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C&M SCIENTIFIC provides qualification protocols for all instruments to IQ and OQ level. For select instruments (commonly multi-component systems) C&M SCIENTIFIC also provide Performance Qualification protocols. C&M's team of validation support personnel will also assist in the preparation of PQ protocols.
Key features of the services and protocols include:
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Trained certified engineers to perform protocols
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Manufacturer and model specific protocols that can be tailored to include individual needs
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Document control analogous to industry and contract laboratory GMP regulations
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Pre-Approval section for protocol to be completed prior to execution
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Performer/Reviewer credentials and signature on each page,
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Identification of the equipment to be qualified
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A listing of traceable materials required to complete qualification to provide fully traceable results
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The detailed procedure of how the qualification is completed,
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Final Approval section to be completed following execution.
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The contact for validation services in C&M SCIENTIFIC LTD is:
Alistair Bamford
Validation is an extremely diverse and complex area of regulatory concern, impacting all areas of pharmaceutical and medical device manufacturing, biological research and clinical testing.
Validation has become one of the most important areas of regulatory compliance for the science laboratory, particularly in the pharmaceutical industry and international regulatory agencies, led by the United States Food and Drug Administration, (FDA) now require laboratories to show validation for both methods and analytical equipment.
The FDA GMP CFR 211 says:
Laboratory controls shall include the establishment of scientifically sound and appropriate test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality and purity.
And an extract from the FDA Compliance Program Guidance Manual says that:
Laboratory equipment and procedures must be qualified and validated.
Within the validation programme lies the whole area of qualification testing which is carried out at predefined intervals and sets out to show that the equipment has been installed and operates or performs to the manufacturer's requirements or specifications and is suitable for its intended use.
The following somewhat simplistic schematic of the qualification programme shows the relationship between the stages of qualification testing and validated use.
The first stage of the qualification testing is known as pre-purchase qualification, which is the user's formal functional qualification. Commonly called a User Requirement Specification (URS), this document lays down the requirements for intended use including application and environmental requirements.
The user requirement specification is of benefit to the user in that
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It establishes a confidence level of the product suitability for use |
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It provides evidence that published specifications accurately reflect the product |
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It allows the evaluation of the published specifications against the requirement specifications for intended use |
The post-purchase element of qualification testing deals with the concepts of Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) to show evidence of testing of the system through installation and operation to suitability for intended use.
Installation Qualification (IQ), verifies that the equipment is installed according to the manufacturer's recommendations. It covers such areas as operating conditions, physical connections, and system configuration.
Operational Qualification (OQ), is carried out to ensure that the equipment operates as it was intended to do by the manufacturer using pre-defined acceptance criteria which are derived from the operational specifications.
The final area of qualification testing is the Performance Qualification (PQ), also termed suitability for use. It generally takes the form of a subset of analytical method validation and is carried out after the operational qualification; therefore it is necessary at the same intervals, periodic or otherwise
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