‫ﺍﻝﺠﻤﻬﻭﺭﻴﺔ ﺍﻝﻌﺭﺒﻴﺔ ﺍﻝﺴﻭﺭﻴﺔ‬

‫ﻭﺯﺍﺭﺓ ﺍﻝﺼﺤﺔ‬

‫ﺩﻝﻴل ﺇﺨﺘﺒﺎﺭﺍﺕ ﺍﻝﺜﺒﺎﺕ‬

‫‪GUIDELINE ON STABILITY‬‬
‫‪TESTING‬‬

‫ﺇﺨﺘﺒﺎﺭﺍﺕ ﺍﻝﺜﺒﺎﺕ ﻝﻠﻤﻭﺍﺩ ﺍﻝﻔﻌﺎﻝﺔ ﻭﺍﻝﻤﺴﺘﺤﻀﺭﺍﺕ‬

‫ﺍﻝﺼﻴﺩﻻﻨﻴﺔ ﺍﻝﺠﺎﻫﺯﺓ‬

‫‪STABILITY TESTING OF‬‬

‫‪EXISTING ACTIVE SUBSTANCES‬‬
‫‪AND RELATED FINISHED‬‬
‫‪PHARMACEUTICAL PRODUCTS‬‬
‫ﺍﻝﺩﻝﻴل ﻫﻭ ﺘﺭﺠﻤﺔ ﻝﻠﻭﺜﻴﻘﺔ ﺍﻝﺼﺎﺩﺭﺓ ﻋﻥ ﺍﻝﻭﻜﺎﻝﺔ ﺍﻷﻭﺭﻭﺒﻴﺔ ﻝﺘﻘﻴﻴﻡ ﺍﻝﻤﺴﺘﺤﻀﺭﺍﺕ ﺍﻝﺩﻭﺍﺌﻴﺔ‬
‫‪(EMEA) The European Agency for the Evaluation of Medicinal Products‬‬

‫ﻭﺯﺍﺭﺓﺍﻝﺼﺤﺔ‪ -‬ﺩﻤﺸﻕ ‪٢٠٠٦‬‬

‫‪١‬‬
 ‫ﺩﻝﻴل ﺇﺨﺘﺒﺎﺭﺍﺕ ﺍﻝﺜﺒﺎﺕ‬
GUIDELINE ON STABILITY TESTING

‫ﺇﺨﺘﺒﺎﺭﺍﺕ ﺍﻝﺜﺒﺎﺕ ﻝﻠﻤﻭﺍﺩ ﺍﻝﻔﻌﺎﻝﺔ ﻭﺍﻝﻤﺴﺘﺤﻀﺭﺍﺕ ﺍﻝﺠﺎﻫﺯﺓ‬

STABILITY TESTING OF EXISTING ACTIVE
SUBSTANCES AND RELATED FINISHED PRODUCTS
‫ﺍﻝﺩﻝﻴل ﻫﻭ ﺘﺭﺠﻤﺔ ﻝﻠﻭﺜﻴﻘﺔ ﺍﻝﺼﺎﺩﺭﺓ ﻋﻥ ﺍﻝﻭﻜﺎﻝﺔ ﺍﻷﻭﺭﻭﺒﻴﺔ ﻝﺘﻘﻴﻴﻡ ﺍﻝﻤﺴﺘﺤﻀﺭﺍﺕ ﺍﻝﺩﻭﺍﺌﻴﺔ‬
(EMEA) The European Agency for the Evaluation of Medicinal Products

٢
 ‫‪ -١‬ﻤﻘﺩﻤﺔ ‪INTRODUCTION‬‬

‫‪ ١-١‬ﺍﻝﻬﺩﻑ ﻤﻥ ﻫﺫﺍ ﺍﻝﺩﻝﻴل ‪Objective of the Guideline‬‬

‫ﻴﺴﺘﺨﺩﻡ ﻫﺫﺍ ﺍﻝﺩﻝﻴل ﻝﻠﻤﻭﺍﺩ ﺍﻷﻭﻝﻴﺔ ﺍﻝﻔﻌﺎﻝﺔ ﻭﺍﻝﻤﺴﺘﺤﻀﺭﺍﺕ ﺍﻝﺠﺎﻫﺯﺓ ﺫﺍﺕ ﺍﻝﻌﻼﻗﺔ‬
‫ﻭﺍﻝﻤﺴﺘﺤﻀﺭﺍﺕ ﺍﻝﻨﺒﺎﺘﻴﺔ ﺍﻝﺩﻭﺍﺌﻴﺔ ﺇﻻ ﺃﻨﻬﺎ ﻻﺘﺸﻤل ﺍﻝﻤﺴﺘﺤﻀﺭﺍﺕ ﺍﻝﺼﻴﺩﻻﻨﻴﺔ‬
‫ﺍﻝﻤﻭﺴﻭﻤﺔ ﺸﻌﺎﻋﻴﺎ ﻭﺍﻝﻤﺴﺘﺤﻀﺭﺍﺕ ﺍﻝﺤﻴﻭﻴﺔ ﻭﺍﻝﻤﺴﺘﺤﻀﺭﺍﺕ ﺍﻝﻤﺼﻨﻌﺔ ﺒﻁﺭﻴﻘﺔ‬
‫ﺍﻝﻬﻨﺩﺴﺔ ﺍﻝﻭﺭﺍﺜﻴﺔ‪.‬‬

‫‪ ٢-١‬ﻤﺠﺎل ﻫﺫﺍ ﺍﻝﺩﻝﻴل ‪Scope of the Guideline‬‬

‫ﻴﺒﻴﻥ ﻫﺫﺍ ﺍﻝﺩﻝﻴل ﺍﻝﻤﻌﻠﻭﻤﺎﺕ ﺍﻝﺘﻲ ﺘﻘﺩﻡ ﻓﻲ ﻤﻠﻔﺎﺕ ﺘﺴﺠﻴل ﺍﻝﻤﻭﺍﺩ ﺍﻝﻔﻌﺎﻝﺔ‬
‫ﻭﺍﻝﻤﺴﺘﺤﻀﺭﺍﺕ ﺍﻝﺼﻴﺩﻻﻨﻴﺔ ﺫﺍﺕ ﺍﻝﻌﻼﻗﺔ‪.‬‬

‫‪ ٣-١‬ﺍﻝﻤﺒﺎﺩﻱﺀ ﺍﻝﻌﺎﻤﺔ ‪General Principles‬‬

‫ﺇﻥ ﺍﻝﻬﺩﻑ ﻤﻥ ﺇﺨﺘﺒﺎﺭﺍﺕ ﺍﻝﺜﺒﺎﺕ ﻫﻭ ﺘﺄﻜﻴﺩ ﻨﻭﻋﻴﺔ ﻭﺠﻭﺩﺓ ﺍﻝﻤﻭﺍﺩ ﺍﻝﻔﻌﺎﻝﺔ‬

‫ﻭﺍﻝﻤﺴﺘﺤﻀﺭﺍﺕ ﺍﻝﺼﻴﺩﻻﻨﻴﺔ ﺫﺍﺕ ﺍﻝﻌﻼﻗﺔ ﻋﻨﺩ ﺘﻌﺭﻀﻬﺎ ﻝﻠﻌﻭﺍﻤل ﺍﻝﺒﻴﺌﻴﺔ ﺍﻝﻤﺨﺘﻠﻔﺔ‬
‫ﺍﻝﻤﺫﻜﻭﺭﺓ ﺃﻋﻼﻩ ‪ ،‬ﻭﺘﻬﺩﻑ ﺃﻴﻀﺎ ﺇﻝﻰ ﻭﻀﻊ ﺍﻝﻤﻘﺘﺭﺤﺎﺕ ﺍﻝﺨﺎﺼﺔ ﺒﻅﺭﻭﻑ‬
‫ﺍﻝﺘﺨﺯﻴﻥ ‪ ،‬ﺇﻋﺎﺩﺓ ﺍﻝﻔﺤﺹ ﻭﺘﺤﺩﻴﺩ ﻤﺩﺓ ﺼﻼﺤﻴﺔ ﺍﻷﺩﻭﻴﺔ‪.‬‬
‫ﺇﻥ ﺃﻜﺜﺭ ﺍﻝﻌﻭﺍﻤل ﺍﻝﺘﻲ ﺘﺴﺎﻫﻡ ﻓﻲ ﺘﺤﻁﻡ ﺍﻝﻤﺴﺘﺤﻀﺭﺍﺕ ﺍﻝﺼﻴﺩﻻﻨﻴﺔ ﻫﻲ ‪:‬‬
‫ﺍﻝﻌﻭﺍﻤل ﺍﻝﺒﻴﺌﻴﺔ ﻜﺎﻹﺸﻌﺎﻉ ‪ ،‬ﺍﻝﺤﺭﺍﺭﺓ ‪ ،‬ﺍﻝﺭﻁﻭﺒﺔ ‪ ،‬ﺍﻝﻀﻭﺀ ‪ ،‬ﺍﻷﻭﻜﺴﺠﻴﻥ‬
‫ﻭﺍﻝﻤﺅﺜﺭﺍﺕ ﺍﻝﻔﻴﺯﻴﺎﺌﻴﺔ) ﺍﻻﻫﺘﺯﺍﺯ‪ ،‬ﺍﻝﺘﺠﻤﻴﺩ (‪.‬‬

‫‪ -١‬ﻋﻭﺍﻤل ﻤﺭﺘﺒﻁﺔ ﺒﺎﻝﻤﺴﺘﺤﻀﺭﺍﺕ ﺍﻝﺼﻴﺩﻻﻨﻴﺔ ‪:‬‬

‫ﺃ‪ -‬ﺍﻝﺨﻭﺍﺹ ﺍﻝﻔﻴﺯﻴﺎﺌﻴﺔ ﻭﺍﻝﻜﻴﻤﻴﺎﺌﻴﺔ ﻝﻠﻤﺎﺩﺓ ﺍﻝﻔﻌﺎﻝﺔ ﻭﺍﻝﺴﻭﺍﻏﺎﺕ‪.‬‬
‫ﺍﻝﺼﻴﻐﺔ ﺍﻝﺩﻭﺍﺌﻴﺔ ﻭﺍﻝﺘﺭﻜﻴﺏ‪.‬‬ ‫ﺏ‪-‬‬
‫ﻁﺭﻕ ﺍﻝﺘﺼﻨﻴﻊ‪.‬‬ ‫ﺕ‪-‬‬
‫‪ -٢‬ﻁﺒﻴﻌﺔ ﻤﻭﺍﺩ ﺍﻝﺘﻌﺒﺌﺔ ﻭﺍﻝﺘﻐﻠﻴﻑ ﻝﻠﻤﺴﺘﺤﻀﺭ‪.‬‬

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 ‫ﺍﻝﺩﻻﺌل ‪Guidelines‬‬ ‫‪-٢‬‬

‫‪ ١-٢‬ﺍﻝﻤﺎﺩﺓ ﺍﻝﻔﻌﺎﻝﺔ ‪Active Substance‬‬

‫‪ ١,١,٢‬ﻋﺎﻡ ‪General‬‬

‫ﺇﻥ ﺍﻝﻤﻌﻠﻭﻤﺎﺕ ﻋﻥ ﺜﺒﺎﺕ ﺍﻝﻤﻭﺍﺩ ﺍﻝﻔﻌﺎﻝﺔ ﺘﻌﺘﺒﺭ ﺠﺯﺀ ﺃﺴﺎﺴﻲ ﻓﻲ ﻤﻔﻬﻭﻡ ﺘﻘﻴﻴﻡ‬
‫ﺩﺭﺍﺴﺎﺕ ﺍﻝﺜﺒﺎﺕ‪.‬‬
‫ﺘﻁﻠﺏ ﺩﺭﺍﺴﺎﺕ ﺍﻝﺜﺒﺎﺕ ﻝﺠﻤﻴﻊ ﺍﻝﻤﻭﺍﺩ ﺍﻝﻔﻌﺎﻝﺔ ﺍﻝﺘﻲ ﻝﻡ ﺘﺫﻜﺭ ﻓﻲ ﺩﺴﺎﺘﻴﺭ ﺍﻷﺩﻭﻴﺔ‬
‫ﺍﻝﻌﺎﻝﻤﻴﺔ ‪.‬‬
‫ﺃﻤﺎ ﺍﻝﻤﻭﺍﺩ ﺍﻝﻔﻌﺎﻝﺔ ﺍﻝﺘﻲ ﺘﻡ ﻭﺼﻔﻬﺎ ﻓﻲ ﺩﺴﺎﺘﻴﺭ ﺍﻷﺩﻭﻴﺔ ﺍﻝﻌﺎﻝﻤﻴﺔ ﻭﺍﻝﺘﻲ ﺘﻐﻁﻲ ﻤﻭﺍﺩ‬
‫ﺍﻝﺘﺨﺭﺏ ﻭﺫﻜﺭ ﻝﻬﺎ ﺤﺩﻭﺩ ﻤﻨﺎﺴﺒﺔ ﻭﻓﻲ ﻨﻔﺱ ﺍﻝﻭﻗﺕ ﻝﻡ ﻴﺤﺩﺩ ﻝﻬﺎ ﺘﺎﺭﻴﺦ ﺇﻋﺎﺩﺓ‬
‫ﺍﻝﺘﺤﻠﻴل ﻓﺈﻨﻪ ﻴﻤﻜﻥ ﻗﺒﻭل ﺇﺤﺘﻤﺎﻝﻴﻥ‪:‬‬
‫ﺃ‪ -‬ﻋﻠﻰ ﻤﻘﺩﻡ ﻤﻠﻑ ﺍﻝﺘﺴﺠﻴل ﺃﻥ ﻴﺒﻴﻥ ﺒﺄﻥ ﺍﻝﻤﺎﺩﺓ ﺍﻝﻔﻌﺎﻝﺔ ﺘﺘﻁﺎﺒﻕ ﻤﻊ ﺍﻝﻨﺹ‬
‫ﺍﻝﺩﺴﺘﻭﺭﻱ ﻤﺒﺎﺸﺭﺓ ﻗﺒل ﺘﺼﻨﻴﻌﻬﺎ ﻓﻲ ﺍﻝﻤﺴﺘﺤﻀﺭ ﺍﻝﻨﻬﺎﺌﻲ‪ .‬ﻓﻲ ﻫﺫﻩ ﺍﻝﺤﺎﻝﺔ‬
‫ﻻﻴﺤﺘﺎﺝ ﺍﻝﻤﺼﻨﻊ ﺃﻥ ﻴﻘﺩﻡ ﺩﺭﺍﺴﺎﺕ ﺜﺒﺎﺕ ‪.‬‬
‫ﻋﻠﻰ ﻤﻘﺩﻡ ﻤﻠﻑ ﺍﻝﺘﺴﺠﻴل ﺃﻥ ﻴﻀﻊ ﺘﺎﺭﻴﺦ ﺇﻋﺎﺩﺓ ﺍﻝﺘﺤﻠﻴل ﺒﺎﻻﺴﺘﻨﺎﺩ ﻋﻠﻰ‬ ‫ﺏ‪-‬‬
‫ﻨﺘﺎﺌﺞ ﺩﺭﺍﺴﺎﺕ ﺍﻝﺜﺒﺎﺕ ﺍﻝﻁﻭﻴﻠﺔ ﺍﻷﻤﺩ‪.‬‬
‫ﻓﻲ ﺤﺎﻝﺔ ﺍﻝﻤﺴﺘﺤﻀﺭﺍﺕ ﺍﻝﺩﻭﺍﺌﻴﺔ ﺍﻝﻨﺒﺎﺘﻴﺔ ﻭﻤﻭﺍﺩﻫﺎ ﺍﻝﻔﻌﺎﻝﺔ ﻓﺈﻨﻬﺎ ﻴﺠﺏ ﺃﻥ ﺘﻜﻭﻥ‬
‫ﻤﻁﺎﺒﻘﺔ ﻝﻠﻤﻭﺍﺼﻔﺎﺕ ﻗﺒل ﺍﻻﺴﺘﻌﻤﺎل) ﻤﺜل ﻗﺒل ﺍﻻﺴﺘﺨﻼﺹ(‪.‬‬

‫‪ ٢,١,٢‬ﺍﻝﺩﺭﺍﺴﺎﺕ ﺍﻝﺘﺸﺩﺩﻴﺔ ‪Stress Testing‬‬

‫ﺇﻥ ﺍﻝﺩﺭﺍﺴﺎﺕ ﺍﻝﺘﺸﺩﺩﻴﺔ ﻝﻠﻤﻭﺍﺩ ﺍﻝﻔﻌﺎﻝﺔ ﻴﻤﻜﻥ ﺃﻥ ﺘﺴﺎﻋﺩ ﻓﻲ ﺘﺤﺩﻴﺩ ﻤﻭﺍﺩ ﺍﻝﺘﺨﺭﺏ‬
‫ﺍﻝﻤﺤﺘﻤﻠﺔ‪ ،‬ﻭﺍﻝﺘﻲ ﺒﺩﻭﺭﻫﺎ ﺘﺴﺎﻋﺩ ﻓﻲ ﻤﻌﺭﻓﺔ ﺁﻝﻴﺔ ﺍﻝﺘﺨﺭﺏ ﻭﺍﻝﺜﺒﺎﺕ ﺍﻝﺤﻘﻴﻘﻲ‬
‫ﻝﻠﻤﺭﻜﺏ ﻭﺍﻝﺘﺤﻘﻕ ﻤﻥ ﻗﻭﺓ ﻤﺅﺸﺭﺍﺕ ﺍﻝﺜﺒﺎﺕ ﺍﻝﻤﺫﻜﻭﺭﺓ ﻓﻲ ﻁﺭﻕ ﺍﻝﺘﺤﻠﻴل‬
‫ﺍﻝﻤﺴﺘﺨﺩﻤﺔ‪.‬‬
‫ﺍﻹﺨﺘﺒﺎﺭﺍﺕ ﺍﻝﺘﺸﺩﺩﻴﺔ ﻫﻲ ﻋﺎﺩﺓ ﻏﻴﺭ ﻀﺭﻭﺭﻴﺔ ﻓﻲ ﺤﺎﻝﺔ ﺍﻷﺩﻭﻴﺔ ﺍﻝﻨﺒﺎﺘﻴﺔ‬
‫ﻭﺍﻝﻤﺴﺘﺤﻀﺭﺍﺕ ﺍﻝﺩﻭﺍﺌﻴﺔ ﺍﻝﻨﺒﺎﺘﻴﺔ‪.‬‬

‫ﻴﻤﻜﻥ ﺍﺴﺘﺨﺩﺍﻡ ﺍﻝﻁﺭﻕ ﺍﻝﺘﺎﻝﻴﺔ ﻝﻠﻤﻭﺍﺩ ﺍﻝﻔﻌﺎﻝﺔ ﺍﻝﻨﺒﺎﺘﻴﺔ‪:‬‬

‫ﺃ‪ -‬ﻋﻨﺩ ﺫﻜﺭ ﺍﻝﻤﺎﺩﺓ ﻓﻲ ﺩﺴﺘﻭﺭ ﺍﻷﺩﻭﻴﺔ ﻭﺘﺤﻘﻴﻘﻬﺎ ﻝﻜﺎﻓﺔ ﺍﻝﻤﺘﻁﻠﺒﺎﺕ ﺍﻝﺩﺴﺘﻭﺭﻴﺔ‬
‫ﻋﻨﺩﻫﺎ ﻻﻴﻁﻠﺏ ﺘﻘﺩﻴﻡ ﺒﻴﺎﻨﺎﺕ ﺘﺘﻌﻠﻕ ﺒﻤﻨﺘﺠﺎﺕ ﺍﻝﺘﺨﺭﺏ ﺇﺫﺍ ﺫﻜﺭﺕ ﻓﻲ ﺍﻝﺩﺴﺘﻭﺭ‬
‫ﺒﺈﺴﻡ ﺘﺤﺕ ﻋﻨﻭﺍﻥ ﺇﺨﺘﺒﺎﺭ ﺍﻝﻨﻘﺎﻭﺓ ﺃﻭ ﺍﻝﻘﺴﻡ ﺍﻝﻤﺘﻌﻠﻕ ﺒﺎﻝﺸﻭﺍﺌﺏ‪.‬‬
‫ﺇﺫﺍ ﻜﺎﻨﺕ ﺍﻝﻤﺎﺩﺓ ﺍﻝﺩﻭﺍﺌﻴﺔ ﻏﻴﺭ ﻤﻨﺼﻭﺹ ﻋﻠﻴﻬﺎ ﻓﻲ ﺩﺴﺘﻭﺭ ﺍﻷﺩﻭﻴﺔ‬ ‫ﺏ‪-‬‬
‫ﻋﻨﺩﻫﺎ ﻴﻭﺠﺩ ﺨﻴﺎﺭﻴﻥ‪:‬‬

