cGMP refers to the Current Good Manufacturing Practice regulations enforced by the US Food and Drug Administration (FDA). 21 CFR 111: cGMP in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements are the regulations requiring systems that assure proper design, monitoring, and control of manufacturing processes, packaging processes and facilities. Adherence to the cGMP regulations assures dietary supplements meet established specifications for identity, purity, strength, composition, and do not exceed their limits for contaminants.
At Bactolac Pharmaceutical, Inc. we are dedicated to producing dietary supplements of the highest quality. To help fulfill this mission we voluntarily maintain certifications and registrations with industry leading organizations. Additionally, we can also produce Kosher and Halal dietary supplements upon request.
The Natural Products Association (NPA) was the first organization to offer a third-party GMP certification program for manufacturers of dietary supplements. NPA GMP Certification is awarded to companies that meet a high level of compliance to the NPA GMP Standard as verified through comprehensive third-party inspections of facilities and GMP-related documentation.
UL provides independent, third-party manufacturing/processing assessments against defined standard that aims to minimize supply chain risk, help protect brand value, and promote consumer and product safety. UL Certificate of Conformance is awarded to companies following assessments of its Good Manufacturing Practice and Quality Systems and finding it in conformance with 21 CFR 111.
NSF International’s GMP Registration Program enables manufacturers to become independently registered by NSF to meet GMP requirements. NSF GMP Certification is awarded to companies that meet the requirements listed in Section 8 of NSF/ANSI 173 which is the only accredited American National Standard in the dietary supplement industry developed in accordance with the FDA’s 21 CFR part 111.
The NSF Certified for Sport® program was created to meet the growing demands of athletes, coaches and all those concerned about banned substances in sports supplements. NSF GMP for Sport® certifies that what is on the label is in the bottle and that the product does not contain unsafe levels of contaminants, prohibited substances and masking agents.
QAI (Quality Assurance International) is a leading USDA-accredited organic product certifying agency that has been providing the highest level of organic certification service to its growing number of customers since 1989. QAI verifies organic integrity from the land on which the product is grown, to the post-harvest facilities and processing plants, to the retail store where it is available for purchase.
The National Organic Program (NOP) develops the rules & regulations for the production, handling, labeling, and enforcement of all USDA organic products. Under the USDA organic regulations organic processors such as Bactolac must use certified organic ingredients and only approved non-organic ingredients for products labeled as organic.
Natural and Non-prescription Health Products Directorate (NNHPD) formerly, The Natural Health Products Directorate (NHPD) is the federal regulator of dietary supplements in Canada. NNHPD issues foreign site reference registration to companies who are found to be in compliance with GMP requirements outlined in Part 3 of the Natural Health Products Regulations (NHPR)