UNICEF Requirements for RUTF Manufacturers

Transcription

1 UNICEF Requirements for RUTF Manufacturers Jan Komrska in collaboration with Quality Assurance Center Consultation with RUTF Suppliers Copenhagen, 18th October, 2010

2 Today s presentation addresses 3 questions: What are UNICEF requirements for RUTF manufacturers? What does UNICEF check before it enters into a contract with a supplier? What does UNICEF check after it enters into a contract with a supplier?

3 Background UNICEF is a buyer of food used for programmatic purposes UNICEF is not a normative organization and we do not want to be seen as one UNICEF uses and refers to available international standards for production of food

4 What are UNICEF requirements for RUTF manufacturers? 1. Food Manufacturing License 2. Manufacturing standards: Codex Alimentarius ISO (Food safety management systems Requirements for any organization in the food chain) ISO 9001:2000 (Quality management systems Requirements) Any other applicable standard

5 Inspection aide memoire Current aide memoire is based on Codex Alimentarius and ISO Used to ensure that important points not are left out during an inspection Not a checklist Will be shared with all the suppliers/bidders

6 Conclusion (1) UNICEF has in place Quality Assurance System supported by a team of professionals. Requirements are shared with all potential manufacturers. What does UNICEF check before it enters into a contract with a supplier?

7 Approval of the RUTF Suppliers All manufacturing sites must be approved by Supply Division QA Center Decision based on the regulatory environment in country of origin and prior experience of UNICEF GMP inspection by UNICEF or a representative selected by UNICEF Contract Manufacture only accepted if subcontractor also is approved by UNICEF

8 GMP inspections by UNICEF To check compliance with UNICEF requirements Primarily done by UNICEF staff 20 GMP inspections carried out in companies failed (15 %) Detailed GMP inspection report forwarded to company with request to respond within 1 month

9 GMP inspections collaborations Local authority invited to participate Joint inspections with MSF UNICEF is an observer to the Pharmaceutical Inspection Cooperation Scheme (PIC-S)

10 Conclusion (2) UNICEF has in place Quality Assurance System supported by a team of professionals. Requirements are shared with all potential manufacturers. Quality Assurance focuses on identifying suppliers able to produce quality products before we sign the first contract. What does UNICEF check after it enters into a contract with a supplier?

11 Quality control of direct shipments (UNICEF) Pre-delivery inspections - third party contractor - country office Review of packing list and Certificate of Analysis Random quality control testing in accordance with prior experience

12 Quality control testing (UNICEF) Analysis performed on a random basis according to an annual plan Microbiological and analytical testing is performed by TÜV SÜD PSB Testing Service in Singapore Aflatoxin is tested by Eclipse Laboratory in UK

13 Certificates of Analysis (Suppliers) All suppliers are expected to submit original Certificates of Analysis together with invoice to Supply Division.

14 GMP inspections All manufacturers are GMP inspected at regular intervals normally every 2 5 years

15 Complaints QAC is responsible to collect and manage the complaints from the customers. Complaints related to: Secondary packaging (quality of cartons) Loading the pallets to containers Short shelf life at arrival Missing required documentations Leakage of sachets Best before date is not understandable Difficult to open sachets/pouches

16 Conclusion (3) UNICEF has in place Quality Assurance System supported by a team of professionals. Requirements are shared with all potential manufacturers. Quality Assurance focuses on identifying suppliers able to produce quality products before we sign the first contract. Quality Assurance closely and continuously monitors performance of suppliers and makes sure products supplied are of consistent quality.

17 Concerns (1) Weak regulatory framework in countries where manufacturing site is located Referral laboratories not available or provide false negative results Aflatoxin level control is weak Complete product analysis in not performed on a regular basis Batch size is too large and therefore it is not homogenous

18 Concerns (2) Stability studies are not performed at the required temperature and humidity. Oil separation testing method is not available.

19 Thank you!