MED DEVICE ONLINE Article| October 28, 2019 The Criticality Of Process Validation Source: Donate By Todd Owens and Raghu Vadlasudi,Donatelle Process validation is ees part of medical device manufacturing, butt often oesr't get the attention it requires. This article explains why validation is imperative in modical device manufacturing, luminates some regulatory changes currently underway, outlines the steps of creating validation processes, and ‘entifes the personnel who should reate and maintain them. Purther, it discusses ‘what medical device ompanies should be looking for in a contracted manufacturer Proce validation in medical device manufacturing is essential as itensures that devices are manufactured to produce the outcome for which they ae designed and intended to serve. Italso requires manufacturers to understand the manufacturing process, know and execute manufacturing praties based on both internal and global health authority requirements, properly rain personnel, and qualify manufacturing equipment. Ths ecle ensures that under normal manufacturing conditions, devices can be accurately and repeated produced. Further, proces validation provides indisputable, objective scientific evidence that this is true before devices are released into distebution ‘arm or even deat to patients, delays in product time to marke, costly produe recalls, supply ehain issues, significant penalties and Sines, a poor industry reputation, and even going out of business are the risks associated with the medical devi manufacturer Understanding risks leads tothe mitigation of those risks, as wel as other sourees of manufacturing variations that could have an adverse effet on the final product. To mitigate these risks validation processes must be in place, As validation processes are ‘implemented and repeated, manufacturers build confidence thatthe products they're creating meet exact specifications and their intended purpose, and they're also complying with federal and global regulations Federal and Global Process Validation Requirements ‘Both international and domestic regulations have been implemented to ensure manufacturing processes are consistent and provide repeatable, reliable outputs that moet the manufacturers goals 100 percent ofthe time, Regulatory guidance for medical device process validation revolves around two different documents International Organization for Standardization (ISO) standard 19485 andthe FDA's Quality System Regulation (QSR) regulation 820.75, (QSR regulation 820.75 as three components related to validation: 820.75(a) covers the initial validation ofa process; 820.750) applies to process performance after validation; and 820.75(¢) covers process changes or problems with process after inital validation. However the FDA s currently in the proces of deregulating EDA 23 CER PART 820 and adunting ISO 13485, bringing change to juldelines and regulation the industry has been adhering to for more than two decades ‘The FDA is making the switeh to 18013485 ~ a voluntary standard recognized by much ofthe rest of the world ~ that defines quality system requirements for mesial device manufacturers, The intent ofthe shift sto help syachronize global regulatory efforts, Having validation in place that meets PART 820 requirements should align with ISO 19485. Bot becoming ISO certified isan entire process that requires an aul by a thied-partyongaazation, Not achieving a certification to ISO 19485 Ubrough a thin-pasty audit puts a medical device manufacturer in danger of no long receiving business. Full detail of ISO 13485 can be found inthe ISO sundae eal, Critical Steps of the Validation Process Planning for validation isa lot more involved than its execution, Without proper planning, manufacturers can fll into continuous loop ofexecute fil, execute, fll — lathe, rinse, repeat, Typically, members ofthe engineering team a a medical device manufacturer ae the primary ereators and testers of validation programs, However, validation isnot limited to just the engineering department, Nearly ‘every positon in every department — operations, quality, production, maintenance, sales te. — ata medical device manufacturer plays ‘roe in contibting to the validation program and is responsible for maintaining it With any device, there ace often multiple manufacturing processes — injection molding, heat sealing, welding, sterilization, ete. ~ that eed tobe validated. These trickle all the way down to components and final assembly, so having an overall mater validation plan fora device isa great starting point. Global Harmonization Task Farce (GHTF) SG3/No9 = Quality Management Systems Process Validation 1Guidance provides the entire spectrum of processes requiring validation in medical device manufacturing, GHTF SGa/No9 sn excelent resource fr creating an overall master validation plan tha is a very effective tol to outline validation strategies. ‘When validation runs propery, and input parameters are acceptable, the final product has the strongest chance of always being correct. ‘Validation requitements must be understood, and manufacturing processes for every aspect a the device shouldbe selected that meet validation requirements, so the final product's specifications are met, Ifevery step ofthe manufacturing process isnt validated, the other option isto test every device, However, this laborious and time-consuming endeavor that can havea negative impact on time to-market and bottom ines For any medical devioe program, planning isthe most important aspect; and the program's sucees hinges on good, thorough plans and execating them well. Theeeore it is essential that thoughtful eare and attention be taken in defining the requirements up front in the device development life eel. Planning