regarding pharmaceutical production area lay out, in our start up company for small scale “specials” production, we are running mixing, extrusion and granulation in separate machines in one room. was thinking if we have to segregate that area into three different smaller areas or if it is fine to keep them in one room. Taking into consideration that we are planning to run just one batch at a time. Would appreciate any help and suggestions with reference.
It is acceptable to place the mixer, extrusion, and granulation equipment in one room.
However, please ensure the following aspects from the GMP point of view.
- To manufacture only one batch of one product at a time (on a campaign basis)
- To ensure that sufficient space is kept between all the referred equipment for easy movement of operators, and materials in this room.
- There should be sufficient space for utilities and other accessories required in this room.
- Also, cleaning and sanitation of equipment and the entire room should be easily performed.
- To facilitate maintenance of equipment in one room.
- There should not be crisscrossing of men and material in and from the room.
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Thanks @sunilrbudhkar. Can i please ask you of any references would help in this recommendation? I struggled to find any reference for room lay out. The SOP will specify that all tools are not mixed in the process but still worth support with reference like ICH to defend our position when we get the inspection.
Following are precautions and measures to be taken during production operations to avoid cross-contamination as stipulated in the Schedule ‘M’ (Part-1) of the Indian Drugs and Cosmetics Act 1940 and Rules thereunder 1945 (The Drug Rules 1945),
18.3. Prevention of cross-contamination and bacterial contamination during production-
18.3.3. Cross-contamination shall be avoided by taking appropriate technical or organizational
measures, namely:-
(a) carrying out production in dedicated and self-contained areas (which may be required for
products such as penicillins, cytotoxic, hormones, spore-forming, live vaccines, live
bacterial preparations and certain other biologicals);
(b) conducting campaign production (separation in time) followed by appropriate cleaning in
accordance with a validated cleaning procedure;
(c) providing appropriately designed airlocks, pressure differentials, and air supply and
extraction systems;
(d) minimising the risk of contamination caused by recirculation or re-entry of untreated or
insufficiently treated air;
(e) wearing protective clothing where products or materials are handled;
(f) using cleaning and decontamination procedures of known effectiveness;
(g) using a closed system in production;
(h) testing for residues; and
(i) using cleanliness status labels on equipment.
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