FDA Releases Draft Guidance on Contract Manufacturing

FDA Releases Draft Guidance on Contract Manufacturing

May 29th, 2013 // 2:13 pm @

Latest FDA and cGMP Compliance News

FDA this week released its draft guidance entitled “Contract Manufacturing Arrangements for Drugs: Quality Agreements’, which details the thinking of the agency on defining, establishing and documenting the responsibilities of all parties who are engaged in contract cGMP manufacturing of pharmaceuticals.

This guidance tells us how parties that are engaged in contract manufacturing of pharmaceuticals can utilize quality agreements to details what each party’s responsibilities are, to best ensure the quality, safety and efficacy of drug products. This guidance is applicable to the commercial production of APIs, finished drugs, biological drugs and combination products.

The new guidance states that the sponsor is responsible for making sure that drugs that are produced for interstate commerce are not adulterated or misbranded due to the actions of their cGMP contracted facilities. All contracted companies have to ensure that they are in compliance with cGMPs for all testing, manufacturing and various support operations for the sponsor.

This guidance tells industry how contract manufacturing companies fit into pharmaceutical quality systems. It also tells us the current thinking at FDA on the roles and responsibilities of all parties that are involved in contract drug manufacturing.

Note that the guidance states that quality agreements are NOT required under current cGMP regulations. But, sponsors and contracted companies can use quality management agreements and principles to execute the complex process of contract drug manufacturing. A quality agreement helps to define, establish and document the roles of all parties that are involved in drug manufacturing operations. That is why FDA strongly recommends that all sponsors and contracted firms have quality agreements to better lay out the various party responsibilities to ensure that drugs are safe and effective.

We have an excellent Webinar on how to write a strong quality agreement – June 12.


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