PATH & WHO & UNFPA Workshop 3 - Preparation of a Product Dossier for Condom Prequalification

Publication date: 2008

Session 3: Preparation of a Product Dossier for Condom Prequalification Session Objectives • Give overview of all necessary components of a Product Dossier • Identify key reference documents • Practice strengthening a Product Dossier Purpose of Product Dossier • Provide UNFPA with a description of the manufacturer’s condom specifications, including raw materials, manufacturing processes, testing, and quality assurance (QA) systems Purpose of Product Dossier (continued) • Enables assessment of: -Whether, through documentation, the product meets requirements of Model Specification -Whether a site inspection should be scheduled Key Reference Documents • Prequalification Scheme for Male Latex Condoms – Annex 2, page 27 • Male Latex Condom Specifications and Guidelines for Condom Procurement 2003 • ISO 4074:2002 – Natural Latex Rubber Condoms: Requirements and Test Methods • ISO 2859-1 – Sampling Procedures and Tables for Inspection by Attributes Introduction • A Product Dossier must be submitted to UNFPA as part of the prequalification process • The information in the Dossier should come from existing documents • The information must be submitted in English • Pages should be numbered Cover Page • The cover page should include: –“Product Dossier – [Company Name]” –[Company address, contact telephone number, and email] –[Date of preparation] –“Strictly Confidential” Table of Contents • Key headings: – Characteristics of the products (design and marketing) – Raw materials – Sites of manufacture – Manufacturing process – Specifications of the products (compare with Model Specification) – Test procedures (evidence of conformity) – Stability Data – Attachments (if any) Characteristics of Product (Design and Marketing) 1. Details of the product 2. Product sample 3. Local, country, regional, and regulatory approvals for the product Raw Materials 1. List all raw materials that are currently used in the manufacture of condom product 2. For all chemicals used, provide chemical name, brand name, and function Sites of Manufacture 1. Provide complete contact information for each site at which ANY aspect of manufacturing occurs 2. Describe the nature of activities performed at each site Manufacturing Process 1. Provide a flow diagram of the complete manufacturing process, giving relevant information for each stage 2. Provide a written description of the manufacturing process and packaging, and scale of production Typical flowchart Mature compound Test compound Dip condoms Wash and powderDry Store Foil Final tests Packing Final inspectionRelease Raw material receipt Raw material acceptance Store ET Make & test dispersion Make solution Latex Make compound Manufacturing Process Provide: 3. Risk management plan for product as required by ISO 13485 4. Sampling plan showing where, when, how samples are taken 5. Test and acceptance criteria performed at critical steps of manufacturing process Can reference the SMF where appropriate Manufacturing Process 6. Final release data of one (1) manufacturing lot. Should contain: • Lot analytical data • Certificates of analysis • Lot production records including lot release test results • Report on unusual findings, modifications or changes with appropriate rationale • Conclusions Specification of the Products 1. Include the specification for the finished product using the Model Specification as a guide 2. Highlight any deviations from the Model Specification Evidence of Conformity 1. Supply documentary evidence that the product conforms to the current Model Specification • Chapter 2, clause 3.1 – General Requirements Stability Data 1. Must present data supporting shelf life of product 2. Should include data demonstrating compliance with minimum stability requirements of ISO 4074:2002, Section 7.2 3. Should include real time data from stability studies conducted at 30°C (range 28°C-35°C) per ISO 4074:2002, Section 7.3 Stability Data 4. If results of real time studies are not available prior to prequalification, studies should be underway. 