Team Biologics has provided the model for establishing a Pharmaceutical Inspectorate to assess drug manufacturing facilities,
particularly those that adopt innovative production and quality control systems. This group has about 45 field officers certified
for their expertise in understanding quality systems in order to tap them for evaluating quality-by-design production approaches.
A major drain on FDA's resources is the need to inspect a growing number of foreign manufacturing facilities that produce
drugs and biologics for the US market. In order to identify those facilities that are most important to inspect, FDA is working
more closely with foreign regulatory agencies to keep abreast of quality issues related to drug and vaccine makers in their
regions. After the Chiron debacle two years ago, FDA signed a formal confidentiality agreement with the United Kingdom's medicines
agency that allows sharing of regulatory information. FDA also has agreements with Canada and the European Medicines Agency
for quality information sharing and is pursuing additional agreements.
FDA hopes to expand its access to GMP information around the world by joining the 29 other nations in the Pharmaceutical Inspection
Cooperation Scheme (PIC/S). Most European regulatory authorities plus inspection officials from Australia, Canada, Malaysia,
and Singapore are members of this organization that seeks to build consensus on manufacturing standards and inspection procedures.
PIC/S provides a forum for representatives of regulatory agencies to exchange information and experiences related to GMPs,
quality inspection systems, and inspector training. Members share inspection reports, but there is no obligation to accept
the findings of other authorities. The group develops guidances on manufacturing and compliance issues, organizes training
seminars, and operates a rapid-alert system to inform other nations of product recalls. A main goal is to promote international
harmonization of GMPs.
FDA has long been an observer of PIC/S activities involving drugs and biologics, with particular involvement in programs for
blood and blood products, notes Malarkey. Last year, FDA applied for formal membership, as did Argentina, Israel, South Africa,
and several other nations. This launched a multiyear review process for PIC/S officers to assess FDA's internal system for
conducting quality inspections, for training investigators, and for ensuring industry compliance with GMPs. A main issue is
that FDA does not issue any kind of manufacturing site authorization, as do the Europeans, explained PIC/S chairman Jacques
Morenos at the PDA/FDA conference. Even CBER no longer requires biologics licenses for biotech production facilities. PIC/S
officials would like FDA to explain more fully how its GMP inspection program can ensure that a manufacturer meets regulatory
requirements as does the European authorization process.
FDA officials recognize the PIC/S approval process may take time, but anticipate playing a more active role in developing
recommendations and guidelines on manufacturing regulatory and compliance issues such as validation and sterility testing.
PIC/S aims to work more closely with the World Health Organization and international health organizations in Asia and other
regions with an eye to ensuring the competency of inspectorates around the world.
Jill Wechsler is BioPharm International's Washington editor, 7715 Rocton Avenue, Chevy Chase, MD 20815, 301.656.4634, firstname.lastname@example.org