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| Good
Manufacturing Practices (GMP) |
GMP refers
to the Good Manufacturing Practice Regulations promulgated by the
Food and Drug Administration These regulations, which have the force
of law, require that manufacturers, processors, and packagers of
drugs, medical devices, some food, and blood take proactive steps to
ensure that their products are safe, pure, and effective. GMP
regulations require a quality approach to manufacturing, enabling
companies to minimize or eliminate instances of contamination,
mixups, and errors. This in turn, protects the consumer from
purchasing a product which is not effective or even dangerous.
GMP regulations address issues including recordkeeping, personnel
qualifications, sanitation, cleanliness, equipment verification,
process validation, and complaint handling. Most GMP requirements
are very general and open-ended, allowing each manufacturer to
decide individually how to best implement the necessary controls.
This provides much flexibility, but also requires that the
manufacturer interpret the requirements in a manner which makes
sense for each individual business.
Benefits of GMP
• Increases the creditability and offers a competitive advantage in
the marketplace for contract manufacturers
• Increases senior management confidence in the preparedness of
manufacturing facilities for FDA inspection
• Demonstrates independent third-party verification of continuing
conformance to GMPs
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| The value of
implementation from Universal Quality Assurance Services (UQAS) |
| In every respect UQAS
measures up to its reputation as a specialist in the field. In
guiding organizations, stage-by-stage, through the implementation
process by our own highly skilled consultant’s who carries the skill
set to meet the requirements of the standards with their experience
with related to your industry. |
| UQAS Methodology for
implementation |
At UQAS we follow the
below approach
Contract signature
Gap Analysis
Defining the best way to operate
Documenting your practices
Deploying the procedures
Demonstrating the actions to certification body
An stage by stage implementation of our approach will assist you in
demonstrating the ability to meet the requirements of the standard
in actions to certification body
Please feel free to
contact us about any of your implementation and
training services for achieving assessment, verification and
certification needs; we will be pleased to assist your organization |
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