Hong Kong Guide to Good Manufacturing Practice for the Secondary ...

3. PREMISES
3.1 Premises used for secondary packaging should be specifically designed, constructed and
laid out to avoid product mix-up and cross-contamination.
3.2 The size of the secondary packaging area(s) should reflect the volume of work involved.
The adequacy of the working space or work bench for secondary packaging should
permit the orderly and logical positioning of equipment and materials so as to avoid
confusion and to minimize the risk of mix-up between different pharmaceutical products
and their components.
3.3 Secondary packaging areas and associated storage areas should be well-lit and
effectively ventilated, with air control facilities (including temperature and, where
necessary, humidity and filtration) appropriate both to the products handled and to the
operations undertaken within them. Temperature and humidity should be monitored
regularly, and record made in a logbook.
3.4 There should be adequate storage areas with general good housekeeping. The storage
areas should be designed and equipped to prevent the entry of insects, rodents and
other animals.
3.5 There should be a pest control program to control the entry of insects, rodents and
other animals. Appropriate records should be kept.
3.6 Segregated areas should be provided for the storage of approved, quarantined, rejected,
recalled and returned materials or products.
3.7 Rest and refreshment rooms should be separate from the secondary packaging area(s).
3.8 Adequate toilet facilities should be available and should be kept clean and in good order.
Toilets should not open directly into the secondary packaging area(s).
3.9 Premises should be cleaned and, where applicable, disinfected according to detailed
written procedures. Appropriate records should be kept.
Hong Kong Guide to Good Manufacturing Practice for the Secondary Packaging of Pharmaceutical Products Page 6