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ENCO Pharmaceutical Development, Inc. is dedicated to maintaining the full compliance of its
operations with all regulatory authorities. Our laboratories operate under cGMP guidelines
to ensure that your projects will conform to applicable regulations and guidance’s.
Audit History
The company has been audited a number of times and by a variety of institutions. Audits are directed by regulatory agencies, accrediting organizations, customers and third parties.
- FDA Audit – July 2008
No 483’s
- A2LA Audit – completed May 2009
Accredited through April 2011
Continuously accredited since June 2006
- DEA Inspection – May 2007
Registered for schedules I-V
The QA group works closely with our customers by hosting on-site audits.
Quality Assurance Responsibilities
The QA group performs numerous in-process audits to verify operational compliance as well
as audits and reviews of data and technical documents. In addition to auditing, the QA
group is also responsible for maintaining document control, training records and other compliance
related information.
Raw Materials |
Methods |
Stability |
Characterization |
Medical Devices |
Quality Assurance
Discovering Solutions...Delivering Excellence
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