A detailed overview is provided for the possible patient exposure to highly potent active
pharmaceutical ingredients (HPAPIs) from potential cross-contamination through the …

Cross contamination is a major concern in the pharmaceutical industry, especially with long-
term dosing and possible cumulative effects. The risk depends on many factors that can be …

Cross-contamination in multi-product pharmaceutical manufacturing facilities can impact
both product safety and quality. This issue has been recognized by regulators and industry …

In the manufacture of potent active pharmaceutical ingredients (APIs) and products, there is
a need to conduct qualitative and/or quantitative healthbased risk assessments for both …

This paper proposes a scientifically justified and harmonized strategy to control cleaning
agent ingredients'(CAIs) residues in pharmaceutical manufacturing. Firstly, we demonstrate …

Cleaning validation is a process used by pharmaceutical manufacturers to ensure that their
equipment and facilities are thoroughly cleaned and free of any residual contaminants that …

Beginning in 2004, a global team of pharmaceutical toxicologists, industrial hygienists,
quality assurance professionals, a cleaning validation professional, and a representative …

Cleaning validation programs must have cleaning limits, worst-case residues to validate,
and recovery factors to accurately determine how clean the equipment must be. If a program …

The cleaning processes used in pharmaceutical operations have achieved an increasing
emphasis in the past decade both by the regulatory agencies and industry itself. At this time …

By avoiding cross-contamination, cleaning and cleaning validation have the greatest
potential to lower patient risk. Ineffective cleaning from previous product batches, cleaning …