‫‪٤‬‬
 ‫‪ -‬ﻴﻤﻜﻥ ﻗﺒﻭل ﺘﻘﺩﻴﻡ ﺒﻴﺎﻨﺎﺕ ﻨﺸﺭﺕ ﻓﻲ ﺍﻝﻤﺭﺍﺠﻊ ﺍﻝﻌﺎﻝﻤﻴﺔ ﻓﻲ ﺤﺎل ﻭﺠﻭﺩﻫﺎ‬
‫ﻭﺫﻝﻙ ﻝﺘﺒﻴﻥ ﻁﺭﻕ ﺍﻝﺘﺨﺭﺏ ﺍﻝﻤﻘﺘﺭﺤﺔ‪.‬‬
‫‪ -‬ﻓﻲ ﺤﺎل ﻋﺩﻡ ﺘﻭﻓﺭ ﺒﻴﺎﻨﺎﺕ ﻓﻲ ﺍﻝﻤﺭﺍﺠﻊ ﺍﻝﻌﻠﻤﻴﺔ ﺒﻤﺎ ﻓﻲ ﺫﻝﻙ ﺩﺴﺎﺘﻴﺭ‬
‫ﺍﻷﺩﻭﻴﺔ ﻋﻨﺩﻫﺎ ﻴﺠﺏ ﺇﺠﺭﺍﺀ ﺩﺭﺍﺴﺎﺕ ﺜﺒﺎﺕ ﺘﺸﺩﺩﻴﺔ ‪ .‬ﺘﺸﻜل ﺍﻝﻤﻌﻠﻭﻤﺎﺕ‬
‫ﺍﻝﺘﻲ ﻴﺘﻡ ﺍﻝﺤﺼﻭل ﻋﻠﻴﻬﺎ ﻤﻥ ﺘﻠﻙ ﺍﻝﺩﺭﺍﺴﺎﺕ ﺍﻝﺠﺯﺀ ﺍﻝﺠﻭﻫﺭﻱ ﺍﻝﺫﻱ ﻴﻘﺩﻡ‬
‫ﻝﻠﺴﻠﻁﺎﺕ ﺍﻝﺼﺤﻴﺔ‪.‬‬
‫ﻤﻥ ﺍﻝﻤﺭﺠﺢ ﺃﻥ ﺘﺠﺭﻯ ﺇﺨﺘﺒﺎﺭﺍﺕ ﺍﻝﺜﺒﺎﺕ ﻝﻠﻤﺎﺩﺓ ﺍﻝﻔﻌﺎﻝﺔ ﻋﻠﻰ ﺘﺤﻀﻴﺭﺓ ﻭﺍﺤﺩﺓ‪.‬‬
‫ﻴﺠﺏ ﺃﻥ ﺘﺘﻀﻤﻥ ﺘﺄﺜﻴﺭ ﺩﺭﺠﺎﺕ ﺍﻝﺤﺭﺍﺭﺓ ﺒﺸﻜل ﻤﺘﺩﺭﺝ ﻜل ‪ ١٠‬ﺩﺭﺠﺎﺕ )‬
‫ﻤﺜﺎل ‪... ٥٠،٦٠‬ﺍﻝﺦ( ﻭﺩﺭﺠﺎﺕ ﺤﺭﺍﺭﺓ ﺃﻋﻠﻰ ﻤﻥ ﺫﻝﻙ ﺒﺎﻝﻨﺴﺒﺔ ﻝﻠﺩﺭﺍﺴﺎﺕ‬
‫ﺍﻝﻤﺘﺸﺩﺩﺓ ﻭﺩﺭﺠﺔ ﺭﻁﻭﺒﺔ ﻨﺴﺒﻴﺔ )‪ %٧٥‬ﺃﻭ ﺃﻋﻠﻰ ﻤﻥ ﺫﻝﻙ ( ﻭﺘﻁﺒﻕ ﺒﺤﺴﺏ‬
‫ﺍﻝﻀﺭﻭﺭﺓ ﺇﺨﺘﺒﺎﺭﺍﺕ ﺍﻷﻜﺴﺩﺓ ﻭﺍﻝﺘﺤﻠل ﺍﻝﻀﻭﺌﻲ ﻋﻠﻰ ﺍﻝﻤﺎﺩﺓ ﺍﻝﻔﻌﺎﻝﺔ ‪ .‬ﻴﺠﺏ ﺃﻥ‬
‫ﺘﻘﻴﻡ ﺍﻹﺨﺘﺒﺎﺭﺍﺕ ﺃﻴﻀﺎ ﻝﻤﻼﺌﻤﺔ ﺍﻝﻤﺎﺩﺓ ﺍﻝﻔﻌﺎﻝﺔ ﻝﻺﻤﺎﻫﺔ ﺒﺩﺭﺠﺎﺕ ﺤﻤﻭﻀﺔ‬
‫ﻤﺨﺘﻠﻔﺔ ﻋﻨﺩﻤﺎ ﺘﻜﻭﻥ ﺍﻝﻤﺎﺩﺓ ﺒﺸﻜل ﻤﺤﻠﻭل ﺃﻭ ﻤﻌﻠﻕ ‪ .‬ﻴﺠﺏ ﺃﻥ ﺘﻜﻭﻥ‬
‫ﺇﺨﺘﺒﺎﺭﺍﺕ ﺍﻝﺜﺒﺎﺕ ﺍﻝﻀﻭﺌﻲ ﺠﺯﺀﺍ ﺃﺴﺎﺴﻴﺎ ﻤﻥ ﺍﻹﺨﺘﺒﺎﺭﺍﺕ ﺍﻝﺘﺸﺩﺩﻴﺔ ‪.‬‬
‫ﺇﻥ ﻓﺤﺹ ﻤﻭﺍﺩ ﺍﻝﺘﺨﺭﺏ ﻓﻲ ﺩﺭﺍﺴﺎﺕ ﺍﻝﺜﺒﺎﺕ ﺍﻝﺘﺸﺩﺩﻴﺔ ﻤﻔﻴﺩ ﻓﻲ ﺘﺤﺩﻴﺩ ﻁﺭﻕ‬
‫ﺍﻝﺘﺨﺭﺏ ﻭﺒﺎﻝﺘﺎﻝﻲ ﺘﻁﻭﻴﺭ ﻭﺍﻝﺘﺤﻘﻕ ﻤﻥ ﺼﻼﺤﻴﺔ ﺨﻁﻁ ﺍﻝﺘﺤﺎﻝﻴل‪ .‬ﻋﻠﻰ ﺃﻴﺔ‬
‫ﺤﺎل ﻝﻴﺱ ﻤﻥ ﺍﻝﻀﺭﻭﺭﻱ ﺍﻝﺒﺤﺙ ﻓﻲ ﻤﺸﺘﻘﺎﺕ ﺘﺨﺭﺏ ﻤﺤﺩﺩﺓ ﺇﺫﺍ ﺜﺒﺕ ﺃﻨﻬﺎ‬
‫ﻻﺘﺘﺸﻜل ﻓﻲ ﻅﺭﻭﻑ ﺩﺭﺍﺴﺎﺕ ﺍﻝﺜﺒﺎﺕ ﺍﻝﻤﺴﺭﻋﺔ ﺃﻭ ﺍﻝﻁﻭﻴﻠﺔ ﺍﻷﻤﺩ ‪.‬‬

‫‪ ٣,١,٢‬ﺇﺨﺘﻴﺎﺭ ﺍﻝﺘﺤﻀﻴﺭﺍﺕ ‪Selection of Batches‬‬

‫ﻴﻭﺠﺩ ﺇﺨﺘﻴﺎﺭﻴﻥ ﻤﻘﺒﻭﻝﻴﻥ‪:‬‬
‫ﺃ( ﻴﺠﺏ ﺘﻘﺩﻴﻡ ﺒﻴﺎﻨﺎﺕ ﻭﻨﺘﺎﺌﺞ ﺩﺭﺍﺴﺎﺕ ﺍﻝﺜﺒﺎﺕ ﺍﻝﻤﺴﺭﻋﺔ ﻭﺍﻝﻁﻭﻴﻠﺔ ﺍﻷﻤﺩ‬
‫ﻝﺘﺤﻀﻴﺭﺘﻴﻥ ﻴﺘﻡ ﺇﻨﺘﺎﺠﻬﻤﺎ ﺒﻁﺎﻗﺔ ﺇﻨﺘﺎﺠﻴﺔ ﻜﺎﻤﻠﺔ ﻝﻠﺨﻁ ﻭﺒﻨﻔﺱ ﻁﺭﻴﻘﺔ‬
‫ﺍﻝﺘﺼﻨﻴﻊ ﺍﻝﻤﻭﺼﻭﻓﺔ ﻓﻲ ﻤﻠﻑ ﺘﺴﺠﻴل ﺍﻝﺩﻭﺍﺀ ‪ ،‬ﻭﺃﻥ ﺘﻜﻭﻥ ﻤﺩﺓ ﻜل‬
‫ﺩﺭﺍﺴﺔ ﻻﺘﻘل ﻋﻥ ﺴﺘﺔ ﺃﺸﻬﺭ ‪.‬‬
‫ﺃﻭ‬
‫ﺏ( ﺘﻘﺩﻴﻡ ﺒﻴﺎﻨﺎﺕ ﻭﻨﺘﺎﺌﺞ ﺩﺭﺍﺴﺎﺕ ﺍﻝﺜﺒﺎﺕ ﺍﻝﻤﺴﺭﻋﺔ ﻭﺍﻝﻁﻭﻴﻠﺔ ﺍﻷﻤﺩ ﻝﺜﻼﺙ‬
‫ﺘﺤﻀﻴﺭﺍﺕ ﺘﺠﺭﻴﺒﻴﺔ ﻴﺘﻡ ﺇﻨﺘﺎﺠﻬﻤﺎ ﺒﻁﺎﻗﺔ ﺇﻨﺘﺎﺠﻴﺔ ﻜﺎﻤﻠﺔ ﻝﻠﺨﻁ ﻭﺒﻨﻔﺱ‬
‫ﻁﺭﻴﻘﺔ ﺍﻝﺘﺼﻨﻴﻊ ﺍﻝﻤﻭﺼﻭﻓﺔ ﻓﻲ ﻤﻠﻑ ﺘﺴﺠﻴل ﺍﻝﺩﻭﺍﺀ ‪ ،‬ﻭﺃﻥ ﺘﻜﻭﻥ ﻤﺩﺓ‬
‫ﻜل ﺩﺭﺍﺴﺔ ﻻﺘﻘل ﻋﻥ ﺴﺘﺔ ﺃﺸﻬﺭ ‪.‬‬
‫‪ ٤,١,٢‬ﻨﻅﺎﻡ ﺍﻝﻌﺒﻭﺓ ﻭﺍﻹﻏﻼﻕ ‪Container Closure System‬‬

‫ﻴﺠﺏ ﺃﻥ ﺘﺠﺭﻯ ﺩﺭﺍﺴﺎﺕ ﺍﻝﺜﺒﺎﺕ ﻝﻠﻤﻭﺍﺩ ﺍﻝﻔﻌﺎﻝﺔ ﻓﻲ ﻨﻔﺱ ﻨﻅﺎﻡ ﺍﻝﻌﺒﻭﺓ‬

‫ﻭﺍﻹﻏﻼﻕ ﺍﻝﻤﺴﺘﺨﺩﻡ ﻓﻲ ﺍﻝﺘﺨﺯﻴﻥ ﻭﺍﻝﺘﻭﺯﻴﻊ ﺃﻭ ﺍﻝﺫﻱ ﻴﻤﺎﺜﻠﻪ ‪.‬‬

‫‪٥‬‬
 ‫‪ ٥,١,٢‬ﺍﻝﻤﻭﺍﺼﻔﺎﺕ ‪Specification‬‬

‫ﻴﺠﺏ ﺃﻥ ﺘﺘﻀﻤﻥ ﺩﺭﺍﺴﺎﺕ ﺍﻝﺜﺒﺎﺕ ﻝﻠﻤﺎﺩﺓ ﺍﻝﻔﻌﺎﻝﺔ ﺍﻹﺨﺘﺒﺎﺭﺍﺕ ﺍﻝﺘﻲ ﺘﻜﺸﻑ‬

‫ﺍﻝﺘﺒﺩﻻﺕ ﺨﻼل ﻓﺘﺭﺓ ﺍﻝﺘﺨﺯﻴﻥ ﻭﺍﻝﺘﻲ ﺘﺅﺜﺭ ﻓﻲ ﺍﻝﺠﻭﺩﺓ ﻭﺍﻝﻔﻌﺎﻝﻴﺔ ﻭﺍﻝﺴﻼﻤﺔ‬
‫‪.‬ﺍﻻﺨﺘﺒﺎﺭﺍﺕ ﻴﺠﺏ ﺃﻥ ﺘﺸﻤل ﺍﻝﻔﺤﻭﺹ ﺍﻝﻔﻴﺯﻴﺎﺌﻴﺔ ﻭﺍﻝﻜﻴﻤﻴﺎﺌﻴﺔ ﻭﺍﻝﺤﻴﻭﻴﺔ‬
‫ﻭﺍﻝﺠﺭﺜﻭﻤﻴﺔ ‪ .‬ﻜﻤﺎ ﺃﻨﻪ ﻴﺠﺏ ﺘﻁﺒﻴﻕ ﺨﻁﻁ ﺘﺤﻠﻴل ﻤﺅﺸﺭﺓ ﻝﻠﺜﺒﺎﺕ ﻗﺩ ﺘﻡ ﺍﻝﺘﺤﻘﻕ‬
‫ﻤﻥ ﺼﻼﺤﻴﺘﻬﺎ‪.‬‬
‫ﺍﻝﺤﺩﻭﺩ ﺍﻝﻤﻘﺒﻭﻝﺔ ﻫﻲ ﻗﻴﻡ ﺭﻗﻤﻴﺔ ﻤﺠﺎﻻﺕ ﻭﻤﻌﺎﻴﻴﺭ ﺃﺨﺭﻯ ﻝﻠﻔﺤﻭﺹ ﺍﻝﻨﻭﻋﻴﺔ‬
‫ﺍﻝﻤﺤﺩﺩﺓ ﻭﺃﻥ ﺘﺘﻀﻤﻥ ﺇﻓﺭﺍﺩﻴﺎ ﻭﻜﻠﻴﺎ ﺍﻝﺤﺩﻭﺩ ﺍﻝﻘﺼﻭﻯ ﻝﻠﺸﻭﺍﺌﺏ ﻭﻤﻭﺍﺩ ﺍﻝﺘﺨﺭﺏ‬
‫‪ .‬ﻴﺠﺏ ﺃﻥ ﻴﺴﺘﻨﺩ ﺍﻝﺘﺒﺭﻴﺭ ﺍﻝﻔﺭﺩﻱ ﻭﺍﻝﻜﻠﻲ ﻝﻠﺤﺩﻭﺩ ﺍﻝﻘﺼﻭﻯ ﻝﻤﻭﺍﺩ ﺍﻝﺘﺨﺭﺏ‬
‫ﻋﻠﻰ ﺇﻋﺘﺒﺎﺭﺍﺕ ﺍﻝﺴﻼﻤﺔ‪ /‬ﺍﻝﻔﻌﺎﻝﻴﺔ‪ .‬ﺒﺎﻝﻨﺴﺒﺔ ﻝﻠﻤﻭﺍﺩ ﺍﻝﻔﻌﺎﻝﺔ ﺍﻝﻤﺫﻜﻭﺭﺓ ﻓﻲ ﺩﺴﺎﺘﻴﺭ‬
‫ﺍﻷﺩﻭﻴﺔ ﻓﺈﻥ ﺍﻹﺨﺘﺒﺎﺭﺍﺕ ﻴﺠﺏ ﺃﻥ ﺘﺠﺭﻯ ﻭﻓﻘﺎ ﻝﻠﻨﺹ ﺍﻝﺩﺴﺘﻭﺭﻱ ﺃﻭ ﺒﺎﺴﺘﺨﺩﺍﻡ‬
‫ﺇﺨﺘﺒﺎﺭﺍﺕ ﺘﻡ ﺍﻝﺘﺤﻘﻕ ﻤﻥ ﺼﻼﺤﻴﺘﻬﺎ ﺒﺄﻜﺜﺭ ﻤﻥ ﻁﺭﻴﻘﺔ ﺒﺎﻝﻤﻘﺎﺭﻨﺔ ﻤﻊ ﺍﻝﻨﺹ‬
‫ﺍﻝﺩﺴﺘﻭﺭﻱ ﻭﺃﻥ ﺘﻘﺩﻡ ﺍﻝﺘﺒﺭﻴﺭﺍﺕ ﻴﺤﺩﺩ ﻓﻴﻬﺎ ﺒﺄﻥ ﺍﻝﺸﻭﺍﺌﺏ ﺍﻝﻤﺤﺘﻤﻠﺔ ) ﺍﻝﺸﻭﺍﺌﺏ‬
‫ﺃﺜﻨﺎﺀ ﺍﻝﺘﺤﻀﻴﺭ ﺃﻭ ﻤﻥ ﻤﺸﺘﻘﺎﺕ ﺍﻝﺘﺨﺭﺏ( ﻋﻨﻬﺎ ﻤﻥ ﺃﻥ ﺍﻝﺸﻭﺍﺌﺏ ﻫﻲ ﺘﻨﺠﻡ‬
‫ﺃﺜﻨﺎﺀ ﻋﻤﻠﻴﺔ ﺍﻝﺘﺨﻠﻴﻕ)ﺍﻝﺘﺼﻨﻴﻊ( ﺍﻝﻤﺘﺒﻌﺔ ﻭﺒﺄﻨﻬﺎ ﻤﺭﺍﻗﺒﺔ ﺒﺸﻜل ﻜﺎﻑ‪.‬‬

‫‪ ٦,١,٢‬ﺘﻜﺭﺍﺭﻴﺔ ﺍﻹﺨﺘﺒﺎﺭﺍﺕ ‪Testing Frequency‬‬

‫ﻓﻲ ﺤﺎﻝﺔ ﺩﺭﺍﺴﺎﺕ ﺍﻝﺜﺒﺎﺕ ﺍﻝﻁﻭﻴﻠﺔ ﺍﻷﻤﺩ ﻓﺈﻥ ﺘﻜﺭﺍﺭﻴﺔ ﺍﻝﻔﺤﻭﺹ ﻴﺠﺏ ﺃﻥ ﺘﻜﻭﻥ‬
‫ﻜﺎﻓﻴﺔ ﻝﺘﺤﻘﻴﻕ ﻤﻠﻑ ﺜﺒﺎﺕ ﺍﻝﻤﺎﺩﺓ ﺍﻝﻔﻌﺎﻝﺔ ‪ .‬ﻓﻲ ﺤﺎﻝﺔ ﺩﺭﺍﺴﺎﺕ ﺍﻝﺜﺒﺎﺕ ﺍﻝﻁﻭﻴﻠﺔ‬
‫ﺍﻷﻤﺩ ﻓﺈﻥ ﺘﻜﺭﺍﺭﻴﺔ ﺍﻝﻔﺤﻭﺹ ﻴﺠﺏ ﺃﻥ ﺘﺘﻡ ﻜل ﺜﻼﺜﺔ ﺃﺸﻬﺭ ﺨﻼل ﺍﻝﺴﻨﺔ‬
‫ﺍﻷﻭﻝﻰ ﻭﻜل ﺴﺘﺔ ﺃﺸﻬﺭ ﺨﻼل ﺍﻝﺴﻨﺔ ﺍﻝﺜﺎﻨﻴﺔ ﻭﺴﻨﻭﻴﺎ ﺒﻌﺩ ﺫﻝﻙ ﻭﻓﻘﺎ ﻝﺘﺎﺭﻴﺦ‬
‫ﺇﻋﺎﺩﺓ ﺍﻹﺨﺘﺒﺎﺭ ﺍﻝﻤﻘﺘﺭﺤﺔ‪.‬‬
‫ﻓﻲ ﺤﺎﻝﺔ ﺸﺭﻭﻁ ﺘﺨﺯﻴﻥ ﻤﺴﺭﻋﺔ ﻓﺈﻥ ﺍﻝﺤﺩﻭﺩ ﺍﻝﺩﻨﻴﺎ ﻝﺩﺭﺍﺴﺎﺕ ﺍﻝﺜﺒﺎﺕ ﻝﻤﺩﺓ ﺴﺘﺔ‬
‫ﺃﺸﻬﺭﻫﻲ ﺜﻼﺙ ﻨﻘﺎﻁ‪ ،‬ﺘﺸﻤل ﺍﻝﺒﺩﺍﻴﺔ ﻭﺍﻝﻨﻬﺎﻴﺔ )ﻤﺜل ‪ ٠،٣،٦‬ﺃﺸﻬﺭ (‪.‬‬
‫ﻋﻨﺩ ﺇﻴﻘﺎﻑ ﺍﻹﺨﺘﺒﺎﺭﺍﺕ ﻓﻲ ﻤﻨﺘﺼﻑ ﻓﺘﺭﺓ ﺍﻝﺘﺨﺯﻴﻥ ﺒﺴﺒﺏ ﺘﺒﺩﻻﺕ ﺸﺩﻴﺩﺓ ﻓﻲ‬
‫ﺸﺭﻭﻁ ﺍﻝﺘﺨﺯﻴﻥ ﺍﻝﻤﺴﺭﻋﺔ ﻋﻨﺩﻫﺎ ﻴﻁﻠﺏ ﺇﺠﺭﺍﺀ ﺃﺭﺒﻊ ﻨﻘﺎﻁ ﺇﺨﺘﺒﺎﺭ ﻜﺤﺩ ﺃﺩﻨﻰ‬
‫ﺒﺤﻴﺙ ﺘﺸﻤل ﺯﻤﻥ ﺍﻝﺒﺩﺍﻴﺔ ﻭﺍﻝﻨﻬﺎﻴﺔ )ﻤﺜل ‪ ٠،٣،٦،١٢‬ﺸﻬﺭ( ﻝﺩﺭﺍﺴﺔ ‪ ١٢‬ﺸﻬﺭ‬
‫ﻤﻘﺘﺭﺤﺔ‪.‬‬
‫ﻓﻲ ﺤﺎﻝﺔ ﺍﻷﺩﻭﻴﺔ ﺍﻝﻨﺒﺎﺘﻴﺔ ﺃﻭ ﺍﻝﻤﺴﺘﺤﻀﺭﺍﺕ ﺍﻝﺩﻭﺍﺌﻴﺔ ﺍﻝﻨﺒﺎﺘﻴﺔ ﺍﻝﺘﻲ ﻴﻘﺩﻡ ﺍﻝﻤﺼﻨﻊ‬
‫ﻝﻬﺎ ﺒﻴﺎﻨﺎﺕ ﺘﺎﺭﻴﺨﻴﺔ ﻝﻠﺘﺤﻀﻴﺭﺓ ﻓﺈﻨﻪ ﻴﻤﻜﻥ ﺘﺨﻔﻴﺽ ﺘﻜﺭﺍﺭﻴﺔ ﺍﻹﺨﺘﺒﺎﺭﺍﺕ ﻝﻬﺎ‪.‬‬

