Quality Assurance of RUTF and similar products. Future areas of focus!

Transcription

1 1 Quality Assurance of RUTF and similar products. Future areas of focus! Peter S. Jakobsen 12 September 2013 Quality Assurance Centre SUPPLY DIVISION

2 2 RUTF Ready to Use Therapeutic Food Standards applied Overview of GMP inspections of manufacturers of therapeutic food Current and future trend for the manufacture of RUTF and similar products Results of RUTF testing Examples of root cause analysis received

3 3 Manufacturing standards Codex Alimentarius ISO (food safety management) Any other available information to understand, where food safety risks are found (used as guidance) such as Microbial Safety of RUTF (WHO / FAO Technical Meeting Summary March 2013)

4 4 Other available information Proposed interim purchase specifications specifications for microbiological hazards for lipid based supplementary foods (RUTF and RUSF) FAO/WHO June 2013 Code of Hygienic Practice for PIF (CAC/RCP ) Control of Salmonella in low moisture foods (

5 5 GMP inspections suppliers (not all is used) 28 GMP inspections carried out 4 joint GMP inspections with WFP and MSF (2010 and 2012) 2 joint GMP inspections with MSF 2 joint GMP inspections with US FDA 8 suppliers approved based on inspection report from MSF or WFP

6 6 Future focus areas Organisation / Hygiene Entry procedures to production is too weak. Good hand washing procedures must always be promoted It must be clear to staff that they now enter a food production area, where all efforts must be taken to prevent contamination of the food Production garments should be suitable and prevent contamination and only be used in the production area

7 7 Future focus areas Quality Management Written procedures should be more detailed System for handling of corrective and preventive actions (CAPA) should be improved Root cause analysis must be more detailed HACCP plan must be specific to product

8 8 Future focus areas Premises Premises must be designed to suit intended purpose and easy to clean Hand washing facility at entry to all areas Core production area with controlled ventilation to ensure a positive pressure where products are exposed Is dry cleaning possible?

9 9 Future focus areas Equipment Improve control at product changeover Cleaning of production equipment must be better controlled. Total removal of water is important. Failures observed several times. High EB counts. Dry cleaning No or limited metal detection Continue focus on closed production systems

10 10 Future focus areas Production procedures - 1 Apply heat treatment where relevant and with no impact on product stability Changes in formulation/manufacturing process must be controlled and well documented Prevent oil separation in product Improve validation efforts to provide documentation for a uniformity of subbatches Reconsider the batch size one week may be too long

11 11 Future focus areas Production procedures - 2 Continue to focus on Salmonella and Enterobacteriaceae in environmental testing Continue focus on batch documentation for dispensing and in-process control (mixing, sealing, printing, residue oxygen in sachets) as 100 % testing of each mix is not carried out

12 Future focus areas Quality control Improve testing / control of raw materials (as these have a direct impact on quality of the finished product) Special attention to peanuts and other materials that may possess a risk (Salmonella, EB, aflatoxin) Always receive Certificate of Analysis for raw materials Always use full pre-mix and stop adding separate vitamins!

13 Future focus areas Quality control Improve testing of finished product, so the whole specification are covered at regular intervals Out of specification test results. Introduced testing by manufacturers has highlighted issue. Specific problems with Omega 3 / 6 and certain vitamins (Vitamin A) Improve documentation of stability studies, so documentation include discussion of obtained results

14 14 UNICEF QC testing of supplies Pre-delivery inspection will continue as UNICEF still wish to gather information on products. Focus will be on salmonella, EB and aflatoxin, but we expect the product always comply with the full specification

15 UNICEF QC testing of RUTF June Sep batches tested from 16 companies (25 samples for salmonella and 10 for EB) 4 batches found positive for Salmonella (2 companies) 18 batches had EB > 10/gram 9 batches were Out of Specification (4 companies)

16 16 Root cause analysis ID of Salmonella strain (by UNICEF) Retest by company with high number of samples (minimum 60 sachets covering all shifts) Potential source of the contamination (review HACCP plan) Retest of raw materials Audit of key suppliers needed? Extended environmental monitoring What are the impact on other batches Do these need retest

17 17 Salmonella positive case 1 ID of Salmonella (Mbandaka) Retest by company with 30 sachets per batch confirmed contamination with Salmonella Potential source of the contamination identified as peanuts Extended environmental monitoring What are the impact on other batches Investigation report did not clearly specify that the suspected peanut lot had been used in already released batches! Company and not UNICEF should take action!

18 18 Salmonella positive case 2 ID of Salmonella (Weltevreden) Retest by company with only 25 samples of 25 gram all negative (minimum 60 sachets covering all shifts should be done) Potential source of the contamination not identified Retest of raw materials (reference samples) Environmental monitoring just referred to monthly testing What are the impact on other batches Audit of critical suppliers not carried out

19 19 EB Out of Specification results Poor cleaning procedure used. Problem actually identified by company, but it failed segregate non-confirming materials, which then was offered to UNICEF. Issue still being investigated Another case with 4 out of 9 batches failing test for EB showed that peanuts was the root cause for the contamination as high EB test results was identified for peanuts.