Process Validation Presentation Final Version

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Process Validation Presentation Final Version

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<p>PROCESS VALIDATIONin a Regulated IndustryDoug Frank Sr. Director of Quality</p> <p>Program Overview </p> <p>Terms &amp; Definitions Systems for Implementing a Validation Program Essential Requirements Software Qualifications Specific Tests</p> <p>Why Validate?</p> <p>Required by: FDAs QSR ISO 13485: 2003</p> <p>ADDITIONAL REASONS FOR VALIDATION Customer satisfaction: Non-conforming product can lead to lost customers. Customer Mandated: Provision for securing new business Product liability: Conformance to product specifications must be maintained. Reduced production costs: PV leads to reduced inspections, testing, scrap and rework. Shifts costs from production to prevention. Supports improvements: Testing data can be used to support improvements in the process or the development of the next generation of the process. Regulatory requirement (CFR Title 21, Part 820.75)</p> <p>CFR Title 21 Part 820.75a) Where the results of a process cannot be fully verified by subsequent inspection and test, the process shall be validated with a high degree of assurance and approved according to established procedures. The validation activities and results, including the date and signature of the individual(s) approving the validation and where appropriate the major equipment validated, shall be documented. Each manufacturer shall establish and maintain procedures for monitoring and control of process parameters for validated processes to ensure that the specified requirements continue to be met. 1) 2) Each manufacturer shall ensure that validated processes are performed by qualified individual(s). For validated processes, the monitoring and control methods and data, the date performed, and, where appropriate, the individual(s) performing the process or the major equipment used shall be documented.</p> <p>b)</p> <p>c)</p> <p>When changes or process deviations occur, the manufacturer shall review and evaluate the process and perform revalidation where appropriate. These activities shall be documented.</p> <p>INTRODUCTIONThe goal of a quality system is to consistently produce products that are fit for their intended use. Process validation is a key element in assuring that these principles and goals are met. Many technologies are used in the production of medical devices. The details of process validation will vary according to the nature of the medical device (e.g., sterile or non-sterile) and the nature and complexity of the process being validated. Processes must be developed according to design controls (820.30) and validated (820.75). The process specifications (parameters) are derived from the specifications for the device, component or other entity to be produced by the process. The parameters are documented in the device master record (820.30, 820.40 and 820.181). The process is developed such that the required parameters are achieved. To ensure that the output of the process will consistently meet the required parameters during routine production, the process is validated.</p> <p>Basic Principles Establish that the process equipment has the capability of operating within required parameters. Demonstrate that controlling, monitoring, and/or measuring equipment and instrumentation are capable of operating within the parameters prescribed for the process equipment. Perform replicate cycles (runs) representing the required operational range of the equipment to demonstrate that the processes have been operated within the prescribed parameters for the process and that the output or product consistently meets predetermined specifications for quality and function. Monitor the validated process during routine operation. As needed, requalify and recertify the equipment. </p> <p>Terms &amp; DefinitionsValidation: Confirmation by examination and provision of objective evidence that the particular requirements for a specific intended use can be consistently fulfilled (820.3(z)). Process validation: Establishing documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its pre-determined specifications and quality attributes (CMI).</p> <p>Terms &amp; DefinitionsInstallation qualification (IQ): Establishing by objective evidence that all key aspects of the process equipment and ancillary system installation adhere to the manufacturers approved specification and that the recommendations of the supplier of the equipment are suitably considered (GHTF/SG3/N99-10:2004).</p> <p>Terms &amp; DefinitionsOperational qualification (OQ): Studies which are designed to challenge the process and process equipment, and establish objective evidence that the process meets predetermined requirements throughout all anticipated operating ranges (CMI).</p> <p>Terms &amp; DefinitionsPerformance qualification (PQ): Studies conducted to demonstrate the process will consistently produce acceptable product under normal operating conditions. Challenges to the process should simulate conditions that will be encountered during actual manufacturing (CMI).