Pharmaceutical Plant Sanitation And Cleanliness: Step One Along The Way For Quality, Safe And Efficacious Drugs

Abstract

Sanitation and Cleanliness plays a very important role in the manufacturing of efficacious, safe pharmaceuticals of high quality standard. A little carelessness or negligence in the follow up of the procedure can have adverse end result on the final product. If any anomaly is found out at the end product, it becomes very difficult to remove that ambiguity resulting in some time of the re-processing of the complete batch, which of course is very difficult and uncomfortable. The requirement for a written Sanitation and Cleanliness programme is mandatory in the pharmaceutical business and also in the regulation and the GMP Guidelines1. In addition to personnel sanitation programmes (including clothing requirements, zonal behavior, general code of conduct, personal hygiene, etc.), the specific assignment of the individual rooms in the pharmaceutical plant to the defined cleanliness grade is also stipulated therein2. Depending on the cleanliness grade, different degrees of disinfection measures must also be carried out. The respective cleaning process must be established, i.e. how, when, with what and by whom sanitation/cleaning process is carried out.  A cautious planned cleaned and documented beginning of the production process, results in quality, safe, efficacious and valuable time saving of the final dosage form.