By Kim Weselak, NOW QA Documentation Specialist
Before our consumers open a new bottle of NOW vitamins, before that bottle debuts on the store shelves, and even before the product in the bottle is manufactured, we insist on an approved Vendor Audit Qualification for each raw material used in that product. The Vendor and Contract Manufacturer Audits are just one part of our Vendor Qualification Program. This qualification process meets the FDA Dietary Supplement Regulation 21 CFR 111 and is required for all our suppliers.
NOW Foods’ audit requirements are broken down into the following sections:
• Company Information
• Manufacturing Information
• Additional Quality Questions
• GMP (Good Manufacturing Practices)
The Company Information section includes the company basics, such as name, address and contact person, while the Manufacturing sections go into more detail. In these sections, we check as to what certifications they hold, whether they are compliant with 21 CFR 111 (Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements) and/or 21 CFR 110 (cGMP in Manufacturing, Packing, or Holding Human Food), what procedures are documented in an SOP (Standard Operating Procedure) and other quality related concerns.
NOW Foods’ Contract Manufacturer Survey includes two additional sections: Additional Quality Questions and GMP Agreement. In the Additional Quality Questions section, we check on our suppliers as to whether or not they themselves have a vendor qualification program, whether they have a HACCP (Hazard Analysis Critical Control Point) plan and other pertinent questions. Finally, our suppliers must agree to and sign our GMP Agreement, in which they:
• Agree to provide a lot-specific COA (Certificate of Analysis) that includes Product name, lot number, manufacture date, list of ingredients, result, specification and method for each tested parameter.
• Agree to notify NOW Foods of formula changes prior to making any change.
• Agree to provide NOW Foods the name, address and contact information of their ingredient suppliers for our regulatory compliance, if requested.
• Agree that they comply with 21 CFR 110 and 111.
After this process is completed, qualifications are reviewed and approved by the Quality Assurance Documentation Specialist, based on 21 CFR 111 Dietary Supplement cGMP requirements. All qualifications are kept on file for reference. This process is a critical step in our Vendor Qualification program. NOW also utilizes other verifications, as needed. Quality must be met at all stages of a product’s life, from the raw material all the way through to the packaged bottle that our consumer purchases from a store shelf.