1.What are the basic requirements of
premises of pharmaceuticals production Area?
Premises of Manufacturing Area
1.Dedicated facilities
2.Logical flows of materials and people.
3.Adequacy of working space and orderly and logical
positioning of equipment.
4.Interior surfaces smooth, crack-free and easy to
clean.
2.What are the basic requirements of
premises of pharmaceuticals product & RM Storage Area?
Premises of RM store Area
1.Storage areas of sufficient capacity
2.Clean, dry and maintained within acceptable
temperature limit
3.QC sampling area with GMP standard
4.Segregated areas for rejected recalled and returned
materials
5.Separate areas for highly active hazardous narcotics
materials
Premises of Manufacturing Area
5.Dedicated facilities
6.Logical flows of materials and people.
7.Adequacy of working space and orderly and logical
positioning of equipment.
8.Interior surfaces smooth, crack-free and easy to
clean.
No comments:
Post a Comment