Joint WQHO/UNICEF/UNFPA suppliers meeting Pre-qualification of male latex condoms Tuesday 24 th November 2015 David Hill David Hill and Associates
Pre-qualification of manufacturing sites UNFPA inspector s rôle:- Review the dossier submitted by the manufacturing site. Confirm that the requirements of the WHO/UNFPA Male Latex Condom: Specification, Prequalification and Guidelines for Procurement have been met. The inspection is firmly based on this WHO/UNFPA publication. Inspect the manufacturing site and report to UNFPA. Oversee the sampling of condoms for independent testing. Review and approve corrective and preventive actions (CAPAs) from the site after the inspection. Sounds simple!
The pre-qualification process Document review is carried out to determine if the manufacturer meets the minimum requirements in the UNFPA Specification and Guidelines and relevant standards such as ISO 4074 and ISO 13485. Acceptable document review will be followed by a site inspection. Site inspection aims to confirm that the production is consistently made to the required specification, and to verify the processes in the Product Dossier and Site Master File.
A few basics first.. The scope of UNFPA male latex condom prequalification reviews and inspections is: Compliance to the UNFPA Specification and Guidelines. Compliance of the condoms to ISO standard 4074. Compliance of the Quality Management Systems to ISO standard 13485:2003. Compliance to other relevant Standards as appropriate (e.g. ISO 14971, ISO 10993, ISO 14001 etc.). Note that a standard defines the minimum standards for safety, whereas a specification defines the buyer s requirements - both are important.
Dossier review The company submits the required information, including a Product Dossier and a Site Master File. UNFPA staff review the information for completeness and appoint suitably qualified inspectors usually two to carry out a technical review. The inspectors review the information against the requirements in the UNFPA Guidelines, and report back to UNFPA within the specified time period. Sounds simple!
Product Dossier The Product Dossier should contain information about the product, including:- Full details of the condoms dimensions, flavours, lubricants, colours, finishing powders. Raw materials, including suppliers. Relevant regulatory approvals for the condoms. Manufacturing sites. Risk management plan to ISO 14971 Condom specifications and compliance to WHO/ISO 4074. Stability data to ISO 4074. Labelling.
Site Master File The Site Master File should contain information about the manufacturing site, including:- Full site details, address, history, corporate structure, capacity, other manufacturing operations, etc. Manufacturing certifications. Personnel, qualifications, training, health and safety procedures, etc. Premises and equipment, including construction, effluent handling, maintenance, calibration, etc. Documentation, record handling, quality control, etc. Customer complaints, internal audits, etc.
Document review All of these requirements are clearly laid out and defined in the WHO/UNFPA Male Latex Condom: Specification, Prequalification and Guidelines for Procurement. So why are they so rarely met? Very frequently the inspectors have to request further information and/or clarification before a report can be made. This causes delays and frustration in the prequalification system.
Common problems with document review Product Dossier Incomplete raw material list. Risk management plan not supplied or inadequate. Stability data inadequate. Biocompatibility/bioburden data incomplete or inadequate. Etc. Site Master File Insufficient details of the premises and equipment Risk management assessment not supplied or inadequate. No/insufficient details on process validation. Etc. In case of doubt, ask UNFPA!
Factory inspection Challenges met during the factory inspection include:- Dipping lines not in production during the inspection. Insufficient batches to sample for independent testing. Document retrieval slow or incomplete. Multiple sites involved in the production not always declared. Inspection timing conflicts with national holidays!
Common problems in prequalification Lack of understanding of a quality management system. No quality manager/inadequate training of the quality manager. Lack of understanding of test equipment. Lack of understanding of calibration. Incorrect sample sizes, wrong temperatures or wrong conclusions in real-time stability studies.
Common problems in prequalification Lack of process validation. Lack of traceability from raw materials through dispersions to finished product. Poor air-handling, specially around dipping. Illogical sampling plans. Poor use of statistical data from in-process QC. Illogical use of protective equipment sometimes window-dressing for inspectors.
And after the factory inspection A summary of the findings is presented at the closing meeting. The findings can include observations as well as any non-conformities. Manufacturers can discuss the conclusions with the inspectors. Any non-conformities must be cleared before the factory can be pre-qualified. Manufacturers supply details of their corrective and preventive actions (CAPAs) to UNFPA to address any non-conformities.
CAPA review The CAPAs will be reviewed by the inspectors, who will look for:- Acceptable actions to address the non-conformities. Verification that the actions have been carried out, or are in progress. If necessary, a second inspection may be made to verify the CAPAs Manufacturers are recommended to address any observations as well. CAPAs should be submitted within 90 days of receiving the report discuss with UNFPA if more time is required.
CAPA review Only two CAPA submissions are now allowed so get it right. Often the inspectors will identify any problem fully, and refer to the relevant clause in the standard. If investigation is required:- Use a methodical approach (e.g. Root Cause Analysis, FMEA, Ishikawa diagrams, etc) Document the process fully Outline the process in the CAPA report Accurate identification of the problem is the key to a successful solution.
Common problems with CAPAs Lack of understanding of the problem. Incorrect identification of corrective actions. Break issues down into bite-size chunks. Liaise with UNFPA if clarification needed. Ensure that sufficient information is provided to allow the inspectors to assess the actions. Lack of familiarity with the WHO/UNFPA guidelines and the ISO standards.
A good CAPA will. Correct problems identified by the inspectors and prevent re-occurrence. Use the simplest and lowest-cost means. Help the company to improve quality. Help the company to become pro-active with respect to quality, rather than reactive. Contribute to the continual improvement programme.
In conclusion.. Structure the Product Dossier and Site Master File as laid out in the WHO/UNFPA Male Latex Condom: Specification, Prequalification and Guidelines for Procurement. Use this book to anticipate and prepare for the inspection. Structure any CAPAs as laid out in the WHO/UNFPA Male Latex Condom: Specification, Prequalification and Guidelines for Procurement. This will help make the pre-qualification process easier, faster and more successful!
Thank you for your attention!