The
FDA defines process
validation as follows:
" Process validation is 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 characteristics."
Process validation is a requirement of the Current Good Manufacturing
Practices Regulations for Finished Pharmaceuticals, 21 CFR Parts
210 and 211, and of the Good Manufacturing Practice Regulations for
Medical Devices, 21 CFR Part 820, and therefore, is applicable to
the manufacture of pharmaceuticals and medical devices. Process validation
begins at The Electrolizing Corporation of Ohio with
a clear understanding of our customers' needs coupled with our Quality
Policy, ISO standards and Current Good Manufacturing Practices. During
the review process of purchase orders and contracts, our management
team develops a validation strategy and a Failure Modes and Effects
Analysis that incorporates qualified machinery and trained personnel
using the most repeatable and reliable test methods. Process development
continues with the manufacturing of “pre-qualification” product.
This helps us understand and define the parameters that may affect
the outcome of a particular process, such as machining, finishing,
assembly and/or packaging process. Our engineering staff may develop
multiple Designs of Experiments to further define the ranges of settings
for process parameters that may not be fixed. The process will then
be qualified by running product at the extremes of these variables,
indicating that all products manufactured within the boundaries of
these variables produces predictable results. Multiple lots of product
are then manufactured and documented at the nominal settings of these
parameters, which completes the validation activities.
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All
validation activities are well documented in our internal Device
Master Records, with a statistical approach towards certification
of product meeting or exceeding our customer’s requirements.
Should our customers make any modifications to their product,
ECO will be able to draw upon the documented evidence to minimize
the impact on product throughput, and will document all process
changes properly. In addition, with the approval of the customer,
if ECO should develop a new technology that improves throughput
or quality, the documented evidence is vital in providing a
baseline for justifying any process changes.
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Glossary
of Validation Acronyms
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IQ
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Installation
Qualification – Documented evidence
that the equipment has been installed per the manufacturer’s
requirements. Often coupled with an OQ. |
OQ
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Operation
Qualification - Documented evidence
that the equipment operates per the manufacturer’s
specifications and includes maintenance requirements.
Often coupled with an IQ. |
I/OQ
|
Installation/Operation
Qualification - A compilation of the IQ
and OQ, often performed simultaneously on a recently
installed piece of equipment. Also written as IQ/OQ. |
PQ
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Process
Qualification – Documented evidence
that a process will provide predictable results.
This is often a challenge of a given range of
process parameters. |
PPQ
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Product
Performance Qualification – Documented
evidence when employing specifically defined
operational and manufacturing criteria that a
product can be
manufactured repeatedly and reliably using a
qualified process. This qualification is typically
performed
over multiple production lots under a variety
of conditions, such as day/night shifts and/or
including
tear down and set up of the process. |
DOE
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Design
of Experiments – An engineering
and statistical tool used to identify critical
process parameters, their acceptable ranges and
their interaction with other process parameters. |
FMEA
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Failure
Mode and Effects Analysis – A
documented analysis developed by a cross-functional
team to
identify and rank potential failure modes of
a process/product based upon the severity, rate
of
occurrence and detectability of the identified
failure modes. |
MSV
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Manufacturing
Software Validation – Documented
evidence that the process specific software used
to perform a task (or multiple tasks) will provide
predictable results. |
Gage
R&R
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Gage
Reliability and Repeatability – A
documented blind test performed on a gage using
multiple inspectors and samples to determine
the inherent variability in the measuring technique. |
TMV
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Test
Method Validation – A validation
of an inspection method for a particular application.
The TMV may include multiple gage R&Rs or
reference to them. |
DMR
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Device
Master Record – A document that
summarizes all documentation relating to the
device, production process, packaging and labeling
specifications,
quality assurance and maintenance procedures
and methods. |
DHR
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Device
History Record – The complete
record of all production lots of a particular
item. It
can also be the combination of all information
of multiple components making a device or package.
In the case of a single component where the entire
production was made in one production lot, DHR
may be synonymous with Lot History Record. |
LHR
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Lot
History Record – The compilation
of documentation of a particular production lot.
The LHR may include documentation of the processes
(the job router), the material certifications,
the certification of outside processes, the finishing
certifications and the lot inspection records,
including in-process and final inspections and
any other quality assurance documents pertinent
to that particular lot. |
cGMP
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(Current)
Good Manufacturing Practices – The
guidelines of the FDA. |
ISO
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International
Organization of Standards – A governing
body that certifies ECO’s quality system
to ISO 9001:2008. |
GHTF
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Global
Harmonization Task Force – A conglomeration
of industry leaders that aid in interpretation
and implementation of the various governing body’s
requirements. |
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