The term “man-in-plant” (MIP), despite its gender-biased political incorrectness, is relatively self-explanatory. It refers to having a project sponsor’s employee or designee present at a contract manufacturing site (CMO) in order to observe operations. Since this individual will represent the project sponsor at the CMO, the individual chosen as the MIP is critical. The manner in which the MIP interacts with the CMO either can enhance the relationship with the CMO or can cause irreparable harm.
This article will highlight some of the key characteristics that are necessary when hiring an MIP and establishing policies and procedures for this function.
The responsibilities of the MIP vary in accordance with the size of the project sponsor. Typically, this individual will serve as the primary conduit of information between the two companies. He or she will coordinate document reviews/approvals, production schedules and general project-related tasks.
For pre-commercial production, the MIP will often be a senior member of the project sponsor’s development team. For commercial production, the MIP is typically a QA/QC representative. The MIP will conduct site audits and will personally observe batch manufacturing activities (compounding, filtration, aseptic filling, terminal sterilization) and will review and approve completed batch records for each product. In essence, they will serve as the project sponsor’s eyes and ears at the contract site.
MIPs must be able to function at various levels in a variety of disciplines. Since they will often serve as the primary conduit of information between the two companies, they must be comfortable discussing chemistry, microbiology, manufacturing and regulatory/quality issues. Please note that the word “comfortable” is not synonymous with the word “expert.” Since the MIP serves as the primary conduit of information between the two companies, he or she must be able to interact on a variety of topics and be able to adequately communicate progress, issues, concerns and questions to their colleagues at the project sponsor’s facility. Just like a project manager, they do not always have to know all the answers. They must, however, know whom to call for answers. They must be very effective communicators and facilitators.
The MIP must also be a consummate politician. Let’s face it, the MIP will always be the outsider looking in and everyone at the CMO is fully aware that they are being observed by this individual. However, a truly effective MIP has the ability to walk the fine line between auditor and colleague. These individuals spend long hours with the CMO’s employees and in some instances spend more time with the CMO’s employees than their own co-workers within the sponsor’s organization.
Through their interactions, MIPs can enhance or destroy a sponsor’s relationship with a CMO. Depending on whether the MIP applies the honey or the vinegar, attitude will largely determine how effectively the two organizations work together. Under certain circumstances, the manner in which the MIP and the contractor’s employees relate can actually form a rift between the two companies. It can start at the hourly employee level but then quickly permeate even the highest level of each organization.
The MIP must also be willing to spend considerable time traveling to contract sites. Not everyone has the constitution necessary to live out of suitcases for weeks or months on end. When selecting an MIP it is essential to ensure that both the potential employee and the employer have a firm understanding of the travel requirements. Some people thrive on a high level of travel while others have the propensity to melt down after the second week on the road. The level of travel should never be underestimated.
Remember, this individual represents the project sponsor in many ways. Since his or her interaction with the contract employees will become synonymous with the way the CMO perceives the project sponsor, it is essential that the MIP always be able to perform his or her function in a very professional manner. Rgardless of the number of situations and personalities encountered, hours slept, middle airplane seats occupied or stale pretzels consumed, an MIP should strive to function as a partner, mentor, auditor and project sponsor simultaneously.
Generally, CMOs will expect the MIP to have authority to participate in on-the-spot trouble-shooting and be able to make decisions regarding product quality when anomalies occur. However, it is actually quite rare for the MIP to have the wide-ranging decision-making authority to approve products for continued processing when a process deviation or OOS is encountered. Instead, the MIP should be viewed as a facilitator who can assemble the collective Resources of both organizations in order to determine the most appropriate course of action and reach consensus in an effective manner.
We are all familiar with the Not Invented Here syndrome. This phenomenon occurs in both CMO and project sponsor facilities and can often become an impediment for both organizations. Project sponsor companies come to a CMO with existing systems and procedures. At the same time, the CMO comes into a business relationship with its own systems and procedures. Just as the project sponsor wants consistent systems across all contract sites, the CMO has a need to maintain consistent systems that apply to each project sponsor.
In the end, as with most effective negotiations, the parties must seek mutual compromise. Systems that are forced upon a CMO or project sponsor (and are customized to only one product) are the most likely ones to fail. It is important for the CMO and project sponsor to implement systems that the production operators can most easily follow. There is certainly something to be said for consistency and repetition. A standard system, unless flawed, is typically the easiest for operators to consistently follow and understand. The MIP is the individual most familiar with the systems of both organizations. It is their role to facilitate documentation systems that are compatible with both organizations.
