Location

Productivity and Quality Institute - Alexandria

Objectives

• It is essential to prevent and reduce the level of cross-contamination in the pharmaceutical industry. Different types of residues need to be considered, including APIs (Active Pharmaceutical Ingredients) residues, degradation products (due to different solubility, toxicity, and cleanability characteristics in comparison with the original compound), particulates, endotoxin, environmental dust, residual rinse water (if product must be dry) as well as potential microbial contaminants In order to reach this goal, cleaning validation study should be carried out to provide a document which proves that process of cleaning has been validated and it can be performed reliably andRepeatedly. This program enabled you to master this important activities.

Outcomes

• Gives the required knowledge to comply with regulations regarding to cleaning validation• Needs for Cleaning after product changeover cleaning requirements• Needs for Between batches in campaigns cleaning requirements• Understanding Different types of cleaning • the worst case scenario and grouping strategy • Learning sampling methods• Learning testing methods• Understanding all cleaning validation side studies eg. CEHT, DEHT• How to select Sampling plan

Course Contents

 Optimization of cleaning procedures Sinner's circle the worst case scenario cleansing agent Types of Cleaning Cleaning validation side studies Grouping strategies Acceptance criteria Calculations of API residues  Calculation of cleansing agent residues Cleaning validation protocol