FDA-Drug Manufacturing Inspections (Pilot Program)

GMP News No 104

GMP News
2 April 2001

FDA-Drug Manufacturing Inspections 
(Pilot Program)

At FDA the realization has grown that it is no longer possible to achieve the intensive supervision of all systems and of all processes every two years. This realization has caused one to start thinking about how inspections of pharmaceutical companies can be conducted more efficiently and more rapidly in future. For this purpose, since January 2001 FDA has been testing a new program in 6 US districts for a period of six months.

With the launch of this program FDA seeks to show the pharmaceutical companies in workshops what it expects of the program and how the pharmaceutical industry should prepare itself for this "new" type of inspection.

In general, FDA pursues two strategies for checking product safety.

  • Within the framework of inspections in the pharmaceutical company
  • Inspecting the quality of the medicinal products
  • The published guide serves the purpose of establishing the first strategy. It defines both the two-year inspection and the system-based inspection.

    "System" is defined as the following sectors from the underlying structure of the cGMP rules.

    • Quality System
    • Facilities and Equipment System
    • Materials System
    • Production System
    • Packaging and Labeling System
    • Laboratory Control System

    FDA's idea is that the assessment of the system properties is usable for the various product classes, for instance in the handling of raw materials. If in this way the handling of raw materials is judged as acceptable in a system-based inspection one can assume that the handling of raw materials is acceptable in all of a company's product classes. Other examples listed may be the dealing with SOPs or the handling of the in-process control.

    Within the framework of the supervision the inspectors can choose between a "Full Inspection Option" and an "Abbreviated Inspection Option". The "Full Inspection Option" comprises at least four systems, one of which must be the Quality System, while the "Abbreviated Inspection Option" comprises at least two systems, one of which must also be the Quality System.

    The "Full Inspection Option" is to give a deep insight into the company's cGMP and is to be used in the following three cases:

  • There is too little information available about the company's cGMP
  • One has doubts as to the observance of the cGMP
  • In the past the authorities have issued orders concerning the cGMP
  • The "Abbreviated Inspection Option" is to be used in the following cases:

  • The company's cGMP history is satisfactory (no significant recalls or major deviations)
  • The production profile has not changed greatly during the past two years
  • You can find further details on the Drug Manufacturing Inspections (Pilot Program) on the FDA website http://www.fda.gov/ora/cpgm/7356_002/7356-002-Draft.DOC


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