Regulatory Roundup: FDA Issues Final Guidance Regarding cGMPs for PET Drugs - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

Regulatory Roundup: FDA Issues Final Guidance Regarding cGMPs for PET Drugs

ePT--the Electronic Newsletter of Pharmaceutical Technology

FDA issued a final guidance in early August regarding cGMPs for positron emission tomography (PET) drugs. The document covers resources, procedures, and documentation for PET drug-production facilities. The 1997 Food and Drug Administration Modernization Act called for these cGMPs to be established, and they are now part of 21 CFR Part 212. This guidance complements those requirements by providing information for small entities working on these drugs, such as academic and nonprofit facilities. Most PET drugs are administered on site because of their short half-life, says the guidance, but more and more facilities are independent and PET drugs are being distributed further away from their manufacturing site. According to the guidance, "Production and cGMP differences among PET drug producers are primarily a function of the size, scope, and complexity of their production operations. We have also found that implementing certain production standards and controls can ensure the production of quality PET drugs, regardless of differences among the various PET drug production facilities." The guidance covers cGMP requirements including USP requirements, production and process controls, labeling and packaging, personnel and pharmacy issues, and more.

USP is inviting stakeholders, especially heparin API manufacturers, to participate in a study evaluating and setting acceptance criteria for newly developed protein impurities and nucleotidic impurities procedures in the USP Heparin Sodium monograph. The study is meant to help disseminate new procedures to users, to solicit batch data using these procedures, and to gain feedback from industry. USP plans to use the information gained to set meaningful acceptance criteria.

ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
What role should the US government play in the current Ebola outbreak?
Finance development of drugs to treat/prevent disease.
Oversee medical treatment of patients in the US.
Provide treatment for patients globally.
All of the above.
No government involvement in patient treatment or drug development.
Finance development of drugs to treat/prevent disease.
26%
Oversee medical treatment of patients in the US.
13%
Provide treatment for patients globally.
11%
All of the above.
39%
No government involvement in patient treatment or drug development.
11%
Jim Miller Outsourcing Outlook Jim MillerCMO Industry Thins Out
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerFluorination Remains Key Challenge in API Synthesis
Marilyn E. Morris Guest EditorialMarilyn E. MorrisBolstering Graduate Education and Research Programs
Jill Wechsler Regulatory Watch Jill Wechsler Biopharma Manufacturers Respond to Ebola Crisis
Sean Milmo European Regulatory WatchSean MilmoHarmonizing Marketing Approval of Generic Drugs in Europe
FDA Reorganization to Promote Drug Quality
FDA Readies Quality Metrics Measures
New FDA Team to Spur Modern Drug Manufacturing
From Generics to Supergenerics
CMOs and the Track-and-Trace Race: Are You Engaged Yet?
Source: ePT--the Electronic Newsletter of Pharmaceutical Technology,
Click here