Effective Date: 11 May 2016 Issued: 04 May 2016 Issue: 18 SI No: P0400 Prepared: K. Chilcot. Date: 05 May 2016 (DD/MMM/YYYY)

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1 Page 1 of 5 Effective Date: 11 May 2016 Issued: 04 May 2016 Issue: 18 SI No: P0400 Prepared: K. Chilcot Reviewed by: G. Ostacchini Approved by: D. Johnson Date: 04 May 2016 Date: 05 May 2016 Title: Quality Plan For Sterile Schirmer Tear Test Date: 04 May Introduction 1.1. This Quality Plan documents the procedure used to control the manufacture, storage and distribution of the Schirmer Sterile Tear Test. 2. General 2.1. Only sub-contractors approved for supplying sterile products can be used for manufacturing this product. These are: Swann Morton (services) Ltd Wesley Coe (Cambridge) Ltd Riverside Medical 2.2. This is a CE marked product. No changes can be made to the packaging or users instructions without approval through change control process The test has a shelf life of 5 years. No test is sold with less than 12 months shelf life remaining. 3. Procedure 3.1. A Purchase Order is raised for sub-contract manufacture of the Sterile Schirmer Tear Test in accordance with procedures. The Purchase Order will call up the Haag-Streit UK specification including Issue Number for the supply of the product. See appendix (i) The received goods are controlled by procedure P0042B flow chart Received Stock Goods A Certificate of Conformity and a copy of the Bioburden test results are required with each batch. See Appendix (i). This documentation is scanned and held for a minimum of 5 years All deliveries are inspected on receipt against Test Schedule All Tear Tests are to be stored in a clean, dry and dust free area of the stores Stock will be allocated on a first in first out basis It is the responsibility of the Operational Logistics Manager to periodically inspect stock, check for deterioration, shelf life and inform the Technical Operations Manager if required.

2 Page 2 of The Operational Logistics Manager will ensure that all consignments are adequately packaged to prevent damage or deterioration to the product during transit to the customer Despatch documentation must reference the lot reference of the despatched product. 4. Re-Validation & Monitoring 4.1. Re-validation of the VD Max study will be carried out circumstances when significant changes to the product or packaging have been proposed. The testing will be carried out before the change implementation Dose audits will be carried out 3 monthly in compliance to BS EN ISO :2015. After four consecutive sterilisation dose audits whose outcomes have required neither dose augmentation nor sterilisation dose re-establishment, a justification can be raised to increase the interval between dose audits to 12 monthly in accordance with the criteria outlined in BS EN ISO :2015.

3 Page 3 of 5 5. Appendix (i) 1. Components HAAG-STREIT UK LTD SPECIFICATION FOR THE SUPPLY OF SCHIRMER TEAR TEST 1.1. One pair of Tear Test Strips (in accordance with drawing ) are sealed in a pouch with the rounded end of each strip at the bottom of the pouch and identified by batch code (lot XYZ) Ten pouches are then placed in an outer polythene bag Five outer polythene bags are placed in a cardboard box together with a copy of the users instructions. Artwork for these items will be supplied by Haag-Streit UK. The box is fitted with tamper evident labels and a label with batch code and expiry date is added All material, packaging and labelling is supplied by the approved sub-contractor All component parts and associated specifications are detailed in item list Manufacturing Process 2.1. Filter papers are perforated cut using standard roller press and perforation tool for the job in a clean area Perforated filter papers are shipped to Riverside Medical for pouch packing in a class 8 (minimum) clean room 2.3. Packed tear strips are returned to Wesley Coe for final packing in shelf cartons, plus IFU, and packing for shipment to sterilisation. This is done in a clean packing room Packed product shipped to Swann Morton for gamma irradiation 2.5. Irradiated product shipped from Swann Morton directly to Haag-Streit Note: 100 complete sealed packs are packed in a sterilisation shipper to be sterilised by Gamma radiation 25 kgy minimum dosage. The packs are marked with batch number (lot XYZ) and `use by' date. Validation and routine control of the sterilisation process will comply with the requirements of BS EN ISO :2015 and is the responsibility of Haag Streit UK Documentation of validation of the sterilisation process will be requested by Haag Streit UK Quality records, including batch manufacturing will be maintained by the sub-contractor for the designed life of the test. The stated shelf life is 5 years from sterilisation.

4 Page 4 of Bioburden tests will be carried out on each batch of product and copies of associated documentation cross-referenced to the batch supplied to Haag-Streit UK. Copies of the test results will be supplied to Haag-Streit UK Delivery notes will be cross referenced to batch GRN's and will be accompanied by a Certificate of Conformity stating that all requirements of this specification have been met All changes to this specification must be agreed in writing by Haag- Streit UK before implementation, together with any change from the approved sub-contractors Concessions raised by any sub-contractor must be authorised by Haag-Streit UK.

5 Page 5 of 5 Revision History: Prepared by: Reviewed by: Approved by: Revision Version: Reason for change: Danielle Roche n/a Gino Ostacchini 10 Request from Wesley Coe Danielle Roche n/a Gino Ostacchini 11 Logo Change Trevor Smith n/a Gino Ostacchini Added a Section on Revalidation and Monitoring 12 Thomas Whay A. Green G. Ostacchini 13 Periodic Review Thomas Whay A.Green D. Johnson 14 Further Changes following Periodic Review Thomas Whay A. Green D. Johnson 15 Request from Wesley Coe Thomas Whay K. Chilcot D. Johnson 16 Updated to change logo from HSUK to CCO Kevin Chilcot G. Ostacchini D. Johnson 17 Updates to sections 3.7 & 3.8 to amend job titles Kevin Chilcot G. Ostacchini D. Johnson 18 Update shelf life to 5 years correct spelling errors and number formatting. Clarification to frequency of Dose audits section 4.