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 ProcessValidation 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”
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 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.
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