Laboratory Qualifications
Source: West Analytical Services
West Analytical Services applies decades of pharmaceutical industry packaging expertise to assist customers through the complex laboratory analysis associated with meeting container closure and packaging regulatory guidelines
Qualified. Experienced. Reliable.
West Analytical Services applies decades of pharmaceutical industry packaging expertise to assist customers through the complex laboratory analysis associated with meeting container closure and packaging regulatory guidelines.
West's laboratories are fully qualified to provide testing for drug administration system and components.
- The laboratories are FDA-registered, GMP-compliant facilities
- Lionville, PA (FDA registration 2531777)
- Maumee, OH (FDA registration 1527830)
- Experienced project managers keep testing programs on schedule
- Dedicated technical, quality assurance and regulatory support staff assures projects will meet client's expectations
- Specific established test methods are filed in a Drug Master File with the FDA
- The laboratories feature state-of-the-art instrumentation, equipment and monitoring and reporting systems
Our key areas of focus include:
- Extractables and leachables
- Package / container testing
- Process development / problem resolution
- Method development / method validation
- Stability testing
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