‫‪٦‬‬
 ‫‪ ٧,١,٢‬ﺸﺭﻭﻁ ﺍﻝﺘﺨﺯﻴﻥ ‪Storage Conditions‬‬

‫ﺒﺸﻜل ﻋﺎﻡ ‪ ،‬ﻴﺠﺏ ﺘﻘﻴﻴﻡ ﺍﻝﻤﺎﺩﺓ ﺍﻝﻔﻌﺎﻝﺔ ﺒﺸﺭﻭﻁ ﺘﺨﺯﻴﻥ )ﺘﺤﻤل ﻤﻨﺎﺴﺏ( ﺘﺨﺘﺒﺭ‬
‫ﺜﺒﺎﺘﻬﺎ ﺍﻝﺤﺭﺍﺭﻱ ﻭﻜﺫﻝﻙ ﺇﺫﺍ ﺍﻨﻁﺒﻕ ﻋﻠﻴﻬﺎ ﺫﻝﻙ ﺤﺴﺎﺴﻴﺘﻬﺎ ﻝﻠﺭﻁﻭﺒﺔ ‪ .‬ﻴﺠﺏ ﺃﻥ‬
‫ﺘﻜﻭﻥ ﻓﺘﺭﺓ ﺍﻝﺩﺭﺍﺴﺔ ﻭﺸﺭﻭﻁﻬﺎ ﻜﺎﻓﻴﺔ ﻝﺘﻐﻁﻲ ﺍﻝﺘﺨﺯﻴﻥ ﻭﺍﻝﺸﺤﻥ ﻭﺍﻹﺴﺘﻌﻤﺎل‬
‫ﺍﻝﻼﺤﻕ‪.‬‬
‫ﺩﺭﺍﺴﺎﺕ ﺍﻝﺜﺒﺎﺕ ﺍﻝﻁﻭﻴﻠﺔ ﺍﻷﻤﺩ ﻝﻠﺨﻴﺎﺭﻴﻥ )ﺃ( ﻭ )ﺏ( ﻴﺠﺏ ﺃﻥ ﺘﻐﻁﻲ ﻤﺎ ﻻ ﻴﻘل‬
‫ﻋﻥ ﺴﺘﺔ ﺃﺸﻬﺭ ﻓﻲ ﻓﺘﺭﺓ ﺘﻘﺩﻴﻡ ﻤﻠﻑ ﺍﻝﺘﺴﺠﻴل ﻜﻤﺎ ﻴﺠﺏ ﺃﻥ ﺘﺴﺘﻤﺭ ﻝﻤﺩﺓ ﻤﻥ‬
‫ﺍﻝﺯﻤﻥ ﺘﻜﻔﻲ ﻝﺘﻐﻁﻴﺔ ﻓﺘﺭﺓ ﺇﻋﺎﺩﺓ ﺍﻹﺨﺘﺒﺎﺭ‪ .‬ﻴﺠﺏ ﺘﻘﺩﻴﻡ ﺒﻴﺎﻨﺎﺕ ﺇﻀﺎﻓﻴﺔ ﺘﻡ‬
‫ﺘﺠﻤﻴﻌﻬﺎ ﺨﻼل ﻓﺘﺭﺓ ﺍﻝﺘﻘﻴﻴﻡ ﻝﻤﻠﻑ ﺍﻝﺘﺴﺠﻴل ﻓﻲ ﺤﺎل ﺘﻡ ﻁﻠﺒﻬﺎ ﻤﻥ ﺍﻝﺴﻠﻁﺎﺕ‬
‫ﺍﻝﺼﺤﻴﺔ ‪ .‬ﺒﻴﺎﻨﺎﺕ ﺩﺭﺍﺴﺎﺕ ﺍﻝﺜﺒﺎﺕ ﺍﻝﻤﺴﺭﻋﺔ ﻭﻤﻥ ﺸﺭﻭﻁ ﺍﻝﺘﺨﺯﻴﻥ ﺍﻝﻤﺘﻭﺴﻁﺔ‬
‫ﻴﻤﻜﻥ ﺃﻥ ﺘﺴﺘﻌﻤل ﻝﺘﻘﻴﻴﻡ ﺘﺄﺜﻴﺭ ﺘﻌﺭﺽ ﺍﻝﻤﺎﺩﺓ ﻝﺸﺭﻭﻁ ﺘﺨﺘﻠﻑ ﻋﻥ ﺸﺭﻭﻁ‬
‫ﺍﻝﺘﺨﺯﻴﻥ ﺍﻝﻤﺼﺭﺡ ﺒﻬﺎ ﻓﻲ ﺍﻝﻌﻨﻭﻨﺔ ) ﻤﺜل ﺍﻝﺘﻲ ﺘﺤﺼل ﺨﻼل ﻓﺘﺭﺓ ﺍﻝﺸﺤﻥ(‪.‬‬

‫ﺇﻥ ﺸﺭﻭﻁ ﺍﻝﺘﺨﺯﻴﻥ ﺍﻝﻤﺴﺭﻋﺔ ﻭﺍﻝﻤﺘﻭﺴﻁﺔ ﻭﺍﻝﻁﻭﻴﻠﺔ ﺍﻷﻤﺩ ﻝﻠﻤﺎﺩﺓ ﺍﻝﻔﻌﺎﻝﺔ ﻴﺘﻡ‬
‫ﺫﻜﺭﻫﺎ ﺒﺎﻝﺘﻔﺼﻴل ﻓﻲ ﺍﻝﺒﻨﻭﺩ ﺍﻝﻤﺫﻜﻭﺭﺓ ﺃﺩﻨﺎﻩ‪ .‬ﺘﻁﺒﻕ ﺍﻝﺤﺎﻝﺔ ﺍﻝﻌﺎﻤﺔ ﺇﺫﺍ ﻝﻡ ﺘﻜﻥ‬
‫ﺍﻝﻔﺼﻭل ﺍﻝﻼﺤﻘﺔ ﺘﻐﻁﻲ ﺍﻝﻤﺎﺩﺓ ﺍﻝﻔﻌﺎﻝﺔ‪ .‬ﻴﻤﻜﻥ ﺍﺴﺘﺨﺩﺍﻡ ﺸﺭﻭﻁ ﺘﺨﺯﻴﻥ ﻤﺨﺘﻠﻔﺔ‬
‫ﺇﺫﺍ ﺘﻡ ﺘﺒﺭﻴﺭ ﺫﻝﻙ‪.‬‬

‫‪ ١,٧,١,٢‬ﺤﺎﻝﺔ ﻋﺎﻤﺔ ‪General case‬‬

‫ﺍﻝﻔﺘﺭﺓ ﺍﻝﺯﻤﻨﻴﺔ ﺍﻝﺩﻨﻴﺎ‬ ‫ﺸﺭﻭﻁ ﺍﻝﺘﺨﺯﻴﻥ‬ ‫ﻨﻭﻉ ﺍﻝﺩﺭﺍﺴﺔ‬

‫ﺍﻝﺘﻲ ﺘﻐﻁﻴﻬﺎ ﺍﻝﺒﻴﺎﻨﺎﺕ ﻓﻲ‬
‫ﺯﻤﻥ ﺘﻘﺩﻴﻡ ﻤﻠﻑ‬
‫ﺍﻝﺘﺴﺠﻴل‬
‫‪ ٦ 25°C ± 2°C/60% RH ± 5% RH‬ﺸﻬﻭﺭ )ﺍﻝﺨﻴﺎﺭ ﺃ ﺃﻭ‬ ‫ﻁﻭﻴﻠﺔ ﺍﻷﻤﺩ‬
‫‪ or‬ﺏ(‬ ‫*‬
‫‪30°C ± 2°C/65% RH ± 5% RH‬‬
‫‪ ٦ 30°C ± 2°C/65% RH ± 5% RH‬ﺸﻬﻭﺭ‬ ‫ﻤﺘﻭﺴﻁﺔ**‬
‫‪ ٦ 40°C ± 2°C/75% RH ± 5% RH‬ﺸﻬﻭﺭ‬ ‫ﻤﺴﺭﻋﺔ**‬

‫*ﻋﻠﻰ ﻤﻘﺩﻡ ﻤﻠﻑ ﺍﻝﺘﺴﺠﻴل ﺃﻥ ﻴﺤﺩﺩ ﻓﻴﻤﺎ ﺇﺫﺍ ﺘﻡ ﺇﺠﺭﺍﺀ ﺩﺭﺍﺴﺎﺕ ﺜﺒﺎﺕ ﻤﺴﺭﻋﺔ ﺒﺸﺭﻭﻁ ‪25°C‬‬
‫‪ ± 2°C/60% RH ± 5% RH‬ﺃﻭ ‪30°C ± 2°C/65% RH ± 5% RH‬‬

‫‪٧‬‬
 ‫** ﻓﻲ ﺤﺎﻝﺔ ﺍﻷﺩﻭﻴﺔ ﺍﻝﻨﺒﺎﺘﻴﺔ ﻭﺍﻝﻤﺴﺘﺤﻀﺭﺍﺕ ﺍﻝﺩﻭﺍﺌﻴﺔ ﺍﻝﻨﺒﺎﺘﻴﺔ ‪ ،‬ﻓﺈﻨﻪ ﻴﻤﻜﻥ ﺤﺫﻑ ﺇﺨﺘﺒﺎﺭﺍﺕ‬
‫ﺍﻝﺜﺒﺎﺕ ﺍﻝﻤﺨﺯﻨﺔ ﺒﺸﺭﻭﻁ ﻤﺴﺭﻋﺔ ﺃﻭ ﻤﺘﻭﺴﻁﺔ ﺇﺫﺍ ﺘﻡ ﺘﺒﺭﻴﺭﻫﺎ ﻤﻥ ﻗﺒل ﻤﻘﺩﻡ ﻤﻠﻑ ﺍﻝﺘﺴﺠﻴل ﻓﻲ‬
‫ﺤﺎل ﺘﻡ ﻅﺭﻭﻑ ﺍﻝﺘﺨﺯﻴﻥ ﺃﻗل ﻤﻥ ‪ 25°C‬ﻭﺒﺄﻨﻪ ﻗﺩ ﺘﻡ ﻋﻨﻭﻨﺘﻬﺎ ﺒﺸﻜل ﻭﺍﻀﺢ ﻋﻠﻰ ﺍﻝﻤﻨﺘﺞ‪.‬‬

‫ﻋﻨﺩ ﺤﺩﻭﺙ ﺘﺒﺩﻻﺕ ﻤﻠﺤﻭﻅﺔ ﻓﻲ ﺃﻱ ﻭﻗﺕ ﺨﻼل ﻓﺘﺭﺓ ﺍﻝﺴﺘﺔ ﺃﺸﻬﺭ ﻓﻲ ﻨﺘﺎﺌﺞ ﻤﺭﺤﻠﺔ ﺸﺭﻭﻁ‬
‫ﺍﻝﺘﺨﺯﻴﻥ ﺍﻝﻤﺴﺭﻋﺔ ‪ ،‬ﻋﻨﺩﻫﺎ ﻴﻁﻠﺏ ﺇﺠﺭﺍﺀ ﺇﺨﺘﺒﺎﺭﺍﺕ ﺇﻀﺎﻓﻴﺔ ﻓﻲ ﺸﺭﻭﻁ ﺍﻝﺘﺨﺯﻴﻥ ﺍﻝﻤﺘﻭﺴﻁﺔ‬
‫ﻭﺃﻥ ﺘﻘﻴﻡ ﺒﺎﻝﻤﻘﺎﺭﻨﺔ ﻤﻊ ﺍﻝﺘﺒﺩﻻﺕ ﺍﻝﻤﻠﺤﻭﻅﺔ ﺍﻝﻤﻘﺎﺴﺔ ﺴﺎﺒﻘﺎ‪ .‬ﻴﺠﺏ ﺃﻥ ﺘﺸﻤل ﺍﻹﺨﺘﺒﺎﺭﺍﺕ ﻓﻲ‬
‫ﺸﺭﻭﻁ ﺍﻝﺘﺨﺯﻴﻥ ﺍﻝﻤﺘﻭﺴﻁﺔ ﻜﺎﻓﺔ ﺍﻝﻔﺤﻭﺹ ‪ ،‬ﻤﺎ ﻝﻡ ﻴﺘﻡ ﺘﻘﺩﻴﻡ ﺃﺩﻝﺔ ﺘﺴﺘﺜﻨﻲ ﺫﻝﻙ‪ .‬ﺍﻝﻁﻠﺏ ﺍﻷﻭﻝﻲ‬
‫ﻴﺠﺏ ﺃﻥ ﻴﺸﻤل ﻨﺘﺎﺌﺞ ‪ ٦‬ﺃﺸﻬﺭ ﻋﻠﻰ ﺍﻷﻗل ﻤﻥ ﺃﺼل ﺩﺭﺍﺴﺔ ‪ ١٢‬ﺸﻬﺭ ﻓﻲ ﻅﺭﻭﻑ ﺘﺨﺯﻴﻥ‬
‫ﻤﺘﻭﺴﻁﺔ‪.‬‬

‫" ﺍﻝﺘﺒﺩﻻﺕ ﺍﻝﻤﻠﺤﻭﻅﺔ" ﺘﻌﺭﻑ ﺒﺎﻝﻨﺴﺒﺔ ﻝﻠﻤﺎﺩﺓ ﺍﻝﻔﻌﺎﻝﺔ ﺒﺄﻨﻬﺎ ﺍﻝﻔﺸل ﻓﻲ ﻤﻁﺎﺒﻘﺔ ﺍﻝﻤﻭﺍﺼﻔﺎﺕ‪.‬‬

‫‪ ٢,٧,١,٢‬ﺍﻝﻤﻭﺍﺩ ﺍﻝﻔﻌﺎﻝﺔ ﺍﻝﺘﻲ ﻴﺠﺏ ﺃﻥ ﺘﺨﺯﻥ ﻓﻲ ﺍﻝﺒﺭﺍﺩ‬

‫‪Active substances intended for storage in a refrigerator‬‬

‫ﺍﻝﻔﺘﺭﺓ ﺍﻝﺯﻤﻨﻴﺔ ﺍﻝﺩﻨﻴﺎ ﺍﻝﺘﻲ‬ ‫ﺸﺭﻭﻁ ﺍﻝﺘﺨﺯﻴﻥ‬ ‫ﻨﻭﻉ ﺍﻝﺩﺭﺍﺴﺔ‬

‫ﺘﻐﻁﻴﻬﺎ ﺍﻝﺒﻴﺎﻨﺎﺕ ﻓﻲ ﺯﻤﻥ‬
‫ﺘﻘﺩﻴﻡ ﻤﻠﻑ ﺍﻝﺘﺴﺠﻴل‬
‫‪ ٦‬ﺸﻬﻭﺭ )ﺍﻝﺨﻴﺎﺭ ﺃ ﺃﻭ ﺏ(‬ ‫‪5°C ± 3°C‬‬ ‫ﻁﻭﻴﻠﺔ ﺍﻷﻤﺩ‬
‫‪ ٦ 25°C ± 2°C/60% RH ± 5% RH‬ﺸﻬﻭﺭ‬ ‫ﻤﺴﺭﻋﺔ‬

‫ﻴﺠﺏ ﺘﻘﻴﻴﻡ ﻨﺘﺎﺌﺞ ﺩﺭﺍﺴﺎﺕ ﺍﻝﺘﺨﺯﻴﻥ ﻓﻲ ﺍﻝﺒﺭﺍﺩ ﺘﺒﻌﺎ ﻝﻠﻘﺴﻡ ﺍﻝﻤﺘﻌﻠﻕ ﺒﺘﻘﻴﻴﻡ ﺩﺭﺍﺴﺎﺕ ﺍﻝﺜﺒﺎﺕ‬
‫ﺍﻝﻤﺫﻜﻭﺭﺓ ﻓﻲ ﻫﺫﺍ ﺍﻝﺩﻝﻴل‪ ،‬ﺒﺎﺴﺘﺜﻨﺎﺀ ﺍﻝﺫﻱ ﺴﻴﺘﻡ ﺫﻜﺭﻩ ﺃﺩﻨﺎﻩ ﺒﻜل ﻭﻀﻭﺡ ﻭﺼﺭﺍﺤﺔ‪.‬‬

‫ﺇﺫﺍ ﺤﺼل ﺘﺒﺩل ﻤﻠﺤﻭﻅ ﺒﻴﻥ ‪ ٣‬ﻭ‪ ٦‬ﺸﻬﻭﺭ ﻓﻲ ﺍﻝﺩﺭﺍﺴﺔ ﺒﺸﺭﻭﻁ ﺘﺨﺯﻴﻥ ﻤﺴﺭﻋﺔ ‪ ،‬ﻓﺈﻥ ﺘﺎﺭﻴﺦ‬
‫ﺇﻋﺎﺩﺓ ﺍﻝﻔﺤﺹ ﻴﺠﺏ ﺃﻥ ﻴﺴﺘﻨﺩ ﻋﻠﻰ ﻨﺘﺎﺌﺞ ﺍﻝﺯﻤﻥ ﺍﻝﺤﻘﻴﻘﻲ ﺍﻝﻤﺘﻭﻓﺭﺓ ﻓﻲ ﺸﺭﻭﻁ ﺍﻝﺘﺨﺯﻴﻥ‬
‫ﺍﻝﻁﻭﻴﻠﺔ ﺍﻷﻤﺩ‪.‬‬

‫ﺇﺫﺍ ﺤﺼل ﺘﺒﺩل ﻤﻠﺤﻭﻅ ﺨﻼل ﺍﻝﺜﻼﺜﺔ ﺃﺸﻬﺭ ﺍﻷﻭﻝﻰ ﻓﻲ ﺇﺨﺘﺒﺎﺭﺍﺕ ﺍﻝﺜﺒﺎﺕ ﺍﻝﻤﺨﺯﻨﺔ ﺒﺸﺭﻭﻁ‬
‫ﻤﺴﺭﻋﺔ ‪ ،‬ﻓﺈﻥ ﺍﻝﻨﻘﺎﺵ ﻴﺠﺏ ﺃﻥ ﻴﻘﺩﻡ ﺩﻻﺌل ﺘﺸﻴﺭ ﺇﻝﻰ ﺍﻝﺘﺄﺜﻴﺭﺍﺕ ﺍﻝﺘﻲ ﺘﺤﺼل ﻋﻨﺩ ﺘﻌﺭﻴﺽ‬
‫ﺍﻝﻤﺴﺘﺤﻀﺭ ﻝﺸﺭﻭﻁ ﺘﺨﺯﻴﻥ ﺘﺨﺘﻠﻑ ﻋﻥ ﺍﻝﻤﻨﺼﻭﺹ ﻋﻠﻴﻬﺎ ﻓﻲ ﺍﻝﻌﻨﻭﻨﺔ‪ .‬ﻤﺜﺎل ﻋﻨﺩ ﺸﺤﻥ ﺍﻝﻤﺎﺩﺓ‬
‫ﺃﻭ ﺍﻝﺘﻌﺎﻭل ﻤﻌﻬﺎ‪ .‬ﻫﺫﺍ ﺍﻝﻨﻘﺎﺵ ﻴﻤﻜﻥ ﺃﻥ ﻴﺩﻋﻡ ‪ ،‬ﺇﺫﺍ ﻜﺎﻥ ﻤﻨﺎﺴﺒﺎ‪ ،‬ﻤﻥ ﺨﻼل ﺇﺨﺘﺒﺎﺭﺍﺕ ﺇﻀﺎﻓﻴﺔ‬
‫ﺘﺠﺭﻯ ﻋﻠﻰ ﺘﺤﻀﻴﺭﺓ ﻭﺍﺤﺩﺓ ﻝﻠﻤﺎﺩﺓ ﺍﻝﻔﻌﺎﻝﺔ ﻝﻤﺩﺓ ﺘﻘل ﻋﻥ ﺜﻼﺜﺔ ﺃﺸﻬﺭ ﻝﻜﻥ ﺒﺘﻜﺭﺍﺭﻴﺔ ﺃﻜﺜﺭ‬

‫‪٨‬‬
 ‫ﻝﻺﺨﺘﺒﺎﺭﺍﺕ ﻋﻥ ﺍﻝﺫﻱ ﻴﺘﻡ ﻋﺎﺩﺓ‪ .‬ﻴﻌﺘﺒﺭ ﻏﻴﺭ ﻀﺭﻭﺭﻱ ﺍﻻﺴﺘﻤﺭﺍﺭ ﻓﻲ ﺩﺭﺍﺴﺔ ﺍﻝﻤﺎﺩﺓ ﺍﻝﻔﻌﺎﻝﺔ‬
‫ﺨﻼل ﺴﺘﺔ ﺃﺸﻬﺭ ﺇﺫﺍ ﺤﺼل ﺘﺒﺩﻻﺕ ﻤﻠﺤﻭﻅﺔ ﺨﻼل ﺍﻝﺜﻼﺜﺔ ﺃﺸﻬﺭ ﺍﻷﻭﻝﻰ‪.‬‬

‫‪ ٣,٧,١,٢‬ﺍﻝﻤﻭﺍﺩ ﺍﻝﻔﻌﺎﻝﺔ ﺍﻝﺘﻲ ﺘﺨﺯﻥ ﻓﻲ ﺍﻝﻤﺠﻤﺩﺓ‬

‫‪Active substances intended for storage in a freezer‬‬

‫ﺍﻝﻔﺘﺭﺓ ﺍﻝﺯﻤﻨﻴﺔ ﺍﻝﺩﻨﻴﺎ ﺍﻝﺘﻲ‬ ‫ﺸﺭﻭﻁ ﺍﻝﺘﺨﺯﻴﻥ‬ ‫ﻨﻭﻉ ﺍﻝﺩﺭﺍﺴﺔ‬

‫ﺘﻐﻁﻴﻬﺎ ﺍﻝﺒﻴﺎﻨﺎﺕ ﻓﻲ ﺯﻤﻥ‬
‫ﺘﻘﺩﻴﻡ ﻤﻠﻑ ﺍﻝﺘﺴﺠﻴل‬
‫‪ ٦‬ﺸﻬﻭﺭ )ﺍﻝﺨﻴﺎﺭ ﺃ ﺃﻭ ﺏ(‬ ‫‪-20°C ± 5°C‬‬ ‫ﻁﻭﻴﻠﺔ ﺍﻷﻤﺩ‬

‫ﺒﺎﻝﻨﺴﺒﺔ ﻝﻠﻤﻭﺍﺩ ﺍﻝﻔﻌﺎﻝﺔ ﺍﻝﺘﻲ ﻴﻌﺩ ﻝﻬﺎ ﺍﻝﺘﺨﺯﻴﻥ ﻓﻲ ﺍﻝﻤﺠﻤﺩﺓ ‪ ،‬ﻓﺈﻥ ﻓﺘﺭﺓ ﺇﻋﺎﺩﺓ ﺍﻹﺨﺘﺒﺎﺭ ﻴﺠﺏ ﺃﻥ‬
‫ﺘﻌﺘﻤﺩ ﻋﻠﻰ ﻨﺘﺎﺌﺞ ﺒﻴﺎﻨﺎﺕ ﺍﻝﺯﻤﻥ ﺍﻝﺤﻘﻴﻘﻲ ﺍﻝﺘﻲ ﻴﺘﻡ ﺍﻝﺤﺼﻭل ﻋﻠﻴﻬﺎ ﻤﻥ ﺍﻝﺩﺭﺍﺴﺔ ﺒﺸﺭﻭﻁ ﺘﺨﺯﻴﻥ‬
‫ﻁﻭﻴﻠﺔ ﺍﻷﻤﺩ‪ .‬ﻓﻲ ﻏﻴﺎﺏ ﺍﻝﺩﺭﺍﺴﺔ ﺒﺸﺭﻭﻁ ﺘﺨﺯﻴﻥ ﻤﺴﺭﻋﺔ ﻝﻠﻤﺎﺩﺓ ﺍﻝﻔﻌﺎﻝﺔ ﻭﺍﻝﺘﻲ ﻴﻌﺩ ﻝﻬﺎ ﺃﻥ‬
‫ﺘﺨﺯﻥ ﻓﻲ ﺍﻝﻤﺠﻤﺩﺓ ‪ ،‬ﻓﺈﻥ ﺍﻝﻔﺤﻭﺹ ﻴﺠﺏ ﺃﻥ ﺘﺠﺭﻯ ﻋﻠﻰ ﺘﺤﻀﻴﺭﺓ ﻭﺍﺤﺩﺓ ﺒﺩﺭﺠﺎﺕ ﺤﺭﺍﺭﺓ‬
‫ﻤﺭﺘﻔﻌﺔ ) ﻤﺜل ‪ 5°C ± 3°C‬ﺃﻭ ‪ ( 25°C ± 2°C‬ﻭﺫﻝﻙ ﻝﻔﺘﺭﺓ ﺯﻤﻨﻴﺔ ﻤﻨﺎﺴﺒﺔ ‪ .‬ﻤﺜل ﻫﺫﻩ‬
‫ﺍﻝﺩﺭﺍﺴﺔ ﺘﻘﺩﻡ ﺒﻴﺎﻨﺎﺕ ﺤﻭل ﺘﺄﺜﻴﺭ ﺘﻌﺭﺽ ﺍﻝﻤﺎﺩﺓ ﻝﻔﺘﺭﺓ ﻗﺼﻴﺭﺓ ﻝﻅﺭﻭﻑ ﺍﻝﻨﻘل ﻭﺍﻝﺸﺤﻥ ﻭﺍﻝﺘﻌﺎﻤل‬
‫ﻤﻊ ﺍﻝﻤﺎﺩﺓ ﺘﺨﺘﻠﻑ ﻋﻥ ﺸﺭﻭﻁ ﺍﻝﺘﺨﺯﻴﻥ ﺍﻝﻤﺼﺭﺡ ﻋﻨﻬﺎ ﻓﻲ ﺍﻝﻌﻨﻭﻨﺔ‪.‬‬

