WHO Technical Report Series, No. 981 - World Health Organization

WHO Expert Committee on Specifications for Pharmaceutical Preparations Forty-seventh report
WHO Technical Report Series, No. 981, 2013
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Professor A. Nunn, Formby, Liverpool, England; Dr A. Ojoo, United Nations
Children's Fund, Copenhagen, Denmark; Mr S. O'Neill, Managing Director, The
Compliance Group, Dublin, Ireland; Dr L. Oresic, Head, Quality Assurance
Department, Croatian Agency for Medicinal Products and Medical Devices,
Zagreb, Croatia; Dr P.B. Orhii, Director-General, National Agency for Food and
Drug Administration and Control, Abuja, Nigeria; Dr N. Orphanos, International
Programs Division, Bureau of Policy, Science, and International Programs,
Therapeutic Products Directorate, Health Products & Food Branch, Health
Canada, Ottawa, Canada; Professor T.L. Paál, Director-General, National Institute
of Pharmacy, Budapest, Hungary; Dr P.R. Pabrai, New Delhi, India; Mrs L.
Paleshnuik, President, LP Inc., Amprior, Ontario, Canada; Dr S. Parra, Manager,
Generic Drugs Quality Division 1, Bureau of Pharmaceutical Sciences,
Therapeutic Products Directorate, Health Canada, Ottawa, Canada; Dr Passek,
Federal Ministry of Health, Bonn, Germany; Dr D.B. Patel, Secretary-General,
Indian Drug Manufacturers' Association, Mumbai, India; Professor S. Patnala,
Professor, Pharmaceutical Analysis and Coordinator, University Instrumentation
Facility, KLE University, Belgaum, India; Mr C. Perrin, Pharmacist, International
Union Against Tuberculosis and Lung Disease, Paris, France; Dr M. Phadke,
Senior Manager, Analytical Research, Ipca Laboratories, Mumbai, India;
Pharmaceutical Inspection Co-operation Scheme, Geneva, Switzerland; Dr B.
Phillips, Medicines and Healthcare Products Regulatory Agency, London,
England; Dr B. Pimentel, European Chemical Industry Council, Brussels,
Belgium; Polychromix, Inc., Wilmington, MA, USA; Dr A. Pontén-Engelhardt,
Head of Stability Management, Global Quality, Operations, AstraZeneca,
Södertälje, Sweden; Ms A. Poompanich, Bangkok, Thailand; Dr R. Prabhu,
Regulatory Affairs Department, Cipla, Mumbai, India; Dr R.P. Prasad, Director,
Department of Drug Administration, Kathmandu, Nepal; Ms S.J. Putter, Walmer,
Port Elizabeth, South Africa; Ms M.-L. Rabouhans, Chiswick, London, England;
Dr A. Rajan, Director, Celogen Lifescience & Technologies, Mumbai, India;
Mr T.L. Rauber, Specialist in Health Surveillance, Agência Nacional de Vigilância
Sanitária Agency, Brasilia, Brazil; Mr N. Raw, Inspection, Emforcement and
Standards Division, Medicines and Healthcare Products Regulatory Agency,
London, England; Dr J.-L. Robert, Service du Contrôle des Médicaments,
Laboratoire National de Santé, Luxembourg; Dr S. Rönninger, Global Quality
Manager, F. Hoffmann-La Roche, Basel, Switzerland; Dr N. Ruangrittinon,
Bureau of Drug and Narcotic Department of Medical Sciences, Ministry of Public
Health, Nonthaburi, Thailand; Dr K.A. Russo, Vice President, Small Molecules,
United States Pharmacopeia, Rockville, MD, USA; Dr A.P. Sam, Merck, the
Netherlands; Dr C. Sánchez, CECMED, Havana, Cuba; Dr L.M. Santos, Scientific
Liaison – International Health, The United States Pharmacopeia, Rockville, MD,
USA; Dr T. Sasaki, Pharmaceutical and Medical Devices Agency, Tokyo, Japan;
Dr J. Satanarayana, Matrix Laboratories, Secunderabad, India; Dr B. Schmauser,