What special requirements must the work area meet if the business involves repackaging or relabelling medicines?

If your business involves secondary packaging of medicines (such as assembling packs) or relabelling, the area where these operations take place must meet a higher standard than an ordinary storage area, approaching that of a basic cleanroom. First, it must be a physically separate, enclosed room with independent access control. Second, it should have its own filtered ventilation system to control airborne dust particles and prevent cross-contamination. The walls, floor and ceiling must be smooth, seamless and easy to clean. Third, there should be an anteroom at the entrance where staff change into dedicated clean workwear, shoe covers and head covers. Fourth, the outer packaging of all materials used for packaging (such as new labels and cartons) must be cleaned before entering the area. Finally, all operations carried out in the area must have detailed batch production records and be traceable.