This document discusses sanitation and maintenance procedures for buildings used in pharmaceutical manufacturing. It outlines that (1) buildings must be kept clean and sanitary without infestation, and there must be written cleaning procedures assigning roles and describing schedules, methods, and materials. (2) There must also be written pest control procedures using registered products. (3) Cleaning procedures apply to all employees and contractors. It also notes that buildings must be kept in good repair, monitoring for issues like cracks, holes, damage, and dust accumulation, and ensuring essential services like utilities are maintained.

1. SRIKRUPA INISTITUTE OF PHARMACEUTICAL SCIENCES
(Approved by AICTE; PCI)
(Affiliated to Osmania University)
ASSIGNMENT ON
SANITATION AND MAINTENANCE
SUBMITTED BY
HUZAIFA NAAZ

2. SANITATION AND MAINTENANCE
Sanitation
(a)Any buildingusedinthe manufacture,processing,packing,orholdingof a drugproduct shall be
maintainedinacleanand sanitarycondition,Anysuchbuildingshallbe free of infestationbyrodents,
birds,insects,andothervermin(otherthanlaboratoryanimals)
.(b)There shall be writtenproceduresassigningresponsibilityforsanitationanddescribinginsufficient
detail the cleaningschedules,methods,equipment,andmaterialstobe usedincleaningthe buildings
and facilities;suchwrittenprocedures shallbe followed.
(c) There shall be writtenproceduresforuse of suitablerodenticides,insecticides,fungicides,
fumigatingagents,andcleaningandsanitizingagents.
 writtenproceduresshall be designedandfollowed.
 Rodenticides,insecticides,andfungicidesshallnotbe usedunlessregisteredandusedin
accordance withthe Federal Insecticide,Fungicide,andRodenticideAct.
(d) Sanitationproceduresshallapplytoworkperformedbycontractorsortemporaryemployeesaswell
as workperformedbyfull-time employeesduringthe ordinarycourse of operations.
Maintenance
Anybuildingusedinthe manufacture,processing,packing,orholdingof a drugproduct shall be
maintainedinagoodstate of repair
Monitorcracks andholesinwalls,floorsandceilings;damage toinsulationorpipes;dustaccumulation
on lightfittingsetc.
Essential serviceswillinclude water,steam,vacuum,compressedairand othergases,electricity,dust
extraction,product/material pipe line,drainage.