(1995; 156 pages)
ANNEX 1: Resolution adopted by the Twenty-second World Health Assembly
WHA22.50 Quality Control of Drugs
The Twenty-second World Health Assembly,
Recalling resolution WHA21.37;
Having considered the report for the Director-General on the quality control of drugs;
Noting with satisfaction the formulation of the "Principles of Pharmaceutical Quality Control"1 and "Good Practices in the Manufacture and Quality Control of Drugs"2 as presented in the report of the Director-General;
1Wld Hlth Org. techn. Rep. Ser., 1969, 418, Annex 1.
2 See Off. Rec. Wld Hlth Org. 176, Annex 12, part 1.
Recognizing that general observance of such principles and practices is essential and, in particular, a prerequisite for a system of certification for drugs in international commerce; and
Considering that general acceptance of such a certification system would be an important first step toward ensuring the desired level of quality control of drugs in international commerce,
1. RECOMMENDS that Member States adopt and apply
(1) the requirements for "Good Practices in the Manufacture and Quality Control of Drugs" as formulated in the report of the Director-General,2
(2) the certification scheme on the quality of pharmaceutical products moving in international commerce as formulated in the report of the Director-General as amended,3
3 See Off. Rec. Wld Hlth Org. 176, Annex 12, part 2.
2. REQUESTS the Director-General to report to the Twenty-third World Health Assembly
(1) on those improvements in the requirements for good manufacturing practice and in the certification scheme which may appear to be necessary; and
(2) on further progress with regard to the certification scheme and the implementation thereof.