‫‪ ٤,٧,١,٢‬ﺍﻝﻤﻭﺍﺩ ﺍﻝﻔﻌﺎﻝﺔ ﺍﻝﻤﻌﺩﺓ ﻝﻠﺘﺨﺯﻴﻥ ﺒﺸﺭﻭﻁ ﺃﻗل ﻤﻥ ‪-20°C‬‬

‫‪Active substances intended for storage below -20°C‬‬

‫ﻴﺠﺏ ﻤﻌﺎﻤﻠﺔ ﺍﻝﻤﻭﺍﺩ ﺍﻷﻭﻝﻴﺔ ﺍﻝﻔﻌﺎﻝﻴﺔ ﺍﻝﻤﻌﺩﺓ ﻝﻠﺘﺨﺯﻴﻥ ﺒﺸﺭﻭﻁ ﺃل ﻤﻥ ‪ -20°C‬ﺒﺤﺴﺏ ﻜل ﺤﺎﻝﺔ‪.‬‬

‫‪ ٨,١,٢‬ﺘﻌﻬﺩ ﺍﻝﺜﺒﺎﺕ ‪Stability commitment‬‬

‫ﻋﻨﺩﻤﺎ ﺘﻜﻭﻥ ﻨﺘﺎﺌﺞ ﺩﺭﺍﺴﺎﺕ ﺍﻝﺜﺒﺎﺕ ﺍﻝﻁﻭﻴﻠﺔ ﺍﻷﻤﺩ ﻝﻠﺘﺤﻀﻴﺭﺍﺕ ﺍﻷﻭﻝﻴﺔ ﻻﺘﻐﻁﻲ ﻓﺘﺭﺓ ﺇﻋﺎﺩﺓ‬
‫ﺍﻹﺨﺘﺒﺎﺭ ﺍﻝﻤﻘﺘﺭﺤﺔ ﻭﺍﻝﺘﻲ ﺘﻡ ﺍﻝﻤﻭﺍﻓﻘﺔ ﻋﻠﻴﻬﺎ ﺨﻼل ﻓﺘﺭﺓ ﺍﻝﺘﻘﻴﻴﻡ ﻝﻤﻠﻑ ﺍﻝﺘﺴﺠﻴل ﻋﻨﺩﻫﺎ ﻴﺠﺏ‬
‫ﺘﻘﺩﻴﻡ ﺘﻌﻬﺩ ﻝﻺﺴﺘﻤﺭﺍﺭ ﺒﺈﺠﺭﺍﺀ ﺩﺭﺍﺴﺎﺕ ﺍﻝﺜﺒﺎﺕ ﺒﻌﺩ ﻤﻨﺢ ﺍﻝﺘﺭﺨﻴﺹ ﺍﻝﻼﺯﻡ ﻤﻥ ﺃﺠل ﺘﺤﻘﻴﻕ‬
‫ﻭﺒﺸﻜل ﻤﺅﻜﺩ ﻓﺘﺭﺓ ﺇﻋﺎﺩﺓ ﺍﻹﺨﺘﺒﺎﺭ‪.‬‬

‫‪٩‬‬
‫ﻋﻨﺩ ﺘﻘﺩﻴﻡ ﻨﺘﺎﺌﺞ ﺩﺭﺍﺴﺎﺕ ﺍﻝﺜﺒﺎﺕ ﺍﻝﻁﻭﻴﻠﺔ ﺍﻷﻤﺩ ﻝﺜﻼﺙ ﺘﺤﻀﻴﺭﺍﺕ ﺼﻨﺎﻋﻴﺔ ﻴﺘﻡ ﻓﻴﻬﺎ ﺘﻐﻁﻴﺔ ﻤﺩﺓ‬
‫ﺍﻹﺨﺘﺒﺎﺭ ‪ ،‬ﻋﻨﺩﻫﺎ ﻝﻴﺱ ﻤﻥ ﺍﻝﻀﺭﻭﺭﻱ ﺘﻘﺩﻴﻡ ﺘﻌﻬﺩ ﺍﻝﺜﺒﺎﺕ ﺒﻌﺩ ﻤﻨﺢ ﺍﻝﺘﺭﺨﻴﺹ ﺍﻝﻼﺯﻡ ‪ .‬ﺨﻼﻑ‬
‫ﺫﻝﻙ ﻓﺈﻨﻪ ﻴﺠﺏ ﺘﻘﺩﻴﻡ ﺃﺤﺩ ﺍﻝﺘﻌﻬﺩﺍﺕ ﺍﻝﺘﺎﻝﻴﺔ‪:‬‬
‫‪ .١‬ﺇﺫﺍ ﻜﺎﻥ ﺍﻝﻤﻠﻑ ﺍﻝﻤﻘﺩﻡ ﻝﻠﺘﺴﺠﻴل ﻴﺘﻀﻤﻥ ﻨﺘﺎﺌﺞ ﺩﺭﺍﺴﺎﺕ ﺍﻝﺜﺒﺎﺕ ﻝﺜﻼﺙ ﺘﺤﻀﻴﺭﺍﺕ‬
‫ﺼﻨﺎﻋﻴﺔ ﻋﻠﻰ ﺍﻷﻗل ‪ ،‬ﻋﻨﺩﻫﺎ ﻴﺠﺏ ﺘﻘﺩﻴﻡ ﺘﻌﻬﺩ ﻝﻺﺴﺘﻤﺭﺍﺭ ﺒﺘﻠﻙ ﺍﻝﺩﺭﺍﺴﺎﺕ‬
‫ﻝﻠﻭﺼﻭل ﻝﻔﺘﺭﺓ ﺇﻋﺎﺩﺓ ﺍﻹﺨﺘﺒﺎﺭ‪.‬‬
‫‪ .٢‬ﺇﺫﺍ ﻜﺎﻥ ﺍﻝﻤﻠﻑ ﺍﻝﻤﻘﺩﻡ ﻝﻠﺘﺴﺠﻴل ﻴﺘﻀﻤﻥ ﻨﺘﺎﺌﺞ ﺩﺭﺍﺴﺎﺕ ﺜﺒﺎﺕ ﺃﻗل ﻤﻥ ﺜﻼﺙ‬
‫ﺘﺤﻀﻴﺭﺍﺕ ﺼﻨﺎﻋﻴﺔ ‪ ،‬ﻋﻨﺩﻫﺎ ﻴﺠﺏ ﺘﻘﺩﻴﻡ ﺘﻌﻬﺩ ﻝﻺﺴﺘﻤﺭﺍﺭ ﺒﺘﻠﻙ ﺍﻝﺩﺭﺍﺴﺎﺕ‬
‫ﻝﻠﻭﺼﻭل ﻝﻔﺘﺭﺓ ﺇﻋﺎﺩﺓ ﺍﻹﺨﺘﺒﺎﺭ ﻭﺇﻀﺎﻓﺔ ﺘﺤﻀﻴﺭﺍﺕ ﺼﻨﺎﻋﻴﺔ ﻝﻠﻭﺼﻭل ﻝﻤﺠﻤﻭﻉ‬
‫ﺜﻼﺙ ﺘﺤﻀﻴﺭﺍﺕ ﻭﺃﻥ ﺘﺠﺭﻯ ﻋﻠﻴﻬﺎ ﺩﺭﺍﺴﺎﺕ ﺜﺒﺎﺕ ﻁﻭﻴﻠﺔ ﺍﻷﻤﺩ ﻝﻠﻭﺼﻭل ﺇﻝﻰ‬
‫ﺘﺎﺭﻴﺦ ﺇﻋﺎﺩﺓ ﺍﻹﺨﺘﺒﺎﺭ ﺍﻝﻤﻘﺘﺭﺤﺔ ﻓﻲ ﻤﻠﻑ ﺍﻝﺘﺴﺠﻴل‪.‬‬
‫‪ .٣‬ﺇﺫﺍ ﻜﺎﻥ ﺍﻝﻤﻠﻑ ﺍﻝﻤﻘﺩﻡ ﻝﻠﺘﺴﺠﻴل ﻻ ﻴﺘﻀﻤﻥ ﻨﺘﺎﺌﺞ ﺩﺭﺍﺴﺎﺕ ﺍﻝﺜﺒﺎﺕ ﻝﺜﻼﺙ‬
‫ﺘﺤﻀﻴﺭﺍﺕ ﺼﻨﺎﻋﻴﺔ ‪ ،‬ﻋﻨﺩﻫﺎ ﻴﺠﺏ ﺘﻘﺩﻴﻡ ﺘﻌﻬﺩ ﻝﻺﺴﺘﻤﺭﺍﺭ ﺒﺘﻠﻙ ﺍﻝﺩﺭﺍﺴﺎﺕ ﻝﺜﻼﺙ‬
‫ﺘﺤﻀﻴﺭﺍﺕ ﺼﻨﺎﻋﻴﺔ ﻭﺃﻥ ﺘﺠﺭﻯ ﻋﻠﻴﻬﺎ ﺩﺭﺍﺴﺎﺕ ﺜﺒﺎﺕ ﻁﻭﻴﻠﺔ ﺍﻷﻤﺩ ﻝﻠﻭﺼﻭل ﺇﻝﻰ‬
‫ﺘﺎﺭﻴﺦ ﺇﻋﺎﺩﺓ ﺍﻹﺨﺘﺒﺎﺭ ﺍﻝﻤﻘﺘﺭﺤﺔ ﻓﻲ ﻤﻠﻑ ﺍﻝﺘﺴﺠﻴل‪.‬‬

‫ﻴﺠﺏ ﺃﻥ ﻴﻜﻭﻥ ﺒﺭﻭﺘﻭﻜﻭل ﺍﻝﺜﺒﺎﺕ ﺍﻝﻤﺘﺒﻊ ﻓﻲ ﺘﻌﻬﺩ ﺩﺭﺍﺴﺎﺕ ﺍﻝﺜﺒﺎﺕ ﺍﻝﻁﻭﻴﻠﺔ ﺍﻷﻤﺩ ﻫﻭ ﻨﻔﺴﻪ‬
‫ﺍﻝﻤﺴﺘﻌﻤل ﻝﻠﺘﺤﻀﻴﺭﺍﺕ ﺍﻝﺘﺠﺭﻴﺒﻴﺔ ﺍﻷﻭﻝﻴﺔ ‪ ،‬ﻤﺎ ﻋﺩﺍ ﺒﻌﺽ ﺍﻝﺤﺎﻻﺕ ﺍﻝﺘﻲ ﻴﻤﻜﻥ ﺘﺒﺭﻴﺭﻫﺎ ﻋﻠﻤﻴﺎ‪.‬‬

‫‪ ٩,١,٢‬ﺍﻝﺘﻘﻴﻴﻡ ‪Evaluation‬‬

‫ﺇﻥ ﺍﻝﻬﺩﻑ ﻤﻥ ﺩﺭﺍﺴﺎﺕ ﺍﻝﺜﺒﺎﺕ ﻫﻭ ﻝﻠﺘﺄﻜﺩ ‪ ،‬ﺒﺎﻻﻋﺘﻤﺎﺩ ﻋﻠﻰ ﺍﻹﺨﺘﺒﺎﺭﺍﺕ ﺍﻝﺘﻲ ﺘﺠﺭﻯ ﻋﻠﻰ ﺍﻷﻗل‬
‫ﻝﺘﺤﻀﻴﺭﺘﻴﻥ ﺃﻭ ﺜﻼﺙ ﺘﺤﻀﻴﺭﺍﺕ ﻤﻥ ﺍﻝﻤﺎﺩﺓ ﺍﻝﻔﻌﺎﻝﺔ ﻭﺘﻘﻴﻴﻡ ﻤﻌﻠﻭﻤﺎﺕ ﺍﻝﺜﺒﺎﺕ ) ﺘﺘﻀﻤﻥ ﺒﺤﺴﺏ‬
‫ﺍﻝﻀﺭﻭﺭﺓ ﻨﺘﺎﺌﺞ ﺍﻹﺨﺘﺒﺎﺭﺍﺕ ﺍﻝﻔﻴﺯﻴﺎﺌﻴﺔ ﻭﺍﻝﻜﻴﻤﻴﺎﺌﻴﺔ ﻭﺍﻝﺤﻴﻭﻴﺔ ﻭﺍﻝﺠﺭﺜﻭﻤﻴﺔ ( ‪ ،‬ﻓﺘﺭﺓ ﺇﻋﺎﺩﺓ‬
‫ﺍﻹﺨﺘﺒﺎﺭ ﺘﻨﻁﺒﻕ ﻋﻠﻰ ﺠﻤﻴﻊ ﺍﻝﺘﺤﻀﻴﺭﺍﺕ ﺍﻝﺘﻲ ﺴﻴﺘﻡ ﺘﺼﻨﻴﻌﻬﺎ ﻤﺴﺘﻘﺒﻼ ﺒﺎﺘﺒﺎﻉ ﻨﻔﺱ ﻁﺭﻴﻘﺔ‬
‫ﺍﻝﺘﺼﻨﻴﻊ ﻝﻠﻤﺎﺩﺓ ﺍﻝﻔﻌﺎﻝﺔ ﻭﺘﺤﺕ ﺸﺭﻭﻁ ﻤﻤﺎﺜﻠﺔ ‪.‬ﺇﻥ ﺩﺭﺠﺔ ﺍﻝﺘﺒﺎﻴﻥ ﻭﺍﻹﺨﺘﻼﻑ ﻓﻲ ﺍﻝﺘﺤﻀﻴﺭﺍﺕ‬
‫ﺍﻝﻔﺭﺩﻴﺔ ﻴﺅﺜﺭ ﻓﻲ ﺍﻝﺜﻘﺔ ﺒﺄﻥ ﺍﻝﺘﺤﻀﻴﺭﺍﺕ ﺍﻝﺘﻲ ﺴﻴﺘﻡ ﺇﻨﺘﺎﺠﻬﺎ ﻤﺴﺘﻘﺒﻼ ﺴﺘﺒﻘﻰ ﻀﻤﻥ ﺍﻝﻤﻭﺍﺼﻔﺎﺕ‬
‫ﻁﻴﻠﺔ ﻓﺘﺭﺓ ﺇﻋﺎﺩﺓ ﺍﻹﺨﺘﺒﺎﺭ‪.‬‬
‫ﻴﻤﻜﻥ ﺃﻥ ﺘﻅﻬﺭ ﺍﻝﺒﻴﺎﻨﺎﺕ ﺘﺨﺭﺏ ﻗﻠﻴل ﻭﺍﺨﺘﻼﻑ ﻗﻠﻴل ﺠﺩﺍ ﻴﻤﻜﻥ ﻤﻼﺤﻅﺘﻪ ﻋﻨﺩ ﺍﻝﻨﻅﺭ ﻓﻲ ﻨﺘﺎﺌﺞ‬
‫ﺍﻝﺩﺭﺍﺴﺔ ﺒﺤﻴﺙ ﻴﺘﻡ ﻤﻨﺢ ﺍﻝﻤﻭﺍﻓﻘﺔ ﻋﻠﻰ ﺘﺎﺭﻴﺦ ﺇﻋﺎﺩﺓ ﺍﻹﺨﺘﺒﺎﺭ ﺍﻝﻤﻁﻠﻭﺏ ‪ .‬ﻓﻲ ﻤﺜل ﺘﻠﻙ ﺍﻝﺤﺎﻻﺕ‬
‫‪ ،‬ﻓﺈﻨﻪ ﻤﻥ ﻏﻴﺭ ﺍﻝﻀﺭﻭﺭﻱ ﻹﺠﺭﺍﺀ ﺘﺤﻠﻴل ﺇﺤﺼﺎﺌﻲ ؛ﺇﺫﺍ ﺜﺒﺕ ﺒﺄﻥ ﺍﻝﺤﺫﻑ ﻤﻘﻨﻌﺎ ‪.‬‬
‫ﺇﻥ ﺍﻝﻤﻨﺤﻰ ﻝﺘﺤﻠﻴل ﺍﻝﻨﺘﺎﺌﺞ ﺒﺸﻜل ﻜﻤﻲ ﻝﻠﻤﻭﺍﺩ ﺍﻝﺘﻲ ﻴﻤﻜﻥ ﺃﻥ ﺘﺘﺒﺩل ﻤﻊ ﺍﻝﺯﻤﻥ ﻭﺫﻝﻙ ﻝﺘﺤﺩﻴﺩ‬
‫ﺍﻝﺯﻤﻥ ﺍﻝﺘﻲ ﺘﺸﻜل ﻓﻴﻪ ﺍﻝﺜﻘﺔ ﻓﻲ ﺍﻝﻨﺘﺎﺌﺞ ﺒﺎﺘﺠﺎﻩ ﻭﺍﺤﺩ ﻨﺴﺒﺘﺔ ‪ %٩٥‬ﻭﺒﺄﻥ ﺍﻝﻤﻨﺤﻨﻰ ﺍﻝﻭﺴﻁﻲ‬
‫ﻴﺘﻘﺎﻁﻊ ﻤﻊ ﻤﺘﻁﻠﺒﺎﺕ ﺍﻝﻘﺒﻭل ﺍﻝﻘﻴﺎﺴﻲ‪ .‬ﺇﺫﺍ ﺒﻴﻨﺕ ﺍﻝﻨﺘﺎﺌﺞ ﺒﺄﻥ ﺍﻹﺨﺘﻼﻓﺎﺕ ﻤﻥ ﺘﺤﻀﻴﺭﺓ ﻝﺘﺤﻀﻴﺭﺓ‬
‫ﺼﻐﻴﺭ ﻋﻨﺩﻫﺎ ﻴﻜﻭﻥ ﻤﻥ ﺍﻝﻤﻔﻀل ﺠﻤﻊ ﺍﻝﺒﻴﺎﻨﺎﺕ ﻝﻠﻭﺼﻭل ﻝﺘﻘﺩﻴﺭ ﺇﺠﻤﺎﻝﻲ‪ .‬ﻴﻤﻜﻥ ﺘﺤﻘﻴﻕ ﺫﻝﻙ‬

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‫ﻤﻥ ﺨﻼل ﺘﻁﺒﻴﻕ ﺇﺨﺘﺒﺎﺭﺍﺕ ﺇﺤﺼﺎﺌﻴﺔ ﻤﻨﺎﺴﺒﺔ )ﻤﺜل ‪ ،.‬ﺤﺩﻭﺩ ﻗﻴﻡ ﺍﻝﺭﻓﺽ ﺫﻭ ﺍﻷﻫﻤﻴﺔ ﺇﺫﺍ ﻜﺎﻨﺕ‬
‫ﺃﻜﺜﺭ ﻤﻥ ‪.( ٠,٢٥‬‬
‫ﺇﻥ ﺃﻱ ﺘﻘﻴﻴﻡ ﻴﺠﺏ ﺃﻥ ﻴﻐﻁﻲ ﻝﻴﺱ ﻓﻘﻁ ﺍﻝﻤﻌﺎﻴﺭﺓ ‪ ،‬ﺒل ﻴﺠﺏ ﺃﻥ ﻴﻐﻁﻲ ﺃﻴﻀﺎ ﻤﻭﺍﺩ ﺍﻝﺘﺨﺭﺏ‬
‫ﻭﺍﻝﻌﻭﺍﻤل ﺍﻝﻤﺸﺎﺭﻜﺔ ﺍﻷﺨﺭﻯ ‪.‬‬

‫‪ ١٠,١,٢‬ﺘﺼﺭﻴﺢ‪ /‬ﺍﻝﻌﻨﻭﻨﺔ ‪Statements/Labelling‬‬

‫ﺸﺭﻭﻁ ﺍﻝﺘﺨﺯﻴﻥ )ﺤﺭﺍﺭﺓ ‪ ،‬ﻀﻭﺀ ‪ ،‬ﺭﻁﻭﺒﺔ( ﺍﻝﻤﺼﺭﺡ ﺒﻬﺎ ﻴﺠﺏ ﺃﻥ ﺘﺴﺘﻨﺩ ﻋﻠﻰ ﺩﻝﻴل ﺘﺼﺭﻴﺢ‬
‫ﺸﺭﻭﻁ ﺘﺨﺯﻴﻥ ﺍﻝﻤﺴﺘﺤﻀﺭﺍﺕ ﺍﻝﺩﻭﺍﺌﻴﺔ – ﺍﻝﻤﻭﺍﺩ ﺍﻝﻔﻌﺎﻝﺔ‪.‬‬
‫ﺇﻥ ﺍﺴﺘﻌﻤﺎل ﺘﻌﺎﺒﻴﺭ ﻤﺜل ﺍﻝﺸﺭﻭﻁ ﺍﻝﻁﺒﻴﻌﻴﺔ ﺃﻭ ﺤﺭﺍﺭﺓ ﺍﻝﻐﺭﻓﺔ ﻫﻭ ﻏﻴﺭ ﻤﻘﺒﻭل‪.‬‬

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 ‫‪ ٢,٢‬ﺍﻝﻤﺴﺘﺤﻀﺭ ﺍﻝﺠﺎﻫﺯ ‪Finished product‬‬
‫‪ ١,٢,٢‬ﻋﺎﻡ ‪General‬‬

‫ﺇﻥ ﺘﺼﻤﻴﻡ ﺩﺭﺍﺴﺎﺕ ﺍﻝﺜﺒﺎﺕ ﻝﻠﻤﺴﺘﺤﻀﺭﺍﺕ ﺍﻝﺠﺎﻫﺯﺓ ﻴﻤﻜﻥ ﺃﻥ ﻴﺴﺘﻨﺩ ﺇﻝﻰ ﺍﻝﻤﻌﺭﻓﺔ ﻓﻲ ﺨﻭﺍﺹ‬
‫ﻭﺴﻠﻭﻙ ﺍﻝﻤﻭﺍﺩ ﺍﻝﻔﻌﺎﻝﺔ ﻭﺍﻝﺸﻜل ﺍﻝﺼﻴﺩﻻﻨﻲ ‪.‬‬

‫‪ ٢,٢,٢‬ﺇﺨﺘﺒﺎﺭﺍﺕ ﺍﻝﺜﺒﺎﺕ ﺍﻝﻀﻭﺌﻲ ‪Photostability Testing‬‬

‫ﻴﺠﺏ ﺇﺠﺭﺍﺀ ﺇﺨﺘﺒﺎﺭ ﺍﻝﺜﺒﺎﺕ ﺍﻝﻀﻭﺌﻲ ﻋﻠﻰ ﺘﺤﻀﻴﺭﺓ ﺘﺠﺭﻴﺒﻴﺔ ﻭﺍﺤﺩﺓ ﻝﻠﻤﺴﺘﺤﻀﺭﺍﻝﺠﺎﻫﺯ ﻋﻠﻰ‬
‫ﺍﻷﻗل ﺇﺫﺍ ﻜﺎﻥ ﺫﻝﻙ ﻤﻼﺌﻤﺎ‪.‬‬

