I recently published a blog titled Contamination Control Strategy (Not Just a Regulatory Requirement). In that blog, I discussed the needs and benefits of having a Contamination Control Strategy (CCS). It was a high-level view of the regulatory requirements and benefits of having a CCS, but I did not go into the key details of how to write a CCS. Having given the “WHYs and WHENs,” I wanted to follow up with this blog on the “WHOs and HOW.”

So, you’ve decided to write your CCS, but the next question is, how do we do this? Well, Volume 4 Annex 1 Manufacture of Sterile Medicinal Products (here after referred to as Annex 1) already gives some guidance. For instance, clauses 2.3 through 2.6 give details of the sort of elements that the CCS should consider (with clause 2.5 giving sixteen points to consider in the CCS). These clauses give clear guidance as to what the CCS needs to include, which is not only consideration of the design of equipment and facility where the manufacturing process is performed, but it further identifies other key elements, such as vendor approval (2.5 VII) and management of outsourced activities (e.g., sterilization activities) (2.5 VIII). This indicates that the CCS needs to be a truly end-to-end (from suppliers to the patient) strategy.

Who in your organization should be drafting the CCS? A commonly seen mistake is that the CCS is not written by the right people; to write the CCS properly, you will require a multidisciplinary team of engineers, representatives from operations (including operators), microbiologists, and supply-chain experts (and, of course, Quality Assurance). You may also want to include people who are not necessarily process experts but are experts in the use of risk-management tools. It is not appropriate, or generally possible, for one person to write the CCS in isolation; you need the engineers to tell you how the system works (and help identify the inherent risks) and you need the operators, who will often tell you that the controls that you think are in place are not practicable or even used in practice!

Typically, the process will start with the multidisciplinary team being “locked” in a room with sticky notes and flipcharts to allow them to properly map out in detail the actual process (not the one that people assume occurs). It is essential that the CCS drafting process starts in this way; otherwise, there is a risk that the CCS will not be of value. In addition, the involvement of the wider team helps embed ownership and understanding, and, therefore, helps ensure that the CCS is properly applied.

Once you have your end-to-end process map, what does the CCS actually look like? My experience so far is that there are two main formats. These tend to be the “road map” approach or the “one-stop shop” approach.

The Roadmap Approach

The roadmap is a high-level document that “points” to foundational documents, such as design qualification, environmental monitoring risk assessments, and technical documents, e.g., the disinfectant efficacy studies.

There are several benefits to the “road map”; it removes the need to duplicate the data in the “foundational” documents and it is easier to keep up to date. However, there are some drawbacks to this approach; one of the drawbacks I’ve seen is the need to ensure that foundational documents are relevant and also kept up to date, which can be problematic for some firms. Therefore, the quality system needs to be robust enough to ensure that documents are all kept up to date.

The One-Stop Shop

With regards to the “one stop shop,” this has different pros and cons to the road-map approach. It can be beneficial to have everything in one place, but it does make it difficult to read and navigate.

Whichever approach you choose to use, there needs to be some way of making it easy to navigate, especially for an auditor or inspector who has just shown up at your facility. For this reason, it is my belief that the document should include a simple high-level schematic of the process, facility, or supply chain that is easy to work back from into the details of the processes used. The other important element is that whatever method of risk identification is used, it includes common sense. When Annex 1 was written and we first started thinking about the CCS, we wanted it to be a common-sense assessment. What does this mean practically? It means going and looking at the process and, for instance, if there is an open-door intervention that requires an operator to lean over the critical sterile product parts of the machine, it does not really matter what your Risk Profile Number (RPN) score is, common sense tells you that it is not an acceptable intervention for control of contamination and should be redesigned. Too often auditors and inspectors hear, “it’s okay, we did it in the media fills.” As I mentioned in my previous blog, but would like to reemphasize here, monitoring alone is not a control measure and “absence of evidence is not evidence of absence.” These are words to live by!

One of the other common issues identified by the CCS is that the correct quality system controls are often not in place. Key things to consider here are ad-hoc updates, e.g., when data from deviations, change controls, or environmental monitoring indicates that the CCS needs to be modified. Additionally, there needs to be a proactive review; this would typically be performed at least annually (but the company should define and justify the frequency). This review should also include intelligence from the quality system, such as trends and issues, but also needs to be outward looking to see whether the design could be updated based on the availability of new technologies. The quality system also needs to ensure that the CCS is part of the senior management review process; this is especially important where “large ticket” items, such as new investment, is required.

So, in summary, we already know firms need a CCS, but it needs to be written by the right people in the organization with the right knowledge of the processes involved. It needs to have a section that makes it simple to use. It needs to be based on “common sense” (and be open and honest). And it needs to be embedded in the quality system with the appropriate formality and controls surrounding it.

Here at Lachman, we have seen multiple examples of CCSs, designed by many different firms, so whatever your firm’s specific needs are, be it facilitating the writing of the strategy, the quality system controls, and/or audits of the strategy, we have extensive experience and can help get your CCS over the finish line. Contact us at LCS@lachmanconsultants.com for assistance with this critical endeavor.