123
20. Offi cial Medicines Control Laboratories Network of the Council of Europe,
Quality Assurance Documents:
— PA/PH/OMCL (08) 73 — Qualifi cation of equipment (http://www.edqm.eu/
medias/fi chiers/NEW_Qualifi cation_of_equipment_core_document.pdf),
— PA/PH/OMCL (07) 17 DEF –Annex 1: Qualifi cation of HPLC equipment
(http://www.edqm.eu/medias/fi chiers/Annex_1_Qualifi cation_of_HPLC_
Equipment.pdf),
— PA/PH/OMCL (06) 86 DEF — Annex 2: Qualifi cation of GC Equipment
(http://www.edqm.eu/medias/fi chiers/Annex_2_Qualifi cation_of_GC_
equipment.pdf),
— PA/PH/OMCL (07) 11 DEF CORR — Annex 3: Qualifi cation of UV-visible
spectrophotometers (http://www.edqm.eu/medias/fi chiers/Annex_3_
Qualifi cation_of_UV_Visible_spectrophotometers.pdf),
— PA/PH/OMCL (07) 12 DEF CORR - Annex 4: Qualifi cation of IR
spectrophotometers (http://www.edqm.eu/medias/fi chiers/Annex_4_
Qualifi cation_of_IR_spectrophotometers.pdf),
— PA/PH/OMCL (07) 108 3R — Annex 5: Qualifi cation of automatic titrators
(http://www.edqm.eu/medias/fi chiers/NEW_Annex_5_Qualifi cation_of_
Automatic_Titrators.pdf).
21. US Pharmacopeia, 32nd ed. General chapters: <1058> Analytical instrument
qualifi cation. Rockville, MD, 2009.
22. WHO guidelines for sampling of pharmaceutical products and related
materials. In: WHO Expert Committee on Specifi cations for Pharmaceutical
Preparations. Thirty-ninth report. Geneva, World Health Organization, 2005,
Annex 4 (WHO Technical Report Series, No. 929).
23. Stability testing of active pharmaceutical ingredients and fi nished
pharmaceutical products. In: WHO Expert Committee on Specifi cations
for Pharmaceutical Preparations. Forty-third report. Geneva, World Health
Organization, 2009, Annex 2 (WHO Technical Report Series, No. 953).
24. Supplementary guidelines in good manufacturing practice: validation.
Analytical method validation. In: WHO Expert Committee on Specifi cations
for Pharmaceutical Preparations. Fortieth report. Geneva, World Health
Organization, 2006, Annex 4, Appendix 4 (WHO Technical Report Series,
No. 937).
25. Guid eline of the International Conference on Harmonisation of Technical
Requirements for Registration of Pharmaceuticals for Human Use (ICH)
Q2(R1): Validation of analytical procedures: text and methodology (http://
www.ich.org/LOB/media/MEDIA417.pdf).
26. Offi cial Medicines Control Laboratories Network of the Council of Europe,
Quality Assurance Documents: PA/PH/OMCL (05) 47 DEF — Validation of
analytical procedures (http://www.edqm.eu/medias/fi chiers/Validation_of_
Analytical_Procedures.pdf).
27. The US Pharmacopeia, 32nd ed. General chapters: <1225> Validation of
compendial procedures and <1226> Verifi cation of compendial procedures.
Rockville, MD, 2009.
28. Offi cial Medicines Control Laboratories Network of the Council of Europe,
Quality Assurance Documents: PA/PH/OMCL (07) 28 DEF CORR —
TRS957.indd 123 21.04.10 11:03