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PharmTech GMP_validation
GMPs/VALIDATION ARTICLES
Determining Facility Mold Infection
The recovery of an occasional mold does not merit any particular concern. On the other hand, evidence of mold proliferation indicative of infection of facilities or equipment must be taken seriously and requires the prompt implementation of corrective and preventive actions.
Using the Guard Band to Determine a Risk-Based Specification
A risk-based guard band surrounds a specification limit and is derived from the uncertainty of the reportable value of the analytical procedure, which includes the uncertainty in the reference standard. The author discusses requirements for generating a reportable value and calculating the associated measurement uncertainty.
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.
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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