Natural Products Insider

MAY-JUN 2019

INSIDER is the leading information source for marketers, manufacturers and formulators of dietary supplements, healthy foods and cosmeceuticals. Since 1997, INSIDER has been serving the needs of the global nutrition industry.

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30 INSIDER May /June 2019 Companies marketing dietary supplements that contract out some or all their operations often fail to consider how little they know about the operations of those providing the contracted services. The concern is that the product owner (the company whose name is on the label) may be taking signifi cant risks of interrupted product supply, FDA regulatory action and damaged brand reputation. Fully addressing the answers to the following questions will signifi cantly reduce those risks. 1 Am I an own-label distributor? Answer: Yes, if a company contracts services for manufacturing, packaging, labeling and/or distribution. 2 May I decide to use a contract manufacturer or laboratory based on its reputation and/or cost? Answer: No! An own-label distributor must fi rst qualify the contract manufacturer. FDA is on record stating that a company cannot contract out its ultimate responsibility to ensure that the dietary supplement "is not adulterated for failure to comply with dietary supplement cGMP [current good manufacturing practice] requirements" (i.e., Title 21 of the Code of Federal Regulations [CFR], Part 111). 3 What must be done to qualify a contract manufacturer or other contract service provider? Answer: A company must: a) confi rm the contract service provider's registration with FDA as a food facility; b) require the contract manufacturer to complete a self-assessment qualifi cation questionnaire initially and then annually; c) conduct an onsite facility audit; and d) qualify the contract manufacturer's or contract laboratory's certifi cate of analysis (CoA) data. 4 Do I need to establish a quality agreement with the contract manufacturer in addition to a business contract? Answer: This is not a regulatory requirement, but it is strongly recommended to clearly establish the quality unit and cGMP compliance responsibilities of each party. FDA inspectors have begun asking if a quality agreement is in p lace. 5 May I rely upon the qualifi ed contract manufacturer to establish documentation related to the production of my product(s)? Answer: No! An own-label distributor must be the originator and primary approver of formulations, specifi cations, labeling and master manufacturing records (MMRs) and packaging records for its products, and for any raw material and primary packaging materials unique to those products. 6 May I rely upon the contract manufacturer's quality unit to be responsible for all approval decisions? Answer: Provided the contract manufacturer has been qualifi ed and approved specifi cations are established, own-label distributors may delegate all decisions to approve materials for use and products for shipment to itself or to its third-party logistics distributor if being used. 7 Who is responsible for approving/ releasing product for fi nal distribution? Answer: The own-label distributor's quality unit is the only unit authorized to approve every product lot for fi nal distribution, including release from a third-party logistics distributor (if used). These and all other responsibilities of the own-label distributor's quality unit must be described in writing. 8 On what basis must my quality unit approve/release each product lot for distribution? Answer: The presence and review of the following documents: a) the contract manufacturer's CoA documenting the product's specifi cation has been met (this is necessary, but by itself insuffi cient); b) a formal contract manufacturer's product lot approval document (e.g., batch folder quality assurance [QA] approval checklist [recommended] or equivalent document confi rming all required product lot documents were reviewed, and the contract manufacturer's quality unit's approval/release decision is documented); and c) the own-label distributor's receipt and inspection report confi rming the product lot was sampled, visually inspected and preferably compared to a product standard. 9 What other quality systems must I establish and manage at my headquarters? Answer: A training program, creation of master formulations and specifi cations, document change control, managing material reviews as well as corrective and preventive actions (CAPAs), handling product complaints, reporting serious adverse events, stability studies/expiry dating (if used), maintaining reserve samples and records retention. 10 How should I monitor my contract manufacturers to have confi dence and evidence that they are continuing to operate in a qualifi ed status and in compliance with FDA regulations? Answer: It is highly recommended that own-label distributors: a) maintain copies of all formulations, specifi cations, MMRs and a sampling of batch production/packaging records; b) conduct periodic onsite audits and maintain records of audit reports and the contract manufacturer's response concerning audit observation; and c) maintain records of contract manufacturer qualifi cations, CoA data qualifi cations and all requalifi cations. All responsibilities and requirements must be covered in standard operating procedures (SOPs) that have been approved by the own-label distributor's quality unit. All the above answers involve additional implementation details and may require compliance with other FDA regulations and guidelines. Bruce D. Elsner is an independent consultant with the EAS Consulting Group LLC ( in Alexan dria, Virginia. His background includes 28 years of technical support and QA roles in three Fortune 250 corporations producing pharmaceuticals and personal care products. For the past 22 years, he has done private and contract consulting helping over-the-counter (OTC) drug and dietary supplement companies. Contract Manufacturer: Selection 10 Key Questions an Own-Label Distributor Should Ask Itself by Bruce D. Elsner

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