Author Archives: Barry A. Friedman, PhD LLC

About Barry A. Friedman, PhD LLC

Regulatory Compliance, Expert Witness, Pharmaceuticals, Biotechnology, Aseptic Processing, GMP, GLP, Quality Control, Positron Emission Tomography (PET), Microbiology, Process Validation, Validation of Analytical and Microbiological Methods

Quality Metrics and Risk Based Inspections

FDA’s Request for Quality Metrics (New Proposed Guidance July 2015) and Its Basis – The FDA’s Safety and Innovation Act (FDASIA) A Live, Interactive Training Webinar; See: http://www.tungstenshield.com/barry-a-friedman-phd/ Date: Tuesday August 18, 2015 Time: 9:30 – 11:30 AM ET (New … Continue reading

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FDA’s CDER LISTING OF TOP NINETEEN OBSERVATIONS FOR 2014

TOP FOUR OBSERVATIONS REMAIN SIMILAR IN NUMBER TO 2013 Each fiscal year the FDA issues the various FDA 483 Observations from the various Centers to include CBER, CDER, CDRH, etc.  This Blog focuses only upon those issued by the Center … Continue reading

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2015 United States Pharmacopeia (USP) Microbiological General and Information Chapters Training Program

7-Part Live Training Program Starts September 30, 2015 Instructor: Barry A. Friedman Ph.D. Biography>>> Click Here to Learn More and to Register for this Live Training Program The United States Pharmacopeia (USP) contains a number of chapters relating to microbiology within its … Continue reading

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VUAB PHARMA, CZECH REPUBLIC, RECEIVES WARNING LETTER (MAY 27, 2015, con’t)

Objectionable Bacillus spp. Found During Customer Sampling  During the FDA’s inspection of VUAB Pharma a.s., Vltayska 53, Roztoky, Czech Republic, from June 09, 2014, through June 13, 2014, an investigator from the U.S. Food and Drug Administration (FDA) identified significant … Continue reading

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VUAB PHARMA, CZECH REPUBLIC, RECEIVES WARNING LETTER (MAY 27, 2015)

Objectionable Anaerobe Found During Customer Sampling During the FDA’s inspection of VUAB Pharma a.s., Vltayska 53, Roztoky, Czech Republic, from June 09, 2014, through June 13, 2014, an investigator from the U.S. Food and Drug Administration (FDA) identified significant deviations … Continue reading

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INSPECTION TRACKER: DRUG MANUFACTURING ESTABLISHMENTS (CANADA)

  Health Canada Begins Publishing Information Regarding Emerging Issues As part of Health Canada’s ongoing commitment to openness and transparency, the Department recently began publishing information regarding emerging issues identified through the drug inspection program. This tracker provides a snapshot … Continue reading

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Sagent Pharmaceuticals Recall due to FDA Observations Pertaining to Aseptic and GMP Practices at the Manufacturer’s Site Potentially Impacting Product Sterility

Sagent Pharmaceuticals, Inc. Schaumburg, IL announced on February 23, 2015 the voluntary nationwide recall of two lots of Atracurium Besylate Injection, USP, 50mg/5mL single-dose vials (NDC 25021-659-05) and four lots of Atracurium Besylate Injection, USP, 100mg/10mL multi-dose vials (NDC 25021-672-10) manufactured by Emcure Pharmaceuticals Ltd. and distributed by Sagent. Sagent has … Continue reading

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