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#GMP #Cleanrooms & Cleanroom #HVAC: A Practical Approach

Identifying the most practical approach to achieve Good Manufacturing Practice (GMP) cleanrooms and cleanroom HVAC in the pharmaceutic...
Fundamental Elements of 21 CFR Part 11 & GMP Annex 11

Along with providing monitoring and validation systems, we often delve into issues that arise for our customers when they are interpreti...
Autoclave Validation / Qualification : 10 Steps

Autoclave Validation / Qualification is mandatory for all machines used for biological sterilization, in the biomedical and pharmaceutic...
Learn From FDA & MHRA GMP Inspection Observations

A comprehensive GMP intelligence program includes monitoring of enforcement actions, including FDA form 483s, warning letters, recalls, ...
Surveying The Current Regulatory Landscape regarding Data Integrity

Failures in data integrity break the essential trust that regulators have with manufactures of medicinal products. Regulatory authorities ...
Tips for Time Management In Pharmaceutical Operations

We all want to maximize the productive use of our time, correct? Over the span of my pharmaceutical industry career, I have been fasci...
What Should You Know About Pharmaceutical Primary Packaging

Starting Early In phase I, researchers are testing a new drug or treatment in a small group of volunteers for the first time to ev...
Validation Strategies For Nonsterile Solid Dosage Forms

Process qualification, which includes pharmaceutical drug products at a stage prior to commercialization or prior to submitting a New Dr...
The Greatest Return From Your Poorly Soluble Molecule

Currently, about 70% of new molecular entities (NMEs) exhibit poor solubility in water and require some form of enhancement in order t...
Pharmaceutical Facilities And Equipment Risk Management

This two-part article focuses on risk management of facilities and equipment. It describes how a risk-based approach to facilities and...