The ever-changing regulatory requirements have created one of the biggest challenges to the food, dietary supplement, functional food, and cosmetics and personal care industries. CPC's one-stop services of regulatory compliance are specialized in:
cGMP stands for current Good Manufacturing Practices, which are regulatory standards established by FDA for a business manufacturing, processing, packaging, labeling, and holding of regulated products such as human and animal foods, dietary supplements, and drugs while current stands for updating technology, interpretation, and enforcement in GMP. CPC has successfully helped many manufacturers, co-packers, warehousing and distributors, and brand owners in all sizes to develop and implement cGMP systems, obtain third-party GMP certifications, and pass FDA inspections.
cGMPs - Foods
cGMP requirements for human and animal foods are included in Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food (21CFR 117) and Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals (PCAF) (21CFR 507), which are the prerequisite programs for HARPC compliance.
cGMPs - Dietary Supplements
Over a decade after the final rule of CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS (21CFR111) became effective in 2007, current FDA warning letters, serious violations (FDA 483s), product recalls, and negative media reports related to the quality and safety of dietary supplements reminds the industry that cGMP compliance is an on-going process. CPC's experts will help you accomplish cGMP compliance based on the FDA enforcement trend using our up-to-date knowledge and innovative technologies.
cGMPs - Cosmetic and Personal Care
The Cosmetic and Personal Care industries are not subject to mandatory cGMP requirements in the US. However, the FDA published draft cosmetic GMP guidelines for the industry. Learn more,