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GUIDANCE DOCUMENT

Testing Limits in Stability Protocols for Standardized Grass Pollen Extracts Guidance for Industry November 2000

Final

Testing Limits in Stability Protocols for Standardized Grass Pollen Extracts

Docket Number:
97D-3010
Issued by:
Guidance Issuing Office
Center for Biologics Evaluation and Research

Standardized grass pollen extracts must demonstrate their potency in accordance with 21 CFR 680.3(e), 610.10, and 600.3(s). Accordingly, manufacturers must demonstrate that their grass pollen extracts maintain potency and are stable until the product's expiration date. The Center for Biologics Evaluation and Research (CBER) is setting forth this document to provide guidance on developing stability protocols for standardized grass pollen extracts. A specific stability protocol that is consistent with CBER lot release is provided, along with all necessary formulas and illustrative numerical examples. This document does not change lot release criteria for these products. To the extent that prior guidance from FDA is or may be interpreted to be inconsistent with this document, this document supersedes such previous guidance. This guidance document finalizes the draft guidance entitled "Testing Limits In Stability Protocols For Standardized Grass Pollen Extracts" that was announced in the Federal Register of August 25, 1997 (62 FR 44975).

 

 


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All written comments should be identified with this document's docket number: 97D-3010.

Questions?

Contact Point
Office of Communication, Outreach and Development (OCOD)
Center for Biologics Evaluation and Research
Food and Drug Administration
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Silver Spring, MD 20993-0002
ocod@fda.hhs.gov
(800) 835-4709
(240) 402-8010