Manufacturing Process Qualification & Validation. Naren Patel. Naren Patel 1
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1 Manufacturing Process Qualification & Validation Naren Patel Naren Patel 1
2 Manufacturing Process Qualification & Validation Tutorial Why to Validate What to Validate Program How to Perform successful Validation Naren Patel 2
3 Regulatory Requirements Required by ISO FDA QSR Subpart The Global Harmonization Task Force (GHTF/SG3/N99-10:2004) Quality Management Systems Process Validation Guidance Makes good business sense Naren Patel 3
4 Purpose of GHTF Guidance Document To assist manufacturers in understanding quality management system requirements for process Validation. General applicability to manufacturing (including servicing and Installation) process for medical devices. Naren Patel 4
5 QSR Process Validation 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 signatures of the individual (s) approving the validation and where appropriate the major equipment validated, shall be documented Naren Patel 5
6 QSR Process Validation, Cont d 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. Each manufacturer shall ensure that validated processes are performed by individual(s) 2. For validated processes, the monitoring and control methods and data, the date performed by qualified individual(s) performing the process or the major equipment used shall be documented. When changes or process deviations occur, the manufacturer shall review and evaluate the process and perform revalidation where appropriate. These activities shall be documented. Naren Patel 6
7 Benefits of Validation Thorough understanding of a process Improves product quality and reliability FDA Perspective: Large portion of field actions and inspection deficiencies could have been prevented if processes were properly validated. Naren Patel 7
8 FDA Inspections Warning Letters In 2007, 33% of industry Quality System Warning Letters cited process validation. The reasons: a) Process Validation procedures weren't established. b) Did not document val. Activities. c) Firm failed to review/evaluate processes after changes or process deviations occurred d) The firm failed to evaluate/validate product functionality and packaging integrity weren t performed. Naren Patel 8
9 FDA Consent Decree Abbott Signs consent decree with FDA, violations were found in process validation, production and process control. The firm has also agreed to pay $100, to US treasury with in 10 days after the decree has been entered by the court. Naren Patel 9
10 Schering-Plough Consent Decree Schering will pay the record $500 million disgorgement in two equal installments of $250 million, If the actions are not completed on time, firm will pay $15,000 a day for every deadline missed. Naren Patel 10
11 Cost of Quality Orthopedic Implant maker Zimmer Holdings temporarily recalled and suspended production costed $70-80 million in lost revenue. Medtronic CRDM: a) Revenue shortfall $130 million b) $80 million due to inability to fill orders c) $35 million in product returns d) $31 million inventory write-offs Naren Patel 11
12 Most Common Issues Cited by FDA Process Validation a) Equipment qualification b) Lack of Validation of Analytical methods. c) Ad hoc manufacturing changes without quality approvals. d) Lack of written protocols. e) Short cuts in performing PQ. Naren Patel 12
13 From GHTF-What to Validate A In Process Output Verifiable Y N B Is Verification Sufficient & Cost Effective Y C Verify & Control the Process D Validate E Redesign Product and/or Process Naren Patel 13
14 What to Validate? Cont d Naren Patel 14
15 PROGRAM How to Successfully carrying out Validation Naren Patel 15
16 Tools & Techniques Understanding the Scope of Validation How to go about Validation Naren Patel 16
17 Major Elements of Validation Design Validation 21 CFR Sec (g) Each manufacturer shall establish and maintain procedures for validating the device design. Design validation shall be performed under defined operating conditions on initial production lots or batches, or their equivalents. Design Validation shall ensure that devices conform to defined user needs and intended uses and shall include testing of production units under actual or simulated use conditions. Design validation shall include software validation and risk analysis, where appropriate and is documented in DHF Naren Patel 17
18 Manufacturing Process Process is a unique combination of machines, tools, methods, materials and personnel engaged in Mfg. operation Capability: is defined as the performance of process itself demonstrated when the process is being operated in the state of statistical control. Naren Patel 18
19 Major Elements of Validation Installation Qualification (IQ): Establishing by key objective evidence that all key aspects of the process equipment and ancillary system installation adhere to the manufacturer s approved specification of the supplier of the equipment are suitably considered. Naren Patel 19
20 Major Elements of Validation, Cont d Operational Qualification (OQ): Establishing by objective evidence process control limits and action levels which result in product that meets all predetermined requirements. In another word in OQ process parameters should be challenged to assure that they will result in a product that meets all defined requirements under all anticipated conditions. Naren Patel 20