teams for any device should have representatives from allanetional areas of the organieation, However a minimum, the team should have representation from engineering, manufacturing, quality assurance, and regulatory funetions For every program, a Master Validation Plan should be developed. Despite the Master Validation Pian not being a requirement for ‘compliance with medial device industry regulations, iti one ofthe most sought-after documents by auditors and investigators Master Validation Plan components include, but aren’ limited to purpose and scope, responsibilities, reference documents, product/process specifications, process overview, validation approach, rsk analysis, and project timeline This plan wil serve a a road ‘map forthe validation team and reerence document for management. (Once the Master Validation Plans developed, atypical validation flowchart looks like this ‘Validation can take soveral weeks and up to several months, or even years, depending onthe complexity of the device. Despite the lengthy time frame for validation, not properly exceuting and maintaining validation i a much lengthier and detrimental endeavor for @ ‘medicel device manufacturer. The medical device manufacturer is ultimately responsible for creating the process validation plan and ‘managing each sep from execution to document contro. However, ifthe medical device company wil rely solely on a contract ‘manufacturer fr validation, the contract manufacturer must be adequately trained and have the appropriate resources to execate on the validation plan and produce acurate, repeatable products. Choose a Contract Manufacturer that Demonstrates These Key Characteristics ‘Manufacturing team members ata medical device manufscturr shouldbe tained to understand engincering end manufacturing concepts, validation processes, and standards and regulations, and have indisputable evidence they are competent in those activities, “This can be achieved through a combination of specialized internal and external training, which can strengthen th team members! knowledge and experience. When medical device companies search for a contract manufacturer, they want a company witha reputation of creating devices ofthe highest quality, wale getting their product to market faster. Building onthe notion of repatation, when medical device companies look fora contract manufacturer, they look fr evidence of valid processes that have been validated previously and the company has studied the methodology and strategy around those validating processes. This evidence ean be found through meny means, bt two standouts are plant visits and a search for regulatory issues, such 135 483 notices from the FDA, Scheduling a plant visit ata contract manufacturer should align withthe device company's desired outcomes based on Class, 2,3 Aevices, When a medical device company contracts a devise manufecturer to create a produc, class ofthe device and the capabilities of ‘he contracted manufacturer are understood, Contracted manufacturers should abide by and maintain GMPe in erating devices, regardless ofthe lass ofthe device. Furthermore, manufacturing controls must be in place and easily identified to show and prove that devices perform to their design and intent. "Finally creating the validation approach early in the development proces lso speeds up time-to-market. Creating the validation plan. ‘on the flys nota recipe for sueces; but developing the validation plan early and evolving in parallel with design and development is eal. This is also a reflection of having properly trained staf atthe company. roces validation isnot only required, but’ also a powerful tool to help atin highly effective processes, These procestes, in tara, create high-quality devices that comply with standards, specifications, and guidelines. However, proces validation activities are nota {call theyre one step in the entire life cyte ofa device, proving the manufacturing processes selected give expected outcomes. About Todd Owens “Todd Owens is vice president of engineering at Donstelle, He has a bachelor’s degree in engineering from the University of Wiscons Stout. Owens has held several engineering, program management, and leadership roles over the past 28 yours. As VP of engineering, he 28works with Donatelle’s customers and technical teams inthe design, development, and validation of tooling and manufsctaring processes for new products, Additionally, Owens works closely with the Sales Department on supporting new business development, He has spent the last 18 years working exclusively inthe medial industry. About Raghu Vadlamudi Raghu Vadlamedt i the chief research and technology director at Donatlle, located in New Brighton, MN, He as more than 20 years of experience inthe medial device manufacturing industry managing process development groups, and directing and coordinating process validation activities utilizing knowledge-based manufacturing practices. Vadlamudl is an ASQ-eertifed biomedical auditor, cette metal cutting professional, ertied medical device compliance professional, and certified process validation professional, He lo co-authored a chapter titled "Process Troubleshooting” in an Injetion Molding Handbook published by Hanser Publishing Company, Germany. Vadlani currently serves asa Plastics Engineering Advisory Board member at University of Wiseonsin-Stout About Donatelle [At Donatelle, we make produts that enhance — and save — lives, We manufacture complex medical devices and components fr low and high-volume needs. That's all we do, And we do it withthe utmost precision, consistency, and rigor, because for you —and your customers — quality is essential. Reliability is a must. And delivering on what's promised is vital. 39