Pharmaceutical Manufacturing Handbook: Production and

for the promulgation of any such regulations by the Commission shall be conducted
by the Commission or by such offi cer or employee of the Commission as the Commission
may designate for that purpose.
(c) Cooperation with Other Departments and Agencies In carrying into effect the
provisions of this chapter, the Secretary and the Commission are authorized to
cooperate with any department or agency of the United States, with any State, Commonwealth,
or possession of the United States, and with any department, agency, or
political subdivision of any such State, Commonwealth, or possession.
(d) Returnable or Reusable Glass Containers for Beverages No regulation adopted
under this chapter shall preclude the continued use of returnable or reusable glass
containers for beverages in inventory or with the trade as of the effective date of
this Act, nor shall any regulation under this chapter preclude the orderly disposal
of packages in inventory or with the trade as of the effective date of such
regulation.
3.2.5.9 United States Pharmacopeia Center for the Advancement of Patient
Safety [45]
For nearly 33 years, the USP has been reporting programs for health care professionals
to share experiences and observations about the quality and safe use of
medications. This year, the USP Center for the Advancement of Patient Safety
publishes its sixth annual report to the nation on medication errors reported to
MEDMARX (Table 6 ). It was observed that drug product packaging/labeling is one
of the main courses of medication errors in hospitals.
3.2.5.10 National Agency of Sanitary Vigilance ( ANVISA , Brazil)
ANVISA is a federal organization linked to Brazil ’ s Health Ministry, which has the
incumbency of looking after medication quality and other health products aimed at
patients ’ safety. Several documents regarding GMP and quality control are easily
accessed. The agency is also responsible for establishing enforcing the rules and can
take corrective measures and punish the offenders [46] .
Product stability and compatibility with the conditioning material are distinct,
separate, and complementary concepts which should be applied to the pharmaceutical
product before being made available for health care.
TABLE 6 Selected Causes of Error Related to Equipment, Product Packaging/Labeling,
and Communication in ICUs
Cause of Error N (Nonharmful + Harmful)
Label (the facility ’ s) design
1,236
Similar packaging/labeling
Packaging/container design
Label (manufacturer ’ s) design
Brand/generic names look - alike
REGULATORY ASPECTS 195
Percent Harmful
Source : MEDMARX Data Report: A Chartbook of 2000 – 2004 Findings from Intensive Care Units
(ICUs) and Radiological Services.
6,9