New guidelines reflect changes

New guidelines reflect changes

The advent of new technologies–such as isolators–has led to the revision of several current guidelines and the introduction of a new facilities guideline. For example, several FDA spokepersons confirmed that the agency is about year away from issuing a revision of its 1987 guidelines on aseptic processing.

The Parenteral Drug Association (PDA) is revising its technical monograph on aseptic processing to cover new technology developments, as well as to expand coverage to other dosage forms. The new document, titled Technical Report No. 22, Process Simulation Testing for Aseptically Filled Products, will supersede two previous PDA documents issued in 1980 (Technical Monograph No. 2, Validation of Aseptic Filling for Solution Drug Products) and 1984 (Technical Report No. 6, Validation of Aseptic Drug Powder Filling Processes).

“This document updates both of the previous ones to include significant advances in facility and equipment design, and that includes isolation and blow-fill-seal technology, as well as changing regulations,” says Russell Madsen, PDA`s vice president of scientific and technical affairs and the PDA staff member working with the Aseptic Processing Monograph Revision Task Force.

“One of the keys of the new document is our attempt to provide people with the means to set and develop their own limits and acceptance criteria when they do a media fill test or a process simulation test. We`ve tried to put together eight basic principles that we feel can be used by any company anywhere in the world to set valid limits for its own particular situation,” Madsen says, including companies still using manual aseptic filling operations. The draft revisions were published in the September-October issue of the PDA Journal of Pharmaceutical Science and Technology. The draft is also available in an Adobe Acrobat (PDF) file at

The International Society for Pharmaceutical Engineering (ISPE) is issuing a series of 12 facilities engineering guidelines, including one on aseptic/sterile processing. These are the first guides ISPE has ever attempted to produce, says executive director Bob Best, and they are being developed in conjunction with pharmaceutical engineering executives and the FDA. The guidelines, intended to help control the cost of building and operating a facility, will provide baseline information on the design, construction and commission of facilities, equipment and systems for regulatory acceptance. They will also attempt to clarify interpretations of qualification and validation regulations.

The draft of the guide on aseptic/sterile processing is currently being written by a group of European members of ISPE. “This is noteworthy because the FDA is enthusiastic about the notion of working in harmony with a group of industry representatives from overseas,” Best says. When completed next year, the guide will carry the logo of the FDA and a letter from the deputy commissioner. “The long-term hope is that it will be a universally accepted document,” Best says.

The chairman of the task team writing the draft, Bruce Davis of the U.K.-based Zeneca Pharmaceutical Co., says the guide will include a chapter on isolation technology. Copies of the draft will be available from ISPE early next year (phone: 813-960-2105; fax: 813-264-2816).

Meanwhile, the last voting round for the ISO aseptic processing document was completed last month. The document, titled ISO Technical Committee (TC) 198 N272 Sterilization of Healthcare Products Working Group 9, Aseptic Processing of Healthcare Products, is expected to be completed and approved by the middle of next year.

Members of Working Group 9 will meet in Germany early next month to review the latest commentary received, says the group`s chairman, Dr. Mike Korczynski of Abbott Laboratories (Chicago, IL). TC 198 is expected to become the official international standard specification on the processes and procedures for the validation and control of aseptically processed healthcare products, with guidance in the areas of personnel, facility design, monitoring, process filtration, sanitation, lyophilization and media fills. Copies of the proposed standards can be purchased from the Association for the Advancement of Medical Instrumentation (Arlington, VA, 703-525-4890, ext. 217).–SG


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