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Tag Archives: FDA Guidance for Industry
CHINESE API MANUFACTURING FACILITIES RECEIVE WARNING LETTER (MARCH 30, 2011)
NINGBO SMART PHARMACEUTICAL RELEASE WITH INCOMPLETE C of As Comment The Ningbo Smart Pharmaceutical Co. Ltd, Ningbo China, received an Active Pharmaceutical Ingredient (API) audit between October 25-29, 2010. During this audit, the investigator identified significant deviations from CGMP for the manufacture of … Continue reading
Posted in FDA Compliance, Warning Letters
Tagged FDA Compliance, Warning Letter, FDA, FDA Guidance for Industry, Phase 1, API, OVI, data integrity, ICH Q7, identity test, raw material testing, 21 CFR, Ningbo, Chinese API
PROPOSED CHANGES TO USP PET COMPOUNDING FEBRUARY 21, 2011
WEBINAR ON PROPOSED CHANGES TO USP<823> RADIOPHARMACEUTICALS FOR POSITRON EMISSION TOMOGRAPHY (PET) — COMPOUNDING FEBRUARY 21, 2011 The proposed USP<823> is planned for issuance in May 2012. Comments may be made to the USP at USP823@usp.org through March 31. I encourage all … Continue reading
FDA’s Guidance for Industry Process Validation Issued Today
JUST RELEASED – January 24, 2011 Guidance for Industry Process Validation: General Principles and Practices; Current Good Manufacturing Practices (CGMP), Rev 1. January 2011. Please contact: Barry A Friedman, PhD at barryafriedman@aol.com for a copy
Posted in New Guidances for Industry
Tagged FDA Guidance for Industry, Process Validation
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