‫‪ ٣,٢,٢‬ﺇﺨﺘﻴﺎﺭ ﺍﻝﺘﺤﻀﻴﺭﺍﺕ ‪Selection of Batches‬‬

‫ﻓﻲ ﺍﻝﻭﻗﺕ ﺍﻝﺫﻱ ﻴﺘﻡ ﻓﻴﻪ ﺘﻘﺩﻴﻡ ﻨﺘﺎﺌﺞ ﺩﺭﺍﺴﺎﺕ ﺍﻝﺜﺒﺎﺕ ﻓﺈﻨﻬﺎ ﻴﺠﺏ ﺃﻥ ﺘﻜﻭﻥ ﻝﺘﺤﻀﻴﺭﺍﺕ ﺒﻨﻔﺱ‬
‫ﺍﻝﺘﺭﻜﻴﺏ ﻭﺍﻝﺸﻜل ﺍﻝﺼﻴﺩﻻﻨﻲ ﻭﻨﻅﺎﻡ ﺍﻝﺘﻌﺒﺌﺔ ﻭﺍﻝﺘﻐﻠﻴﻑ ﻝﻠﻤﺴﺘﺤﻀﺭ ﺍﻝﺫﻱ ﺴﻴﻁﺭﺡ ﻓﻲ ﺍﻷﺴﻭﺍﻕ‪.‬‬
‫ﻴﻭﺠﺩ ﺇﺨﺘﻴﺎﺭﻴﻥ ﻤﻘﺒﻭﻝﻴﻥ‪:‬‬
‫ﺃ( ﻓﻲ ﺤﺎﻝﺔ ﺍﻷﺸﻜﺎل ﺍﻝﺼﻴﺩﻻﻨﻴﺔ ﺍﻝﺘﻘﻠﻴﺩﻴﺔ )ﻤﺜل‪ ،‬ﺍﻷﺸﻜﺎل ﺍﻝﺼﻴﺩﻻﻨﻴﺔ‬
‫ﺍﻝﻔﻭﺭﻴﺔ ﺍﻝﺘﺤﺭﻴﺭ‪ ،‬ﺍﻝﻤﺤﺎﻝﻴل( ﻭﺇﺫﺍ ﻜﺎﻨﺕ ﺍﻝﻤﺎﺩﺓ ﺍﻝﻔﻌﺎﻝﺔ ﻤﻌﺭﻭﻓﺔ ﺒﺄﻨﻬﺎ ﺜﺎﺒﺘﺔ‬
‫‪ ،‬ﻓﺈﻨﻪ ﻴﻤﻜﻥ ﻗﺒﻭل ﻨﺘﺎﺌﺞ ﺩﺭﺍﺴﺎﺕ ﺍﻝﺜﺒﺎﺕ ﻝﺘﺤﻀﻴﺭﺘﻴﻥ ﺘﺠﺭﻴﺒﻴﺘﻴﻥ‪.‬‬

‫ﺏ( ﻓﻲ ﺤﺎﻝﺔ ﺍﻷﺸﻜﺎل ﺍﻝﺼﻴﺩﻻﻨﻴﺔ ﺍﻝﺤﺭﺠﺔ ﺃﻭ ﻓﻲ ﺤﺎﻝﺔ ﺍﻝﻤﻭﺍﺩ ﺍﻝﻔﻌﺎﻝﺔ‬

‫ﺍﻝﻤﻌﺭﻭﻑ ﺒﺄﻨﻬﺎ ﻏﻴﺭ ﺜﺎﺒﺘﺔ ‪ ،‬ﻋﻨﺩﻫﺎ ﻴﺠﺏ ﺘﻘﺩﻴﻡ ﻨﺘﺎﺌﺞ ﺩﺭﺍﺴﺎﺕ ﺍﻝﺜﺒﺎﺕ‬
‫ﻝﺘﺤﻀﻴﺭﺘﻴﻥ ﺘﺠﺭﻴﺒﻴﺘﻴﻥ ﻭﺍﻝﺘﺤﻀﻴﺭﺓ ﺍﻝﺜﺎﻝﺜﺔ ﻴﻤﻜﻥ ﺃﻥ ﺘﻜﻭﻥ ﺃﺼﻐﺭ‪.‬‬

‫ﻴﺠﺏ ﺃﻥ ﺘﻜﻭﻥ ﻁﺭﻕ ﺍﻝﺘﺼﻨﻴﻊ ﻝﻠﺘﺤﻀﻴﺭﺍﺕ ﺍﻝﺘﺠﺭﻴﺒﻴﺔ ﺘﻤﺎﺜل ﻁﺭﻕ ﺍﻝﺘﺼﻨﻴﻊ ﺍﻝﺘﻲ‬
‫ﺴﺘﺘﺒﻊ ﻓﻲ ﺍﻝﺘﺤﻀﻴﺭﺍﺕ ﺍﻝﺼﻨﺎﻋﻴﺔ ﻭﺃﻥ ﻴﻘﺩﻡ ﻤﺴﺘﺤﻀﺭ ﺒﻨﻔﺱ ﺍﻝﻤﻭﺍﺼﻔﺎﺕ ﻭﺍﻝﺠﻭﺩﺓ‬
‫ﻝﻠﻤﺴﺘﺤﻀﺭ ﺍﻝﺫﻱ ﺴﻴﻁﺭﺡ ﻓﻲ ﺍﻷﺴﻭﺍﻕ ‪ .‬ﻴﻔﻀل ﺇﺫﺍ ﻜﺎﻥ ﻤﻤﻜﻨﺎ ﺍﺴﺘﺨﺩﺍﻡ ﺃﺭﻗﺎﻡ‬
‫ﺘﺤﻀﻴﺭﺍﺕ ﻤﺨﺘﻠﻔﺔ ﻤﻥ ﺍﻝﻤﻭﺍﺩ ﺍﻷﻭﻝﻴﺔ ﺍﻝﻔﻌﺎﻝﺔ ﻓﻲ ﺘﺼﻨﻴﻊ ﺍﻝﺘﺤﻀﻴﺭﺍﺕ ﺍﻝﺘﺠﺭﻴﺒﻴﺔ‬
‫ﻝﺩﺭﺍﺴﺎﺕ ﺍﻝﺜﺒﺎﺕ‪.‬‬
‫ﺩﺭﺍﺴﺎﺕ ﺍﻝﺜﺒﺎﺕ ﻴﺠﺏ ﺃﻥ ﺘﺠﺭﻯ ﻝﻜل ﺸﻜل ﺼﻴﺩﻻﻨﻲ ﻭﻝﻜل ﻋﻴﺎﺭ ﻤﺴﺘﻘل ﻭﻝﻜل ﺤﺠﻡ‬
‫ﺘﻌﺒﺌﺔ ﺇﻻ ﻓﻲ ﺤﺎﻝﺔ ﺇﺠﺭﺍﺀ ﺩﺭﺍﺴﺎﺕ ﺍﻝﺜﺒﺎﺕ ﺒﻁﺭﻴﻘﺔ ﺍﻝﺘﻌﻘﻴﻑ)‪ ( Bracketing‬ﺃﻭ‬
‫ﺒﻁﺭﻴﻘﺔ ﺍﻝﺘﺼﻔﻴﻑ ) ‪.( Matrixing‬‬

‫ﻴﻤﻜﻥ ﺘﻘﺩﻴﻡ ﺒﻴﺎﻨﺎﺕ ﺇﻀﺎﻓﻴﺔ ﺘﺩﻋﻡ ﺍﻝﺩﺭﺍﺴﺎﺕ‪.‬‬

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 ‫‪ ٤,٢,٢‬ﻨﻅﺎﻡ ﺍﻝﻌﺒﻭﺓ ﻭ ﺍﻹﻏﻼﻕ ‪Container Closure System‬‬

‫ﻴﺠﺏ ﺃﻥ ﺘﺠﺭﻯ ﺩﺭﺍﺴﺎﺕ ﺍﻝﺜﺒﺎﺕ ﻝﻠﻤﺴﺘﺤﻀﺭ ﻓﻲ ﻨﻔﺱ ﻨﻅﺎﻡ ﺍﻝﻌﺒﻭﺓ ﻭﺍﻹﻏﻼﻕ‬

‫ﺍﻝﻤﺴﺘﺨﺩﻡ ﻓﻲ ﺍﻝﺘﺨﺯﻴﻥ ﻭﺍﻝﺘﻭﺯﻴﻊ ﺃﻭ ﺍﻝﺫﻱ ﻴﻤﺎﺜﻠﻪ)ﺒﻤﺎ ﻓﻲ ﺫﻝﻙ ﺍﻝﺘﻌﺒﺌﺔ ﻭﺍﻝﻌﻨﻭﻨﺔ‬
‫ﺍﻝﺜﺎﻨﻭﻴﺔ ‪ ،‬ﺤﻴﺜﻤﺎ ﺍﻨﻁﺒﻕ ﺫﻝﻙ(‪.‬‬
‫ﻴﻤﻜﻥ ﻷﻱ ﺩﺭﺍﺴﺔ ﺜﺒﺎﺕ ﻤﺴﺭﻋﺔ ﺘﺘﻡ ﻤﺒﺎﺸﺭﺓ ﻋﻠﻰ ﺍﻝﻤﺴﺘﺤﻀﺭ ﺨﺎﺭﺝ ﺍﻝﻌﺒﻭﺓ‬
‫ﺃﻭ ﺃﻱ ﻤﻭﺍﺩ ﺘﻌﺒﺌﺔ ﺃﺨﺭﻯ ‪ ،‬ﺃﻥ ﺘﻘﺩﻡ ﻤﻌﻠﻭﻤﺎﺕ ﻤﻔﻴﺩﺓ ﺩﺍﻋﻤﺔ ﻝﻠﺩﺭﺍﺴﺔ‪.‬‬

‫‪ ٥,٢,٢‬ﺍﻝﻤﻭﺍﺼﻔﺔ ‪Specification‬‬

‫ﻴﺠﺏ ﺃﻥ ﺘﺘﻀﻤﻥ ﺩﺭﺍﺴﺎﺕ ﺍﻝﺜﺒﺎﺕ ﻝﻠﻤﺴﺘﺤﻀﺭ ﺍﻝﺠﺎﻫﺯ ﺍﻹﺨﺘﺒﺎﺭﺍﺕ ﺍﻝﺘﻲ‬

‫ﺘﻜﺸﻑ ﺍﻝﺘﺒﺩﻻﺕ ﺨﻼل ﻓﺘﺭﺓ ﺍﻝﺘﺨﺯﻴﻥ ﻭﺍﻝﺘﻲ ﺘﺅﺜﺭ ﻓﻲ ﺍﻝﺠﻭﺩﺓ ﻭﺍﻝﻔﻌﺎﻝﻴﺔ‬
‫ﻭﺍﻝﺴﻼﻤﺔ ‪.‬ﺍﻻﺨﺘﺒﺎﺭﺍﺕ ﻴﺠﺏ ﺃﻥ ﺘﺸﻤل ﺍﻝﻔﺤﻭﺹ ﺍﻝﻔﻴﺯﻴﺎﺌﻴﺔ ﻭﺍﻝﻜﻴﻤﻴﺎﺌﻴﺔ‬
‫ﻭﺍﻝﺤﻴﻭﻴﺔ ﻭﺍﻝﺠﺭﺜﻭﻤﻴﺔ ‪ ،‬ﻜﻤﻴﺔ ﺍﻝﻤﺎﺩﺓ ﺍﻝﺤﺎﻓﻅﺔ ) ﻤﺜﺎل ‪ ،‬ﻤﻀﺎﺩﺍﺕ ﺍﻝﺘﺄﻜﺴﺩ ‪،‬‬
‫ﺍﻝﻤﻭﺍﺩ ﺍﻝﺤﺎﻓﻅﺔ ﺍﻝﻤﻀﺎﺩﺓ ﻝﻠﺠﺭﺍﺜﻴﻡ( ‪ ،‬ﺇﺨﺘﺒﺎﺭﺍﺕ ﺍﻝﻭﻅﺎﺌﻑ) ﻤﺜﺎل ‪ ،‬ﻁﺭﻕ ﻨﻅﺎﻡ‬
‫ﺍﻝﺠﺭﻋﺎﺕ ﺍﻝﺩﻭﺍﺌﻴﺔ(‪ .‬ﻜﻤﺎ ﺃﻨﻪ ﻴﺠﺏ ﺘﻁﺒﻴﻕ ﺨﻁﻁ ﺘﺤﻠﻴل ﻤﺅﺸﺭﺓ ﻝﻠﺜﺒﺎﺕ ﻗﺩ ﺘﻡ‬
‫ﺍﻝﺘﺤﻘﻕ ﻤﻥ ﺼﻼﺤﻴﺘﻬﺎ‪.‬‬
‫ﺇﻥ ﻤﻌﻴﺎﺭﻗﺒﻭل ﻋﻤﺭ ﺍﻝﺩﻭﺍﺀ ﻋﻠﻰ ﺍﻝﺭﻑ ﻴﺠﺏ ﺃﻥ ﻴﺘﻡ ﺍﻝﻭﺼﻭل ﺇﻝﻴﻪ ﺒﻌﺩ ﺍﻷﺨﺫ‬
‫ﺒﻌﻴﻥ ﺍﻹﻋﺘﺒﺎﺭ ﺠﻤﻴﻊ ﺍﻝﻤﻌﻠﻭﻤﺎﺕ ﺍﻝﻤﺘﻭﻓﺭﺓ ‪ .‬ﻗﺩ ﻴﻜﻭﻥ ﻤﻥ ﺍﻝﻤﻨﺎﺴﺏ ﻭﺠﻭﺩ‬
‫ﺇﺨﺘﻼﻑ ﻤﺒﺭﺭ ﺒﻴﻥ ﻋﻤﺭ ﺍﻝﺩﻭﺍﺀ ﻋﻠﻰ ﺍﻝﺭﻑ ﻭﺒﻴﻥ ﻤﻌﻴﺎﺭ ﻗﺒﻭل ﻭﺘﺤﺭﻴﺭ‬
‫ﺍﻝﺘﺤﻀﻴﺭﺓ ﺒﺎﻻﺴﺘﻨﺎﺩ ﻋﻠﻰ ﺘﻘﻴﻴﻡ ﺍﻝﺜﺒﺎﺕ ﻭﺍﻝﺘﺒﺩﻻﺕ ﺍﻝﺘﻲ ﻴﺘﻡ ﻤﻼﺤﻅﺘﻬﺎ ﺃﺜﻨﺎﺀ‬
‫ﻓﺘﺭﺓ ﺍﻝﺘﺨﺯﻴﻥ ‪ .‬ﺇﻥ ﺃﻱ ﺇﺨﺘﻼﻑ ﺒﻴﻥ ﻤﻌﺎﻴﻴﺭ ﻗﺒﻭل ﺍﻝﺘﺤﺭﻴﺭ ﻭﻋﻤﺭ ﺍﻝﺩﻭﺍﺀ‬
‫ﻋﻠﻰ ﺍﻝﺭﻑ ﻝﻤﺤﺘﻭﻯ ﻭﻓﻌﺎﻝﻴﺔ ﺍﻝﻌﻭﺍﻤل ﺍﻝﺤﺎﻓﻅﺔ ﻤﻥ ﺍﻝﺠﺭﺍﺜﻴﻡ ﻓﻲ ﺍﻝﺸﻜل‬
‫ﺍﻝﺼﻴﺩﻻﻨﻲ ﺍﻝﺠﺎﻫﺯ ﻴﺠﺏ ﺃﻥ ﺘﺴﻨﺩ ﺒﻤﻌﺎﻴﺭﺍﺕ ﻗﺩ ﺘﻡ ﺍﻝﺘﺤﻘﻕ ﻤﻥ ﺼﻼﺤﻴﺘﻬﺎ‬
‫ﺘﺒﻴﻥ ﺍﻝﻤﺤﺘﻭﻯ ﻤﻥ ﺍﻝﻤﻭﺍﺩ ﺍﻝﺤﺎﻓﻅﺔ ﺨﻼل ﻓﺘﺭﺓ ﺍﻝﺩﺭﺍﺴﺔ ‪.‬‬
‫ﻴﺠﺏ ﺇﺨﺘﺒﺎﺭ ﺘﺤﻀﻴﺭﺓ ﺘﺠﺭﻴﺒﻴﺔ ﻭﺍﺤﺩﺓ ﻝﻠﺸﻜل ﺍﻝﺼﻴﺩﻻﻨﻲ ﺍﻝﺠﺎﻫﺯ ﻴﺘﻡ ﺇﺠﺭﺍﺀ‬
‫ﺇﺨﺘﺒﺎﺭﺍﺕ ﺍﻝﺘﺤﻘﻕ ﻤﻥ ﻓﻌﺎﻝﻴﺔ ﻭﺘﺭﻜﻴﺯ ﺍﻝﻌﻭﺍﻤل ﺍﻝﺤﺎﻓﻅﺔ ﺨﻼل ﻓﺘﺭﺓ ﻋﻤﺭ‬
‫ﺍﻝﺩﻭﺍﺀ ﻋﻠﻰ ﺍﻝﺭﻑ ‪ ،‬ﻭﺫﻝﻙ ﺒﻐﺽ ﺍﻝﻨﻅﺭ ﻓﻴﻤﺎ ﺇﺫﺍ ﻜﺎﻥ ﻫﻨﺎﻙ ﺇﺨﺘﻼﻑ ﺒﻴﻥ‬
‫ﻤﻌﺎﻴﻴﺭ ﻗﺒﻭل ﻋﻤﺭ ﺍﻝﺩﻭﺍﺀ ﻋﻠﻰ ﺍﻝﺭﻑ ﻭﺍﻝﺘﺤﺭﻴﺭ ﻝﻜﻤﻴﺔ ﺍﻝﻌﻭﺍﻤل ﺍﻝﺤﺎﻓﻅﺔ‪.‬‬

‫ﺘﻜﺭﺍﺭﻴﺔ ﺍﻹﺨﺘﺒﺎﺭﺍﺕ ‪Testing Frequency‬‬ ‫‪٦,٢,٢‬‬

‫ﻓﻲ ﺤﺎﻝﺔ ﺩﺭﺍﺴﺎﺕ ﺍﻝﺜﺒﺎﺕ ﺍﻝﻁﻭﻴﻠﺔ ﺍﻷﻤﺩ ﻓﺈﻥ ﺘﻜﺭﺍﺭﻴﺔ ﺍﻝﻔﺤﻭﺹ ﻴﺠﺏ ﺃﻥ ﺘﻜﻭﻥ‬
‫ﻜﺎﻓﻴﺔ ﻝﺘﺤﻘﻴﻕ ﻤﻠﻑ ﺜﺒﺎﺕ ﺍﻝﻤﺴﺘﺤﻀﺭ ﺍﻝﺠﺎﻫﺯ ‪ .‬ﻓﻲ ﺤﺎﻝﺔ ﺩﺭﺍﺴﺎﺕ ﺍﻝﺜﺒﺎﺕ‬
‫ﺍﻝﻁﻭﻴﻠﺔ ﺍﻷﻤﺩ ﻓﺈﻥ ﺘﻜﺭﺍﺭﻴﺔ ﺍﻝﻔﺤﻭﺹ ﻴﺠﺏ ﺃﻥ ﺘﺘﻡ ﻜل ﺜﻼﺜﺔ ﺃﺸﻬﺭ ﺨﻼل‬

‫‪١٣‬‬
‫ﺍﻝﺴﻨﺔ ﺍﻷﻭﻝﻰ ﻭﻜل ﺴﺘﺔ ﺃﺸﻬﺭ ﺨﻼل ﺍﻝﺴﻨﺔ ﺍﻝﺜﺎﻨﻴﺔ ﻭﺴﻨﻭﻴﺎ ﺒﻌﺩ ﺫﻝﻙ ﻭﻓﻘﺎ ﻝﻌﻤﺭ‬
‫ﺍﻝﺩﻭﺍﺀ ﻋﻠﻰ ﺍﻝﺭﻑ ﺍﻝﻤﻘﺘﺭﺡ‪.‬‬
‫ﻓﻲ ﺤﺎﻝﺔ ﺸﺭﻭﻁ ﺘﺨﺯﻴﻥ ﻤﺴﺭﻋﺔ ﻓﺈﻥ ﺍﻝﺤﺩﻭﺩ ﺍﻝﺩﻨﻴﺎ ﻝﺩﺭﺍﺴﺎﺕ ﺍﻝﺜﺒﺎﺕ ﻝﻤﺩﺓ ﺴﺘﺔ‬
‫ﺃﺸﻬﺭﻫﻲ ﺜﻼﺙ ﻨﻘﺎﻁ‪ ،‬ﺘﺸﻤل ﺍﻝﺒﺩﺍﻴﺔ ﻭﺍﻝﻨﻬﺎﻴﺔ )ﻤﺜل ‪ ٠،٣،٦‬ﺃﺸﻬﺭ (‪.‬‬
‫ﻋﻨﺩ ﺇﻴﻘﺎﻑ ﺍﻹﺨﺘﺒﺎﺭﺍﺕ ﻓﻲ ﻤﻨﺘﺼﻑ ﻓﺘﺭﺓ ﺍﻝﺘﺨﺯﻴﻥ ﺒﺴﺒﺏ ﺘﺒﺩﻻﺕ ﺸﺩﻴﺩﺓ ﻓﻲ‬
‫ﺸﺭﻭﻁ ﺍﻝﺘﺨﺯﻴﻥ ﺍﻝﻤﺴﺭﻋﺔ ﻋﻨﺩﻫﺎ ﻴﻁﻠﺏ ﺇﺠﺭﺍﺀ ﺃﺭﺒﻊ ﻨﻘﺎﻁ ﺇﺨﺘﺒﺎﺭ ﻜﺤﺩ ﺃﺩﻨﻰ‬
‫ﺒﺤﻴﺙ ﺘﺸﻤل ﺯﻤﻥ ﺍﻝﺒﺩﺍﻴﺔ ﻭﺍﻝﻨﻬﺎﻴﺔ )ﻤﺜل ‪ ٠،٣،٦،١٢‬ﺸﻬﺭ( ﻝﺩﺭﺍﺴﺔ ‪ ١٢‬ﺸﻬﺭ‬
‫ﻤﻘﺘﺭﺤﺔ‪.‬‬
‫ﺍﻝﺘﺼﺎﻤﻴﻡ ﺍﻝﻤﺨﺘﺼﺭﺓ ﻤﺜل ﺍﻝﺘﺼﻔﻴﻑ ﻭﺍﻝﺘﻌﻘﻴﻑ ‪Bracketing & Matrixing‬‬
‫‪ ،‬ﻭﺍﻝﺘﻲ ﻴﺘﻡ ﻓﻴﻬﺎ ﺇﺨﺘﺼﺎﺭ ﺘﻜﺭﺍﺭﻴﺔ ﺍﻝﻔﺤﻭﺹ ﺃﻭ ﺃﻥ ﻤﺠﻤﻭﻉ ﺒﻌﺽ ﺍﻝﺒﻨﻭﺩ‬
‫ﻻﻴﺘﻡ ﺇﺨﺘﺒﺎﺭﻫﺎ ﺇﻁﻼﻗﺎ ‪ ،‬ﻓﺈﻨﻪ ﻴﻤﻜﻥ ﺘﻁﺒﻴﻘﻬﺎ ﺇﺫﺍ ﻜﺎﻥ ﺫﻝﻙ ﻤﺒﺭﺭﺍ‪.‬‬

