srearo20 [ASTM E2500 Vendor Documentation -Perfocmance Validation oT PERFORMANCE “"?s!/Perval.com) VW VALIDATION ASTM E2500 Vendor Documentation (https://perfval.com/astm-e2500-vendor- documentation/) Overview The American Society for Testing and Materials issued E 2500-07, Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment, which includes (http://perfval.comiwp- content/uploads/2015/10/ASTM-E2500- “ifinadequacies are found in the vendor Highlight.jpg) guidance about many topics quailty system, technical capability, or . . appicetion of GEP. thenthe reguiated including vendor documentation. Section 6.8 of company may choose to mkigate potential EtG, ouhag sudhe Green this standard deals specifically with the use of addtional verification checks or other vendor documentation in the verification process controls rather than repeating vendor activities and replicating vendor of equipment and systems. Contingent on an documentation.” ReaTNNE BSR TT SSeS SD audit, vendor documentation may be used or additional vendor controls may be instituted as Figure 4: ASTM E 2600-07 Designation Highlignt highlighted in Figure 1. This white paper will provide an overview of the method developed by Performance Validation (PV) to conduct Quality System audits of critical suppliers and vendors, with a focus on Good Engineering Practice (GEP) and Good Documentation Practice (GDP). Leveraging vendor documentation in the verification process can lead to cost and time savings for GMP-regulated companies by reducing or eliminating repeat work during the testing of systems and equipment. When implementing the entire E 2500-07 standard, including Section 6.8, some users{1] have reported savings of up to 80% less paper generated for documentation and $20,000 in project cost savings. hitpsperval com/astm-e2500-vendor-documentation’ 18sreareo20 [ASTM E2500 Vendor Documentation -Perfocmance Validation Significance of Leveraging Vendor Documentation Leveraging vendor documentation provides a way for the GMP-regulated company to realize cost savings by eliminating or reducing redundant testing documents and verification. Per the guidance given in Section 6.8 of the standard, vendor documentation may be used, with any necessary vendor controls instituted, as part of verification, provided the GMP-regulated company has audited the vendor for evidence of: (http://perfval.comiwp- - - content/uploads/2015/10/astm-testing jpg) ‘Wout nde Cua Sten Aut + Acceptable vendor quality system + Vendor technical competence + Application of GEP to ensure information provided by the vendor is accurate and acceptable for use in testing Lower verification costs and faster release to service are possible because the guidance allows for the leverage of vendor documentation, even if inadequacies are uncovered during a vendor audit, provided Pique? Fesungwinauctexeaaan mitigating steps have been taken. Since the vendor documentation may be used, this reduces the need to perform testing at the vendor site and then perform identical testing at the GMP-regulated company site. Figure 2 shows this savings in a pictorial approach that clearly shows the reduced overlap of vendor and owner testing when Vendor Audits are leveraged. Audit Development PV has developed a program for use in vendor documentation audits to guide our ASQ Certified Quality Auditors. The uniform guides and internal training of auditors ensures that a Vendor Documentation audit performed by PV will be of the same scope, quality, and level of detail regardless which PV auditor conducts the audit. (http://pertval.com/wp- content/uploads/2015/10/astm-audit-tool.jpg) Section 6.8 of E 2500-07 does not provide details about the requirements or expected state of vendor documentation. However, Section 6.6 discusses in great detail the need for use of GEP. As a result, PV developed the Audit Assessment Tools (see Figure 3 for an example of hitpsperval com/astm-62500-vendor-documentation’ 216,sreareo20 [ASTM E2500 Vendor Documentation -Perfocmance Validation content) and an Auditor Workbook to align with the sn soe nea oi ni en Wa Cea ISPE Good Engineering say RaaETE Practice Guide. Ifthe vendor ||| soo s.cuc fos ae practices meet the «|e requirements of GEP, then it || | pssusas = ST Ses i may be concluded that the s las sangsuopaenen sd zea vendor documentation is Figure 3: Samole content from an Audit Assessment Tool appropriate. The audit is necessary to discover any deficiencies in documentation and practice Audit Process Performance Validation's audit process is in alignment with the American Society for Quality (ASQ) Certified Quality Auditor's (CQA) handbook. This approach is time tested and proven to work, PV brings to the table decades of experience in Commissioning, Qualification, Validation, Change Control, Quality Programs development and Management. PV Audit Assessment tools are available for Common Practices, Core Concepts, Operations and Management, and Project Engineering. Figure 4 shows a flowchart of the typical audit process as discussed below. (http:/perfval.com/wp-content/uploads/2015/10/ASTM- audit-process jpg) First, the PV auditor will hold the Client Opening Meeting. A solidified scope, including vendor divisions / departments / projects to be involved in the audit, and an audit schedule result from a well executed and effectively facilitated opening meeting, The client will review the PV Audit Assessment tools for applicability, including GEP Aspects recommended by PV to result in a failing audit if not met and revise the list according to their needs for the purposes of the specific audit. The PV auditor helps step through risk assessment, so that a focused audit plan