FDA Revises Vaccine Processing Regulation
Manufacturers will be subject to a new rule effective March 18, 2008, designed to give more flexibility to firms regarding buildings and equipment used to produce live vaccines.
The FDA published the final rule in the Oct. 18 Federal Register. The rule, modifying section 600.11 (4) of the Code of Federal Regulations, basically retains its original facility requirements but only as one option for firms to follow.
“The revisions provide for the use of modern manufacturing approaches to assist vaccine manufacturers who engage in live vaccine processing, e.g., manufacturers of influenza virus vaccines,” the FDA said.
Current requirements stipulate that live vaccine processing operations be physically segregated either in a separate building, in a separate wing of a building or in quarters at the blind end of a corridor. Test procedures that use microorganisms other than the vaccine strains and tissue culture cell lines not from the primary cultures are not to be conducted in the same space where vaccines are processed.
Under the new rule, if production takes place in a multiproduct manufacturing facility, procedural controls and, if necessary, process containment, defined as a system that mechanically isolates equipment or the processing area, may be used.
“Process containment is deemed to be necessary unless procedural controls are sufficient to prevent cross-contamination of other products and other manufacturing areas within the building,” the final rule says.
Comments are due Jan. 2, 2008. Information on the final rule can be accessed at www.fda.gov/OHRMS/DOCKETS/98fr/E7-20610.pdf.