5. Pending the outcome of the real-time studies, manufacturers may provide data on either: – Accelerated stability studies at elevated temperatures; or – Their own established and validated procedures for establishing shelf-life estimates Attachments 1. Ensure that a list of attachments is included as a first page of this section 2. Ensure that each attachment is numbered as per your list so that it may be readily identified Questions? Practice Strengthening a Product Dossier Small Group Exercise Instructions: • Work in small groups • Each group reviews section of Product Dossier • For each section, note problems and suggestions for improving the adequacy of the Product Dossier Session 3 Handout 1 PRODUCT DOSSIER CASE STUDY EXERCISE SIEVE CONDOMS INC NEW ZEALAND www.sieve.nz The WHO Prequalification Programme for Condoms: A Workshop for Male Latex Condom Manufacturers 1 Session 3 Handout 1 Contents 1. Characteristics of product 2. Raw materials 3. Sites of manufacture 4. Manufacturing process 5. Control of the products 6. Test procedures (evidence of conformity) 7. Shelf life 8. Attachments 9. Lot test result 10. Risk assessment 11. Compliance with WHO General Requirements 12. Shelf life information The WHO Prequalification Programme for Condoms: A Workshop for Male Latex Condom Manufacturers 2 Session 3 Handout 1 1. Characteristics of Product Details of the product 1. 48 mm 2. 53 mm 3. 57 mm Local, country, regional, and regulatory approvals for the product The products are registered and for sale in the following countries: • New Zealand • Fiji • Tuvalu • Tonga The products have been withdrawn from the market in the following country: • Kiribati An application for marketing authorization is currently pending in: • Western Samoa 2. Raw Materials Chemical name Brand Function Sulphur BASF Compounding Antioxidant 1 Nonoxo Compounding Antioxidant 2 Great Wall Compounding Alkali Chemo Stripping bath Accelerator Hivulc Compounding Talc Desorba Powdering Sodium Chloride Saxa ET electolyte Toluene Shell Swelling test Supplier(s) Latex is purchased from Mitsui Trading Co. 3. Sites of Manufacture The only manufacturing site is at our main address, listed on the front cover. The WHO Prequalification Programme for Condoms: A Workshop for Male Latex Condom Manufacturers 3 Session 3 Handout 1 4. Manufacturing Process The process consists of the following steps: 1. Compounding of latex with vulcanizing chemicals 2. Dipping of formers in the latex 3. Drying of formers 4. Dipping of formers in the latex 5. Drying of formers 6. Rolling of bead 7. Vulcanization 8. Stripping of condoms from formers 9. Powdering and washing 10. Drying 11. Electronic testing 12. Foiling 13. Final packing Process Stage Test Type Sample Size and Frequency Specification Accept/Reject or Rework Criteria Dipping Mass 5 per 2 hrs 1.62 to 1.65 Ac 1 Re 2 After processng Mass Visual Holes Inflation 5 per 2 hrs 50 per 2 hrs 50 per 2 hrs 50 per 2 hrs 1.55 to 1.58 See list ISO 4074 Min V 32 L Min P 1.8 kPa Ac 1 Re 2 Ac 2 Rework 3 Ac 1 Reject 3 Ac 3 Reject 4 After ET Holes 50 per 2 hrs per machine ISO 4074 Ac 0 Rework 1 After foiling Holes Pack seal Lub quantity 50 per 2 hrs per machine 30 per 2 hrs per machine 20 per 2 hrs per machine ISO 4074 ISO 4074 200 to 600 mg Ac 1 Rework 2 Ac 1 Reject 2 Ac 1 Reject 2 Final packing None Release test Full ISO ISO ISO ISO Product test report A test report for one batch is included in the attachments. Risk Management A copy of the risk management study is in the attachments. The WHO Prequalification Programme for Condoms: A Workshop for Male Latex Condom Manufacturers 4 Session 3 Handout 1 The WHO Prequalification Programme for Condoms: A Workshop for Male Latex Condom Manufacturers 5 5. Control of the Products (specifications) The products comply completely with the WHO requirements. 6. Test procedures Data showing compliance with the general requirements of the WHO Model Specification are given in the attachments 7. Stability Data Shelf life information is given in the attachments Session 3 Handout 2 Sieve Condoms Inc Case Study Exercise for Strengthening a Product Dossier Problems with Product Dossier 1. 2. 3. 4. Suggestions for Addressing Each Problem Above 1. 2. 3. 4. The WHO Prequalification Programme for Condoms: A Workshop for Male Latex Condom Manufacturers 3a - PPT - Preparation of Product Dossier Session 3:��Preparation of a �Product Dossier for Condom �Prequalification Session Objectives Purpose of Product Dossier Purpose of Product Dossier�(continued) Key Reference Documents Introduction Cover Page Table of Contents Characteristics of Product�(Design and Marketing) Raw Materials Sites of Manufacture Manufacturing Process Typical flowchart Manufacturing Process Manufacturing Process Specification of the Products Evidence of Conformity Stability Data Stability Data Attachments Slide Number 21 Practice Strengthening a �Product Dossier 3b - H1 - Product Dossier Case Study PRODUCT DOSSIER NEW ZEALAND 3c - H2 - Participant Handout for Exercise 3d - Trainers Aid - Exercise << /ASCII85EncodePages false /AllowTransparency false /AutoPositionEPSFiles true /AutoRotatePages /None /Binding /Left /CalGrayProfile (Dot Gain 20%) /CalRGBProfile (sRGB 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