Nutraceutical Products Consulting
cGMP Compliance
cGMP establishes basic standards of operation at the manufacturing level
to ensure that finished dietary supplement products meet established specifications
for identity, purity, strength, composition and limits on contaminants. Manufacturers
must adhere to standards regarding production and process controls, manufacturing
and testing equipment, quality control personnel approvals, detailed specifications,
master manufacturing records, and batch production records. Procedures must
be followed for investigating and documenting product complaints and returns.
AIBMR Life Sciences has a comprehensive program in place to assist your company
in achieving compliance with the cGMP Final Rule. We provide an assessment
and gap analysis of your current Standard Operating Procedures (SOPs), specifications,
quality assurance program and documentation. We conduct on-site audits of
your manufacturing and distribution facilities and deliver comprehensive
audit reports with recommended action items for meeting cGMP requirements.
Specifically, AIBMR Life Sciences can help you with the following:
- On-site audits and inspections of manufacturing and distribution facilities
- Designing a Quality Assurance Master Plan as a roadmap to cGMP compliance
- Raw materials and finished products specifications
- Preparation and review of Master Manufacturing and Batch Production Records
- Analytical testing protocols for raw materials and finished products
- Writing SOPs for cGMP compliance
- QA maintenance and cGMP regulatory support
About cGMP Compliance
On June 25, 2007, the FDA issued its long-awaited "Final
Rule on Current Good Manufacturing Practice in Manufacturing, Packing, Labeling,
or Holding Operations for Dietary Supplements" (21 CFR Part 111). Small companies
with fewer than twenty Full-Time-Equivalent Employees (FTEEs) have until
June 25th of 2010 to comply. Firms with 20 to 499 FTEEs must comply by June
25, 2009, while large companies with 500 or more FTEEs are subject to FDA
inspection for compliance with the rule as of June 25th of 2008.
