Process Validation


Process Validation

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.

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.

  





ISO 9001:2015


Process Validation

Glossary of Validation Acronyms
IQ
 Installation Qualification – Documented evidence that the equipment has been installed per the manufacturer’s requirements. Often coupled with an OQ.
OQ
 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
 Process Qualification – Documented evidence that a process will provide predictable results. This is often a challenge of a given range of process parameters.
PPQ
 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
 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
 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
 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
 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
 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
 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
 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
 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
 (Current) Good Manufacturing Practices – The guidelines of the FDA.
ISO
 International Organization of Standards – A governing body that certifies ECO’s quality system to ISO 9001:2015.
GHTF
 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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