Drain on CMO Resources
Due to the confidential nature of contract manufacturing, most CMOs have strict visitor policies and require that visitors be escorted at all times. Therefore, the MIP can unintentionally diminish a CMO’s resource pool due to the need for escorts. Considering that CMOs may run from two to eight sterile filling operations simultaneously, it is easy to see the potential resource drain that can occur on the part of the CMO when several project sponsors are on-site to observe filling operations. This issue must be managed very carefully by both organizations. Otherwise it can cause significant logistical issues for both parties.
There is also a tendency for the MIP to arrange for a number of meetings while on-site. While this is an efficient use of time, both parties need to be sensitive to the resource drain that this can create. Both parties must work together to effectively manage meetings and to utilize the face-to-face opportunity to maximum benefit.
Companies that have MIP personnel often require that those individuals be present for every batch of product manufactured. For one product manufactured at a contract site, scheduling is not typically a significant issue. However, when a project sponsor has several products manufactured at a contract site, a number of logistical issues come into play. Issues such as campaigning one project sponsor’s products, travel related delays, illness and vacation schedules can place a hardship on the scheduling and manufacturing of the product at the contract site. The requirement of having an MIP should never be allowed to interfere with the CMO’s production planning.
Whenever possible, the project sponsor should have back-up systems in place to ensure that an alternate MIP will be made available or the contract site will be allowed to continue with processing when an MIP is not otherwise available. This is of particular importance if the contract facility has the contractual right to assess cancellation fees in the event that a project sponsor cancels manufacturing just shortly before it is scheduled to begin. If the project sponsor does not have the basic level of trust in the CMO to allow manufacturing without supervision, then the project sponsor should reassess why it is doing business with that CMO.
The MIP must always be careful not to interfere with operations at the contract site. Due to the many hours that the MIP spends with the CMO’s employees and their knowledge of the process, there is often a propensity to be a part of the team and assist in operations. However, unless management at both companies has given clear approval, it is essential that the MIP restrict his or her participation to observation only. The general rule is that, unless someone is in danger of losing life or limb, the MIP should never touch equipment or participate directly in any processes.
From a legal standpoint, any interference on the part of the MIP in an aberrant production lot (regardless of intention) can blur the lines of liability. Even with the best of intentions, an MIP can inadvertently shift liability from the CMO to the project sponsor if he or she participated in the processing, provided direction to the CMO’s employees, caused a distraction or granted approval for in-process deviations of a product that fails to meet specification.
The accommodations provided by the CMO vary significantly. Most contract organizations will provide conference rooms or vacant offices for the MIP to use while on site. Some recently built or remodeled contract sites now have project sponsor offices. These offices provide basic necessities such as access to faxes, modem lines and phones. In a few contract facilities, the project sponsor offices actually have monitoring equipment, which allows the remote viewing of operations. While this certainly alleviates the drain on CMO resources by not having to provide escorts, most project sponsors prefer not to view the operations remotely, believing that the best way to oversee the operation is to be physically close to the operation and be able to interact directly with the contract personnel.
Some MIPs derive benefit from closed circuit television systems, since they provide an opportunity to increase efficiency by accessing e-mail, drafting reports and returning phone calls, all while remaining present and available during processing activities.
Most contract sites have limited office space and do not have the luxury of providing dedicated project sponsor offices. It is therefore important to proactively communicate any special requirements to the CMO at the earliest stages of the relationship.
Refusal to Admit
Most mainstream CMOs will allow project sponsor employees to be present during operations. There are, however, a rare number of CMOs that may prohibit project sponsors from observing operations. While these are the exception to the rule, it is important for a project sponsor to specifically ask the CMO for their policies on MIP. The time to make this inquiry is during the due diligence phase and not after the relationship is underway.
In order to have a clear understanding of the nature of the MIP, both parties need to clearly define their expectations and duties to the other parties. These terms can be defined in many ways, both formal and informal. The most common method of detailing the rights and duties of an MIP is a Quality Agreement. This agreement should outline such things as when an MIP is allowed on-site, how he or she can interact with the process and the duties to be performed while on-site.
The use of a man-in-plant can be a powerful tool in the verification of quality and in the effective management of a contract relationship. However, as with any relationship, the use of an MIP requires clearly communicated expectations, understanding and compromise.