‫ﺸﺭﻭﻁ ﺍﻝﺘﺨﺯﻴﻥ ‪Storage Conditions‬‬ ‫‪٧,٢,٢‬‬

‫ﺒﺸﻜل ﻋﺎﻡ ‪ ،‬ﻴﺠﺏ ﺘﻘﻴﻴﻡ ﺍﻝﻤﺴﺘﺤﻀﺭ ﺍﻝﺠﺎﻫﺯ ﺒﺸﺭﻭﻁ ﺘﺨﺯﻴﻥ )ﺘﺤﻤل ﻤﻨﺎﺴﺏ(‬
‫ﺘﺨﺘﺒﺭ ﺜﺒﺎﺘﻬﺎ ﺍﻝﺤﺭﺍﺭﻱ ﻭﻜﺫﻝﻙ ﺇﺫﺍ ﺍﻨﻁﺒﻕ ﻋﻠﻴﻬﺎ ﺫﻝﻙ ﺤﺴﺎﺴﻴﺘﻬﺎ ﻝﻠﺭﻁﻭﺒﺔ ‪.‬‬
‫ﻴﺠﺏ ﺃﻥ ﺘﻜﻭﻥ ﻓﺘﺭﺓ ﺍﻝﺩﺭﺍﺴﺔ ﻭﺸﺭﻭﻁﻬﺎ ﻜﺎﻓﻴﺔ ﻝﺘﻐﻁﻲ ﺍﻝﺘﺨﺯﻴﻥ ﻭﺍﻝﺸﺤﻥ‬
‫ﻭﺍﻹﺴﺘﻌﻤﺎل ﺍﻝﻼﺤﻕ‪.‬‬
‫ﻴﺠﺏ ﺃﻥ ﺘﺠﺭﻯ ﺩﺭﺍﺴﺎﺕ ﺍﻝﺜﺒﺎﺕ ﻝﻠﻤﺴﺘﺤﻀﺭ ﺍﻝﺠﺎﻫﺯ ﺒﻌﺩ ﺍﻝﻤﺯﺝ ﻭﺍﻝﺘﻤﺩﻴﺩ‪ ،‬ﺇﺫﺍ‬
‫ﺍﻨﻁﺒﻕ ﺫﻝﻙ‪ ،‬ﻝﺘﻌﻁﻲ ﻤﻌﻠﻭﻤﺎﺕ ﻝﻌﻨﻭﻨﺔ ﺍﻝﻤﺴﺘﺤﻀﺭ‪ ،‬ﺸﺭﻭﻁ ﺍﻝﺘﺨﺯﻴﻥ‪،‬‬
‫ﻭﺼﻼﺤﻴﺔ ﺍﻝﻤﺴﺘﺤﻀﺭ ﺨﻼل ﻓﺘﺭﺓ ﺍﻻﺴﺘﻌﻤﺎل ﺒﻌﺩ ﺍﻝﻤﺯﺝ ﻭﺍﻝﺘﻤﺩﻴﺩ‪.‬‬
‫ﺍﻻﺨﺘﺒﺎﺭﺍﺕ ﻴﺠﺏ ﺃﻥ ﺘﺠﺭﻯ ﻋﻠﻰ ﺍﻝﻤﺴﺘﺤﻀﺭ ﺒﻌﺩ ﻤﺯﺠﻪ ﺃﻭ ﺘﻤﺩﻴﺩﻩ ﺨﻼل‬
‫ﻓﺘﺭﺓ ﺍﻻﺴﺘﻌﻤﺎل ﺍﻝﻤﻘﺘﺭﺤﺔ ﻭﺫﻝﻙ ﻋﻠﻰ ﻋﻴﻨﺎﺕ ﺘﺠﺭﻴﺒﻴﺔ ﻜﺠﺯﺀ ﻤﻥ ﺩﺭﺍﺴﺎﺕ‬
‫ﺍﻝﺜﺒﺎﺕ ﻭﺃﻥ ﺘﺠﺭﻯ ﻨﻘﺎﻁ ﺍﻝﻤﻌﺎﻴﺭﺓ ﻓﻲ ﺒﺩﺍﻴﺔ ﺍﻻﺴﺘﻌﻤﺎل ﻭﻨﻬﺎﻴﺘﻪ‪ ،‬ﺇﺫﺍ ﻝﻡ ﺘﺘﻭﻓﺭ‬
‫ﻨﺘﺎﺌﺞ ﻜﺎﻤﻠﺔ ﻋﻥ ﺩﺭﺍﺴﺎﺕ ﺍﻝﺜﺒﺎﺕ ﻁﻴﻠﺔ ﻓﺘﺭﺓ ﻋﻤﺭ ﺍﻝﺩﻭﺍﺀ ﻋﻠﻰ ﺍﻝﺭﻑ ﻭﺫﻝﻙ‬
‫ﻗﺒل ﺘﻘﺩﻴﻡ ﻤﻠﻑ ﺘﺴﺠﻴل ﺍﻝﺩﻭﺍﺀ ‪ ،‬ﺃﻱ ﺒﻌﺩ ﺴﺘﺔ ﺃﺸﻬﺭ ﺃﻭ ﺁﺨﺭ ﻨﻘﻁﺔ ﻤﻌﺎﻴﺭﺓ‪.‬‬
‫ﺒﺸﻜل ﻋﺎﻡ ﻻﻴﻭﺠﺩ ﺤﺎﺠﺔ ﻝﺘﻜﺭﺍﺭ ﺘﻠﻙ ﺍﻹﺨﺘﺒﺎﺭﺍﺕ ﻓﻲ ﺍﻝﺘﺤﻀﻴﺭﺍﺕ‬
‫ﺍﻝﻤﻨﺼﻭﺹ ﻋﻠﻴﻬﺎ ﻓﻲ ﺍﻝﺩﺭﺍﺴﺔ‪.‬‬
‫ﺩﺭﺍﺴﺎﺕ ﺍﻝﺜﺒﺎﺕ ﺍﻝﻁﻭﻴﻠﺔ ﺍﻷﻤﺩ ﻝﻠﺨﻴﺎﺭ )ﺃ( ﻴﺠﺏ ﺃﻥ ﺘﻐﻁﻲ ﻤﺎ ﻻ ﻴﻘل ﻋﻥ ﺴﺘﺔ‬
‫ﺃﺸﻬﺭ ﻭﻓﺘﺭﺓ ‪ ١٢‬ﺸﻬﺭ ﻝﻠﺨﻴﺎﺭ )ﺏ( ﻓﻲ ﻓﺘﺭﺓ ﺘﻘﺩﻴﻡ ﻤﻠﻑ ﺍﻝﺘﺴﺠﻴل ﻜﻤﺎ ﻴﺠﺏ‬
‫ﺃﻥ ﺘﺴﺘﻤﺭ ﻝﻤﺩﺓ ﻤﻥ ﺍﻝﺯﻤﻥ ﺘﻜﻔﻲ ﻝﺘﻐﻁﻴﺔ ﻓﺘﺭﺓ ﺇﻋﺎﺩﺓ ﺍﻹﺨﺘﺒﺎﺭ‪ .‬ﻴﺠﺏ ﺘﻘﺩﻴﻡ‬
‫ﺒﻴﺎﻨﺎﺕ ﺇﻀﺎﻓﻴﺔ ﺘﻡ ﺘﺠﻤﻴﻌﻬﺎ ﺨﻼل ﻓﺘﺭﺓ ﺍﻝﺘﻘﻴﻴﻡ ﻝﻤﻠﻑ ﺍﻝﺘﺴﺠﻴل ﻓﻲ ﺤﺎل ﺘﻡ‬
‫ﻁﻠﺒﻬﺎ ﻤﻥ ﺍﻝﺴﻠﻁﺎﺕ ﺍﻝﺼﺤﻴﺔ ‪ .‬ﺒﻴﺎﻨﺎﺕ ﺩﺭﺍﺴﺎﺕ ﺍﻝﺜﺒﺎﺕ ﺍﻝﻤﺴﺭﻋﺔ ﻭﻤﻥ ﺸﺭﻭﻁ‬
‫ﺍﻝﺘﺨﺯﻴﻥ ﺍﻝﻤﺘﻭﺴﻁﺔ ﻴﻤﻜﻥ ﺃﻥ ﺘﺴﺘﻌﻤل ﻝﺘﻘﻴﻴﻡ ﺘﺄﺜﻴﺭ ﺘﻌﺭﺽ ﺍﻝﻤﺴﺘﺤﻀﺭ‬
‫ﻝﺸﺭﻭﻁ ﺘﺨﺘﻠﻑ ﻋﻥ ﺸﺭﻭﻁ ﺍﻝﺘﺨﺯﻴﻥ ﺍﻝﻤﺼﺭﺡ ﺒﻬﺎ ﻓﻲ ﺍﻝﻌﻨﻭﻨﺔ ) ﻤﺜل ﺍﻝﺘﻲ‬
‫ﺘﺤﺼل ﺨﻼل ﻓﺘﺭﺓ ﺍﻝﺸﺤﻥ(‪.‬‬

‫‪١٤‬‬
 ‫ﺇﻥ ﺸﺭﻭﻁ ﺍﻝﺘﺨﺯﻴﻥ ﺍﻝﻤﺴﺭﻋﺔ ﻭﺍﻝﻤﺘﻭﺴﻁﺔ ﻭﺍﻝﻁﻭﻴﻠﺔ ﺍﻷﻤﺩ ﻝﻠﻤﺴﺘﺤﻀﺭ ﺍﻝﺠﺎﻫﺯ‬
‫ﻴﺘﻡ ﺫﻜﺭﻫﺎ ﺒﺎﻝﺘﻔﺼﻴل ﻓﻲ ﺍﻝﺒﻨﻭﺩ ﺍﻝﻤﺫﻜﻭﺭﺓ ﺃﺩﻨﺎﻩ‪ .‬ﺘﻁﺒﻕ ﺍﻝﺤﺎﻝﺔ ﺍﻝﻌﺎﻤﺔ ﺇﺫﺍ ﻝﻡ‬
‫ﺘﻜﻥ ﺍﻝﻔﺼﻭل ﺍﻝﻼﺤﻘﺔ ﺘﻐﻁﻲ ﺍﻝﻤﺴﺘﺤﻀﺭ ﺍﻝﺠﺎﻫﺯ‪ .‬ﻴﻤﻜﻥ ﺍﺴﺘﺨﺩﺍﻡ ﺸﺭﻭﻁ‬
‫ﺘﺨﺯﻴﻥ ﻤﺨﺘﻠﻔﺔ ﺇﺫﺍ ﺘﻡ ﺘﺒﺭﻴﺭ ﺫﻝﻙ‪.‬‬

‫‪ ١,٧,٢,٢‬ﺤﺎﻝﺔ ﻋﺎﻤﺔ ‪General case‬‬

‫ﺍﻝﻔﺘﺭﺓ ﺍﻝﺯﻤﻨﻴﺔ ﺍﻝﺩﻨﻴﺎ ﺍﻝﺘﻲ‬ ‫ﻨﻭﻉ ﺍﻝﺩﺭﺍﺴﺔ ﺸﺭﻭﻁ ﺍﻝﺘﺨﺯﻴﻥ‬

‫ﺘﻐﻁﻴﻬﺎ ﺍﻝﺒﻴﺎﻨﺎﺕ ﻓﻲ‬
‫ﺯﻤﻥ ﺘﻘﺩﻴﻡ ﻤﻠﻑ‬
‫ﺍﻝﺘﺴﺠﻴل‬
‫‪ ٦ 25°C ± 2°C/60% RH ± 5% RH‬ﺸﻬﻭﺭ )ﺍﻝﺨﻴﺎﺭ ﺃ (‬ ‫ﻁﻭﻴﻠﺔ ﺍﻷﻤﺩ‬
‫‪ ١٢ or‬ﺸﻬﺭ ) ﺍﻝﺨﻴﺎﺭ ﺏ(‬ ‫*‬
‫‪30°C ± 2°C/65% RH ± 5% RH‬‬
‫‪ ٦ 30°C ± 2°C/65% RH ± 5% RH‬ﺸﻬﻭﺭ‬ ‫ﻤﺘﻭﺴﻁﺔ‬
‫‪ ٦ 40°C ± 2°C/75% RH ± 5% RH‬ﺸﻬﻭﺭ‬ ‫ﻤﺴﺭﻋﺔ‬

‫*ﻋﻠﻰ ﻤﻘﺩﻡ ﻤﻠﻑ ﺍﻝﺘﺴﺠﻴل ﺃﻥ ﻴﻘﺭﺭ ﻓﻲ ﺇﺠﺭﺍﺀ ﺩﺭﺍﺴﺎﺕ ﺍﻝﺜﺒﺎﺕ ﺍﻝﻁﻭﻴﻠﺔ ﺍﻷﻤﺩ ﺒﺸﺭﻭﻁ‬
‫‪ 25°C ± 2°C/60% RH ± 5% RH‬ﺃﻭ ‪ 30°C ± 2°C/65% RH ± 5% RH‬ﻓﻲ ﺤﺎل‬
‫ﺇﺠﺭﺍﺀ ﺍﻝﺨﻴﺎﺭ ﺍﻝﺜﺎﻨﻲ ‪ ،‬ﻋﻨﺩﻫﺎﻻﻴﻭﺠﺩ ﺤﺎﺠﺔ ﻹﺠﺭﺍﺀ ﺍﻝﺩﺭﺍﺴﺎﺕ ﺒﺸﺭﻭﻁ ﻤﺘﻭﺴﻁﺔ‪.‬‬

‫ﻋﻨﺩ ﺤﺩﻭﺙ ﺘﺒﺩﻻﺕ ﻤﻠﺤﻭﻅﺔ ﻓﻲ ﺃﻱ ﻭﻗﺕ ﺨﻼل ﻓﺘﺭﺓ ﺍﻝﺴﺘﺔ ﺃﺸﻬﺭ ﻓﻲ ﻨﺘﺎﺌﺞ ﻤﺭﺤﻠﺔ ﺸﺭﻭﻁ‬
‫ﺍﻝﺘﺨﺯﻴﻥ ﺍﻝﻤﺴﺭﻋﺔ ‪ ،‬ﻋﻨﺩﻫﺎ ﻴﻁﻠﺏ ﺇﺠﺭﺍﺀ ﺇﺨﺘﺒﺎﺭﺍﺕ ﺇﻀﺎﻓﻴﺔ ﻓﻲ ﺸﺭﻭﻁ ﺍﻝﺘﺨﺯﻴﻥ ﺍﻝﻤﺘﻭﺴﻁﺔ‬
‫ﻭﺃﻥ ﺘﻘﻴﻡ ﺒﺎﻝﻤﻘﺎﺭﻨﺔ ﻤﻊ ﺍﻝﺘﺒﺩﻻﺕ ﺍﻝﻤﻠﺤﻭﻅﺔ ﺍﻝﻤﻘﺎﺴﺔ ﺴﺎﺒﻘﺎ‪ .‬ﻴﺠﺏ ﺃﻥ ﻴﺘﻀﻤﻥ ﺍﻝﻁﻠﺏ ﺍﻷﻭﻝﻲ‬
‫ﻨﺘﺎﺌﺞ ﺩﺭﺍﺴﺎﺕ ﺍﻝﺜﺒﺎﺕ ﻝﺴﺘﺔ ﺃﺸﻬﺭ ﻋﻠﻰ ﺍﻷﻗل ﻤﻥ ﺃﺼل ﺍل ‪ ١٢‬ﺸﻬﺭ ﻓﻲ ﺸﺭﻭﻁ ﺘﺨﺯﻴﻥ‬
‫ﺍﻝﻤﺭﺤﻠﺔ ﺍﻝﻤﺘﻭﺴﻁﺔ‪.‬‬

‫ﺒﺸﻜل ﻋﺎﻡ ‪ ،‬ﻴﻌﺭﻑ ﺍﻝﺘﺒﺩل ﺍﻝﻤﻬﻡ ﻝﻠﻤﺴﺘﺤﻀﺭ ﺍﻝﺠﺎﻫﺯ ﺒﺄﻨﻪ‪:‬‬

‫‪ -١‬ﺘﺒﺩل ﻓﻲ ﺍﻝﻔﻌﺎﻝﻴﺔ ﺒﻨﺴﺒﺔ ‪ %٥‬ﻋﻥ ﺍﻝﻘﻴﻤﺔ ﺍﻷﻭﻝﻴﺔ )ﺒﺩﺍﻴﺔ ﺍﻝﺩﺭﺍﺴﺔ( ‪ :‬ﺃﻭ ﺍﻝﻔﺸل ﻓﻲ ﺘﺤﻘﻴﻕ‬
‫ﻤﻌﺎﻴﻴﺭ ﺍﻝﻔﻌﺎﻝﻴﺔ ﺍﻝﻤﻘﺒﻭﻝﺔ ﻋﻨﺩ ﺍﺴﺘﻌﻤﺎل ﺨﻁﻁ ﺤﻴﻭﻴﺔ ﺃﻭ ﻤﻨﺎﻋﻴﺔ؛‬
‫‪ -٢‬ﺃﻱ ﻤﻭﺍﺩ ﺘﺨﺭﺏ ﺘﺯﻴﺩ ﻋﻥ ﺍﻝﺤﺩﻭﺩ ﺍﻝﻤﺴﻤﻭﺡ ﺒﻬﺎ‪.‬‬
‫‪ -٣‬ﺍﻝﻔﺸل ﻓﻲ ﺘﺤﻘﻴﻕ ﺍﻝﻤﻌﺎﻴﻴﺭ ﺍﻝﻤﻘﺒﻭﻝﺔ ﺍﻝﻤﺘﻌﻠﻘﺔ ﺒﺎﻝﻤﻅﻬﺭ ‪ ،‬ﺍﻝﺨﻭﺍﺹ ﺍﻝﻔﻴﺯﻴﺎﺌﻴﺔ ‪ ،‬ﺇﺨﺘﺒﺎﺭﺍﺕ‬
‫ﺍﻝﻭﻅﺎﺌﻑ ) ﻤﺜل‪ ،‬ﺍﻝﻠﻭﻥ ‪ ،‬ﻓﺼل ﺍﻝﻁﻭﺭ‪ ،‬ﺇﻋﺎﺩﺓ ﺍﻝﺘﻌﻠﻴﻕ‪ ،‬ﺍﻝﺘﺭﺴﺏ ﺒﺸﻜل ﺍﻝﻜﻌﻜﺔ‪ ،‬ﺍﻝﻘﺴﺎﻭﺓ‪،‬‬
‫ﻜﻤﻴﺔ ﺍﻝﻤﺎﺩﺓ ﻓﻲ ﻜل ﺠﺭﻋﺔ (؛ ﻋﻠﻰ ﺃﻴﺔ ﺤﺎل ﻴﻤﻜﻥ ﺘﻭﻗﻊ ﺒﻌﺽ ﺍﻝﺘﺒﺩﻻﺕ ﺍﻝﺘﻲ ﺘﻌﺯﻯ ﺇﻝﻰ‬
‫ﺍﻝﺨﻭﺍﺹ ﺍﻝﻔﻴﺯﻴﺎﺌﻴﺔ ) ﻤﺜل ‪ ،‬ﻝﻴﻭﻨﺔ ﺍﻝﺘﺤﺎﻤﻴل‪ ،‬ﺇﻨﺼﻬﺎﺭ ﺍﻝﻜﺭﻴﻤﺎﺕ‪ ،‬ﻓﻘﺩﺍﻥ ﺠﺯﺀ ﻤﻥ ﺍﻝﻤﺎﺩﺓ‬
‫ﺍﻝﻼﺼﻘﺔ ﻝﻠﻤﺴﺤﻀﺭﺍﺕ ﺍﻝﻤﻁﺒﻘﺔ ﻋﻠﻰ ﺍﻝﺠﻠﺩ ﻜﻠﺼﺎﻗﺎﺕ(‪:‬‬

‫‪١٥‬‬
 ‫ﻭﻜﺫﻝﻙ‪ ،‬ﺒﺤﺴﺏ ﻁﺒﻴﻌﺔ ﺍﻝﺸﻜل ﺍﻝﺼﻴﺩﻻﻨﻲ ‪:‬‬
‫‪ -٤‬ﺍﻝﻔﺸل ﻓﻲ ﺘﺤﻘﻴﻕ ﻤﺠﺎل ﺍﻝﻘﺒﻭل ﻝﺩﺭﺠﺔ ﺍﻝﺤﻤﻭﻀﺔ‪.‬‬
‫‪ -٥‬ﺍﻝﻔﺸل ﻓﻲ ﺘﺤﻘﻴﻕ ﻤﻌﺎﻴﻴﺭ ﺍﻝﻘﺒﻭل ﺒﺎﻝﻨﺴﺒﺔ ﻹﻨﺤﻼﻝﻴﺔ ‪ ١٢‬ﻭﺤﺩﺓ ﺠﺭﻋﺔ‪.‬‬

‫‪ ٢,٧,٢,٢‬ﺍﻝﻤﺴﺘﺤﻀﺭﺍﺕ ﺍﻝﺠﺎﻫﺯﺓ ﺍﻝﻤﻌﻠﺒﺔ ﻓﻲ ﺃﻭﻋﻴﺔ ﻏﻴﺭ ﻨﻔﻭﺫﺓ‬

‫‪Finished products packaged in impermeable container‬‬

‫ﺍﻝﺤﺴﺎﺴﻴﺔ ﻝﻠﺭﻁﻭﺒﺔ ﺇﺤﺘﻤﺎل ﻓﻘﺩﺍﻥ ﺍﻝﻤﺫﻴﺒﺎﺕ ﻻﻴﺸﻜل ﺇﻫﺘﻤﺎﻡ ﻝﻠﻤﺴﺘﺤﻀﺭﺍﺕ ﺍﻝﺠﺎﻫﺯﺓ ﺍﻝﻤﻌﺒﺌﺔ ﻓﻲ‬
‫ﺃﻭﻋﻴﺔ ﻏﻴﺭ ﻨﻔﻭﺫﺓ ﻭﺍﻝﺘﻲ ﺘﺸﻜل ﺤﺎﺠﺯﺍ ﻜﺘﻴﻤﺎ ﺩﺍﺌﻤﺎ ﺘﻤﻨﻊ ﻋﺒﻭﺭ ﺍﻝﻤﺫﻴﺏ ﺃﻭ ﺍﻝﺭﻁﻭﺒﺔ ‪ .‬ﻭﻫﻜﺫﺍ‪،‬‬
‫ﻓﺈﻨﻪ ﻴﻤﻜﻥ ﺇﺠﺭﺍﺀ ﺩﺭﺍﺴﺔ ﺍﻝﺜﺒﺎﺕ ﻝﻠﻤﺴﺘﺤﻀﺭﺍﺕ ﺍﻝﻤﻌﺒﺄﺓ ﻓﻲ ﺃﻭﻋﻴﺔ ﻏﻴﺭ ﻨﻔﻭﺫﺓ ﺘﺤﺕ ﺃﻴﺔ ﺸﺭﻭﻁ‬
‫ﻤﺭﺍﻗﺒﺔ ﺃﻭ ﻓﻲ ﺸﺭﻭﻁ ﺍﻝﺭﻁﻭﺒﺔ ﺍﻝﻁﺒﻴﻌﻴﺔ‪.‬‬

