GLOBAL HEALTH SUPPLY CHAIN QUALITY ASSURANCE QA.APP.GEN-52 Laboratory Commodities and Consumables: Supplier Technical Questionnaire

Transcription

1 GLOBAL HEALTH SUPPLY CHAIN QUALITY ASSURANCE Laboratory Commodities and Consumables: Supplier Technical Questionnaire This questionnaire is used to collect information from offerors of Laboratory Commodities and Consumables. Additional documentation may be required and/or requested at the discretion of GHSC - QA. INSTRUCTIONS Complete the fields in this questionnaire as applicable. Tick or place an X in any of the blocks that are true/applicable. Include a comment reference number, where applicable. Comments by reference should be provided in Section 9.0 Add rows to tables to include requested information. Alternatively, you may attach information in a separate sheet using the same format requested. Refer to Instructions for Creating a GHSC-QA Technical Questionnaire Submission and Instructions to Access and Upload Documentation to GHSC-QA SharePoint Site to complete the submission. Page 1 of 9

2 Request for Proposal Number Questionnaire Submission Date (DD/MON/YYYY) Company Name (Supplier) (name of company submitting bid) Physical address Postal address Telephone number Fax Website Organization capabilities (Select all that apply) Marketing license holder Distributor/wholesaler Manufacturer Other (Specify): Provide contact information for each of the following: Technical Name: Specifications and Telephone: Quality Assurance Cell phone: Regulatory and patent Name: Telephone: Cell phone: General Inquiries Name: Telephone: Cell phone: Page 2 of 9

3 Section 1. Supplier General Information 1.1 Legal Business Name 1.2 Doing Business As (if different than legal business name) Not Applicable 1.2 Legal entity / ownership 1.4 Name and Physical Address of all locations providing warehouse and distribution services. Identify which ones are bonded. Name Address Bonded Section 2. Organizational Structure and Regulatory Status 2.1 Do you have a current organizational chart? Attach a copy of your organizational chart and indicate name of individual for key positions and length of time employed. 2.2 Indicate the number of personnel employed within the following key functional departments: Management Product/Supplier Assessment Quality Assurance/Quality Control Purchasing Warehousing Distribution and shipping Pharmacist(s) Total number of staff 2.3 Describe the organization main clients. Attach a list of Government and International health organizations/non-government clients (for past 2 years) and provide a list of product types ordered by each organization. 2.4 Indicate (below) the availability of the following licenses/certificates/inspection reports issued by a national/regional regulatory authority and other certifying organizations and attach copies. NOTE: If applicant operates more than one facility, provide information for each facility including facility address, contact information and licenses/certificates). ISO (Specify) Attach a copy of the most recent valid certification/license ISO (Specify) Attach a copy of the most recent valid certification/license Pharmaceutical Wholesaler or Distributor Attach a copy of the most recent valid certification/license (Specify) Page 3 of 9

4 Other Certifications or licenses issued by a regulatory authority Attach a copy of the most recent valid certification/licenses (Specify) 2.5 Regulatory authority inspection Provide a list of regulatory inspections conducted by date and any action indicated over the last 3 years. Agency Inspection Date Inspection Outcome Section 3. Manufacturer/Supplier Management 3.1 Do you have current written standard operating procedures (SOPs) for evaluating manufacturers/suppliers? 3.2 Does the organization maintain a register of approved products and suppliers that include the scope of approval? 3.3 Does the organization periodically review supplier performance? Attach SOP for monitoring supplier performance 3.4 Does the organization define the necessary actions to take when dealing with products/suppliers that do not meet requirements? 3.5 Does the organization ensure that the function having responsibility for approving supplier quality systems has the authority to disapprove the use of sources? 3.6 Does the organization maintain product specifications for laboratory commodities and consumables? 3.7 Does your staff or a contracted external inspection group perform on-site inspections of suppliers? If yes, attach SOP for inspections of suppliers. 3.8 Do you maintain product documentation (Certificate of Analysis, Regulatory Approvals, Certificate of Compliance, QC Testing Reports etc) for each product purchased from a supplier? Section 4. Procurement 4.1 Do you have current written procurement SOPs for procurement activities? Page 4 of 9

5 4.2 Does the organization ensure that product conforms to specified purchase requirements? 4.3 Does purchasing information describe the product to be purchased, including where appropriate: Requirements for approval of product? Supplier Quality management systems requirements? Name and other positive identification, and other relevant technical data for the product? Requirements for examination, inspection and related instructions for acceptance by the organization? Requirements for supplier to notify organization of nonconforming product? Requirements to notify the organization of changes in product and/or critical process and, where required, obtain organizational approval? Right of access by the organization, their customer(s), and authorities to facilities involved in the order and to all applicable records? Requirements for the supplier to flow down to subtier suppliers the applicable requirements in the purchasing documents, including key characteristics where required? 4.4 Does the organization conduct activities necessary for ensuring that product meets specified purchase requirements? This may include obtaining objective evidence of the quality of the product from suppliers (e.g., accompanying documentation, certificate of conformity, test reports, statistical records, process control), review of the required documentation, product inspection upon receipt, and, delegation of verification to the supplier, or supplier certification? 4.5 Can you provide readily retrievable documents to authenticate the source and origin for products? At a minimum, this includes Manufacturer COA corresponding to the product specifications and manufacturer invoice/packing list corresponding to lot shown on COA. 4.6 Are you licensed as a manufacturer? If yes, provide a copy of the license(s) and a description of products Does labeling of repackaged commodities include the name of the original manufacturer, and expiration date (when required)? Page 5 of 9

