PATH & WHO & UNFPA Workshop Prequalification Programme in Procurement Practices: Session 7 Procurement and QA

Publication date: 2008

World Health Organization The Prequalification Programme created by WHO undertakes comprehensive evaluation of the quality, safety, and efficacy of reproductive health medicines, based on: • Information submitted by the manufacturers • Inspection of the manufacturing sites The Purchaser Continuously monitors products for quality assurance (QA) from prequalified manufacturers through defined purchasing mechanisms, storage, and distribution Communication For a comprehensive QA program to be effective, it is imperative that WHO and the purchaser not only communicate with each other, but also with the National Regulatory Authority (NRA) Purchaser Quality Assurance Activities Even when a product/manufacturer is prequalified by WHO, the purchaser is still responsible for: • Using the most current WHO list • Ensuring compliance with country legislation on registration, patents, or other restrictions Purchaser Quality Assurance Activities (continued) • Managing the protective terms of the purchase contract, including no substitutions for the prequalified product • The product supplied was produced in the plant specified in the manufacturer’s WHO- approved product dossier • Evaluating appropriate documents and certificates from the manufacturer Purchaser Quality Assurance Activities (continued) • Visual inspections of products such as shelf life, compliance with labeling, packing, and shipping instructions are carried out • Products are delivered and stored under suitable conditions which are specified with regard to temperature, humidity, or protection from light, etc. When a Problem Arises • Communication among parties is essential • If the quality and integrity of a product is in question, the NRA, manufacturer, importer, and WHO must be informed • For adverse events, the local policy must be known and adhered to, including recall procedures Day 2: Session 7 Trainer’s Aid Quality Assurance Activities Covered by WHO and the Purchaser Blue Wall Exercise Instructions to the trainer: 1. Ask the participants to form six groups (approximately five people to a group). 2. Hand out stacks of 4x6-inch blank cards, 4x6-inch “sticky notes,” or half sheets of paper to each table. 3. Ask the participants to brainstorm in their groups on the key questions: What are the most critical QA activities covered by WHO, the procurer, or other country systems? Give 1-2 examples from the trainer’s aid. 4. Ask the participants to write one idea per card. Remind them to write in large letters so that it can be seen when it is later posted on the blue wall. Write an example with the words “one idea per card” and post it on the blue wall. 5. Allow participants approximately 15 to 20 minutes to complete the brainstorming. 6. Where there are multiple languages, ask the translators to work with each table and write the translation in the facilitator’s language on each card. 7. Prepare a “blue wall” or other large blank space on any big wall. Typically, a blue sheet of fabric works. If you are not allowed to attach things to the wall, group 4-5 flipchart stands side-to-side and attach the fabric with large binder clips. Cut small pieces of double-sided tape (or masking tape) and have them available for participants to affix their cards to the blue wall. 8. After 15 to 20 minutes of brainstorming, ask the groups to select the top 5 to 6 most critical QA activities and ask one person to bring them to the blue wall and attach them. 9. The following will take 20 to 30 minutes. 10. The facilitator should ask participants to identify cards that include QA activities that can be managed by WHO, and move all the identified cards together. Write “WHO” on a card, and tape it as a heading to that group of cards. 11. The facilitator should then start arranging the remaining cards in groups where the QA activities represent similar themes, while double checking with participants for agreement. When there is disagreement, invite short discussions, but put cards into a side category if consensus is difficult. There may be several themes. 12. Once all QA activities have been grouped thematically, ask the participants to identify who is responsible for those activities within each theme. 13. Write heading cards according to who the responsible entity is, and place them as headers above each category. 14. The facilitator should refer to the list in the trainer’s aid for any significant QA activities that are missing and read them aloud and ask the participants to assign them to one of the themed groups. 15. Have a 5-minute wrap-up discussion. Possible facilitation questions include: • What are some of the primary differences between activities that WHO is responsible for and activities that the purchaser is responsible for? • Which activities are the most important for WHO? For the purchaser? • What communication challenges can arise as part of these QA activities? • Which activities need to involve regulatory agencies? 