EDQM issues Guidelines for OMCL Network

End of 2008, the European Directorate for the Quality of Medicines and HealthCare (EDQM) provided a number of quality assurance guidelines for the OMCL (Official Medicines Control Laboratory) network. One of these guidelines describes the qualification of equipment (Core Document - Qualification of Equipment) - aiming at harmonising the interpretation and application of the requirements from ISO 17025 for the OMCL network.

Because the terms DQ, IQ, OQ and PQ are not explicitly mentioned in the ISO 17025, they are also not demanded in this core document. They still can be used in OMCL labs though.

This core document defines the general requirements for the qualification of analytical equipment. In addition, there are separate annexes for the qualification of the following additional equipment types:

  • HPLC
  • GC
  • UV-Vis
  • IR
  • Automatic Titrators

For the OMCLs the document proposes the following four levels of equipment qualification:

  • 1. Choice of instrument and manufacturer
  • 2. Installation and approval for the application
  • 3. Periodic inspection of devices and inspection if required
  • 4. In-use instrument check

The complete EDQM core document is available here.

On 17 pages the document for the qualification of HPLC equipment lists in detail the specific requirements including typical tolerance limits for the single modules of a HPLC equipment. To find further details, please go here.

These specifications and recommendations are certainly not valid for analytical equipment in pharmaceutical analytics and quality control! They are only valid for the OMCLs like medicines examinations centres controlling the quality of medicinal products on the market.

Still, for staff and management in labs in the pharmaceutical industry it is certainly quite interesting to take a look at these documents for the comparison with own proceedings and acceptance limits.

Just recently - in early July - four guidelines for the validation of computerised systems were added.

The complete listing of the specific QA guidelines of the EDQM are available here.

Dr Günter Brendelberger
On behalf of the European Compliance Academy (ECA)

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