There are many good reasons to outsource analytical chemistry, manufacturing, and controls (CMC) activities. These may be motivated by the lack of in-house capacities, the prioritization of critical and important activities or the need to access niche or non-available expertise and technology.
 
In today’s competitive environment, it is easy for a pharmaceutical company to procure CMC services as an increasing range of those services are commoditized by the vendors and therefore auspicious for outsourcing. It becomes, then, necessary for the organizations to have well-established tools for deciding whether to perform an analytical activity in-house or turn it over to an external vendor.
 
The objective here is to present a simple tool that facilitates outsourcing decision-making by considering three characteristics of the analytical CMC activity: The Value-added generated, the Complexity perceived and the Reactivity needed. Outsourcing managers have to answer three questions about the activity:
 
1. Does the activity generate knowledge for an in-depth understanding of the compound and the related manufacturing process at all stages of the product lifecycle?
To get a concrete idea, knowledge generated from forced degradation is used primarily to establish the specificity of a stability indicating analytical method and to predict impurities that could form during stability studies. It can also be used to provide information about the selection and the compatibility of excipients during formulation development, to improve manufacturing process or to define degradation profiles during storage and transportation.
 
2. Is the activity to be performed complex?
To answer this question, one could ask if the activity requires high level skills? Are there sub-tasks associated with the main activity? Does the activity require a continuous information exchange so that it is performed reliably and with acceptable quality? For example, it is the aim of a Specifications setting exercise to understand and prioritize the key quality attributes that merit direct control throughout the clinical development cycle. Specifications are then defined to confirm the quality of the product rather than characterizing it. As pointed out by ICH Q6B, Specifications should “be based on data obtained from lots used to demonstrate manufacturing consistency” – “account for the stability of drug substance and drug product” – “be based on data obtained for lots used in pre-clinical and clinical studies” – “be linked to analytical procedures.”
 
The most important element of complexity when establishing and justifying Specifications is achieving the trade-off among all the above-mentioned aspects by taking into consideration a broad and differing range of information within multidisciplinary working groups including experts from the different disciplines involved.
 
3. At what speed and with which reactivity should the task be performed?
For example, in an API chemical plant, most chemical reactions require close surveillance and monitoring of their progress. In-process controls should be conducted with the highest reactivity to ensure that the process is producing a quality material in the predefined yield. These analysis should be performed as close to the chemical plant as possible. 
 
Together, the answers to these three questions help when developing a sourcing strategy according to the decision matrix shown in Figure 1.

Figure 1. Value/Reactivity/Complexity Matrix