technicalquestionnaireforpharmaceutical.docVIP

TECHNICAL QUESTIONNAIRE FOR PHARMACEUTICAL MANUFACTURERS To be completed and returned to UNICEF Supply Division, Quality Assurance Centre, Freeport, DK-2100 Copenhagen, Denmark, with all requested documents attached. This information is requested in addition to the information requested through the registration at United Nations Global Market Place. . Further information about UNICEF’s purchase of pharmaceutical products and general quality requirements can be found on /supply/index_suppliers.html 1. GENERAL INFORMATION Name, address, telephone, email, fax, Internet address of the company: 2. AFFILIATES If the company is owned by another company, or belongs to a group of companies, please indicate your position within the structure: 3. REGULATORY ISSUES 3.1. Good manufacturing practice Indicate the GMP standards (WHO, PIC-S/EU, FDA or other) with which the company complies: 3.2. Manufacturing licence for medicinal products Please list the pharmaceutical dosage forms you are licensed to manufacture by the National Regulatory Authority and attach a copy of the Manufacturing licence(s) or GMP certificate (it must indicate dosage forms manufactured): 3.3. Inspection Date of last inspection by the National Regulatory Authority: Please attach a copy of the last inspection report if it can be made available for review by UNICEF on a confidential basis. Names of all other Regulatory Authorities and International Organisations who have inspected the company. Please also state the outcome of the inspection: Please attach a copy of the last inspection report if it can be made available for review by UNICEF on a confidential basis. 4. MANUFACTURING 4.1. Manufacturing site Please state all addresses at which manufacturing of pharmaceutical products takes place, and indicate which year the factory was built (complete one questionnaire for each site): 4.2. Personnel Please indicate the name and the education of the f