Capacitación

MAINTENANCE OF VALIDATION STATE (1st. part)

This concept was one of the ítems that were modified in the last revision of the Mexican GMP Regulations (NOM-059 and NOM-164) and it is a subject of great interest.

Everybody as Validation or Compliance practitioners are well aware thet the conformance lots of process validation, or the IQ/OQ/PQ of support services and equipments, are events that serve to document standard perfomance when completed in a satisfactory way. However, they do not guarantee continued good performance.

It is through monitoring, data evaluation, statistical analysis, change control, and other programs, that ongojng good performance is maintained. All this concepts could be integrated if we refer to GMP Monitoring.

This GMP Monitoring entails the following three distinct activities:

  • Collecting data and information over the time
  • Reviewing and analizing the information collected, thus continually being aware of the current state
  • Defining controls and warning systems

 

Collecting data and filing it without review and analysis is considered gathering not monitoring. Monitoring implies collection of data and information over a long period of time at pre-established intervals, or when certain events occur. This enables the understanding of what is going on, anticipation and corrections of problems, and enhaced control of the operation.

The need to monitor is not only dictated by the regulation but also by Good Practices. Monitoring is used to do the following:

  • Fulfill the promise of continuous improvement in that collection and analysis of operating data improves the understanding of the underlying technology and supports continuous improvement.
  • Ensure systems and opertion (facilities, services, processes and personnel) are always in a state of contro, compliant with GMO and in a validated state.
  • Develop baseline information to establish operating capabilities
  • Identify problems before they occur
  • Maintain the validated state and demonstrate consistency.

 

References:

  • Journal of Validation Technology. Gamal Amer, Ph.D.
  • FDA Guidance for Industry, Proess Validation, General Principles and Practices
  • The Complete Validation Handbook. GMP Validation Guuidance for Pharma