Abstract
On February 1, 1985, FDA published a Notice of Availability of a draft guideline on aseptic processing of sterile drug products. The draft guideline, dated January 1985, provides guidance on acceptable ways to comply with several CGMP regulations governing aseptic processing, such as 21 CFR 211.42 (design and construction features), 211.84 (testing of components, containers and closures), 211.113 (control of microbiological contamination/validation), and 211.167 (sterility test requirements). The draft guideline was prepared in-house and has not been made available before to persons outside FDA. The guideline covers a number of areas in which wide variation in compliance has been observed in the industry, including air quality specifications and monitoring in processing areas, sterile media fills, and investigation of sterility test failures. Comments from the affected industry, such as that represented by the Parenteral Drug Association, will be carefully considered, and incorporated into the guideline if appropriate. We at FDA desire to publish a final guideline that represents current good manufacturing practice and will have a positive impact on industry compliance.
- Received May 7, 1985.
- Accepted May 13, 1985.
- Copyright © Parenteral Drug Association. All rights reserved.
PDA members receive access to all articles published in the current year and previous volume year. Institutional subscribers received access to all content. Log in below to receive access to this article if you are either of these.
If you are neither or you are a PDA member trying to access an article outside of your membership license, then you must purchase access to this article (below). If you do not have a username or password for JPST, you will be required to create an account prior to purchasing.
Full issue PDFs are for PDA members only.
Note to pda.org users
The PDA and PDA bookstore websites (www.pda.org and www.pda.org/bookstore) are separate websites from the PDA JPST website. When you first join PDA, your initial UserID and Password are sent to HighWirePress to create your PDA JPST account. Subsequent UserrID and Password changes required at the PDA websites will not pass on to PDA JPST and vice versa. If you forget your PDA JPST UserID and/or Password, you can request help to retrieve UserID and reset Password below.