GMP for PET Drugs Proposed by FDA

The Food and Drug Administration (FDA) just announced a proposed current good manufacturing practices (CGMP) regulation for the production of Positron Emission Tomography (PET) drugs.

Positron emision tomography is a medical imaging modality involving the use of radiopharmaceutical drug products. The majority of PET drug products are injected intravenously into patients for diagnostic purposes. Most PET drugs are produced at locations that are close to the patients to whom the drugs are administered (e.g. in hospitals or academic institutions). Due to their short half-lives, PET drugs usually are administered within a few minutes or hours of production.

In the announcement, FDA defines the difference between a Rule or Regulation and a Guidance Document.

They say that rules state binding requirements and are enforceable in the courts. A guidance describes FDA’s current thinking on an issue, recommending approaches which, if followed by industry, would in our judgment meet the requirements set forth in the regulations. Guidances do not establish legally enforceable rights or responsibilities. They do not legally bind the public or FDA. (Note: Our experience has shown that FDA expects us to comply with Guidances pretty much to the same degree that we comply with Rules/Regulations.)

Find FDA's announcement about PET cGMPs and supporting documentation at www.GMPTrainingSystems.com/asp/articles.asp Scroll down to the section marked cGMP for PET.

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We design and conduct GMP and related training for the Pharmaceutical, Medical Device, and related industries. Our clients include Pfizer, Bristol-Myers Squibb, Baxa Corp., Genentech, Wyeth, Glaxo SmithKline, Grifols Biologicals, and several others.