Ph. Eur. / USP Prospective Harmonization — API Pilot Project: Industry Perspective  

USP Response to Stimuli Article European Pharmacopoeia–US Pharmacopeia Prospective Harmonization: API Pilot Project—Industry Perspective 
A Rapid Capillary Electrophoresis Method for the Detection of Microbial Contamination: An Alternative Approach for Sterility Testing  

Determination of Organic Carbon Contamination in Packaged Pharmaceutical Water—Contributions by the Container   

Updating Sterile Packaged Water Attributes: Conductivity and Total Organic Carbon   

 

USP Responses to Comments on Stimuli Article: Performance-based Monographs 
USP Responses to Comments on Stimuli Article: Acceptable, Equivalent, or Better: Approaches for Alternatives to Official Compendial Procedures  

The Use of Stratified Sampling of Blend and Dosage Units to Demonstrate Adequacy of Mix for Powder Blends (PDF)

 

New developments in weighing technology -NEW

A Light-obscuration Method Specific for Quantifying Subvisible Particles in Protein Therapeutics - NEW
Generalized Simplified Approaches for Mass Median Aerodynamic Determination -NEW

ISO 17025 New

 

Analytical Method Validation New

 

21 CFR Part 11 New

 

Computer System Validation New

 

Good Laboratory Practice Regulations New

 

Analytical Instrument Qualification(AIQ) New

 

GAMP 5 - A Quality risk management approach

 

Transfer of analytical procedures for suitable colums of reduced dimensions and particle size

 

Transfer of Analytical Procedures: A Proposal for a New General Information Chapter 

 

Elemental Impurities—Information 

Elemental Impurities—Comments and Responses 
Flow Microscopy—Dynamic Image Analysis for Particle Counting 
A Recombinant Factor C Procedure for the Detection of Gram-negative Bacterial Endotoxin