</p> <p>Terms &amp; DefinitionsValidation protocol: A written plan stating how validation will be conducted, including test parameters, product characteristics, production equipment, and decision points on what constitutes acceptable test results (FDA Guidance). Verification: Confirmation by examination and provision of objective evidence that specified requirements have been fulfilled (820.3(aa)).</p> <p>WHEN SHOULD PROCESSES BE VALIDATED?</p> <p>Where process results cannot be fully verified during routine production by inspection and test, the process must be validated according to established procedures [820.75(a)].T h e fo llo w in g m o d e l m a y b e u s e fu l in d e te r m in in g w h e th e r o r n o t a p r o c e s s s h o u ld v a lid a te d :</p> <p>A Is P ro c e s s O u tp u t V e r ifia b le</p> <p>YE S</p> <p>B Is V e r ific a tio n S u ffic ie n t &amp; C o s t E ffe c tiv e</p> <p>YE S</p> <p>C V e r ify &amp; C o n tro l th e P ro c e s s</p> <p>N O</p> <p>N O</p> <p>D V a lid a te</p> <p>E R e d e s ig n P r o d u c t a n d /o r P ro c e s s</p> <p>(GHTF/SG3/N99-10:2004)</p> <p>WHEN SHOULD PROCESSES BE VALIDATED? Routine end-product tests have insufficient sensitivity to verify the enddesired safety and efficacy of the finished devices. devices. Clinical or destructive testing would be required to show that the manufacturing process has produced the desired result or product. Routine end-product tests do not reveal all variations in safety and endefficacy that may occur in the finished devices. The process capability is unknown, or it is suspected that the process is barely capable of meeting the device specifications.</p> <p>Relation of Risk AnalysisFor complex or critical processes, a risk analysis is normally conducted prior to establishing validation requirements. The risk analysis will reveal which output parameters should be concentrated upon, and assist in the development of appropriate tests.</p> <p>Getting Started Develop a Validation Program that Defines: </p> <p>Responsibilities Process Type Definition Flow Chart With Decision Points Methods Forms Documentation Oversight</p> <p>CarboMedics System</p> <p>Policies Implemented for : </p> <p>Process Validation Design ControlsDesign Change Test Plan &amp; Protocol Policies Risk Analysis Corrective &amp; Preventative Action Events &amp; Complaints Documentation &amp; Records Management Review</p> <p>CarboMedics SystemProcess Validation Policy provides Requirements for:</p> <p>Validation Review Board/Design Change (VRB/DCN Committee) Validation Master Plan (PVMP) Request for Validation Status (RFVS) Process Validation Summary Report (PVSR)</p> <p>CarboMedics SystemValidation Review Board </p> <p>Oversees and ensures compliance Reviews and Approves PVMPs Review RFVSs &amp; Selected Test Plans/Protocols Provides consultation &amp; Guidance on validation approach</p> <p>CarboMedics SystemPROCESS VALIDATION MASTER PLAN Provides the roadmap for conducting validations. Establishes criticality of the process. Defines the validation approach. Documents rationale for decisions to not validate. Provides documented evidence of the validation Provides an easy to follow trail to locate relevant validation documents and test data. Establishes requirements for process changes.</p> <p>Request for Validation Status A CarboMedics form used to communicate planned validations to the VRB that have not been documented on a PVMP. Alternatively, the form is also used to present formal questions or issues that may or may not be covered in the policy to the VRB for disposition.</p> <p>Process Validation Summary Report PVSR is a controlled document which lists all current validation documentation to demonstrate that processes are validated and specifies any revalidation requirements. Each PVSR document number is referenced on the Process Validation Master Plan, for ease of document retrieval. The PVSR contains: Process title Applicable uncontrolled documentation (attached) List of all validation documentation (IQ, OQ and PQ) Revalidation requirements Recurring validation requirements</p> <p>EXAMPLE - PROCESS VALIDATION SUMMARY REPORT (Instructions are in parentheses in italics)</p> <p>PROCESS VALIDATION SUMMARY REPORTTitle: APPLICABLE Documents:(List documents applicable to the process validation file such as memos, etc. If none, state "None." Attach all included documents to PVSR.)</p> <p>LK Coordinate Measuring Machine (CMM) #1</p> <p>None VALIDATION Documentation:(Enter test plan / reports or protocols under the applicable section (IQ, OQ, PQ))</p> <p>Installation Qualifications (IQs)T /T -0878-1 T /T -1489-2 q i ent Q Inst ll tion Q lific tion of LK G80 MM #1 lific tion for LK oor inate Meas ring Mac ine # 445</p> <p>Operational Qualifications (OQs)T /T -1056-1Perfor ance Q alifications (PQs)</p> <p>Revalidation Requirements:LIST any known occurrences that will require revalidation. If not required, enter None.