Contamination of drugs during manufacturing is not a new phenomenon. In today's global manufacturing landscape, it becomes even more imperative the manufacturers have processes in place to mitigate the risk of contamination.
Nevertheless, drug contamination has emerged as a leading cause of recalls lately. According to the Medicines & Healthcare Products Regulatory Agency in the United Kingdom, product contamination is the second to third highest reason for recalls in the UK in recent years.
In 2009, 84 Nigerian children were reported to have died after being given My Pikin, teething syrup contaminated with diethylene glycol. In November 2012 404 cases of fungal infection occurred with 29 deaths due to contaminated injectable medication in the New England Compounding Center meningitis outbreak.
The regulatory authorities need to re-examine the approach to quality control. Companies and regulatory bodies like World Health Organization (WHO) and the U.S. Food and Drug Administration (FDA) have to ensure that processes for detecting and controlling contamination and cross-contamination and risk management strategies are put in place at manufacturing facilities.
Process and equipment need to be designed to avoid or minimise risks of contamination. Irrespective of contaminants like products / substances, foreign products, particulate matter, micro-organisms, endotoxins, drugs have to be purified by dilution of contaminants or flushing contaminants.
The cover story in this issue by Alan Fisher, Contamination Control Specialist, Dycem USA Limited, talks about how reducing costs and increasing output are affecting the risks involved in contamination and what associated risk pharmaceutical products and processes have. The article also covers what Risk Management Plans have to be followed to prevent the contamination and cross-contamination problems.
Also in this issue we present articles on regulation of nanomedicines by Rajneesh Kumar Gaur from Ministry of Science and Technology, Government of India; Rajesh Nair and Manish Gupta from Indegene, US write about reorganising for the future; Brian D Smith, Pragmedic, UK writes about the challenges facing pharma; and Jan Lilja and AsaGaasvik, KeyPlants AB and ParAlmhem, ModWave LLC. write about the modularisation in biologics manufacturing.
-- Issue 19 --