The Cost Of Inadequately Scheduling Cleaning Validation

Charlie Neal

By Charlie Neal, Area Manager, Southeast Region, ProPharma Group

Ever wonder why some—most—projects don’t go as planned? Let me take a cut at explaining what I have observed in the last few decades. Firstly, let us assume that you have contracted a well-known consulting firm to assure that you reach the established key milestones.

Let us also assume that a Contract Manufacturing Organization (CMO) has agreed to contract process validation services. In particular, the CMO needs support validating the process for a new product. In addition to process validation, this firm will also need to have cleaning validation performed to verify that there are no detrimental residues of this new product left on common processing equipment.

The CMO has been instructed by corporate to have this new product validated with launch quantities in the warehouse within twelve months. Luckily, the CMO has the advantage of having a good product development department that has diligently identified Critical Process Parameters (CPPs) and Critical Quality Attributes (CQAs). They have solid development reports in which these are identified. Unfortunately, they have not identified any cleaning methods. Our focus will therefore be the need for developing, implementing and validating a cleaning process.

While it may be reasonably straight-forward to scale the process up to commercial scale, the fact that no commercial cleaning methods exist will require time and effort to develop, implement, and validate suitable commercial scale cleaning methods. The fact that time will be required to develop commercial cleaning methods is often either overlooked and/or not planned for and/or not budgeted for. This is a costly omission on behalf of the CMO’s corporate office. While the CMO may be counseled by the contracted firm, often times they demand that the project be delivered by the pre-established project end date. Unfortunately, this means the consulting firm will have to try and deliver the extended project on time and on the original budget.