Does the concept of self-contained facilities apply equally to research and development laboratories (susceptible to contain highly sensitizing, highly potent or potentially pathogenic material in the analytical scale) that may be in the same building as the manufacturing facilities, or is this concept limited to actual manufacturing operations?

It is the responsibility of the manufacturer to ensure that their premises and operations have been
designed in such a manner that the risk of contamination between products is minimized. This would include
research and development areas within facilities where marketed drug products are fabricated and packaged.
Further guidance can be found under Interpretation 11, Section C.02.004 Premises of the “Good
Manufacturing Practices Guidelines, 2009 Edition (GUI-0001)”.