sop for validation plan


sop for validation plan

1.1 The objective of this SOP is to define the procedure for validation plan.
2.1 This SOP is applicable for validation plan
3.1 Executive -Quality Assurance – Prepare the SOP and follow-up the SOP accordingly.
3.2 Asst. Manager –Quality Assurance -Provide the support to the implementation of SOP and maintained the records.
4.1 Head – Quality Assurance Department / Chief Executive Officer

5.1 Approval of Validation Documentation
The approval requirements for validation documents will vary depending on the nature of the document. The following is a list of standard minimum requirements:
5.1.1 Validation Plan All members of the validation team.
5.1.2 User Requirement Specification All members of the validation team.
5.1.3 DQ/FAT/IQ/OQ Documents Relevant Technical Personnel User Dept. Representative (Owner) Quality Assurance Department
5.1.4 PD/ PQ/PV Documents* User Dept. Representative (Owner) Quality Assurance Department, Quality Control Representative and Qualified Person (for Production Processes)

5.1.5 If the PD/ PQ/ PV documents have registration implications, the protocols and reports may require a signatory from the Registration Compliance Officer.
5.1.6 Where any of the above documents are supplied by a vendor or contractor operating a satisfactory Quality Management System, the documents may only require one signature on behalf of Company name. provided they have been reviewed and approved by the Vendor’s Quality Assurance representative.
5.2 Approval of validation stages
5.2.1 Unless otherwise specified in the Validation Plan, the progress of each validation project will be reviewed and approval given to proceed prior to each of the following stages: Installation Qualification/Operational Qualification Performance Qualification Process Development (if required) Process Validation Issue of validation maintenance certificate/final validation report. Where appropriate and documented in the Validation Plan, the FAT, IQ, OQ & PQ phases may be combined.
5.3 Approval to proceed with the next stage of the project will be signified by the issue of a Validation Phase Certificate or report. The documentation must contain the following:
5.3.1 Action to be taken following any failure to fully comply, along with responsibilities and target dates for completion
5.3.2 Identification of whether outstanding points have a direct effect on product quality and personnel safety and therefore must be addressed prior to validation sign off.
5.3.3 A statement to denote that all related standard operating procedures for the operation, maintenance and cleaning of the equipment are approved and issued. Where relevant it must also denote that master batch records and training records are up to date. This is only applicable for the last validation stage prior to any testing that may involve the use of product, equipment or systems that will effect the manufacture, analysis, storage, distribution or documentation of product released for human consumption by a Qualified Person, including clinical trial materials.
5.4 A Validation Phase Certificate may be used where there is insufficient time to produce a full report signed by all the Team Members before moving to the next stage of validation. The Certificate must indicate that the required testing has been undertaken with satisfactory results to allow progression to the next phase. The certificate only needs to be signed by the Validation Section and one other appropriate team member, as a minimum.
5.5 Large projects may be split into subsections consisting of several protocols and reports. A certificate may also be used to summaries the completion of a subsection.
5.6 Where the validation stage does not consist of a protocol followed by testing, such as Design Qualification, a certificate may be used in place of a report. This should be approved and issued in the same way, but will consist of a statement of the status of that phase and reference to the supporting documentation.
5.7 Validation Maintenance
5.7.1 A validation maintenance certificate will only be generated when all reports and standard operating procedures identified by the validation project have been issued. All outstanding points from the validation reports which have a direct impact on product quality and personnel safety must have been followed up, documented and approved.
5.7.2 The validation maintenance certificate will provide the following information: Identify the reports that support the successful completion of each phase of the validation project.
5.7.3 Document the completion of outstanding issues from the phase reports which are product quality/safety critical. Associated documentation may be attached if required.
5.7.4 Provide a record of any deviations from the details stated within the current version of the Validation Plan together with an explanation for why this deviation occurred. If no deviations were observed, this must also be documented.
5.7.5 Confirm and state that adequate re-validation provisions have been made during the project life-cycle.
5.7.6 Detail the requirements for maintaining the validation status of the project and identify that the issue of the certificate signifies the official transfer of the project to a ‘maintenance’ status.
5.7.7 The validation maintenance certificate and any associated final validation reports must be approved by all members of the validation team. For research processes, the Research QA.
5.7.8 Manager will also approve the certificate. The signatories are approving the validation status of the project and its suitability for use within routine production or research activities.

