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22 4. หลักเกณฑ์วิธีการที่ดีในการจัดส่งยา ท้ายคําสั่งกระทรวงสาธารณสุข ที942/2556

หลักเกณฑ์วิธีการที่ดีในการจัดส่งยาและหลักเกณฑ์วิธีการที่ดีในการจัดเก็บยา

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ประเทศไทยมีหลักเกณฑ์วิธีการที่ดีในการจัดส่งยา (Good distribution practices) และหลักเกณฑ์วิธีการที่ดีในการจัดเก็บยา (Good storage practices) เกิดขึ้นแล้ว โดยอยู่ที่ท้ายคำสั่งกระทรวงสาธารณสุข ที่ 942/2556 เรื่อง แก้ไขทะเบียนตำรับยา epoetin ชนิด alfa และ beta ซึ่งสามารถใช้เป็นต้นแบบหลักเกณฑ์วิธีการที่ดีในการจัดส่งยา และหลักเกณฑ์วิธีการที่ดีในการจัดเก็บยา ของยาประเภทต่าง ๆ ได้

Text of หลักเกณฑ์วิธีการที่ดีในการจัดส่งยาและหลักเกณฑ์วิธีการที่ดีในการจัดเก็บยา...

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2. (Introduction) 24 (Glossary) 24 1. (Organization and management) 28 2. (Personnel) 29 3. (Quality management) 29 4. (Premises, warehousing and storage) 30 5. (Vehicles and equipment) 31 6. 32(Shipment containers and container labelling) 7. (Dispatch) 33 8. (Transportation and products in transit) 34 9. 35 10. (Repackaging and relabelling) 36 11. (Complaints) 36 12. (Recalls) 36 13. (Rejected and returned products) 37 14. (Counterfeit pharmaceutical products) 37 15. (Importation) 37 16. (Contract activities) 38 17. (Self-inspection) 3823 3. 24 (Introduction) guide to good distributionpractices for pharmaceutical products (quality management) (premises, warehousing and storage) (vehicles and equipment) (shipment containers and container labelling) ( dispatch) (transportation and products in transit) (documentation) (repackaging and relabelling) (complaints) (recalls) (rejected and returnedproducts) (counterfeit pharmaceutical products) (importation) (contract activities) (shelf-inspection) (Glossary)/ / (Agreement) (Auditing) (governance) (Batch) (Batch number) / (certificates of analysis) (Consignment or delivery) 4. 25 (Container) (Contamination) (handling) (Contract) (Counterfeit) / (Cross-contamination) (Distribution) / (Excipient) (Expiry date) / (First expiry/first out - FEFO) / (First in/first out - FIFO) 5. (Good distribution practices - GDP) (Good manufacturing practices - GMP) (Good storage practices - GSP) (Good trade and distribution practices - GTDP) (Health establishment) (Importation) 26 (free zone) (Intermediate product) (bulk product) (Labelling) / (Manufacture) // (Material) ( ) /(reagent) (solvent) 6. 27 (Pharmaceutical product) (Product recall) (Quality assurance) (Quality control) (Quality system) (Quarantine) (reprocessing) (Sampling) (Shelf-life) (Standard operating procedure) ( ) 7. 28 (Storage) (Supplier) (Transit) (Validation) (Vehicle) 1. 1.1 1.2 (job description) 1.3 1.4 1.5 1.6 1.7 8. 2. (Personnel)2.1 ( / ) 2.2 2.3 2.4 (personal hygiene) (sanitation)2.5 / 3. (Quality management)3.1 3.2 1. 2. 3. 3.3 3.4 3.5 (approved supplier and approved entities)3.6 (supply chain) 3.7 ISO(International Standardization Organization) : 29 9. 4. (Premises, warehousing and storage) (Storage areas)4.1 4.2 (sanitation) (pest control) 4.3 (pallets) 4.4 (bay) 4.5 4.6 4.7 (abuse) ( ) (security) 4.8 4.9 (FEFO, first expiry / first out)4.10 (rejected) 4.11 4.12 (usable stock)4.13 4.14 30 10. 