ISPE's White Paper on "Risk-Based Approach to 21 CFR Part 11"

GMP News No. 289

GMP News
17 February 2003

ISPE's White Paper on 
"Risk-Based Approach to 21 CFR Part 11"

Since the publication of 21 CFR Part 11 in 1997, FDA has issued or announced a great number of Draft Guidances for Industry as interpretation aid. However, rather than facilitating the implementation of 21 CFR Part 11, these documents have shown the tendency to make it even more difficult.

During the last few weeks, there have been several announcements by FDA to rethink the Part-11 regulations, above all in order to find a risk-based approach to Part-11 implementation within the framework of the "CGMP Initiative" announced on 21 August 2002.

In this context, ISPE has published a White Paper for commenting by the industry - maybe in part at the request of PDA - that is meant to answer the most important questions.

The following key topics are discussed:

  • Definition of "electronic records"
  • Audit trails
  • Retention and maintenance of records
  • Electronic copies for inspection
  • Hybrid and procedural solutions
  • Application of electronic signatures

The essence of the document is that the GxP risk (risk to the patient or to product quality) should be analysed in each case individually and that further measures should be taken on the basis of the risk analysis. For the example of electronic records, this means that batch records and laboratory test results are considered to be highly GxP critical, while e.g. records of personnel training measures are classified as comparatively uncritical.

Records that relate directly to the product are thus considered to be highly critical and, therefore, their integrity has to be assured in any case, whereas less effort is required with regard to data that are not directly product-related - and therefore less critical.

On the whole, this Initiative is a good thing and might have been applied similarly in the world of GMP up to now. It is to be hoped, however, that the problems will not shift towards the question of "what is GMP critical."

This link leads you to the White Paper.

Dr Andreas Mangel

Go back

GMP Conferences by Topics