WHO Specifications for Pharmaceutical Preparations, 6/11

WHO Specifications for Pharmaceutical Preparations, 6/11


This WHO Expert Committee Report was published in 2011. Usage and controls for computerized systems are described throughout the documents.


WHO Specifications for Pharmaceutical Preparations, 6/11

The WHO Expert Committee Report on Specifications for Pharmaceutical Preparations was published in 2011. It contains the collective views of an international group of experts including representatives from international regulatory agencies, EU, IFPMA, IGPA, IPEC, PIC/S, UNICEF, BSP and USP.

Usage and controls for computerized systems are discussed throughout the documents.

  • Section 15.9 outlines requirements for electronic document management systems. These include security, audit trails, back-ups, and retention.
  • Sections 15.25 and 15.28 contains recommendations to use validated computer programs for batch records

Annex 4: Guidelines on GMP for Blood Establishments

  • This annex describes acceptable and recommends uses of computer systems within sections 3.11, 7.4, 8.2, 8.3, 9.2.3, 9.2.5,, and 9.8
  • Section 5.2.2 and 6 provide a list of required controls for computerized systems. These include security, validation, periodic revalidation or annual checks, back-ups, archival, retention, procedures, change control, training, audit trails, and 2nd person verification of critical data entry.

Annex 5: Guidelines on GMP for HVAC Systems for Non-sterile Pharmaceutical Dosage Forms

  • Section 7.1.3 briefly describes the use of computerized HVAC systems

Annex 9: Guidance for the Storage and Transport of Time- and Temperature-Sensitive Pharmaceutical Products

  • Section 9.2.1 details requirements for computer records

Annex 13: Guidelines for Preparing a Laboratory Information File

  • Section 6.4 lists LIF elements related to computer systems, such as validation, access, back-ups, and data integrity management

Annex 14: Guidelines for Drafting a Site Master File

  • Sections 4.2.3 and 6.1.1 contain the requirement for inclusion of a description of GMP critical systems in the Site Master File
Issuing Body WHO


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