FDA Approval for Parenteral Products in Plastic Immediate Containers

GMP News
28 February 2008
 

FDA Approval for Parenteral Products in Plastic Immediate Containers

 
Already in April 2007 the Office of New Drugs within the FDA Center for Drug Evaluation and Research (CDER) published the document MAPP 6020.2 entitled „Applications for Parenteral Products in Plastic Immediate Containers“. Although this document is of high relevance, it is relatively unknown in the industry.

The CDER Manuals of Policies and Procedures (MAPP) describe processes and regulations for the CDER employees. These MAPPs are a sort of internal SOP system for the information of FDA employees. They are supposed to ensure that all personnel follow the same processes in their daily work, especially in regard to reviewing applications for approval. Via the FDA website these MAPPs are available to everyone.

With regard to plastic immediate containers the document MAPP 6020.2 was issued some time ago. This document defines the FDA requirements relative to the approval of parenteral products that are supposed to be packaged in plastic immediate containers. In detail, this document deals with the implementation of the requirement in 21 CFR 310.509(a). According to this regulation, for every parenteral product to be packaged in plastic immediate containers an approved NDA (new drug application) has to be generally available – for large volume parenterals as well as for small volume products.

 

The control of immediate containers is also an important topic at the ECA course „Quality Control and Quality Assurance of Pharmaceutical Packaging Materials“ in Barcelona, Spain, on 4-5 March 2008.


Author:
Dr. Günter Brendelberger
On behalf of the European Compliance Academy (ECA)

Source:
The complete document MAPP 6020.2 from 25 April 2007 can be found here:
http://www.fda.gov/cder/mapp/6020-2R.pdf

 

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