Validation Times , 09/01/1999 1 6
Panel opposes site-specific data, backs process validation.(Food and Drug Administration's Advisory Committee on Pharmaceutical Science)(Brief Article) Reid, Ken *~|~*
COPYRIGHT 1999 Washington Information Source
A special subcommittee of FDA's Advisory Committee on Pharmaceutical Science Sept. 22 sided with industry in recommending against site-specific stability studies for new and generic drugs, but said the three-tiered method FDA proposed in March could be an alternative to process validation. The panel, meeting in Rockville, MD, agreed that process validation could supplant stability testing for each site where a drug is produced.
Charles Ireland, a CMC regulatory affairs manager at Sanofi Pharmaceuticals, attended the meeting and reported the panel's findings to an Institute for International Research (IIR) conference in Bethesda, MD, the same day.
He said that in lieu of site-specific shelf-life testing, companies could:
1. Obtain a certificate of analysis or the equivalent for validation batches.
2. Certify that they have successfully completed validation.
3. Note any changes in regulatory in-process controls.
4. Follow complete ICH stability requirements at the time they file an NDA, BLA or ANDA.
5. In the case of innovator products, present data in their submission three months prior to the user fee "action date," in the first year of the FDA guidance; two months prior in the second year of the guidance and one month prior to the action date in the document's third year and beyond.
Ireland said the requirements would address both the drug substance and drug product. However, FDA is not going to require the submission of a "Validation Report," which is submitted for European Union (EU) clearance.
FDA gave no inkling when a final stability guidance would be issued.
The original guidance was released in June 1998 and the three-tiered site-specific stability compromise the agency offered to industry was issued in March (See May issue, page 1).
At the IIR meeting, Frank Diana, director of analytical technology for DuPont Pharmaceuticals, advised companies to keep copies of the 1998 document, which contain "very helpful tables" describing stability studies needed for a variety of post-approval changes, including packaging.
Diana said the only reason FDA is canning the tables in the final guidance is because they repeat diagrams found in Scale-Up Post-Approval Changes (SUPAC) guidance.
Diana also said the final stability guidance will not allow companies to reduce shelf life on products without stability data.
He also said FDA will require mean kinetic temperatures -- high and low values for the week -- for each site where drugs are stored, not just where they are manufactured.
Diana contended FDA also will want stability data for physician samples and Phase III drugs, though the latter requirement is still being disputed by the industry.
Diana's presentation, including examples of 483 citations for stability problems, is available along with other conference material for a packaged rate of $50 plus retrieval (Doc. 110020R).
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