GMP Compliance for Nutraceutical Testing

GMP compliance includes many components. ASI routinely follows some GMP requirements for all testing conducted. These include:

  • Adequate facilities are available.
  • Personnel are appropriately educated and experienced and are properly trained and qualified to perform their duties. Personnel are also provided with ongoing GMP and GLP training.
  • Instruments are properly installed and operation and performance are qualified. Instruments are calibrated, and all calibration, maintenance and operation activities are described in written procedures (Standard Operating Procedures or SOPs) and are properly documented.
  • Sample receipt is documented, and samples are stored securely according to their storage requirements.
  • Testing procedures are thoroughly documented.
  • Data obtained from testing is properly identified and retained along with records of all calculations.
  • Test results are reported including the signatures of the analyst and a second reviewer.
  • SOPs are maintained which outline overall operations of the laboratory.

GMP compliance also includes the components in the following table. These requirements can be met for nutraceutical testing upon request. In some cases, meeting these requirements will require cooperation from the client, and may necessitate additional fees.

FDA GMP compliance requires…

ASI routinely…

ASI can, upon request and with client cooperation…

The use of well-characterized reference standards

Uses the best available reference material

Obtain well-characterized reference material, if not available routinely

Release and stability testing performed with validated methods

Uses established methods where available, and modifies methods when necessary for specific products following sound scientific principles

Validate methods for use with specific products

Comparison of test results with established product specifications

Compares results with specifications if provided by the client

Compare results with client-provided specifications and indicate pass/fail results on reports

Documentation and approval of deviations from written standard operating procedures and test procedures

Documents deviations from written test procedures in laboratory notebooks

Document deviations in a formal report which is provided to the client for approval

The use of written test procedures

Uses written test procedures when available; records all test procedures in laboratory notebooks

Ensure that formal and approved written test procedures are available before proceeding with testing

A separate Quality Assurance Unit responsible for reviewing all aspects of a test for compliance with GMP regulations

Requires a second person to review all notebook entries, raw data, calculations, and reports before issuance of results

Provide a QA review of test results along with a Quality Assurance statement for each report

GMP compliance entails more than GMP compliance of analytical testing. ASI will assert GMP compliance only for testing conducted at ASI and not for GMP compliance requirements outside the control of ASI. ASI will not assert GMP compliance for testing that does not include all components of GMP regulations.

Sub-contracting
On occasion, ASI may sub-contract sample storage or testing. If so, ASI performs an audit to assure GMP compliance of services being performed by the sub-contractor.

Audits
ASI’s internal QA function performs routine audits of laboratory systems.

ASI welcomes audits from potential and current clients. Please contact ASI to arrange a scheduled audit, during which ASI scientific and QA staff will be available to review laboratory and QA systems. For more information contact ASI.

Back to Nutraceuticals

 

Call us at (919) 549-9700 or Email us at info@ASI-RTP.com

Request for Information or Quotation Form
Nutraceutical Sample Submission Form

Home . About ASI . Services . Nutraceutical . Contact Us

Copyright © 2007, Analytical Solutions, Inc. All Rights Reserved.
www.asi-rtp.com