21 Major Elements of Validation, OQ Cont d OQ Includes: a) Process control limits (Time. Temperature, pressure, setup conditions, etc.) b) Raw material specs. c) Process operating procedures, material requirements training d) Short term capability and stability of process, control chart etc. e) Potential failure modes, action levels and worst conditions. Naren Patel 21
22 Major Elements of Validation, Cont d Process Characterization: Identifying and quantifying all significant sources of variation, especially variation inherent to the materials and technology as applied to the specific product design Naren Patel 22
23 Major Elements of Validation, Cont d Performance Qualification (PQ): Establishing by objective evidence that a process, under anticipated conditions, consistently produces a product which meets all predetermined requirements. In this phase the objective is to demonstrate the process will consistently produce acceptable product under normal operating conditions. Naren Patel 23
24 Major Elements of Validation, PQ Cont d PQ considerations include: a) Actual product and process parameters and procedures established in OQ b) Acceptability of the product c) Assurance of process capability as established in OQ d) Process Stability and long term process stability Naren Patel 24
25 Major Elements of Validation, Cont d Qualification: The activity and analysis performed on equipment, process, or product to demonstrate adherence to predetermined criteria. Naren Patel 25
26 Major Elements of Validation, Cont d Worst-Case: A set of process settings and conditions encompassing upper and lower processing limits. These settings pose the greatest chance of process or product failure when compared to ideal conditions. Such conditions do not necessarily induce product or process failure. Naren Patel 26
27 Major Elements of Validation, Cont d Protocol: Is a variable document, depending on the nature of the device, the procedure to be used and the purpose of the protocol. The protocols are comprehensive and that the final packages are well documented and easy to follow Naren Patel 27
28 Major Elements of Validation, Protocol Cont d Protocol Steps: a) Write protocol plan describing all the steps to be taken including sample size. b) List characteristics/ features to be verified. c) Get approvals from Quality and development team on protocol plan prior to carryout the protocol. d) Review the completed protocol to insure that the original intent of the protocol is satisfied. e) Go back to the drawing board If protocol fails. Naren Patel 28
29 Steps for Validation per GHTF Guideline IQ OQ Process Characterization PQ Qualification Run Naren Patel 29
30 For IQ, OQ and PQ Determine what and when to verify/measure Determine How to verify/measure Determine how many to verify/measure (Statistical techniques) Define Accept/ Reject criteria Define Required documentation including IQ, OQ and PQ records. Naren Patel 30
31 Manufacturing Validation Basic Statistical methods and Tools
32 Degree of Assurance Degree of Assurance is measured in terms of Confidence Level and Reliability Naren Patel 32
33 Degree of Assurance Cont d Confidence Level: It simply means that the more we know about anything the better our chances are of being right. It is a mathematical probability relating to the true value of a parameter to an estimate of that parameter. Only infinitely large sample size can give us 100% confidence that our measurement coincide with the true value. Naren Patel 33
34 Reliability Mathematical definition is probability of success. In our business Reliability is our statement of the performance of our process. Naren Patel 34
35 Sample size for various Confidence/ Reliability Risk Level Confidence Level Reliability Attribute Sample Size Low Medium Medium/ High High Very High Note: All Sample sizes requires 0 Non conformances to achieve the confidence/ reliability indicated Naren Patel 35
36 Process Capability Naren PatelNaren 36
37 Process Capability, Cont d Capability: is defined as the performance of process itself demonstrated when the process is being operated in the state of statistical control. Capability can be determined only after the process is in Statistical Control. A stable process in statistical control does not have any special causes remain. Common causes are inherent in the process. Naren Patel 37
38 Control Vs. Capability Control is concerned with process variation relative to stability and predictability only common causes present Capability is concerned with the ability of the stable process to meet specifications/ expectations Naren Patel 38
39 Process Capability Naren Patel 39
40 Stability & Capability Naren Patel 40
41 Unstable Process Naren Patel 41
42 Process Variation Examples Naren Patel 42
43 Transmission of Variation Naren Patel 43
44 Process Capability Indices Naren Patel 44
45 Relationship between Cp and Cpk Cp = 1.5, Cpk = 1.5 Cp = 1.5, Cpk = 1 Cp = 1.5, Cpk < 1 Cp = 1.5, Cpk = 0 Cp = 1.5, Cpk < 0 Cp = Cpk when process mean is at the nominal Cp > Cpk otherwise Naren Patel 45
46 Robust Design Naren Patel 46
47 Stable & Capable Process Naren Patel 47
48 Process Monitoring and Controls Naren Patel 48
49 Monitoring & Control Naren Patel 49
50 ? Thank You
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