16. Hand out copies of the list in the trainer’s aid to participants as future reference. The WHO Prequalification Programme for Essential Reproductive Health Medicines: A Workshop on Using the Programme in Procurement Practices Day 2: Session 7 Handout Quality Assurance Activities Covered by WHO and the Purchaser Key Points QA activities covered by WHO prequalification systems: • Develops, establishes, and promotes norms and international standards to ensure safety and quality assurance for products. • Assists countries in building national regulatory capacity through networking, training, and information-sharing. • Provides expertise and technical assistance through various activities in the areas of quality assurance, regulation and legislation, safety, and efficacy. • Provides guidance in regulation, safety, and quality assurance. • Provides list of prequalified products and manufacturers that comply with unified international standards. • Assesses data from manufacturer regarding the quality, safety, and efficacy of its product, including details about the purity of all ingredients used in manufacture, data about finished products, such as information about stability, and the results of in vivo bioequivalence tests (clinical trials conducted in healthy volunteers). • Performs inspections at the manufacturing site and assesses working procedure for compliance with WHO current good manufacturing practices (cGMP). • Sends product to professional control testing laboratories for analytical verification of quality. • Requalifies all medicines after three years or earlier if needed. • Carries out random quality control testing of prequalified medicines that have been supplied to countries. • Monitors complaints. QA activities covered by the purchaser: • Maintains a comprehensive documentation infrastructure including policies, guidelines, norms, standards, manuals, procedures, records, and related documents. • Checks that the most current WHO prequalification list of products is used. • Ensures products supplied comply with country legislation on registration licensing status and patent registration or restrictions. • Uses correct technical specifications and quantification of requirements. • Articulates quality conformance requirements for procurement contract documents. • Ensures the contracted manufacturer will supply the product as was prequalified in all aspects in the product dossier (including specifications, Active Pharmaceutical Ingredient, formula, manufacturing method, etc.) that was assessed by WHO. • Ensures the product supplied by the manufacturer was manufactured in the site as listed in the product dossier assessed by WHO and inspected by WHO (as appearing on the prequalified list). • Evaluates documents and certificates from the manufacturer (i.e., certificate of analysis, cGMP certificate, etc.) The WHO Prequalification Programme for Essential Reproductive Health Medicines: A Workshop on Using the Programme in Procurement Practices 1 Day 2: Session 7 Handout • Visually inspects products such as shelf life, compliance with labeling, packaging and shipping instructions, and performs laboratory analysis when appropriate (e.g., identification or assay). • Continuously monitors product from prequalified manufacturers through defined purchasing mechanisms, storage and distribution. • Ensures products are delivered and stored under suitable conditions which are specified with regard to temperature, humidity, or protection from light, etc. • Ensures products are received and stored in such a way that their quality and integrity is preserved, batch traceability is maintained, and stock can be rotated. • Takes precautions to ensure rejected products cannot be used. • Knows recall procedures. • Maintains constant supply of product. • Develops procedures to minimize losses due to spoilage and expiry throughout the transportation, storage and delivery processes. • Maintains accurate inventory records. • Rationalizes medicine storage points. • Takes measures to reduce theft and fraud through the development of storage and delivery procedures, and by executing strong shipping contracts. • Provides information for forecasting medicine needs. • Reports poor manufacturing practices or discrepancies found in product to WHO. • Resolves packaging, storage, freight, and transportation issues with manufacturer. The WHO Prequalification Programme for Essential Reproductive Health Medicines: A Workshop on Using the Programme in Procurement Practices 2 7a - Trainer's Aid - Blue Wall Activity 7b - Handout - QA Activities 7c - PPT - QA Activities Session 7:�Quality Assurance Activities World Health Organization The Purchaser Communication Purchaser Quality Assurance Activities Purchaser Quality Assurance Activities (continued) Purchaser Quality Assurance Activities (continued) When a Problem Arises << /ASCII85EncodePages false /AllowTransparency false /AutoPositionEPSFiles true /AutoRotatePages /None /Binding /Left /CalGrayProfile (Dot Gain 20%) /CalRGBProfile (sRGB IEC61966-2.1) /CalCMYKProfile (U.S. Web Coated \050SWOP\051 v2) /sRGBProfile (sRGB IEC61966-2.1) /CannotEmbedFontPolicy /Error /CompatibilityLevel 1.4 /CompressObjects /Tags /CompressPages true /ConvertImagesToIndexed true /PassThroughJPEGImages true /CreateJobTicket false /DefaultRenderingIntent /Default /DetectBlends true 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