6 Section 5. Storage 5.1 Does your organization comply with Good Storage Practices similar to those published by WHO? Reference: 1. s/s18675en/s18675en.pdf 5.2 Under what temperature /humidity conditions are products stored. (If more than one warehouse, provide information for each) Attach SOP for monitoring of environmental conditions (e.g. temperature) Are records maintained to demonstrate compliance with product temperature storage requirements? For commodities that must be stored under defined storage conditions (e.g. do not store over or under X C or protect from moisture, light) is documentation available that indicates compliance with indicated storage condition? Attach SOP for handling of materials and/or products requiring special storage conditions 5.3 Do you have written Standard Operating Procedures (SOPs) and associated records of documentation applicable to all storage activities including but not limited to the following (if available, indicate month/year reviewed or revised): Product Receiving Attach SOP for Product Receiving Product quarantine (i.e. products not released to general storage are for distribution until physical inspection is completed) Attach SOP for Product Quarantine Cold Storage Attach SOP for Cold Storage Rejected products (damaged/returned/expired, etc.) Attach SOP for Rejected Products Sanitation (cleaning) Attach SOP for Sanitation Pest Control Attach SOP for Pest Control Security (ex. Restricted entry to pharmaceutical storage areas, alarm system) Attach SOP for Security Section 6. Distribution 6.1 Do you have written Standard Operating Procedures (SOPs) for distribution in line with principles of Good Distribution Practice? Page 6 of 9

7 Reference: uality_assurance/gooddistributionpracticestrs957 Annex5.pdf. p Prior to shipment, do you verify that applicable commodities are registered in the consignee s country? 6.3 Does the organization records for dispatch include: date of dispatch; name and address of entity responsible for transportation; name, address and status of addressee; description of the products; quantity of products; assigned lot number and expiry date; applicable transport and storage conditions; unique order number 6.4 Does the organization have SOPs in place for all transport activities and equipment involved in the distribution process, including: cleaning; pest control; ensuring the product s identity is maintained; prevention of cross-contamination; precautions against spillage or breakage. Attach SOP for transport activities Section 7. Quality Management 7.1 Do you have a quality manual that includes policy statements, SOPs and documentation for all activities, including: Attach a copy of the Quality Manual Table of Contents and a Copy of the Quality Policy Manufacturer/Supplier Evaluation Product Evaluation Purchasing Attach SOP for ordering product(s) from supplier or manufacturer Stock Management and Inventory Control Attach SOP for stock management and inventory control 7.2 Do you retain samples of product lots extending to or beyond the product expiration date? Attach SOP for sample retention 7.3 Do you visually inspect (labeling, appearance, etc.) a sample of lots received prior to release for sale? 7.4 Do you perform random laboratory testing against defined standards for products? If you perform random laboratory testing, what is the Comment # average number of tests performed for the past 2 #tests/#failed #tests/#failed years and indicate # of tests failing products, if any. Page 7 of 9

8 7.4.2 Do you outsource any product testing activities? Attach name and address of lab(s) and testing activities outsourced. 7.5 Do you have a procedure for receiving and managing customer complaints? Attach SOP for handling of complaints 7.6 Do you have a procedure for recall/market withdrawal activities? Attach SOP for handling of recalls/market withdrawal activities 7.7 Does the organization conduct internal audits at planned intervals to determine whether the quality management system conforms to the requirements of the applicable International Standard and to the quality management system requirements established by the organization? Attach SOP for internal audits Section 8. Management Information System/Record Keeping System 8.1 Do you maintain a Management Information System that can provide prompt retrieval of all records that document activities including but not limited to: Attach SOP for document/record control Attach SOP for retention of product documentation Attach SOP for traceability of batches supplied to customers Evaluation of manufacturers/suppliers Procurement Product Receipt Product Storage Quality Control testing Disposal of outdated/damaged/recalled/substandard products Product Distribution Client complaints (e.g. service, product) Product recalls Section 9. Offeror Comments Use this section to include the comments referenced in above sections. Comment # : Comment # : ATTESTMENT Page 8 of 9

9 I (insert name) am authorized by (name of company) to provide the information requested in this application and certify that all information is correct and true and documentation is available upon request that will validate all responses. Signature: Date: Print Name: Title and Position Phone Page 9 of 9