Pharmaceutical medicines are expected to be efficacious and to perform according to the product licence or as directed by the medical practitioner. Medicines are also expected to be safe, and the basis of a safe medicine is one that has been manufactured consistently and with a review of potential manufacturing Hazards completed.
In relation to the issue of hazards, Tim Sandle has written a review for Microbioz India of the types of hazards common to pharmaceutical manufacturing (including microbial and chemical) and the risk mitigations that can be deployed to address them. This includes consideration of risk assessment tools and techniques.
The reference is:
Sandle, T. (2017) Risk assessment and pharmaceutical processing hazards, Microbioz India 3 (3): 10-18
Posted by Dr. Tim Sandle
