Regulatory Beat: Biotech Manufacturers Face Streamlined Inspection Programs - Compliance officials are implementing new approaches and promoting international cooperation to make inspection processes


Regulatory Beat: Biotech Manufacturers Face Streamlined Inspection Programs
Compliance officials are implementing new approaches and promoting international cooperation to make inspection processes more efficient

BioPharm International
Volume 19, Issue 11

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,

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