gmpflows

GMP Flows are used to describe and analyze all items in a facility move through that
facility...Flows affect personnel, material, and equipment, among other things. Flows can be
bi-directional or uni-directional and can impact cross-contamination risks and process
operations. Drawings are often prepared to provide a diagrammatic representation of the
movment and status, i.e. clean versus used, gowning levels, etc.

GMP Flow Diagrams are typically prepared for:

- Personnel- indicating gowning levels and movement
- Material- indicating raw material, work-in-progress, and product movement
- Equipment- indicating points of use, cleaning and staging locations, and movement
- Waste- indicating collection, segregation, and movemnt of waste materials
- Samples- indicating collection and movement of in-process quality control samples

Segregation

Flows within a GMP facility should also be segregated. Regulators expect that access will be
limited to authorized personnel only for process areas, and that operating personnel will
conform to SOPs for gowning and circulation requirements. Process operations determine
the restrictions on flows within and through various areas of a facility.

Unidirectional versus Bi-directional

Flows are typically classified as bi-directional
or uni-directional.

Bi-directional flow indicates that items
(personnel, equipment, etc.) may move both
into and out of a space or that a space is both
entered and left through the same access
point, i.e. material airlock or gowning room.

Uni-directional flows is restricted in that items
may move into or out of a space in only one
direction and may not "back-track".

Other thoughts...

If it's not clean, it's dirty- make sure you have a
positive status on clean...if you're not positive
it's clean and can prove it, default to dirty

It's not dirty, it's "used"- never refer to a piece of
equipment as dirty, it's in a pharmaceutical
facility, it's clean...cars in the parking lot are
dirty...it's just been used and it's not ready for
re-use...

It's not clean, it's "bioburden reduced"- if you
give a status a name that indicates a specific
requirement, i.e. clean, the validation people
will drive you nuts trying to prove or disprove
whatever claim you need to make the facility
operate...same goes for words like "sterile"...