FDA streamlines GMP for combination products
pharmafile | October 2, 2009 | News story | Manufacturing and Production |Â Â FDA, US, regÂ
The US Food and Drug Administration has said it will draw up new rules on Good Manufacturing Practices (GMP) for companies developing products that are based on drugs, biologics or medical devices in combination.
The agency said the intention was to eliminate "inconsistencies" in the way companies currently apply GMP to these products that "could affect product safety and the public health".
Combination products are typically the combination of a device and a drug or biologic, such as a coated stent, but could also include combinations of drugs and biologics, it added.
The headline news from the proposed rule – details of which are published in the Federal Register here – is that manufacturers of some combination products may no longer have to adhere to GMP requirements for the drug/biologic components and the equivalent QS regulations which apply to medical devices.
The new streamlined approach applies to single-entity combinations, in which the components are made as one unit product, as well as co-packaged combinations where two or more separate products are included together in a single presentation.
"For single-entity and co-packaged combination products, a cGMP operating system that satisfies the cGMP regulations applicable to one constituent part will also satisfy most of the cGMP requirements applicable to the other constituent part", says the document.
The proposed rule also lays out specific criteria for combination products that include human cellular and tissue-based material.
The FDA estimates that approximately 300 manufacturers of combination products will be affected by the proposed rule, and the hope is that the streamlined approach will make it easier for them to comply with GMP in addition to reducing the Agency's regulatory oversight burden.
A key factor in drawing up the rule – which is up for comment until December 22 – was the creation of an Office of Combination Products at the FDA in 2002 and the need to develop a consistent, agency-wide approach to GMP.
The FDA said the rule should make GMP requirements "clear and consistent, regardless of which agency component has lead jurisdiction for the combination product".
Comments on the proposal will be accepted by the FDA until December 22, 2009.
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