4.15 1 4.16 (calibration) 4.17 () 4.18 (SOP) (Stock rotation and control )4.19 4.20 5. (Vehicles and equipment)5.1 5.2 5.3 5.4 5.5 5.6 5.7 5.8 (shipping carton or case)31 11. 5.9 ( /) 1 5.10 1 5.11 5.12 5.13 6. (Shipment containers32and container labelling)6.1 6.2 () 6.3 6.4 6.5 6.6 12. 7. (Dispatch)7.1 / 7.2 7.3 7.4 7.5 - - - ( )- ()- - - - 7.6 (distribution chain) 7.7 7.8 7.9 First out/ last in(FOLI) 7.10 8. (Transportation and products in transit)8.1 : 33 13. 8.2 8.3 - - - - 8.4 8.5 8.6 ( ) 8.7 8.8 ( ) 8.9 8.10 8.11 ( ) 8.12 8.13 : 8.14 : 34 14. 8.15 8.16 (SOP) 8.17 9. 9.1 9.2 (SOP) 9.3 9.4 9.5 9.6 9.7 9.8 9.9 9.10 () () 9.11 (SOP) 9.12 1 9.13 (back-up) 35 15. 10. (Repackaging and relabelling)10.1 / . 11. (Complaints)11.1 11.2 11.3 11.4 11.5 12. (Recalls)12.1 12.2 12.3 12.4 12.5 12.6 12.7 (competent authorities) 12.8 ()36 16. 12.9 13. (Rejected and returned products)13.1 ( ) 13.2 13.3 13.4 13.5 13.6 / 14. (Counterfeit pharmaceutical products)14.1 14.2 14.3 14.4 15. (Importation)15.1 15.2 37 17. 15.3 15.4 15.5 16. (Contract activities)16.1 16.2 16.3 16.4 16.5 17. (Self-inspection)17.1 GDP 17.2 17.3 38 18. 5. 942/255639 19. (Introduction) 41 (Glossary) 41 1. (Personnel) 43 2. (Premise and facilities) 43 3. (Storage requirements) 45 4. (Returned goods) 46 5. (Dispatch and transport) 47 6. (Product recalls) 4740 20. 41 (Introduction) Guide to good storage practices forpharmaceuticals (Glossary) (Active Pharmaceutical Ingredient, API) (dosage form) (Contamination) (starting material) (intermediate) (finishedproduct) (production) (sampling) (packaging) (repackaging) (storage) (transport) (Cross-contamination) , (Excipient) (drug delivery system) (stability) (bioavailability) (patient acceptability) 21. 42 (Expiry date) (Labelling) (line clearance) (Manufacture) / (Materials) (Packaging material) (Primary) (Secondary) (Pharmaceutical product) (Production) (Retest date) (Storage) (Suppier) 22. 1. (Personnel)1.1 1.2 (safety)1.3 (personal hygiene) (sanitation)1.4 2. (Premises and facilities) (Storage areas)2.1 2.2 2.3 2.4 ( ) (pallets) 2.5 (sanitation) (pest control) 2.6 (bay) 43 23. 2.7 (validation) (security) 2.8 (contamination) (cross-contamination) 2.9 2.10 (abuse) ( ) (security) 2.11 2.12 2.13 (FEFO, first expiry/first out)2.14 (rejected) 2.15 2.16 (usable stock)2.17 (Storage conditions)2.18 (Monitoring of storage conditions)2.19 1 44 24. 2.20 (calibration) 3. (Storage requirements) (Documentation) (Written instructions and records)3.1 3.2 (retest date) (pharmacopoeial requirements) 3.3 ( 1 )3.4 (Labelling and containers)3.5 3.6 (Receipt of incoming materials and pharmaceutical products)3.7 (purchase order) 3.8 3.9 45 25. 3.10 3.11 3.12 3.13 (Stock rotation and control )3.14 3.15 3.16 3.17 (Control of obsolete and outdated materials andpharmaceutical products)3.18 4. (Returned goods)4.1 (recalled goods) (approved procedures) 4.2 4.3 46 26. 5. (Dispatch and transport)5.1 5.2 5.3 5.4 5.5 5.6 5.7 - - - - 5.8 6. (Product recalls)6.1 47