‫‪ ٣,٧,٢,٢‬ﺍﻝﻤﺴﺘﺤﻀﺭﺍﺕ ﺍﻝﺠﺎﻫﺯﺓ ﺍﻝﻤﻌﺒﺄﺓ ﻓﻲ ﺃﻭﻋﻴﺔ ﻨﺼﻑ ﻨﻔﻭﺫﺓ‬

‫‪Finished products packaged in semi-permeable containers‬‬

‫ﺍﻝﻤﺴﺘﺤﻀﺭﺍﺕ ﺍﻝﺘﻲ ﺃﺴﺎﺴﻬﺎ ﻤﺎﺌﻲ ﺍﻝﻤﻌﻠﺒﺔ ﻓﻲ ﺃﻭﻋﻴﺔ ﻨﺼﻑ ﻨﻔﻭﺫﺓ ﻓﺈﻨﻪ ﻴﺠﺏ ﺃﻥ ﺘﻘﻴﻡ ﻤﻥ ﺤﻴﺙ‬
‫ﻓﻘﺩﺍﻥ ﺍﻝﻤﺎﺀ ﺇﻀﺎﻓﺔ ﺍﻝﺜﺒﺎﺕ ﺍﻝﻔﻴﺯﻴﺎﺌﻲ ﻭﺍﻝﻜﻴﻤﻴﺎﺌﻲ ﻭﺍﻝﺠﺭﺜﻭﻤﻲ ‪ .‬ﻴﻤﻜﻥ ﺃﻥ ﻴﺘﻡ ﻫﺫﺍ ﺍﻝﺘﻘﻴﻴﻡ ﺘﺤﺕ‬
‫ﺸﺭﻭﻁ ﻤﻨﺨﻔﻀﺔ ﺍﻝﺭﻁﻭﺒﺔ ﻜﻤﺎ ﺴﻴﺘﻡ ﻤﻨﺎﻗﺸﺘﻪ ﻻﺤﻘﺎ‪ .‬ﻭﺒﺸﻜل ﻨﻬﺎﺌﻲ ‪ ،‬ﻴﺠﺏ ﺃﻥ ﻴﻌﺭﺽ‬
‫ﻭﻴﻭﻀﺢ ﺒﺄﻥ ﺍﻝﻤﺴﺘﺤﻀﺭﺍﺕ ﺍﻝﺠﺎﻫﺯﺓ ﺍﻝﺘﻲ ﺃﺴﺎﺴﻬﺎ ﻤﺎﺌﻲ ﻭﺍﻝﻤﺨﺯﻨﺔ ﻓﻲ ﺃﻭﻋﻴﺔ ﻨﺼﻑ ﻨﻔﻭﺫﺓ‬
‫ﺒﺄﻨﻬﺎ ﻴﻤﻜﻥ ﺃﻥ ﺘﺘﺤﻤل ﻅﺭﻭﻑ ﺭﻁﻭﺒﺔ ﻤﻨﺨﻔﻀﺔ ﻨﺴﺒﻴﺎ‪.‬‬
‫ﻴﻤﻜﻥ ﺘﻁﻭﻴﺭ ﻭﺍﻹﺒﻼﻍ ﻋﻥ ﺒﻌﺽ ﺍﻝﻁﺭﻕ ﺍﻝﻤﻤﺎﺜﻠﺔ ﺍﻷﺨﺭﻯ ﻝﻠﻤﺴﺘﺤﻀﺭﺍﺕ ﺍﻝﺘﻲ ﺃﺴﺎﺴﻬﺎ ﻏﻴﺭ‬
‫ﻤﺎﺌﻲ‪.‬‬

‫ﺍﻝﻔﺘﺭﺓ ﺍﻝﺯﻤﻨﻴﺔ ﺍﻝﺩﻨﻴﺎ‬ ‫ﺸﺭﻭﻁ ﺍﻝﺘﺨﺯﻴﻥ‬ ‫ﻨﻭﻉ‬

‫ﺍﻝﺘﻲ ﺘﻐﻁﻴﻬﺎ ﺍﻝﺒﻴﺎﻨﺎﺕ‬ ‫ﺍﻝﺩﺭﺍﺴﺔ‬
‫ﻓﻲ ﺯﻤﻥ ﺘﻘﺩﻴﻡ ﻤﻠﻑ‬
‫ﺍﻝﺘﺴﺠﻴل‬
‫‪ ٦‬ﺸﻬﻭﺭ )ﺍﻝﺨﻴﺎﺭ ﺃ (‬ ‫‪25°C ± 2°C/40% RH ± 5% RH or‬‬ ‫ﻁﻭﻴﻠﺔ‬
‫‪ ١٢‬ﺸﻬﺭ ) ﺍﻝﺨﻴﺎﺭ ﺏ(‬ ‫‪30°C ± 2°C/35% RH ± 5% RH‬‬ ‫ﺍﻷﻤﺩ‬
‫‪ ٦‬ﺸﻬﻭﺭ‬ ‫‪30°C ± 2°C/65% RH ± 5% RH‬‬ ‫ﻤﺘﻭﺴﻁﺔ‬
‫‪ ٦‬ﺸﻬﻭﺭ‬ ‫)‪40°C ± 2°C/not more than(NMT‬‬ ‫ﻤﺴﺭﻋﺔ‬
‫‪25% RH‬‬

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 ‫ﻋﻨﺩ ﺤﺩﻭﺙ ﺃﻱ ﺘﺒﺩل ﺠﻭﻫﺭﻱ ﺨﻼل ﺍﻝﺴﺘﺔ ﺃﺸﻬﺭ ﻓﻲ ﺩﺭﺍﺴﺔ ﺍﻝﺜﺒﺎﺕ ﺒﺸﺭﻭﻁ ﺘﺨﺯﻴﻥ ﻤﺴﺭﻋﺔ‬
‫ﺒﺎﺴﺘﺜﻨﺎﺀ ﻓﻘﺩﺍﻥ ﺍﻝﻤﺎﺀ ‪ ،‬ﻋﻨﺩﻫﺎ ﻴﺠﺏ ﺇﺠﺭﺍﺀ ﺩﺭﺍﺴﺎﺕ ﺜﺒﺎﺕ ﺒﺸﺭﻭﻁ ﺘﺨﺯﻴﻥ ﻤﺘﻭﺴﻁﺔ ﻜﻤﺎ ﻫﻭ‬
‫ﻤﻭﻀﺢ ﻓﻲ ﺍﻝﺤﺎﻝﺔ ﺍﻝﻌﺎﻤﺔ ﺒﺘﻘﻴﻴﻡ ﺘﺄﺜﻴﺭ ﺍﻝﺤﺭﺍﺭﺓ ﺒﺎﻝﺩﺭﺠﺔ ‪. 30°C‬‬
‫ﺇﻥ ﻓﻘﺩﺍﻥ ﺍﻝﻤﺎﺀ ﺒﻜﻤﻴﺔ ﻤﻠﺤﻭﻅﺔ ﻓﻘﻁ ﺃﺜﻨﺎﺀ ﺩﺭﺍﺴﺔ ﺍﻝﺜﺒﺎﺕ ﺒﺸﺭﻭﻁ ﺘﺨﺯﻴﻥ ﻤﺴﺭﻋﺔ ﻻﻴﺤﺘﻡ ﺇﺠﺭﺍﺀ‬
‫ﺍﻹﺨﺘﺒﺎﺭﺍﺕ ﺒﺸﺭﻭﻁ ﺘﺨﺯﻴﻥ ﻤﺘﻭﺴﻁﺔ‪ .‬ﻋﻠﻰ ﺃﻴﺔ ﺤﺎل‪ ،‬ﻴﺠﺏ ﺘﻘﺩﻴﻡ ﻨﺘﺎﺌﺞ ﺩﺭﺍﺴﺎﺕ ﺍﻝﺜﺒﺎﺕ‬
‫ﻹﺜﺒﺎﺕ ﺃﻥ ﺍﻝﻤﺴﺘﺤﻀﺭ ﺍﻝﺠﺎﻫﺯ ﻝﻥ ﻴﺘﻌﺭﺽ ﻝﻔﻘﺩﺍﻥ ﻜﻤﻴﺔ ﻜﺒﻴﺭﺓ ﻤﻥ ﺍﻝﻤﺎﺀ ﺨﻼل ﻓﺘﺭﺓ ﻋﻤﺭ‬
‫ﺍﻝﺩﻭﺍﺀ ﻋﻠﻰ ﺍﻝﺭﻑ ﺇﺫﺍ ﺘﻡ ﺘﺨﺯﻴﻨﻪ ﺒﺩﺭﺠﺔ ﺤﺭﺍﺭﺓ ‪ 25°C‬ﻭﺒﺩﺭﺠﺔ ﺭﻁﻭﺒﺔ ﻨﺴﺒﻴﺔ ‪. 40% RH‬‬
‫ﺇﻥ ﻓﻘﺩﺍﻥ ‪ %٥‬ﻤﻥ ﺍﻝﻤﺎﺀ ﻋﻥ ﺍﻝﻜﻤﻴﺔ ﺍﻷﻭﻝﻴﺔ ﻓﻲ ﺒﺩﺍﻴﺔ ﺍﻝﺘﺼﻨﻴﻊ ﻴﻌﺘﺒﺭ ﺘﺒﺩل ﺠﻭﻫﺭﻱ‬
‫ﻝﻤﺴﺘﺤﻀﺭ ﻤﻌﺒﺄ ﻓﻲ ﺃﻭﻋﻴﺔ ﻨﺼﻑ ﻨﻔﻭﺫﺓ ﺒﻌﺩ ﺘﺨﺯﻴﻨﻪ ﻝﻤﺩﺓ ‪ ٣‬ﺃﺸﻬﺭ ﺒﺸﺭﻭﻁ‬
‫‪ . 40°C ± 2°C/not more than(NMT) 25% RH‬ﻋﻠﻰ ﺃﻴﺔ ﺤﺎل ‪ ،‬ﺒﺎﻝﻨﺴﺒﺔ ﻝﻠﻌﺒﻭﺍﺕ‬
‫ﺍﻝﺼﻐﻴﺭﺓ ) ‪١‬ﻤل ﺃﻭ ﺃﻗل( ﺃﻭ ﺍﻝﻤﺴﺘﺤﻀﺭﺍﺕ ﻭﺤﻴﺩﺓ ﺍﻝﺠﺭﻋﺎﺕ ‪ ،‬ﻓﺈﻥ ﻓﻘﺩﺍﻥ ﻜﻤﻴﺔ ‪ %٥‬ﺃﻭ‬
‫ﺃﻜﺜﺭ ﻤﻥ ﺍﻝﻤﺎﺀ ﺒﻌﺩ ﺍﻝﺘﺨﺯﻴﻥ ﻝﻤﺩﺓ ‪ ٣‬ﺃﺸﻬﺭ ﺒﺸﺭﻭﻁ‬
‫‪ 40°C ± 2°C/not more than(NMT) 25% RH‬ﻓﺈﻨﻪ ﻴﻌﺘﺒﺭ ﻤﻘﺒﻭﻻ ‪ ،‬ﺇﺫﺍ ﺘﻡ ﺘﺒﺭﻴﺭ ﺫﻝﻙ‪.‬‬

‫ﺍﻝﻁﺭﻴﻘﺔ ﺍﻝﺒﺩﻴﻠﺔ ﻝﻠﺩﺭﺍﺴﺔ ﺒﺸﺭﻭﻁ ﻤﺭﺠﻌﻴﺔ ﻝﻠﺭﻁﻭﺒﺔ ﺍﻝﻨﺴﺒﻴﺔ ﻜﻤﺎ ﺃﻗﺘﺭﺡ ﻓﻲ ﺍﻝﺠﺩﻭل ﺃﻋﻼﻩ‬
‫) ﺍﻹﺨﺘﺒﺎﺭﺍﺕ ﺍﻝﻁﻭﻴﻠﺔ ﺍﻷﻤﺩ ﺃﻭ ﺍﻝﻤﺴﺭﻋﺔ( ﻫﻭ ﺇﺠﺭﺍﺀ ﺩﺭﺍﺴﺎﺕ ﺍﻝﺜﺒﺎﺕ ﻓﻲ ﺭﻁﻭﺒﺔ ﻨﺴﺒﻴﺔ‬
‫ﺃﻋﻠﻰ ﻭﻤﻥ ﺜﻡ ﺇﺸﺘﻘﺎﻕ ﻜﻤﻴﺔ ﺍﻝﻤﺎﺀ ﺍﻝﻤﻔﻘﻭﺩﺓ ﺒﻁﺭﻴﻘﺔ ﺤﺴﺎﺒﻴﺔ‪ .‬ﻴﻤﻜﻥ ﺇﻨﺠﺎﺯ ﺫﻝﻙ ﺘﺠﺭﻴﺒﻴﺎ ﻤﻥ‬
‫ﺨﻼل ﺘﺤﺩﻴﺩ ﻤﻌﺎﻤل ﺍﻝﻨﻔﻭﺫﻴﺔ ‪ permeation coefficient‬ﻝﻨﻅﺎﻡ ﺍﻝﺘﻌﺒﺌﺔ ﻭﺍﻹﻏﻼﻕ ﺃﻭ‪ ،‬ﻜﻤﺎ‬
‫ﻫﻭ ﻤﻭﻀﺢ ﻓﻲ ﺍﻝﻤﺜﺎل ﺍﻝﻤﺫﻜﻭﺭ ﺃﺩﻨﺎﻩ‪ ،‬ﺒﺎﺴﺘﺨﺩﺍﻡ ﻨﺴﺒﺔ ﺤﺴﺎﺒﻴﺔ ﻝﻔﻘﺩﺍﻥ ﺍﻝﻤﺎﺀ ﺒﻴﻥ ﺸﺭﻁﻲ‬
‫ﺭﻁﻭﺒﺔ ﻓﻲ ﻨﻔﺱ ﺩﺭﺠﺔ ﺍﻝﺤﺭﺍﺭﺓ ‪ .‬ﻴﻤﻜﻥ ﺘﺤﺩﻴﺩ ﻋﺎﻤل ﺍﻝﻨﻔﻭﺫﻴﺔ ﺘﺠﺭﻴﺒﻴﺎ ﻝﻨﻅﺎﻡ ﺍﻝﺘﻌﺒﺌﺔ‬
‫ﻭﺍﻹﻏﻼﻕ ﺒﺎﺴﺘﺨﺩﺍﻡ ﺃﺴﻭﺃ ﺴﻴﻨﺎﺭﻴﻭ ) ﻤﺜﺎل‪ ،.‬ﺃﻜﺒﺭ ﺘﻤﺩﻴﺩ ﻝﺴﻠﺴﻠﺔ ﺘﺭﺍﻜﻴﺯ( ﻝﻠﻤﺴﺘﺤﻀﺭ ﺍﻝﺠﺎﻫﺯ‬
‫ﺍﻝﻤﻘﺘﺭﺡ‪.‬‬

‫ﻤﺜﺎل ﻴﻭﻀﺢ ﻁﺭﻴﻘﺔ ﺘﺤﺩﻴﺩ ﻓﻘﺩﺍﻥ ﺍﻝﻤﺎﺀ‪:‬‬

‫ﺇﻥ ﺍﻝﻁﺭﻴﻘﺔ ﺍﻝﻤﻨﺎﺴﺒﺔ ﻻﺸﺘﻘﺎﻕ ﻨﺴﺒﺔ ﻜﻤﻴﺔ ﻓﻘﺩﺍﻥ ﺍﻝﻤﺎﺀ ﻝﻤﺴﺘﺤﻀﺭ ﻤﻌﺩ ﺒﻨﻅﺎﻡ ﺘﻌﺒﺌﺔ ﻭﺇﻏﻼﻕ ‪،‬‬
‫ﻭﺒﺤﺠﻡ ﻋﺒﻭﺓ ﻭﺘﻌﺒﺌﺔ ﻤﺤﺩﺩ ﻓﻲ ﺭﻅﻭﺒﺔ ﻨﺴﺒﻴﺔ ﻤﺭﺠﻌﻴﺔ ﻫﻭ ﻓﻲ ﻤﻀﺎﻋﻔﺔ ﻨﺴﺒﺔ ﻜﻤﻴﺔ ﻓﻘﺩﺍﻥ‬
‫ﺍﻝﻤﺎﺀ ﺍﻝﻤﻘﺎﺴﺔ ﺒﺭﻁﻭﺒﺔ ﻨﺴﺒﻴﺔ ﺒﻨﻔﺱ ﺩﺭﺠﺔ ﺍﻝﺤﺭﺍﺭﺓ ﻓﻲ ﻨﺴﺒﺔ ﺴﺭﻋﺔ ﻓﻘﺩﺍﻥ ﺍﻝﻤﺎﺀ ﺍﻝﻤﺤﺩﺩﺓ ﻓﻲ‬
‫ﺍﻝﺠﺩﻭل ﺍﻝﻤﺫﻜﻭﺭ ﺃﺩﻨﺎﻩ ‪ .‬ﺇﻥ ﻓﻘﺩﺍﻥ ﺍﻝﻤﺎﺀ ﺒﻨﺴﺏ ﺨﻁﻴﺔ ﻓﻲ ﺍﻝﺭﻁﻭﺒﺔ ﺍﻝﻨﺴﺒﻴﺔ ﺍﻝﺒﺩﻴﻠﺔ ﺨﻼل ﻓﺘﺭﺓ‬
‫ﺍﻝﺘﺨﺯﻴﻥ ﻴﺠﺏ ﺃﻥ ﻴﻭﻀﺢ ‪.‬‬
‫ﻋﻠﻰ ﺴﺒﻴل ﺍﻝﻤﺜﺎل ‪ ،‬ﺇﻥ ﻜﻤﻴﺔ ﻨﺴﺒﺔ ﻓﻘﺩﺍﻥ ﺍﻝﻤﺎﺀ ﺍﻝﻤﻘﺎﺴﺔ ﺒﺎﻝﺩﺭﺠﺔ ‪ ، 40°C‬ﻭﺒﺭﻁﻭﺒﺔ ﻨﺴﺒﻴﺔ‬
‫‪ not more than(NMT) 25% RH‬ﻫﻲ ﻜﻤﻴﺔ ﻨﺴﺒﺔ ﺍﻝﻤﺎﺀ ﺍﻝﻤﻔﻘﻭﺩﺓ ﺍﻝﻤﻘﺎﺴﺔ ﺒﺭﻁﻭﺒﺔ ﻨﺴﺒﻴﺔ‬
‫‪ 75% RH‬ﻤﻀﺎﻋﻔﺔ ﺏ ‪ ، ٣,٠‬ﻤﻥ ﻨﺴﺒﺔ ﺴﺭﻋﺔ ﻓﻘﺩﺍﻥ ﺍﻝﻤﺎﺀ ﺒﺎﻝﺸﺭﻭﻁ ﺫﺍﺕ ﺍﻝﻌﻼﻗﺔ‪.‬‬

‫‪١٧‬‬
 ‫ﺍﻝﺭﻁﻭﺒﺔ ﺍﻝﻨﺴﺒﻴﺔ ﺍﻝﻤﺭﺠﻌﻴﺔ ﺸﺭﻭﻁ ﺍﻝﺘﺨﺯﻴﻥ ﺍﻝﻌﺎﻤﺔ ﻨﺴﺒﺔ ﺴﺭﻋﺔ ﻓﻘﺩﺍﻥ ﺍﻝﻤﺎﺀ‬
‫ﺒﺩﺭﺠﺔ ﺍﻝﺤﺭﺍﺭﺓ ﺍﻝﻤﺫﻜﻭﺭﺓ‬ ‫ﺒﻨﻔﺱ ﺩﺭﺠﺔ ﺍﻝﺤﺭﺍﺭﺓ‬
‫‪1.9 =(100-25) : (100- 25°C /60% RH‬‬ ‫‪25°C /25% RH‬‬
‫)‪60‬‬
‫‪1.5 =(100-40) : (100- 25°C /60% RH‬‬ ‫‪25°C /40% RH‬‬
‫)‪60‬‬
‫‪3.0 =(100-25) : (100- 25°C /75% RH‬‬ ‫‪40°C /75% RH‬‬
‫)‪75‬‬

‫ﻴﻤﻜﻥ ﺍﺴﺘﻌﻤﺎل ﻨﺴﺏ ﺴﺭﻋﺔ ﻓﻘﺩﺍﻥ ﺍﻝﻤﺎﺀ ﺒﺸﺭﻭﻁ ﺭﻁﻭﺒﺔ ﻨﺴﺒﻴﺔ ﺃﺨﺭﻯ ﺘﺨﺘﻠﻑ ﻋﻥ ﺍﻝﻘﻴﻡ‬
‫ﺍﻝﻤﺫﻜﻭﺭﺓ ﻓﻲ ﺍﻝﺠﺩﻭل ﺃﻋﻼﻩ‪.‬‬

‫‪ ٤,٧,٢,٢‬ﺍﻝﻤﺴﺘﺤﻀﺭﺍﺕ ﺍﻝﺠﺎﻫﺯﺓ ﺍﻝﻤﻌﺩﺓ ﻝﻠﺘﺨﺯﻴﻥ ﻓﻲ ﺍﻝﺒﺭﺍﺩ‬

‫‪Finished products intended for storage in a refrigerator‬‬

‫ﺍﻝﻔﺘﺭﺓ ﺍﻝﺯﻤﻨﻴﺔ ﺍﻝﺩﻨﻴﺎ ﺍﻝﺘﻲ‬ ‫ﺸﺭﻭﻁ ﺍﻝﺘﺨﺯﻴﻥ‬ ‫ﻨﻭﻉ ﺍﻝﺩﺭﺍﺴﺔ‬

‫ﺘﻐﻁﻴﻬﺎ ﺍﻝﺒﻴﺎﻨﺎﺕ ﻓﻲ ﺯﻤﻥ‬
‫ﺘﻘﺩﻴﻡ ﻤﻠﻑ ﺍﻝﺘﺴﺠﻴل‬
‫‪ ٦‬ﺸﻬﻭﺭ )ﺍﻝﺨﻴﺎﺭ ﺃ ﺃﻭ ﺏ(‬ ‫‪5°C ± 3°C‬‬ ‫ﻁﻭﻴﻠﺔ ﺍﻷﻤﺩ‬
‫‪ ٦ 25°C ± 2°C/60% RH ± 5% RH‬ﺸﻬﻭﺭ‬ ‫ﻤﺴﺭﻋﺔ‬

