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GMPs & Validation

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GMPs/VALIDATION ARTICLES
Achieving More Effective and Efficient GMP Auditing
The authors present solutions based on a review of current service offerings and their audit experience.
A Lifecycle Approach to Process Validation
A science- and risk-based approach to verify and demonstrate that a process operating within predefined specified parameters consistently produces material that meets all its critical quality attributes.
The Lifecycle Change of Process Validation and Analytical Testing
BioPharm International spoke with industry experts about the effect FDA's 2011 process validation guidance has had on industry.
Using a Systematic Approach to Select Critical Process Parameters
Harmonized regulations call for a risk-based and systematic approach to evaluating and selecting CPPs.
Defining Quality Metrics is No Easy Task
ISPE and PDA take on the challenge of recommending quality metrics.
GMPs/VALIDATION NEWS
FDA Outlines Agenda for New Guidances in 2014
February 5, 2014
FDA Prohibits Another Ranbaxy Facility from Producing Drugs for US Market
January 24, 2014
Genzyme Receives Complete Response Letter from FDA on Lemtrada Application
December 31, 2013
Baxter Initiates Worldwide Voluntary Recall
December 30, 2013
FDA Approves Extended-Release, Single-Entity Hydrocodone Product
October 28, 2013
SPONSORED WHITEPAPERS
Novel pH Gradient Separation Platform for Monoclonal Antibody Charge Variant Analysis
July 30, 2013
High-resolution Analysis of Charge Heterogeneity in Monoclonal Antibodies Using pH-gradient Cation Exchange Chromatography
June 25, 2013
GMPs/VALIDATION EVENTS
GMPs/VALIDATION RESOURCES
Building Blocks of Quality by Design | IVT
This is the first of a monthly series of short commentaries on the use of QbD in the pharma and biotech industries.
Analytical methods and QbD: A Perfect Match | IVT
Take the long view of analytical methods and continue to build a strong knowledge base for them; to learn from history and improve their quality at every opportunity.
Improvement Alphabet: QbD, PAT, LSS, DOE, SPC?How Do They Fit Together? | IVT
Consider the following scenario, a new pharmaceutical or biotech scientist or engineer is assigned the job of solving a problem, improving a process, or just developing better understanding how a process works. Five different people are asked for advice and guidance, and five different recommendations are received and summarized as ? QbD, PAT, LSS, DOE, and SPC.
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