March 26, 2008, Puyallup, WA. - AIBMR Life Sciences, Inc., (www.aibmr.com) one of the world's oldest and most respected nutraceutical consulting firms, has added Dietary Supplement CGMP Compliance to its extensive list of consulting services.
The long-awaited Final Rule on Current Good Manufacturing Practices (CGMP) for Dietary Supplements was issued by the Food and Drug Administration on June 25, 2007. This rule applies to all firms - in the U.S. and globally - that manufacture, package, label or distribute dietary supplements.
Welcomed by the nutraceutical industry, the CGMP Rule is intended to ensure that dietary supplement products meet quality standards. Anyone who manufactures or handles supplements must have controls in place to maintain product identity, purity, strength and composition - from initial processing to the end of shelf life.
On the manufacturing side, facilities must be properly designed, constructed and maintained. Processing, blending and testing equipment must be suitable for use, correctly installed, cleaned and calibrated regularly. Raw materials must be safe and tested to confirm identity. Specifications and quality control procedures for in-process materials and finished products must be established, followed and documented. Plant personnel must be properly trained and adhere to basic standards of hygiene.
Firms that distribute dietary supplements under their own labels are fully responsible for ensuring their products comply with CGMP requirements throughout the entire product life cycle, regardless of whether or not they manufacture the products in their own facilities. Companies employing contract manufacturers must monitor the GMP compliance of their contractors and retain batch records for every lot. Standard Operating Procedures (SOPs) must be implemented for handling product complaints and returns. And complete, traceable records must be kept at every step of the way.
AIBMR guides supplement firms in designing, implementing and maintaining SOPs in the critical areas of CGMP compliance. AIBMR's highly qualified technical staff is able to function as a third party quality assurance department, assisting with CGMP compliance at all phases of product development, manufacturing and distribution.
Founded in 1978, AIBMR has helped more than 600 nutraceutical companies in everything from raw material sourcing and testing to concept screening and formula design; prototype testing and validation; scale-up; science and regulatory review; QA/QC plan development and clinical trials.
According to Alexander Schauss, CEO of AIBMR and noted industry expert, "Complying with the CGMP rule starts at the first stage of product development and continues past customer purchase and consumption." The CGMP rule emphasizes that quality must be built into the manufacturing process and cannot simply be tested in at the end. "Quality-minded companies have always understood this," Schauss points out. "The new rule codifies this basic principle into law as it applies to dietary supplements."
AIBMR's CGMP Compliance Consulting services include:
- Specifications for raw materials and finished products
- SOPs for raw material and finished good testing
- Master Manufacturing Record and Batch Record review and analysis
- SOPs and documentation for product complaints and returns
- CGMP Self-Evaluation and Process Improvement
- Site visits; assessment and gap analysis
- Quality Assurance Master Plans
- Documentation and record keeping