PATH & WHO & UNFPA Workshop Prequalification Programme in Procurement Practices: Session 8 QA and no PQ Programme

Publication date: 2008

Session 8: Quality Assurance of Products Not Listed Under the WHO Prequalification Programme Question for Participants How do we ensure the quality and integrity of a product that has not been prequalified by WHO? Note: WHO has on options that are included in WHO prequalification and regulatory processes. Disclaimer: Not all tests or options presented in this session are recommended by WHO All health products need to comply with acceptable selection criteria … Procurement agencies and NRAs must be able to answer: • Is the product safe and effective? • Have sufficient measures been taken to ensure quality throughout the supply chain? • Has competition been effective? • Have you assessed your own capacity to judge these requirements? Specify quality in tender and contract documents Determine quality requirements in advance by: • Knowing the best available standards • Knowing the marketplace and products • Involving chief pharmacists and quality assurance (QA) personnel • Engaging procurement managers to ensure neutrality in specifications • Being specific in tender and contract on how you will measure and hold manufacturers accountable for QA EXAMPLE: Pharmaceutical products Some key quality questions … • Was the product manufactured under cGMP conditions? • Is the active ingredient of good quality? • Is the test data supporting the expiry date validated? • Is the product stable in the local climate? • Can I use it interchangeably with more affordable options, but not jeopardise quality ? EXAMPLE: Pharmaceuticals Building on what exists … cGMP API Expiry date Stable in hot humid climate Inter- changeable Registered in ICH country √ √ √ ? + or - Registered in PICS country √ + or - ? ? ? Registered for export only ? ? ? ? ? Registered in your own country ? ? ? ? ? Other Quality Assurance Activities Site visits to manufacturing facility: • With a qualified inspector (trained NRA representative or other credible party), visit the facility to inspect for: – QA procedures and documentation – Shipment and storage areas – Current good manufacturing practices (cGMP) – Data verification of batches already supplied Range of Other Quality Assurance Measures • QA measures can range from simple to complex and can depend on the resources available Be proactive l e a s t i n t e n s i v e m o s t I n t e n s i v e Develop criteria for action, for example… Test batches with credible test laboratories prior to shipment Conduct site visits of the facility Test batches on arrival by NRA or credible laboratory Include penalties in contracts for failure to comply with QA specifics Use documentary review or pre- shipment inspections Check references Other aspects … • Review certificates of analysis and sterility, bio-equivalence and other relevant documents • Have the batch independently tested to assure that results correspond with those documented – Use laboratories with credible certifications (e.g., WHO) • Follow up on product updates (variations), product complaints, and take action Require specific packaging, markings, to detect contraband and protect against poor storage conditions Use temperature indicators where relevant Others? Low Impact Medium Impact High Impact Low Difficulty Medium Difficulty High Difficulty Risk Mitigation Day 2: Session 8 Trainer’s Aid Quality Assurance Options for Products Not Listed Under the WHO Prequalification Programme Group Exercise Instructions to trainer: List of materials: • Handout 1: “Things a purchaser can do when goods are not prequalified by WHO.” • Handout 2: “Categorizing options when prequalified systems are not available.” If you prefer to have participants brainstorm without the suggestions, then Handout 2 is not needed. • Half or quarter sheets of paper for brainstorming ideas. • You will need a large chart simulating the prioritization matrix in Handout 2. A color version of the matrix is also in the PowerPoint for this session. The large matrix could use a “blue wall” (large cloth that is used in other exercises) with grids made from tape, or flipchart pages arranged in a similar grid. The chart should be large enough for participants to post responses within the grids on the box. If possible, it is helpful to color code the grids using colored tape, or a marker, that correspond to the colors use in the power point example. 1. Distribute Handouts 1 and 2. 2. Print or write each example from Handout 1 on a small slip of paper and distribute them to participants. If time is limited, split up the examples, and have half of the groups begin with number 1 on Handout 1 and work down the list, and that the other half of the groups start with number 27 and work up the list. 3. Ask participants to work in small groups. They should review the slips of paper, the other handouts, and also brainstorm any additional options for assuring quality when prequalification is not available. Each new idea should be written on its own slip of paper. 4. Participants should work as a group to decide where each example or additional idea belongs on the prioritization matrix (Handout 2). They should make note of it in preparation of posting it later. 5. When participants are finished, have a representative from each group come to the large prioritization grid and post them in the boxes as agreed by their group. 