Life Science Leader Magazine Supplements

CMO 2017

The vision of Life Science Leader is to help facilitate connections and foster collaborations in pharma and med device development to get more life-saving and life-improving therapies to market in an efficient manner. Connect, Collaborate, Contribute

Issue link:

Contents of this Issue


Page 25 of 81

LIFESCIENCELEADER.COM THE CMO LEADERSHIP AWARDS 2017 24 By B. Chatterjee HARMONIZING QUALITY MANAGEMENT SYSTEMS IN EARLY DRUG DEVELOPMENT CONTRACT SERVICE PROVIDERS Collaboration Another element of complexity, depending on the sever- ity of the excursion, occurs when the CSP can choose to limit an observation to the sponsor's specific lot, but the sponsor determines that the excursion is part of a larger, fundamental issue. It's vital to have a clearly articulated process for handling this type of discussion. LABORATORY SERVICES One of the most challenging elements of any develop- ment program is the transfer and implementation of laboratory testing. Of course it is essential to have con- fidence in the tools being used to measure your product and process performance, and again, a thorough audit can uncover small differences – those that could have a meaningful impact on product testing. For example, how is the sample treated when placed in the sample log-in area? Can it sit for a day waiting to be logged in and placed in the appropriate storage unit? The abil- ity to infuse technical considerations into the assess- ment is a typical way to prompt a dialogue regarding product-specific requirements. Method transfer is another area where it is important to have clarity regarding what information will be pro- vided to the sponsor. Since methods are not validated early in the development program, it is important to have access to all of the raw data associated with the testing performed. Some CSPs will only provide a sum- mary report, so if raw data is required, a discussion regarding the prerequisites to release this information to the sponsor is a good place to start. Questions to ask include: Is all of the data QA reviewed and released? Will the CSP release data that has not been QA reviewed? Out-of-specification (OOS) test results are another area where it is crucial to be explicit, especially in early development programs. If a method constantly has Phase 1 laboratory investigation reports (LIRs), then perhaps the method needs some adjustment. Understanding the level of partnership in the success- ful deployment of the method is important to establish early on in the relationship. Engaging a contract service provider requires much more than evaluating the technicality, quality, and robustness of the organization. Understanding the roles, responsibilities, and expectations between spon- sor and provider early in the engagement process will ensure a smoother and more effective relationship, and one of the keys in early development is harmonizing quality management systems. L 3. Does the sponsor have a clear process for capturing changes in the CDMO's process within its own QMS? 4. Is that process compatible with the CSP's current process? This last point particularly is often overlooked and can be a major point of friction for sponsors with their own well-developed QMS. Moreover, this can be espe- cially critical for sponsors with products that utilize a device component, which could entail a cross-reference between the design history file, if changes are required. INVESTIGATING DEVIATIONS/NONCONFORMANCES Deviations require both the CSP and sponsor to under- stand the root cause and implications of a process or QMS excursion. Unfortunately, the thoroughness of the root cause investigation can also become a point of con- tention, particularly because it can impact both mate- rial supply and financial responsibility. Understanding whether a sponsor can be involved in an investiga- tion — and to what extent — is critical to conducting and documenting an effective root cause investigation. For early development programs, where the technical insight is fluid, it is not unusual to have the sponsor intimately involved. In later stage programs, the spon- sor may have only review and approve authorization. In fact, some CSPs will only allow review and approve authorization. This, though, can place a great deal of responsibility back on the sponsor in its assessment of the provider's ability to effectively execute a thorough root cause analysis. Most CSPs are, in fact, reluctant to modify their typi- cal deviation template, because they would constant- ly be revising the document for each new customer engaged. In addition, deviations will reside in the pro- vider's QMS, and so the sponsor needs to decide if it is important to have corresponding references within its own system. One of the most challenging elements of any development program is the transfer and implementation of laboratory testing. BIKASH CHATTERJEE is president and chief science officer of Pharmatech Associates.

Articles in this issue

Links on this page

Archives of this issue

view archives of Life Science Leader Magazine Supplements - CMO 2017