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32D April 2018 Tablets & Capsules by incorporating a responsibilities table into the document. The table outlines the topics and designates the party—OLD or contractor—responsible for each. Some topics will require that both parties share responsibility, while others will primarily be the responsibility of one party but necessitate the other party's cooperation. The document should also include a description of responsibilities that correlates with the responsibilities table and details each party's obligations. Regulatory matters. The quality agreement should include a regulatory matters section to ensure that both the OLD and the contractor hold all the necessary licenses, registrations, claim files, submission reports, pre- approvals, notifications, filings, and other authorizations to manufacture the dietary supplement product. The parties must agree upon and sustain compliance with the applicable GMPs and other statutory requirements. The contractor should then conduct routine internal audits to verify compliance, but the OLD should also have the right to audit the contractor. In the event of a government agency inspection, the parties must notify each other and cooperate with the inspection and share any subsequent communications—including the issuance of an FDA Form 483, a list of observations, or warning letters. It's also vital to delegate responsibilities for product complaints, serious adverse events and reporting, and product recall situations. Quality systems. Both parties must develop and implement appropriate SOPs for the processes and controls necessary for GMP compliance. This includes a document control and management of change procedure to govern facility, equipment, materials, manufacturing/ packaging processes, records, labels, specifications, test methods, and release requirements. All records must be kept in accordance with GMP requirements. The contractor should also implement a quality incident reporting system encompassing deviations, out-of-spec investigations, material reviews, non-conformances, product complaints, product returns, and corrective and preventative actions (CAPA) to address trending quality issues, audit findings, and regulatory authority observations. The contractor must notify the OLD of any incident impacting its material, product, or service. This section of the quality agreement should also delineate requirements for the acquisition and retention of reserve samples. The assignment of a product expiration date must be supported by scientific data. Also, the quality agreement should indicate the party responsible for generating, control (QC)—must have oversight responsibilities over all operations. The QU must also have the authority to approve or reject materials and products based on whether they meet specified quality requirements such as identity, purity, strength, quality, and limits of potential contaminants [2]. A quality agreement is the best means for an OLD to ensure GMP compliance. While there is no regulatory requirement for a quality agreement when manufacturing dietary supplements, the FDA frequently requests this document during facility inspections to verify quality responsibilities for all aspects of the manufacturing process. Quality agreements A quality agreement is a comprehensive, formal document that defines the individual and shared responsibilities of the QUs for the OLD and each contracting party for all GMP activities and potential regulatory matters. It is not a commercial, financial, or business agreement and should be an entirely separate document that includes: • a statement of the scope and purpose of the agreement; • the terms of the agreement such as an effective date and termination clause; • a detailed assignment of QU responsibilities; • a dispute resolution discussion; • revision and amendment allowances; • confidentiality and non-disclosure requirements for both parties; and • the signatures from key personnel and QU representatives from both parties. The agreement may also use appendices to list specific contractor materials, products, or services as well as mutually agreed upon and/or approved suppliers or acceptable third parties. A standard operating procedure (SOP) should be established by the OLD to govern the preparation and use of a quality agreement for all potential contractors. The SOP should describe the quality agreement's purpose and content as well as provide a quality agreement template. The OLD's QU must monitor contractor compliance with the quality agreement SOP and with the agreement itself. Assigning responsibilities The principal purpose of the quality agreement is to assign QU responsibilities, which is best accomplished

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