The FDA Modernization Act was adopted in 1997 by the US Congress. Section 121 of this Modernization Act directed FDA to establish appropriate approval procedures and GMP requirements for PET drugs. The respective procedures were established by the FDA and published in December 2009. Within 2 years after the date of publication, a new NDA (New Drug Application) or ANDA (Abbreviated new drug application) must be submitted for all PET drugs marketed for clinical use in the USA.
Recognising that many manufacturers have difficulties with the approval process, the FDA organised a public meeting in March 2011to assist those manufacturers in preparing approvals for the 3 most commonly used PET drugs. During this meeting, stakeholders requested from the FDA to provide more detailed guidance about media fills for PET drugs.
Most PET drugs are designed for parenteral administration and are manufactured by aseptic processing. As a consequence, a media fill is part of the validation of an aseptic manufacturing process. With the draft Guidance for Industry "Media Fills for Validation of Aseptic Preparations for Positron Emission Tomography (PET) Drugs", the FDA tried to present the fundamental requirements and issues regarding media fill in a Q&A form.
Answers are given to the following questions:
- What is a media fill?
- What can I evaluate with a media fill?
- What are the steps involved in a media fill?
- How to choose the growth medium?
- Number of media fills?
- Qualification of the medium
- What is growth promotion testing? How is it used in PET production?
- What is the difference between a growth promotion test and a positive control?
- When do I use a positive control?
As to the content, it is basically similar to what is presented about the topic media fill in the Guidance for Industry "Sterile Drugs Products produced by Aseptic Processing". In a word, this is a brief and good introduction to the basics of media fills.
For further details please see the draft Guidance for Industry "Media Fills for the Validation of Aseptic Preparations for Positron Emission Tomography (PET) Drugs" as well as the Guidance for Industry "Sterile Drug Products produced by Aseptic Processing - current Good Manufacturing Practices".
Dr Andreas Mangel
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)