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Specifications: Review, Writing, and Modernization
Specifications: Review, Writing, and Modernization
Grounded in Identity. Measured for Stremgth. Proven for Purity.
Inadequate specifications are among the most common compliance gaps observed in the supplement industry and are frequently cited as a top five violation on the FDA Form-483 (Inspectional Observations). Under Good Manufacturing Practice (GMP) regulations, specifications must include five required elements, and each must be utilized appropriately.
We support the review, development, and modernization of specifications to ensure they are fit for purpose, aligned with regulatory expectations, and integrated into your quality system. This includes specifications for identity, purity, strength, composition, and limits for potential contaminants.
Specification development and maintenance are a coordinated processes involving your suppliers, manufacturers, and laboratories. We help align these stakeholders.
Testing and monitoring plans are then aligned to ensure products consistantly meet established specifications. Our approach focuses on building efficient and practical systems.