FDA is stressing that quality agreements between product owners and the contract manufacturing organizations (CMOs) they work with should be drafted jointly by both parties and reflect the depth of understanding each has regarding their roles and responsibilities in the intimate relationship they share.
Lack of a well thought-out, comprehensive quality agreement, the agency cautions, is resulting in products not meeting specifications, recalls, unsuccessful pre-approval inspections, and GMP enforcement actions.
Recent GMP warning letters to both product owners and CMOs have cited concerns that could have been headed off, compliance officials point out, if the firms involved had better communicated relevant development information and delineated the specific responsibilities of each party – key building blocks of a contracting relationship in which the quality agreement plays a critical role.
[Editor’s Note: The issues around contract manufacturing that FDA has been citing in warning letters and other concerns involving CMOs have been covered extensively by IPQ, including: ● case studies showing quality agreement breakdowns ● balancing GMP enforcement with drug shortage prevention ● remediation efforts at contract manufacturers resulting from warning letters ● the impact and aftermath of consent decrees at CMOs, and ● negative inspection findings resulting from poor sponsor/contactor communications .]
The drug GMP’s state that contract manufacturers are “an extension of the manufacturer’s own facility,” and that the drug product owner’s quality unit is “responsible for approving or rejecting drug products manufactured, processed, packed, or held under contract by another company.” While the GMPs do not explicitly require quality agreements, the agency is stressing that they are the best way to facilitate compliance with the GMP requirements that apply to contract manufacturing arrangements.
The point was underscored by CDER Office of Manufacturing & Product Quality (OMPQ) Acting Branch Chief for Regulatory Policy & Collaboration Paula Katz in discussing FDA’s new draft guidance on “Quality Agreements for Contract Manufacturing Arrangements for Drugs” at the annual PDA/FDA conference in mid-September in Washington.
Katz emphasized that “it would be difficult to engage in a compliant contract drug manufacturing operation without having a written quality agreement in place.”
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