We’ve seen facilities, for example, where primary and secondary packaging are combined and have only a single gowning access. As a consequence, secondary packaging must be maintained at the same high level of cleanliness that is required for primary packaging. In these facilities, the flow of materials for both primary and secondary share the same routing and result in intermixing of raw and in-process materials as well as primary and secondary packaging components. In this example, the easily identified misapplication of gowning reveals a larger GMP issue of confused and disorganized material handling. In addition, always gowning to the higher level increases operating costs in terms of gowning materials used and operational time.
Gowning inconsistency
Do you see gowned personnel walking outside their production areas? There are older facilities where the delineation between production and controlled non-classified areas is not strictly drawn. If gowned and un-gowned personnel are walking past each other in the same hallway, this is a significant problem. Problems that can be surmised about such a facility include:
•Gowning is not centralized and time is wasted entering and exiting production suites.
•Functional areas and hygiene zones are not organized for greatest operational effectiveness.
•Flows are not unidirectional, resulting in raw and in-process materials routinely crossing paths.
•The risk of mix-up and cross contamination is heightened.
•There is an excessive amount of standard operating procedures.
•Air-handling units are not efficiently designed or operated.
Although efficient air-handling units are not strictly a GMP issue, like all the other issues enumerated, these operational inefficiencies are reflected in a higher than necessary cost of goods. In air handling, for example, an economy of scale, duct layout, and energy usage is realized when functions of a single cleanliness zone are clustered together.
Questions to ask
To evaluate a facility, consider asking the following questions about the facility’s gowning operations:
•Is the gowning operation easy to diagram?
•Is the hierarchy of gowning simple and clear?
•Is the hierarchy of gowning sequential relative to air classifications or grades?
•Is there clear and complete segregation of types of gowning?
•Are there exceptions to gowning protocols?
•What do gowned personnel do when they go to the restrooms?
•What do gowned personnel do when they go to the cafeteria?
•Do you need to gown and de-gown just to get to a desired destination?
Regulatory guidelines for GMPs include straightforward statements, but the application of cGMPs to a facility is not so simple nor is it obvious. Because gowning is deeply integrated into a facility’s operation, many cGMP fundamentals are reflected in gowning implementation. These questions can be used to help conduct a simple, initial evaluation and to gain a better understanding of compliance issues in a facility. The result will reveal where a facility is compliant and where there is room for improvement. Either finding will enable proceeding from a basis of knowledge and moving forward with confidence and a clear goal for maintaining compliance.
Reference
1. FDA, “Facts About Current Good Manufacturing Practices (cGMPs),” accessed Feb. 28, 2014.
Eric Bohn
About the Author
Eric Bohn is partner at Jacobs Wyper Architects, 1232 Chancellor St., Philadelphia, PA 19107, tel: 215.985.0400, www.jacobswyper.com.