| Jill Webb at RSSL Pharma explores the various ways in which risks can be avoided along the supply chain
Despite the best efforts of pharmaceutical manufacturers and packagers to work to the highest standards, there is always the potential for something to go wrong. Whether through some unforeseen event during manufacture or distribution, there are many ways in which the quality of the end product can be compromised. These defects may be detected during routine quality control checks, or may only come to light when the product is returned in a complaint, but all should be investigated.
Such investigative analysis will very often require the skills of chemists, microscopists and microbiologists working together. This is because few incidents are easily explained, and chemical taints may have microbial spoilage at their route, or foreign bodies in liquids may be the result of precipitation due to chemical imbalance. There is then a need for manufacturers and packagers to have access to multi-disciplinary laboratories that are capable of investigating highly complex problems, and where these facilities are not available in-house, external, trusted partners must be found. They need, of course, to be found before an incident occurs, because it is too late to start sourcing reliable help once the problem comes to light.
CHEMICAL CONTAMINANTS
Chemical contaminants will often be invisible to the naked eye, but will be revealed either through a routine quality control (QC) analysis, or through someone reporting a problem in the product. In the latter instance, the problem is often identified as a bad/wrong smell or taste, or discolouration of the product. Such descriptions will only go a little way towards identifying the contaminant, and in any event, they depend on the user’s ability to detect an anomaly in a product with which they may be unfamiliar. |