6. When all activities are placed on the wall, have a wrap-up discussion including the following questions: • What are the trends that appear in the box with high impact and low difficulty? Are these being done in countries now? If not, what could be done to promote or encourage them? • How useful was it for participants to categorize quality assurance options? • Which activities are the most important for ensuring quality assurance products? • What other parties, departments, or personnel work with the Ministry of Health and who are other stakeholders? • What can be done to make the difficult, yet high impact activities possible? The WHO Prequalification Programme for Essential Reproductive Health Medicines: A Workshop on Using the Programme in Procurement Practices Day 2: Session 8 Handout 1 What a Purchaser Can Do When Goods Are Not Prequalified by WHO 1. Arrange pre-shipment inspections of batches prior to shipment. 2. Work with independent testing laboratories. 3. Arrange destination inspections. 4. Contact the national regulatory authority to establish what types of inspections are performed at manufacturing sites and what medicines are quality control-tested for analytical verification of quality. (Levels and types of inspections, if any, can vary from country to country.) 5. Work with pharmacy staff to understand the quality indicators. 6. Review WHO’s model list of essential medicines. 7. Request certificate of analysis from manufacturer along with any other relevant shipping documentation. 8. Request temperature monitors on temperature sensitive medicines or other monitors for physical condition during transport. 9. Establish penalties in contracts for failure to meet quality standards. 10. Review documentary evidence of any regulatory agency documents prior to ordering. 11. Require evidence, such as certificates of analysis in letters of credit (or other forms of documentary collection). 12. Request references and CHECK them, especially requesting any concerns or episodes of quality problems. 13. Establish whether or not the supplier has a reliable quality control laboratory. 14. Establish whether products are tested independently or only by the manufacturer. 15. Evaluate proof of tests—chemical, biological, stability, accelerated stability, or others—that are routinely performed during and after the manufacturing process. 16. Establish if any special tests are performed for stability of product in tropical environments. 17. Establish which, if any, official government agencies or reputable international organizations have inspected the manufacturing facilities. 18. Review the results of the most recent inspections. 19. Review certification documents that are available from the regulatory agency concerning the supplier’s status and compliance with current good manufacturing practices (cGMP). 20. Review any internationally recognized certificates that the manufacturer holds (i.e., ISO). 21. Evaluate the qualifications of key production and quality control personnel. 22. Understand the capacity of the supplier’s plant(s). 23. Investigate how the supplier is regarded by knowledgeable physicians and pharmacists. 24. Review any information available from public sources (such as newspapers or trade journals) concerning the supplier’s performance locally or in other countries. 25. Establish whether or not the product is produced by a known, high-quality manufacturer. 26. Review how the products are labeled (i.e., look at samples). 27. Understand how the products are packaged and shipped for export. The WHO Prequalification Programme for Essential Reproductive Health Medicines: A Workshop on Using the Programme in Procurement Practices Day 2: Session 8 Handout 2 Categorizing Options When Prequalified Systems Are Not Available Review the examples of what procurement entities and stakeholders can do in situations where a prequalification system does not address a particular commodity. Add any others to the list that you feel are missing. Using the examples above, categorize the options according to their effectiveness and how many resources they require. As contexts change relative to the commodity and the systems of each country, you may find this activity helpful in identifying the most rational approach to managing situations where prequalification is not readily available. Low Effect Medium Effect High Effect Lo w R es ou rc e M ed iu m R es ou rc e H ig h R es ou rc e The WHO Prequalification Programme for Essential Reproductive Health Medicines: A Workshop on Using the Programme in Procurement Practices 8a - PPT - QA Options Session 8:�Quality Assurance of Products Not Listed Under the WHO Prequalification Programme Question for Participants All health products need to comply with acceptable selection criteria … Specify quality in tender and contract documents EXAMPLE: �Pharmaceutical products�Some key quality questions … EXAMPLE: Pharmaceuticals�Building on what exists … Other Quality Assurance Activities Range of Other �Quality Assurance Measures Develop criteria for action, �for example… Other aspects … Slide Number 11 Slide Number 12 Slide Number 13 Risk Mitigation 8b - Trainer's Aid - Exercise - QA Options 8c - Handout 1 - What a Purchaser Can Do 8d - Handout 2 - Categorizing Options << /ASCII85EncodePages false /AllowTransparency false 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