PDA Releases Comments on Annex 1: Manufacture of Sterile Medicinal Products

PDA recommends changes to section on PUPSIT; recognizes EMA's effort to improve guidance

Metadata
Provider: 
PRWebPRWeb
URL: 
http://www.prweb.com/releases/2018/03/prweb15368791.htmhttp://www.prweb.com/releases/2018/03/prweb15368791.htm
Retrieved on: 
Wednesday, March 28, 2018
Information
Tags: 
Personal digital assistant, Time management, Parenteral Drug Association, Health
Summary
Key Points: 
  • The Parenteral Drug Association (PDA) today released its comments to the European Medicine Agencys revision of GMP Annex 1: Manufacture of Sterile Medicinal Products.
  • EMA tackled a wide range of complex topics with some excellent and much needed improvements, said PDA President Richard Johnson.
  • The comments were reviewed and approved first by PDAs volunteer Science Advisory Board and then its Board of Directors.
  • Following a brief cover letter, the PDA comments are set up in an easy-to-use table with General Comments first and then section-by-section recommendations.