develops, and the team can turn over an appropriately detailed summary at the conclusion of the process. Once the Client Opening Meeting has been completed and the audit plan has been developed, the PV auditor will hold a Vendor Opening Meeting. A mutual understanding of audit purpose and scope will be established at this meeting, along with PV auditor introduction to key vendor stakeholders to facilitate audit execution. Then, the PV auditor begins the work of executing the audit using PV Audit Assessment tools. During the audit execution, the PV auditor examines documents, practices, and processes to gain a complete understanding of vendor operations to complete the Audit hitpsperval com/astm-62500-vendor-documentation’ 36‘12412020 [ASTM E2500 Vendor Documentation - Performance Validation Assessment tool(s) applicable to the vendor's products / services, Each tool, developed by PY, is setup to guide the auditor through a systematic examination of the vendor. The tool provides a clear indication of GEP Aspects that, if unmet will result in an audit failure. The culmination of the performance of Audit Assessment Tool use is a summary sheet that itemizes all audit observations. For the audit overall, the PV auditor will provide a written executive summary of findings from all Audit Assessment Tools used during the audit After the findings are detailed, recommended actions for remediation must be developed. While this is typically done by the client, PV can participate in this process. PV staff have validation and quality system experience, and are highly capable of providing suggestions that will result in a compliant vendor quality system. Any remedial actions should be verified to be effective once implemented to ensure the subsequent vendor documentation meets the intended requirements. Remedial actions will vary based on the type of Figures: Aud Process Flowenart inadequacy found, the severity of the inadequacy, and the ability of the client's own quality system to identify inadequacies of that type upon receipt of the product / service. A remedial action for a vendor with an inadequacy in version control of documents could be to require the vendor to establish a controlled electronic repository for documents with document approval included in the system features. An example of a more client-focused remedial action would be to identify that a vendor has particular trouble with executing a specific test properly and making it a policy not to accept or pay for that type of testing from the vendor. Some remedial actions may be a hybrid of a client and vendor relationship. For example, perhaps the client identifies that the vendor should sample their product on a more frequent basis to verify product quality so that the product supplied to the client is accepted. The Benefits hitpsperval com/astm-62500-vendor-documentation’ 48,‘12412020 [ASTM E2500 Vendor Documentation - Performance Validation Conducting vendor / supplier audits prior to project commencement can provide time and cost savings during project installation, verification, and validation. These vendor / supplier audits performed with a focus on GEP Aspects may uncover information not found during standard audits that could create delays or inaccuracies in vendor documentation. The audit outcomes assist in predicting the accuracy and detail to expect in vendor documents. This helps in the decision whether or not to rely on vendor documentation for portions of equipment or system verification testing. If the vendor's Quality System is deemed to be acceptable, the leveraging of vendor testing documentation can lead to a reduced verification effort after system / equipment delivery. If the audit uncovers deficiencies in the Quality System, the client can take steps to remediate the vendor's practices, add additional controls based on risk, or can opt not to rely on the vendor for verification documentation This can reduce or eliminate the possibility of paying the vendor for low quality documentation which will later require repeating during onsite verification activities. Once the vendor audit is complete, the client will have a better understanding of what they are buying when they create a contract that includes a vendor documentation package. In addition, performing vendor / supplier audits will help the client form a partnership with the vendor, This occurs because the vendor will be made more aware of how their product / service impacts quality for the client and will be more capable of assessing information needs for the client in the future. Once this partnership is established, future projects with the vendor should be more efficient since expectations are clear to both the vendor and the client. About the Author This white paper was written in 2010 by Marcy Gallagher, P-E., a Performance Validation Engineer. Marcy is no longer with Performance Validation, and is currently employed with a Fortune 500 pharmaceutical company. = PV Services Commissioning, Qualification & Validation (https://pertval.com/commissioning-qualification/) Building Commissioning (https://pertval.com/building-commissioning/) Environmental Mapping (https://pertval. com/environmental-temperaturehumidity-mapping/) Critical Airflow Visualization - Smoke Studies (https:!/perfval.com/critical-airflow-visualization-smoke- studies!) Computer Systems Validation (https://perfval.com/csv/) Med Device Validation (https://perfval.com/medical-device-qsr-support/) hitpsperval com/astm-62500-vendor-documentation 98sreareo20 [ASTM E2500 Vendor Documentation -Perfocmance Validation Corporate Headquarters Two Park Fletcher 5420 W. 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