Process Validation for Medical Devices Overview of FDA Requirements

1. Process Validation for Medical Devices: Overview of FDA Requirements The word validation is not new to today’s world but its requirement differs from field to field. In pharmaceutical industry and later in medical device field it almost become mandatory and based on risk assessment and class of the device its importance was seen as important both by regulators as well as manufacturers. In USA also the word MDR is popular in medical device. This is regarding medical device reporting guidance where in lot of guidelines with lot of reference of legislation is given. This makes every manufacturer whether doing business in USA or abroad but device is manufactured in USA. Similarly, the manufacturer is outside USA but sells product in USA are all governed by MDR. MDR is about medical device reporting. Why validation is important in MDR part? The Process Validation definition states that “(a) 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”

2. This definition is quite simple but it generates various possibilities of verification by subsequent inspection and test. Sterility test is destructive test so whole batch cannot be evaluated while partial testing cannot guarantee each piece to be sterile that is why sterilisation process requires validation. Lot of guidance documents about how to do is available. The same situation does not exist for all products many are more complex so whatever best verification and testing and limited validation we might have done it brings issues open as adverse event and some are serious which may result into death. How do we manage such situation? Risk assessment must be to the depth by team and all possibilities must be checked. Right from the design stage validation concept must be included. Even clinical evaluation also needs thorough thinking which can also result from limitations of validation because it ask for some evidence in broader manner to prove as validated what we define as acceptance criteria. In case of devices which partly interact with body tissues or go inside the body generates lot of questions on biocompatibility and toxicity. (Starts from simple irritation to sensitisation and may end in genotoxicity to carcinogenicity). If some devices are made from established and proved safe material then it is not necessary to conduct all clinical or biological testing but it needs more control and check on those material its source and incoming inspection which becomes the design part validation. Indirectly it becomes IQ (installation qualification of process). FDA recommends ISO 10993-1 devised for biological evaluation of medical devices. It provides general framework for biological testing and some time specific tests can help evaluate. Considering such as acceptance criteria for your validation process makes your process stronger with better control and first-time right approach and will reduce adverse events. Even with all guidance and standards available issues and complexities in certain products do not vanish and that time individual product guideline if available may be refereed. You may then require special process validation consultant which can guide you with latest guidance available and latest requirement.As you have seen above that with advancement of scientific knowledge new techniques are developed or existing are modified. Such changes may require review at manufacturing level and may warrant re-validation of the process. This also requires that your procedure to carryout process validation is also kept updated and all new development within or outside must be incorporated if it is related to your product. This also requires that validation be to be performed by qualified person. With advent of new things coming into picture the qualified person must not only be aware but also to be trained for that advancement if needed. Documentation at each stage is especially important in process validation and proper justification documentation if certain exemptions are taken. Documents involves all data including raw data, detailed work instructions, who did them and when with date and time (both start and completion) review comment by other qualified and independent person usually QA. Revalidation may be required if there are any process changes happen or any product related or process related deviation occur. IZiel’s Onshore-Offshore Model works with 1 Onsite Member supported by a team of 3-4 engineers from our Technical Center in India. Typically, the data is collected, evaluated and evidence is developed from the process design stage throughout production. Our Model enables the company to complete the project faster and in a cost-effective manner.