: Where deviations arise and where not already covered in the results analysis, then full explanations and justifications need to be provided. The justifications will include detailed analysis or reasons why deviations may have arisen, the potential impacts of such deviations and explanation of potential impacts on process or product capability.
Ongoing re-validation / re-qualification criteria: Will the process require further ongoing re-validation? What are the critical process parameters, which if subject to change would necessitate re-validation?
The Validation Report. Product and Process Validation.
Report conclusion: Summary of the final outcome of the validation / qualification and recommendations. There recommendations may be that the process should be “released for use”, or that a re-validation should be performed after implementation of specified changes, or that the process is in-capable as currently designed and needs substantive redesign, etc..
Reference documentation and data: Copies of original data recorded where possible should be attached as references to the report. Material samples used during the validation may be retained. If so, the location and retention times of the samples should be detailed in the report.
Change history: Where the report has undergone a number of revisions, the revision history needs to be clearly evident and the locations of previous revisions detailed. (The previous revisions will often be retained under formal control by Document Control).
Signatures and date: Sign-off and approval signatures need to be clearly evident and include all those identified as needed to sign-off the report.
Information & Training.
Product and Process Validation.
- Validation versus Verification
- Integration of Risk into Validation
- Validation Gap Analysis
- Implementing a Validation Process (IQ, OQ, PQ)
- The Validation Master Plan (VMP)
- Validation during the Design processes
- Software Validation
- Cleaning Validation
- Cleaning Process Sampling and Test Methods
- Documentation Management for Validation compliance
- Equipment, Component, Material and Facility Validation
- Implementation of a re-Validation process
- Protocol Reporting
- Implementation of the Audit process to assure Validation effectiveness
- How to ensure that Validation activity is appropriately documented, reviewed and aligned with requirements.
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