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PharmTech GMP_validation
GMPs/VALIDATION ARTICLES
A Practical Approach of Implementing GMP for Excipients
Using a model quality risk-management process according to ICH Q9, the authors discuss ways to apply this guideline.
Complying with Revised Weighing Guidelines
The latest revisions to the USP General Chapters <41> Balances and <1251> Weighing on an Analytical Balance aim to ensure weighing accuracy and eliminate unnecessary overtesting by simplifying previous descriptions and reflecting current state-of-the-art weighing practices.
Reducing False Out-of-Control Signals
Control charts that are properly constructed and maintained prevent false out-of-control signals and provide a useful method for monitoring a process.
FDA Issues Warning Letter to Italian API Manufacturer
Trifarma cited for significant deviations in data collection and security, and employee training.
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.
GMPs/VALIDATION NEWS
Meggle Receives EXCiPACT Certification
Meggle Group Wasserburg has been granted an EXCiPACT certificate.
FDA Issues Warning Letter to India's Marck Biosciences
FDA found violations of cGMP at finished-drug manufacturer in India.
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.
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
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