Part 2 The Process Area

Important as one starts to review the process area compliance is to monitor the company’s policy on movement in/out of the process area. This ingress/egress can be the first important step in assuring that the product is going to be in compliance. Attitudes towards gowning, such as the use of beard covers, hair covers, shoe covers, non-powder shedding rubber gloves, laboratory coats/bunny-suits and other PPE, will shape the fundamentals for the rest of the operation, so it is important to check this is done properly and that personnel follow the SOP’s in place. Do they use hand sanitizer after gowning? Be thorough here is the advice!

Monitor the disposal of wrappers, the use of waste bins and those ancillary things that may be left lying around, to ensure that the company has things under control.

Moving into the process area through a vestibule (gowning pass-through), note whether there is proper differential pressurization control ingress from the process space. Process material for the formulation will enter the process space on a plastic or aluminum pallet via a separate (larger), differential space. Under no circumstances should wood enter the process space!

Material containers may have sanitizing wipe down procedures, so make sure these are in place and being used.

Check out the access corridor condition after leaving the ingress/ egress space. The floor ideally should be epoxy covered and the walls should be epoxy painted. Ceilings should be constructed of non- shedding material and lighting needs to be appropriate and fit for purpose, depending upon the product manufactured. Looking for dirty areas, signs of pests should also be noted as one progresses down the access corridor to the individual process unit operation spaces, such as blending. Material being staged should be appropriately labeled with the lot numbers and put into a control space; usually designated by a yellow floor marking or plastic chained off area. If the material is product labels for example, these will be locked in a cart, having previously been issued by label QA personnel. In all cases the material will have a transit record accompanying the materials to assure proper chain of custody and control.

The in the blending room (if we consider a V- blender as an example), the batch record should be set out with the separate components and these should be individually checked into the blender, by sequence, as listed in the batch record.

Look at an example of this batch record and note the times, dates and initials (signatures), to assure each action was performed properly. If actual production is ongoing, then observe the practice to further assure that the batch record is followed accurately. Depending upon the process steps, these should be countersigned off by a “check “person, such as a supervisor or a lead operator. The condition of the space, how the material components added, whether in sequence or not for example, should be noted and how the batch record notations are recorded. Is the batch record in the process room or somewhere else? Carefully watch the operators including (in this case) how the material is offloaded, such as into drums that are double lined with plastic bags. How is the material labeled and is there any possibility for mix-ups? Note how the process material is moved within the facility. Is there a good chain of custody if it’s being on processed or moved to the warehouse? Is there movement on plastic/aluminum pallets? In relation to personnel, is there a need for additional gowning, or when they leave the process area, what procedure is followed in relation to the de-gowning?

Asking questions about room classification, cleaning regimes and labeling are a few other routine points that should be noted as one tours the process area. All these elements are points for one to establish whether the space is under control, and whether the staff operating the process know their jobs and responsibilities.

Auditing a process area is a detailed activity, but this should provide some basic guidance points to enable a review to be approached in the correct way.