The US FDA has finalized its guidelines on cGMP and
quality system compliance for drug and delivery device combination products.
The guidance – entitled ‘Current Good Manufacturing
Practice (cGMP) Requirements for Combination Products’ – was published in the
Federal Register this week, two years after the US Food and Drug Administration
(FDA) invited industry to comment on a draft.
The (attached) offers drug and device makers
guidelines on how to implement the FDA regulation of 2013 on combination products – defined as a product
composed of two or more different types of medical products, i.e. a drug,
device, and/or biological product with one another – and clarifies “that
the cGMP requirements that apply to each of the constituent parts apply to the
combination product they constitute.”
The Agency gives guidelines on the responsibilities of
specific manufacturers and facilities, and how compliance should be coordinated
across sites.
“A facility that manufacturers a constituent part of a
combination product or a complete combination product must be compliant with
the CGMP requirements applicable to each manufacturing process that occurs at
that specific facility,” the
document says.
In fitting with other FDA guidance,
responsibility lies with the marketing authorization holder across all
components of the manufacture, whether or not a third-party is involved.
The Agency adds: “A facility that manufactures
only a finished device intended to be a constituent part of a combination must
comply only with the device QS [quality system] regulation. Similarly, a
facility that manufactures only a drug intended to be a constituent part of a
combination product must comply only with the drug cGMPs.”
But even if a facility is manufacturing only one type
of constituent part for a combination product, the Agency says the cGMP
operating system should take into account considerations for the combination
product as a whole, where appropriate.
“Before changes are made to the manufacturing process
of a constituent part, the cGMP operating system should ensure consideration of
whether such changes could affect performance and/or interaction with the other
constituent part(s) and, if so, whether the safety and effectiveness of the
combination product could be impacted.”
Each manufacturing facility must also have
documentation specifying its respective responsibilities, the FDA says, and the
manufacturer of the finished combination product should have access to this
documentation.
By Dan Stanton
Anexo:
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