CGMP Compliant Contract Manufacturer

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• How to Respond to (& Avoid) FDA 483s (.pdf)
  No cGMP compliant manufacturer wants to receive a Form 483 ("Notice of Inspectional Observations"). In such stringently controlled industries as pharmaceutical/biotechnical development, manufacturing and warehousing, receiving a list of deficiencies can feel like a heavy blow to your quality...
• Events Calendar
  : Maximizing Facility Use & Output to Benefit Your Bottom Line Implementing Successful PAT Initiatives Without Decimating Your Profit Margin Developing a cGMP Compliant Outsource Manufacturing Network From Contract to Validation RFID: Will the Early Bird Get the Worm? Timing RFID Implementation to Reap...
• Reduce Calibration Costs and Improve Sensor Integrity through Redundancy and Statistical Analysis
  , pharmaceutical companies write elaborate calibration protocols that are consistent (and sometimes overly compliant) with FDA cGMP guidelines to maintain the reported process value integrity. This can result in extremely high cost for compliance with only a minimum ROI for improved productivity or product...
• Demystifying GMPs for Nutritional Supplements
  to companies or persons who "manufacture, package, label, or hold a dietary supplement" but does not apply to ingredient manufacturers or suppliers. Excluding raw dietary ingredient producers/suppliers from cGMP pushes the burden for ensuring quality of the supplement to the manufacturer of the final product...
• Don t Drift out of Control
  , pharmaceutical companies write elaborate calibration protocols that are consistent (and sometimes overly compliant) with FDA cGMP guidelines to maintain the reported process value integrity. This can result in extremely high cost for compliance with only a minimum ROI for improved productivity or product...
• Don t Drift out of Control
  initiative. This paper addresses another aspect for cGMP - data integrity. It takes a novel approach. Pharmaceutical Statistical Control | Don’t Drift out of Control | Pharmaceutical Manufacturing. Digital Magazine: Read / Subscribe. RSS. Contact Us. Advertise. All. Articles. White Papers. Products...
• A Compliance and Traceability Toolkit
  for several key aspects of cGMP compliance to be automated, among them electronic documents, CAPA training and audit management as well as complaint handling. Initially, says Fischer, 12 vendors were evaluated but three were invited for a live demo and discussion with a cross-functional team...
• Outsourcing: Cost versus Benefit
  . Needed are thousands of FDA inspectors, many thousands of civilian scientists and QA personnel to monitor/train the personnel at the outsource locations. The cost will be many billions of dollars to bring them to the level of adherence as current cGMP-compliant suppliers. Upon reaching scientific...
• Vaccine Manufacturing Deja vu: A 483 Review
  In 2003, MHRA's and FDA's investigation of Chiron's Fluvirin flu vaccine manufacturing facility in the U.K. brought to light some important cGMP deficiencies. However, since then, 483's for a number of vaccine manufacturing facilities (including two subsequent reinspections of Chiron's Liverpool...
• Interphex Booth Previews
  11-compliant controls are complemented by optional CIP/SIP, LN2, full system redundancy. Instrumentation That Covers All Bases offers a number of solutions for pharmaceutical applications: Anatel analyzers for measuring TOC concentrations; Met One and HIAC devices for measuring particulates...

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