Purity & Quality
What we do to ensure purity and quality
Many sellers' quality control programs start and end with a manufacturer's certificate of analysis. Their quality control starts and ends with a piece of paper from their vendors.
This is because they do not have proper in-house testing facilities to validate vendor quality. Setting up and running a quality control program is expensive and complex.
With the sheer number and scope of today's regulatory requirements the extra burden of commissioning new testing systems and keeping them in compliance can put a strain on many internal resources and few labs are up to the task. Many do not even pass ISO 9001 equipment certification.
And quality control is not just a laboratory but a comprehensive quality program extending from the vendor's facilities all the way to finished goods.
We test IN-HOUSE in our own quality control lab.
The initial testing of products we sell is conducted by vendors vetted by us.
- Documentation (DQ/IQ/OQ/PQ) with step-by-step IQ/OQ procedures and sign-off documents at all steps.
- Procedures that follow industry-standard methodologies such as ASTM, ISO, as well as US, European, and Japanese Pharmacopoeia.
- Traceable reference materials, available in formats for either manual or automated testing procedures
- Factory-certified instrument performance test data.
- Software for performing and tracking instrument OQ test results.
- An active validation plan.
- User requirements.
- Specification and functional requirements.
- Specification documentation.
- Requirements traceability matrix.
- Validation of test protocols and scripts.