Handling of OOT for FDA Inspections !!

Concerns to GMPs are generally linked to the fear of FDA Auditors. As if the systems and procedures of organization are designed for the inspectors rather then for the internal improvements. 

First, there is no separate point of view of FDA from cGMP / system requirements. A self justified system with appropriate scientific rational must be acceptable to anyone, including FDA inspectors. 

The OOT procedure must have : 

(a) OOT identifying mechanism 
(b) OOT addressing mechanism (or action / alert program), and 
(c) Link to CAPA. 

The risk assessment study of process highlights the parameters where OOT must be identified. An appropriate study of available data helps in laying the limits for alert and / or action points (which are nothing but OOT action limits). 

The action plan for OOT (alert / action) is different for different parameters. 

The action plan may be linked to CAPA program so that (i) root cause of OOT is identified and (ii) repetition of OOT is eliminated.

Readers Encourage me !

It's good to see you all here following 'Realm of Quality'. Indeed it gives immense pleasure to see the numbers growing - not just for the sake of numbers, but to see you all who are interested to know more on practical GMPs and basic Industrial Quality Management per se.
Currently working on Environment Monitoring for non-sterile Manufacturing. It is taking bit time, but shall come back soon on the requirements which are not recommended by any International guideline.

Change Room and Air Lock - Design & Layout

What is the difference between a ‘change room’ and an ‘air-lock’? When Michael requested for more clarification on change rooms design vis-à-vis pressure differentials and movement of air, I didn’t thought that our discussion will go in so detail. While a change room is generally required for change of outside attire before entering a clean zone, the applied air-pressure differentials makes it an air-lock keeping outside air out and not allowing contamination to fly inside. Thus an airlock divides two different zones or classes of clean areas.
As Michael impressed on our discussions, I thought to share some of the useful bullet points emerging out of it.
Air lock connects two different environments, usually at different pressures, that enable personnel to transfer from one environment to the other.
An air lock is required when the particles from adjacent area is less clean than the clean-room of concern, therefore, the infiltration of particles can be minimized by controlling the air flow direction so that air flows from the clean room to its adjacent space (less clean). This can be easily accomplished by supplying more air than return air (++ condition), thus slightly pressurizing the room.
Above picture gives the schematic view of change room with requirement of pressure differentials across different zones.
See carefully the blue arrows for direction of air –flow, direction in which doors are opening and ‘+’ sign for pressure differentials.