Pharmaceutical Technology

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PharmTech

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PharmTech Europe

PharmTech GMP_validation
GMPs/VALIDATION ARTICLES
FDA Issues Warning Letter to Italian API Manufacturer
Trifarma cited for significant deviations in data collection and security, and employee training.
Sterilization of Blow-Fill-Seal Equipment for Aseptic Filling
Nitrogen dioxide can sterilize and depyrogenate an aseptic fill area in a blow-fill-seal process.
Data Integrity
Siegfried Schmitt, Principal Consultant, PAREXEL International, discusses how to ensure data integrity.
Cleanability of Pharmaceutical Soils from Different Materials of Construction
The authors look at the cleanability of pharmaceutical soils from a variety of materials of construction to determine the relative ease of cleaning and explore potential grouping strategies as part of a comprehensive cleaning validation program.
Gowning Practices Provide Clues to cGMP Compliance
In legacy facilities and as buildings age, ensuring cGMP compliance can become complex. A review of a facility's gowning operations can bring insight into the current state of cGMP compliance. The author presents characteristics to look for and questions to ask.
GMPs/VALIDATION NEWS
Particulate Matter Prompts Baxter's Recall of IV Solutions
Baxter investigates root cause of cellulosic fibers and/or plastics in four lots of IV solutions.
Dissolution Problems Spur Three Recalls
Sun Pharma, Forest Pharmaceuticals and West-Ward Pharmaceuticals issue recalls over dissolution issues.
Baxter Issues Recall Due to Particulate Matter
Baxter Healthcare has initiated a nationwide recall of more than 20,000 containers of a pre-mixed beta blocker due to the presence of particulate matter.
BMS Recalls Coumadin Vials Due to Particulate Matter
Bristol-Myers Squibb issues a voluntary US recall of Coumadin (warfarin sodium) for injection due to presence of particulate matter.
FDA Issues Warning Letter to GSK Biologicals
GSK Biologicals receives warning about cGMP compliance issues at its Quebec facility.
GMPs/VALIDATION RESOURCES
Process Validation Strategy Templates
This strategy/validation plan defines what needs to be validation (i.e. equipment, systems, and processes) and how validation needs will be met for a given project.
Example Validation Master Plan
This Validation Master Plan serves as a summary of the overall strategy for the validation of a facility.
Traceability Matrix for Process Validation | IVT
Take a lesson for the CSV group. Add a traceability matrix to your documentation.
CROs Face Issues with Talent Retention
A recent survey shows that talent retention is an issue on industry level for contract research organizations (CROs), particularly for CROs located outside the United States.
Novartis Receives EU Approval for Juvenile Arthritis Treatment
Novartis Ilaris, an interleukin-1 beta inhibitor, treats active system juvenile idiopathic arthritis.
GMPs/VALIDATION EVENTS
Aug 14, 2014 - Aug 15, 2014
MES 2014
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