Slide 1

Group 3

Andam Dewi Pertiwi(2014001194)Arsillia Rochimatus(2014001201)Auva Marwah Murod(2014001296) Christian Purba(2014001207)Dewi Astuti(2014001218)

Operational instructions the application of GMPParts: building and facilitiesBuildings and facilities for the manufacture of drugs should be:1. Design, construction and layout are adequate, and adjusted condition.2. Properly maintained to facilitate the implementation of correct operation.3. The layout and design of the room is made in such a way to minimize the risk of errors and cross-contamination, as well as easy cleaning, sanitation and maintenance.FundamentalNot traversed by unauthorized personsAvoided from environmental pollutionSuitable for protection during the production process.Humidity, temperature, lighting, and ventilation should be sufficient.in order to all the rooms and facilities are always clean.FACILITIES SUPPORTNON-STERILE PRODUCTION ROOM

ASEPTIC PRODUCTION ROOM

FINAL STERILIZATION PRODUCTION ROOM

STORAGE ROOM

QUALITY CONTROL LABORATORY