Author Archives: Raymond W. Nims

Contractor Responsibilities in Outsourced Pharmaceutical Quality Control Testing

    Pharmaceutical companies of all sizes outsource at least some quality control (QC) testing to contract analytical testing laboratories. Virtual and smaller companies may not have the staff to conduct such testing, whereas mid- to large-size companies may outsource testing that they do not wish to perform in-house. In the relationship between a pharmaceutical company and its outsourcing partner, each partner has clearly delineated responsibilities, both business and compliance related. In May 2010, we discussed a contractee’s (contract giver’s)…

Contractee Responsibilities in Outsourced Pharmaceutical Quality Control Testing

    Certain types of quality control (QC) testing are often outsourced by pharmaceutical companies, regardless of an organization’s size — typically because the company is either incapable of performing the assays in-house or does not wish to bring them into its facility. The decision to outsource may be based on the complexity of techniques involved special skills required for conducting the assays a need for biohazardous reagents such as radioisotopes limited testing frequency for the assays or (in biologics…