5.7.9 Once the signed certificate has been returned to the Validation Section, the
5.7.10 Validation person responsible for the project must change the status on the Quality Database to ‘maintenance’.
5.7.11 It may be appropriate to hold a project review at this point to analyse the project’s performance. The review should include discussions about the successes and failures from each stage of the project, including supplier and contractor performances. This information should be reported and utilized to help improve performance in future projects.
5.7.12 The validated system will remain in the maintenance stage throughout the system’s life time and will be subject to change control procedures.
5.8 Validation Closure
5.8.1 When the validated system is no longer required for use within the facility, the project will be transferred to the ‘closed’ status. When this occurs a validation closure certificate will be generated which indicates this status change. This certificate only requires a signature from a member of the validation section from within the Quality Assurance department.
5.8.2 Some projects do not progress to the maintenance stage of validation due to the project being terminated during the implementation phase. For these validation projects, a validation closure certificate will be generated indicating the formal transfer of the project to the closed status. This certificate must be approved by all members of the validation team.
5.8.3 In both of the cases above the project status on the Quality database must be changed to ‘closed’.
5.9 Maintenance Review
5.9.1 A validation project will only be transferred to “maintenance” status if there are no outstanding points that effect project quality or personnel safety. Minor, non-critical points/snags may be outstanding. These points will have been identified, assessed and approved as having no impact on product quality and safety. These outstanding snags still need to be followed up.
5.9.2 The Validation person responsible for the project must ensure that any outstanding items are followed up and resolved. Once all items have been completed the complete’ status should be recorded to reflect this.
5.10 Re-Validation
Re-validation within Company name. is the method through which the function of the equipment, process or system, as tested during the active validation phase, is maintained throughout its life-cycle. This specifically applies to parameters that are known to have the potential for change over time. Examples of this include measuring equipment, electronic devices, motorized and moveable parts, and processes that involve a high level of manual input, e.g. cleaning.
5.10.1 Assessment of re-validation requirements Critical parameters that may require re-testing at pre-determined intervals must be identified during the active period of the validation life-cycle.
5.10.2 Aspects for consideration include: Expected life span of an item obtained through reliability data. Expected life span of an item obtained through Supplier’s and in-house historical evidence. Potential weaknesses identified by risk assessment.
5.10.3 Re-validation should encompass requirements for calibration, maintenance, chemical and microbiological analysis. Where possible the re-testing will be included as part of a routine procedure. For example accuracy checking of gauges and probes should be included on the calibration schedule.
5.10.4 If it is not possible to determine all re-validation requirements during the live phase of the project, it may be necessary to carry out periodic assessment to identify any re-testing that needs to be performed.
5.10.5 Requirements for re-validation must be documented at appropriate stages throughout the project. Adequacy of the re-validation provisions must be confirmed and documented on the Validation Maintenance Certificate.
5.10.6 Changes to the equipment, processes or systems that were not anticipated at the time of the original validation activities must be monitored and reported using the Company name. procedures for change control which will ensure requirements for appropriate validation testing are considered.
5.10.7 Product Re-validation
Revalidation for products will be covered by the annual product review. This review will consider analytical trends, change controls and procedural revisions. The Annual Product Review report will indicate any aspects of the process that may require further validation work in which case a change control procedure will be initiated.
5.11 Storage of Validation Documents
5.11.1 Logging of Documents: All validation documents identified as being necessary by the Validation Plan will be stored in a Validation Master Plan (VMP) retained by Quality Assurance. Except analytical equipment validations for QC office which will be stored in the respective department. The VMP includes master copies of protocols and reports and other relevant information. The location of the VMP will be recorded in the quality database. This must be up-dated throughout the life cycle of the validated system by quality assurance personnel whenever the VMP is relocated. The VMF will contain an index of the protocols and protocol reports contained within the file, showing the identification, edition and issue date of each document. For master protocols, the index will display all versions of the documents issued, although the file will only contain the current edition. For protocol reports, the index will display and contain all e

ditions. The approved superseded master protocols are stored in Quality Assurance / Validation Office. Unless otherwise stated in the Validation Plan, protocol or report, all raw data and completed test sheets will be retained in the VMP with the relevant report.
5.12 Archiving of validation documents
5.12.1 On issue of a Validation Maintenance Certificate, the Validation Master Plan will be placed in the secure QA office. The VMFs for analytical equipment used within QC technical support, Analytical and Pharmaceutical Sciences and Technical support will be stored by the respective departments.
5.12.2 The location of the VMP will be recorded in the Quality Database.
5.12.3 Any further updates to the VMF, as a result of changes or re-validation, will be carried out and added to the file index by the QA Validation Section member responsible for the project or User department if the VMP is kept by the Department.


SOP : Standard Operating Procedure
BMR : Batch Manufacturing Record
QA : Quality Assurance
VMP : Validation Master Plan

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