Gary Riccio Email and Phone Number

Contact me at: 562-244-9785 - griccio@gmrengineering.com ➡ Top 7 FDA cGMP Citations (January 2016)• The responsibilities and procedures applicable to the quality control unit are not in writing or fully followed - 2.11.22(d)• Laboratory controls do not include the establishment of scientifically sound and appropriate specifications, standards, sampling plans, and test procedures - 211.160(b)• Failure to thoroughly review any unexplained discrepancy or the failure of a batch or any of its components to meet any of its specifications whether or not batch has been already distributed - 211.192• Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established, written or followed - 211.113(b)• There are no written procedures for production and process controls designed to assure that the drug products have identity, strength, quality, and purity they purport or are represented to possess - 211.100(a)• Aseptic processing areas are deficient regarding the system for monitoring environmental condition -211.42(c)(10)(iv)Any of these sound familiar? .... Contact us at 562-244-9785 • cGMP Consultants - Process Design, Installation, Automation, Validation, FDA Submission • Partial Client List - Baxter, Shire, Amgen, Gilead Sciences, TEVA, BBraunWhat We Specialize In: Technical Transfer: Clinical & Commercial Scale Process Development: Design, Engineering, Installation, Validation & FDA Submissions Manufacturing: