Pharma Talk

Would additional process validation studies be needed to support a change in the source of an API starting material? Any change in the API s...

When is it acceptable for an API manufacturer to extend an API retest date [ICH Q7, 11.6]?  The purpose of a retest date is to ensure that t...

Introduction: Cannabis, often associated with recreational use, has emerged as a fascinating subject in the realm of medicine. Its medicinal...

Company Antaria Pty. Ltd, Australia Synopsis  1.Inadequate Investigation  2. Own Analytal Methods used but proved to equivalent to USP metho...

Harm is an adverse outcome or impact, hazard is a potential source of harm, and risk is the likelihood of harm occurring under certain circu...

ISO 14971 Basic Concepts – Hazard, Hazardous Situation and Harm 1) Hazard ISO 14971 defines a hazard as a potential source of harm. What doe...

1.High levels of subjectivity in risk assessments and in QRM outputs Subjectivity is commonly present in a QRM process, as it can be introdu...

Statistical Process Control in Pharmaceutical Quality Assurance  1.Control Charts: X-bar, R-chart, S-chart, and p-chart keep process variati...

Synopsis of the US FDA 483on Process Validation  In the Warning Letter, the FDA criticised the fact that no microbiological tests were named...

The authority has issued a new Form 483 following an inspection of Alkem Laboratories Limited, a drug manufacturer located in Baddi, Himacha...