Virtual Sponsor Companies Outsourcing Manufacture of Investigational Products

Small virtual companies and spin-out organisations frequently need to call upon GMP Quality expertise e.g. Quality consultants, to supplement the experience within their small teams. This expertise is often only sought by a Sponsor organisation when they have already chosen a contract manufacturing organisation (CMO), and their investors have stipulated that they conduct an audit.

There are clear advantages in seeking GMP Quality expertise earlier in the CMO selection process. By using this expertise to perform some pre-selection qualification activities to check your potential CMO(s), you will uncover any red flags associated with the organisation(s), and potentially save yourself an expensive audit. For example, pre-selection activities may help avoid selecting an organisation with a weak Pharmaceutical Quality System (PQS). A weak PQS could lead to potential delays and increased costs caused by slow and incomplete resolution of issues.

Involving GMP Quality expertise whilst setting up a project, and in its early phases, will help you to check whether the CMO’s capabilities are acceptable before making long term manufacturing decisions. Potential issues will be flagged up during project set up when there should be sufficient time to resolve them. This knowledge can then be taken forward to an audit, which will facilitate resolution of issues, as well as confirmation over the choice of organisation.

Contact us to arrange a short introductory call to explore how we can help you check your CMO choice and support the continued QA oversight of your outsourced manufacturing activities.