</p> <p>Recurring Validation Requirements:(Enter frequency of revalidation to be performed. If recurring revalidation is not required, enter "None.") ec rring validation consisting of three lots processed in accor dance with TP -1234 is req ired annually. 1.</p> <p>1. 2.</p> <p>omplete revalidation is req ired when drive motor is replaced. evalidation in accordance with TP -XXXX is req ired when carrier bearings are replaced.</p> <p>TP/T -0930-2 TP-T -0930-5 TP-T -0930-7</p> <p>Q alification of MM Windows ased M erating stem - PHV Stiffening ing eq alification of MM Windows ased M S erating System - Global, PHV Orifice, and TS Stiffening Q alification of MM Windows ased M S Operating System - TS Orifice pplication</p> <p>T /T -1056-5</p> <p>MI</p> <p>MI Di ensional Database ali ation Di ensional Database and File er er alidation</p> <p>ing Software</p> <p>Process Type CarboMedics bases process validation requirements on the Process Type. Four process types have been established to clarify what qualifications are required, and when these qualifications must be completed. Verified - A process which is fully verified by subsequent inspections or tests, and does not have any equipment that would require an Installation Qualification. No validation is required. Type I - A process which is fully verified by subsequent inspections or tests, but relies on relevant equipment. An Installation Qualification and a Software Qualification (if applicable) are required prior to pilot or production use. Type II - A process the results of which cannot be fully verified by subsequent inspection and tests. Process validation must be completed prior to production use.</p> <p>Process Type Type III - A Type II process that if not satisfactorily performed could result in serious injury to the patient. Process validation must be completed prior to shipment of product for human surgical use. Examples are: o Sterilization o Aseptic Transfer o Performance tests o Injection Molding of critical parts o Blending / Mixing of critical solutions Note: Serious injury is defined as an injury that (1) is life threatening, (2) results in permanent impairment of a body function or permanent damage to body structure, or (3) necessitates medical or surgical intervention by a health care professional.</p> <p>Test Plans and Test Reports Qualifications are planned, conducted and reported using controlled plans and reports or Test Protocols. Test Plans are required to include: o Scope statement that includes the objectives of the test o Hypothesis/Expected Outcome o Sample requirements and description including a rationale for the number of samples to be tested o Test methods or procedures o Requirements for test report o Reference Documents (if required)</p> <p>Test Reports are required to include: Reference Documents (if not previously listed in the Test Plan) Any deviations from the original Test Plan, along with a rationale for acceptability of the deviation Test results as required by the Test Plan Discussion and interpretation of the test results as required by the Test Plan Conclusions drawn directly from and supported by the test data Traceability documentation of test parts or specimens (as required) Raw data attached or reference to a laboratory notebook Validation test parts are required to be retained with the Test Report. All original Test Plans and Test Reports are retained in a central Documentation Center.</p> <p>Protocol Plans and Reports In some cases, it is necessary to evaluate a change using production parts. An example would be a minor change in a polishing process, where a large sample is desired to ensure accurate results. In these cases, CarboMedics uses a Protocol Plan and Report system, which requires approval from Manufacturing, Quality Control, Quality Assurance, Engineering, and Regulatory Affairs management. Unless specifically stated in the protocol plan, the product must be held until approval and disposition is obtained for the protocol report.</p> <p>The protocol plan must contain: Title - the process or item to be evaluated Purpose - the proposed change and the reason for making it. Scope - the range of products, processes, or equipment to which the protocol applies. Hypothesis / Expected Outcome - the criteria by which success will be judged. Reference Documents - Any procedures or test methods to be used, or other forms, diagrams, or relevant documents needed to conduct the protocol. Sample Requirements - A rationale for the number and type of parts to be tested. Test Description - The required test parameters, quantity, and frequency that will result in sufficient data for evaluation. Procedure - A step-by-step description of the work to be done. Disposition Of Parts both during and after the protocol Attachments - Any forms or relevant documents needed to conduct the protocol</p> <p>The Protocol Report will include: Title - the process or item that was evaluated Purpose &amp; Scope - as described above Reference Documents - only if not included in the Protocol Plan Results - The results of the testing, and identification of all tested product Discussion - The meaning of the test results as compared to the purpose Deviations &amp; Additions - Identify...</p>