‫ﺇﺫﺍ ﺘﻡ ﺘﻌﺒﺌﺔ ﺍﻝﻤﺴﺘﺤﻀﺭ ﺍﻝﻨﻬﺎﺌﻲ ﻓﻲ ﻭﻋﺎﺀ ﻨﺼﻑ ﻨﻔﻭﺫ ‪ ،‬ﻋﻨﺩﻫﺎ ﻴﺠﺏ ﺘﻘﺩﻴﻡ ﻤﻌﻠﻭﻤﺎﺕ ﻤﻨﺎﺴﺒﺔ‬
‫ﺘﺒﻴﻥ ﻜﻤﻴﺔ ﻓﻘﺩﺍﻥ ﺍﻝﻤﺎﺀ‪.‬‬

‫ﻴﺠﺏ ﺘﻘﻴﻴﻡ ﻨﺘﺎﺌﺞ ﺩﺭﺍﺴﺎﺕ ﺍﻝﺘﺨﺯﻴﻥ ﻓﻲ ﺍﻝﺒﺭﺍﺩ ﺘﺒﻌﺎ ﻝﻠﻘﺴﻡ ﺍﻝﻤﺘﻌﻠﻕ ﺒﺘﻘﻴﻴﻡ ﺩﺭﺍﺴﺎﺕ ﺍﻝﺜﺒﺎﺕ‬
‫ﺍﻝﻤﺫﻜﻭﺭﺓ ﻓﻲ ﻫﺫﺍ ﺍﻝﺩﻝﻴل‪ ،‬ﺒﺎﺴﺘﺜﻨﺎﺀ ﺍﻝﺫﻱ ﺴﻴﺘﻡ ﺫﻜﺭﻩ ﺃﺩﻨﺎﻩ ﺒﻜل ﻭﻀﻭﺡ ﻭﺼﺭﺍﺤﺔ‪.‬‬

‫ﺇﺫﺍ ﺤﺼل ﺘﺒﺩل ﻤﻠﺤﻭﻅ ﺒﻴﻥ ‪ ٣‬ﻭ‪ ٦‬ﺸﻬﻭﺭ ﻓﻲ ﺍﻝﺩﺭﺍﺴﺔ ﺒﺸﺭﻭﻁ ﺘﺨﺯﻴﻥ ﻤﺴﺭﻋﺔ ‪ ،‬ﻓﺈﻥ ﺘﺎﺭﻴﺦ‬
‫ﺇﻋﺎﺩﺓ ﺍﻝﻔﺤﺹ ﻴﺠﺏ ﺃﻥ ﻴﺴﺘﻨﺩ ﻋﻠﻰ ﻨﺘﺎﺌﺞ ﺍﻝﺯﻤﻥ ﺍﻝﺤﻘﻴﻘﻲ ﺍﻝﻤﺘﻭﻓﺭﺓ ﻓﻲ ﺸﺭﻭﻁ ﺍﻝﺘﺨﺯﻴﻥ‬
‫ﺍﻝﻁﻭﻴﻠﺔ ﺍﻷﻤﺩ‪.‬‬

‫ﺇﺫﺍ ﺤﺼل ﺘﺒﺩل ﻤﻠﺤﻭﻅ ﺨﻼل ﺍﻝﺜﻼﺜﺔ ﺃﺸﻬﺭ ﺍﻷﻭﻝﻰ ﻓﻲ ﺇﺨﺘﺒﺎﺭﺍﺕ ﺍﻝﺜﺒﺎﺕ ﺍﻝﻤﺨﺯﻨﺔ ﺒﺸﺭﻭﻁ‬
‫ﻤﺴﺭﻋﺔ ‪ ،‬ﻓﺈﻥ ﺍﻝﻨﻘﺎﺵ ﻴﺠﺏ ﺃﻥ ﻴﻘﺩﻡ ﺩﻻﺌل ﺘﺸﻴﺭ ﺇﻝﻰ ﺍﻝﺘﺄﺜﻴﺭﺍﺕ ﺍﻝﺘﻲ ﺘﺤﺼل ﻋﻨﺩ ﺘﻌﺭﻴﺽ‬
‫ﺍﻝﻤﺴﺘﺤﻀﺭ ﻝﺸﺭﻭﻁ ﺘﺨﺯﻴﻥ ﺘﺨﺘﻠﻑ ﻋﻥ ﺍﻝﻤﻨﺼﻭﺹ ﻋﻠﻴﻬﺎ ﻓﻲ ﺍﻝﻌﻨﻭﻨﺔ‪ .‬ﻤﺜﺎل ﻋﻨﺩ ﺸﺤﻥ ﺍﻝﻤﺎﺩﺓ‬
‫ﺃﻭ ﺍﻝﺘﻌﺎﻭل ﻤﻌﻬﺎ‪ .‬ﻫﺫﺍ ﺍﻝﻨﻘﺎﺵ ﻴﻤﻜﻥ ﺃﻥ ﻴﺩﻋﻡ ‪ ،‬ﺇﺫﺍ ﻜﺎﻥ ﻤﻨﺎﺴﺒﺎ‪ ،‬ﻤﻥ ﺨﻼل ﺇﺨﺘﺒﺎﺭﺍﺕ ﺇﻀﺎﻓﻴﺔ‬

‫‪١٨‬‬
 ‫ﺘﺠﺭﻯ ﻋﻠﻰ ﺘﺤﻀﻴﺭﺓ ﻭﺍﺤﺩﺓ ﻝﻠﻤﺎﺩﺓ ﺍﻝﻔﻌﺎﻝﺔ ﻝﻤﺩﺓ ﺘﻘل ﻋﻥ ﺜﻼﺜﺔ ﺃﺸﻬﺭ ﻝﻜﻥ ﺒﺘﻜﺭﺍﺭﻴﺔ ﺃﻜﺜﺭ‬
‫ﻝﻺﺨﺘﺒﺎﺭﺍﺕ ﻋﻥ ﺍﻝﺫﻱ ﻴﺘﻡ ﻋﺎﺩﺓ‪ .‬ﻴﻌﺘﺒﺭ ﻏﻴﺭ ﻀﺭﻭﺭﻱ ﺍﻻﺴﺘﻤﺭﺍﺭ ﻓﻲ ﺩﺭﺍﺴﺔ ﺍﻝﻤﺎﺩﺓ ﺍﻝﻔﻌﺎﻝﺔ‬
‫ﺨﻼل ﺴﺘﺔ ﺃﺸﻬﺭ ﺇﺫﺍ ﺤﺼل ﺘﺒﺩﻻﺕ ﻤﻠﺤﻭﻅﺔ ﺨﻼل ﺍﻝﺜﻼﺜﺔ ﺃﺸﻬﺭ ﺍﻷﻭﻝﻰ‪.‬‬

‫‪ ٥,٧,٢,٢‬ﺍﻝﻤﺴﺘﺤﻀﺭﺍﺕ ﺍﻝﺠﺎﻫﺯﺓ ﺍﻝﻤﻌﺩﺓ ﻝﻠﺘﺨﺯﻴﻥ ﻓﻲ ﺍﻝﻤﺠﻤﺩﺓ‬

‫‪Finished products intended for storage in a freezer‬‬

‫ﺍﻝﻔﺘﺭﺓ ﺍﻝﺯﻤﻨﻴﺔ ﺍﻝﺩﻨﻴﺎ ﺍﻝﺘﻲ‬ ‫ﺸﺭﻭﻁ ﺍﻝﺘﺨﺯﻴﻥ‬ ‫ﻨﻭﻉ ﺍﻝﺩﺭﺍﺴﺔ‬

‫ﺘﻐﻁﻴﻬﺎ ﺍﻝﺒﻴﺎﻨﺎﺕ ﻓﻲ ﺯﻤﻥ‬
‫ﺘﻘﺩﻴﻡ ﻤﻠﻑ ﺍﻝﺘﺴﺠﻴل‬
‫‪ ٦‬ﺸﻬﻭﺭ )ﺍﻝﺨﻴﺎﺭ ﺃ (‬ ‫‪-20°C ± 5°C‬‬ ‫ﻁﻭﻴﻠﺔ ﺍﻷﻤﺩ‬
‫‪ ١٢‬ﺸﻬﺭ ﺍﻝﺨﻴﺎﺭ) ﺏ(‬

‫ﺒﺎﻝﻨﺴﺒﺔ ﻝﻠﻤﺴﺘﺤﻀﺭﺍﺕ ﺍﻝﺠﺎﻫﺯﺓ ﺍﻝﻤﻌﺩﺓ ﻝﻠﺘﺨﺯﻴﻥ ﻓﻲ ﺍﻝﻤﺠﻤﺩﺓ ‪ ،‬ﻓﺈﻥ ﻓﺘﺭﺓ ﺇﻋﺎﺩﺓ ﺍﻹﺨﺘﺒﺎﺭ ﻴﺠﺏ‬
‫ﺃﻥ ﺘﻌﺘﻤﺩ ﻋﻠﻰ ﻨﺘﺎﺌﺞ ﺒﻴﺎﻨﺎﺕ ﺍﻝﺯﻤﻥ ﺍﻝﺤﻘﻴﻘﻲ ﺍﻝﺘﻲ ﻴﺘﻡ ﺍﻝﺤﺼﻭل ﻋﻠﻴﻬﺎ ﻤﻥ ﺍﻝﺩﺭﺍﺴﺔ ﺒﺸﺭﻭﻁ‬
‫ﺘﺨﺯﻴﻥ ﻁﻭﻴﻠﺔ ﺍﻷﻤﺩ‪ .‬ﻓﻲ ﻏﻴﺎﺏ ﺍﻝﺩﺭﺍﺴﺔ ﺒﺸﺭﻭﻁ ﺘﺨﺯﻴﻥ ﻤﺴﺭﻋﺔ ﻝﻠﻤﺴﺘﺤﻀﺭ ﺍﻝﻨﻬﺎﺌﻲ ﻭﺍﻝﺘﻲ‬
‫ﻴﻌﺩ ﻝﻬﺎ ﺃﻥ ﺘﺨﺯﻥ ﻓﻲ ﺍﻝﻤﺠﻤﺩﺓ ‪ ،‬ﻓﺈﻥ ﺍﻝﻔﺤﻭﺹ ﻴﺠﺏ ﺃﻥ ﺘﺠﺭﻯ ﻋﻠﻰ ﺘﺤﻀﻴﺭﺓ ﻭﺍﺤﺩﺓ‬
‫ﺒﺩﺭﺠﺎﺕ ﺤﺭﺍﺭﺓ ﻤﺭﺘﻔﻌﺔ ) ﻤﺜل ‪ 5°C ± 3°C‬ﺃﻭ ‪ ( 25°C ± 2°C‬ﻭﺫﻝﻙ ﻝﻔﺘﺭﺓ ﺯﻤﻨﻴﺔ ﻤﻨﺎﺴﺒﺔ‬
‫‪ .‬ﻤﺜل ﻫﺫﻩ ﺍﻝﺩﺭﺍﺴﺔ ﺘﻘﺩﻡ ﺒﻴﺎﻨﺎﺕ ﺤﻭل ﺘﺄﺜﻴﺭ ﺘﻌﺭﺽ ﺍﻝﻤﺎﺩﺓ ﻝﻔﺘﺭﺓ ﻗﺼﻴﺭﺓ ﻝﻅﺭﻭﻑ ﺍﻝﻨﻘل‬
‫ﻭﺍﻝﺸﺤﻥ ﻭﺍﻝﺘﻌﺎﻤل ﻤﻊ ﺍﻝﻤﺎﺩﺓ ﺘﺨﺘﻠﻑ ﻋﻥ ﺸﺭﻭﻁ ﺍﻝﺘﺨﺯﻴﻥ ﺍﻝﻤﺼﺭﺡ ﻋﻨﻬﺎ ﻓﻲ ﺍﻝﻌﻨﻭﻨﺔ‪.‬‬

‫‪ ٦,٧,٢,٢‬ﺍﻝﻤﺴﺘﺤﻀﺭﺍﺕ ﺍﻝﻨﻬﺎﺌﻴﺔﺍﻝﻤﻌﺩﺓ ﻝﻠﺘﺨﺯﻴﻥ ﺒﺸﺭﻭﻁ ﺃﻗل ﻤﻥ ‪-20°C‬‬

‫‪Finished products intended for storage below -20°C‬‬

‫ﻴﺠﺏ ﻤﻌﺎﻤﻠﺔ ﺍﻝﻤﺴﺘﺤﻀﺭﺍﺕ ﺍﻝﻨﻬﺎﺌﻴﺔ ﺍﻝﻤﻌﺩﺓ ﻝﻠﺘﺨﺯﻴﻥ ﺒﺸﺭﻭﻁ ﺃل ﻤﻥ ‪ -20°C‬ﺒﺤﺴﺏ ﻜل‬

‫ﺤﺎﻝﺔ‪.‬‬

‫‪١٩‬‬
 ‫‪ ٨,٢,٢‬ﺘﻌﻬﺩ ﺍﻝﺜﺒﺎﺕ ‪Stability commitment‬‬

‫ﻋﻨﺩﻤﺎ ﺘﻜﻭﻥ ﻨﺘﺎﺌﺞ ﺩﺭﺍﺴﺎﺕ ﺍﻝﺜﺒﺎﺕ ﺍﻝﻁﻭﻴﻠﺔ ﺍﻷﻤﺩ ﻝﻠﺘﺤﻀﻴﺭﺍﺕ ﺍﻷﻭﻝﻴﺔ ﻻﺘﻐﻁﻲ ﻓﺘﺭﺓ ﺇﻋﺎﺩﺓ‬
‫ﺍﻹﺨﺘﺒﺎﺭ ﺍﻝﻤﻘﺘﺭﺤﺔ ﻭﺍﻝﺘﻲ ﺘﻡ ﺍﻝﻤﻭﺍﻓﻘﺔ ﻋﻠﻴﻬﺎ ﺨﻼل ﻓﺘﺭﺓ ﺍﻝﺘﻘﻴﻴﻡ ﻝﻤﻠﻑ ﺍﻝﺘﺴﺠﻴل ﻋﻨﺩﻫﺎ ﻴﺠﺏ‬
‫ﺘﻘﺩﻴﻡ ﺘﻌﻬﺩ ﻝﻺﺴﺘﻤﺭﺍﺭ ﺒﺈﺠﺭﺍﺀ ﺩﺭﺍﺴﺎﺕ ﺍﻝﺜﺒﺎﺕ ﺒﻌﺩ ﻤﻨﺢ ﺍﻝﺘﺭﺨﻴﺹ ﺍﻝﻼﺯﻡ ﻤﻥ ﺃﺠل ﺘﺤﻘﻴﻕ‬
‫ﻭﺒﺸﻜل ﻤﺅﻜﺩ ﻓﺘﺭﺓ ﺇﻋﺎﺩﺓ ﺍﻹﺨﺘﺒﺎﺭ‪.‬‬

‫ﻋﻨﺩ ﺘﻘﺩﻴﻡ ﻨﺘﺎﺌﺞ ﺩﺭﺍﺴﺎﺕ ﺍﻝﺜﺒﺎﺕ ﺍﻝﻁﻭﻴﻠﺔ ﺍﻷﻤﺩ ﻝﺜﻼﺙ ﺘﺤﻀﻴﺭﺍﺕ ﺼﻨﺎﻋﻴﺔ ﻴﺘﻡ ﻓﻴﻬﺎ ﺘﻐﻁﻴﺔ ﻤﺩﺓ‬
‫ﺍﻹﺨﺘﺒﺎﺭ ‪ ،‬ﻋﻨﺩﻫﺎ ﻝﻴﺱ ﻤﻥ ﺍﻝﻀﺭﻭﺭﻱ ﺘﻘﺩﻴﻡ ﺘﻌﻬﺩ ﺍﻝﺜﺒﺎﺕ ﺒﻌﺩ ﻤﻨﺢ ﺍﻝﺘﺭﺨﻴﺹ ﺍﻝﻼﺯﻡ ‪ .‬ﺨﻼﻑ‬
‫ﺫﻝﻙ ﻓﺈﻨﻪ ﻴﺠﺏ ﺘﻘﺩﻴﻡ ﺃﺤﺩ ﺍﻝﺘﻌﻬﺩﺍﺕ ﺍﻝﺘﺎﻝﻴﺔ‪:‬‬
‫‪ .١‬ﺇﺫﺍ ﻜﺎﻥ ﺍﻝﻤﻠﻑ ﺍﻝﻤﻘﺩﻡ ﻝﻠﺘﺴﺠﻴل ﻴﺘﻀﻤﻥ ﻨﺘﺎﺌﺞ ﺩﺭﺍﺴﺎﺕ ﺍﻝﺜﺒﺎﺕ ﻝﺜﻼﺙ‬
‫ﺘﺤﻀﻴﺭﺍﺕ ﺼﻨﺎﻋﻴﺔ ﻋﻠﻰ ﺍﻷﻗل ‪ ،‬ﻋﻨﺩﻫﺎ ﻴﺠﺏ ﺘﻘﺩﻴﻡ ﺘﻌﻬﺩ ﻝﻺﺴﺘﻤﺭﺍﺭ ﺒﺘﻠﻙ‬
‫ﺍﻝﺩﺭﺍﺴﺎﺕ ﻝﻠﻭﺼﻭل ﻝﻔﺘﺭﺓ ﺇﻋﺎﺩﺓ ﺍﻹﺨﺘﺒﺎﺭ‪.‬‬
‫‪ .٢‬ﺇﺫﺍ ﻜﺎﻥ ﺍﻝﻤﻠﻑ ﺍﻝﻤﻘﺩﻡ ﻝﻠﺘﺴﺠﻴل ﻴﺘﻀﻤﻥ ﻨﺘﺎﺌﺞ ﺩﺭﺍﺴﺎﺕ ﺍﻝﺜﺒﺎﺕ ﻋﺩﺩ ﺃﻗل ﻤﻥ‬
‫ﺜﻼﺙ ﺘﺤﻀﻴﺭﺍﺕ ﺼﻨﺎﻋﻴﺔ ‪ ،‬ﻋﻨﺩﻫﺎ ﻴﺠﺏ ﺘﻘﺩﻴﻡ ﺘﻌﻬﺩ ﻝﻺﺴﺘﻤﺭﺍﺭ ﺒﺘﻠﻙ‬
‫ﺍﻝﺩﺭﺍﺴﺎﺕ ﻝﻠﻭﺼﻭل ﻝﻔﺘﺭﺓ ﺇﻋﺎﺩﺓ ﺍﻹﺨﺘﺒﺎﺭ ﻭﺇﻀﺎﻓﺔ ﺘﺤﻀﻴﺭﺍﺕ ﺼﻨﺎﻋﻴﺔ‬
‫ﻝﻠﻭﺼﻭل ﻝﻤﺠﻤﻭﻉ ﺜﻼﺙ ﺘﺤﻀﻴﺭﺍﺕ ﻭﺃﻥ ﺘﺠﺭﻯ ﻋﻠﻴﻬﺎ ﺩﺭﺍﺴﺎﺕ ﺜﺒﺎﺕ ﻁﻭﻴﻠﺔ‬
‫ﺍﻷﻤﺩ ﻝﻠﻭﺼﻭل ﺇﻝﻰ ﺘﺎﺭﻴﺦ ﺇﻋﺎﺩﺓ ﺍﻹﺨﺘﺒﺎﺭ ﺍﻝﻤﻘﺘﺭﺤﺔ ﻓﻲ ﻤﻠﻑ ﺍﻝﺘﺴﺠﻴل ﻭﻜﺫﻝﻙ‬
‫ﺘﺘﻤﺔ ﺩﺭﺍﺴﺎﺕ ﺍﻝﺜﺒﺎﺕ ﺍﻝﻤﺴﺭﻋﺔ ﻝﻤﺩﺓ ﺴﺘﺔ ﺃﺸﻬﺭ‪.‬‬
‫‪ .٣‬ﺇﺫﺍ ﻜﺎﻥ ﺍﻝﻤﻠﻑ ﺍﻝﻤﻘﺩﻡ ﻝﻠﺘﺴﺠﻴل ﻻ ﻴﺘﻀﻤﻥ ﻨﺘﺎﺌﺞ ﺩﺭﺍﺴﺎﺕ ﺍﻝﺜﺒﺎﺕ ﻝﺜﻼﺙ‬
‫ﺘﺤﻀﻴﺭﺍﺕ ﺼﻨﺎﻋﻴﺔ ‪ ،‬ﻋﻨﺩﻫﺎ ﻴﺠﺏ ﺘﻘﺩﻴﻡ ﺘﻌﻬﺩ ﻝﻺﺴﺘﻤﺭﺍﺭ ﺒﺘﻠﻙ ﺍﻝﺩﺭﺍﺴﺎﺕ‬
‫ﻝﺜﻼﺙ ﺘﺤﻀﻴﺭﺍﺕ ﺼﻨﺎﻋﻴﺔ ﻭﺃﻥ ﺘﺠﺭﻯ ﻋﻠﻴﻬﺎ ﺩﺭﺍﺴﺎﺕ ﺜﺒﺎﺕ ﻁﻭﻴﻠﺔ ﺍﻷﻤﺩ‬
‫ﻝﻠﻭﺼﻭل ﺇﻝﻰ ﺘﺎﺭﻴﺦ ﺇﻋﺎﺩﺓ ﺍﻹﺨﺘﺒﺎﺭ ﺍﻝﻤﻘﺘﺭﺤﺔ ﻓﻲ ﻤﻠﻑ ﺍﻝﺘﺴﺠﻴل ﻭﻜﺫﻝﻙ ﺘﺘﻤﺔ‬
‫ﺩﺭﺍﺴﺎﺕ ﺍﻝﺜﺒﺎﺕ ﺍﻝﻤﺴﺭﻋﺔ ﻝﻤﺩﺓ ﺴﺘﺔ ﺃﺸﻬﺭ‪.‬‬

‫ﻴﺠﺏ ﺃﻥ ﻴﻜﻭﻥ ﺒﺭﻭﺘﻭﻜﻭل ﺍﻝﺜﺒﺎﺕ ﺍﻝﻤﺘﺒﻊ ﻓﻲ ﺘﻌﻬﺩ ﺩﺭﺍﺴﺎﺕ ﺍﻝﺜﺒﺎﺕ ﺍﻝﻁﻭﻴﻠﺔ ﺍﻷﻤﺩ ﻫﻭ ﻨﻔﺴﻪ‬
‫ﺍﻝﻤﺴﺘﻌﻤل ﻝﻠﺘﺤﻀﻴﺭﺍﺕ ﺍﻝﺘﺠﺭﻴﺒﻴﺔ ﺍﻷﻭﻝﻴﺔ ‪ ،‬ﻤﺎ ﻋﺩﺍ ﺒﻌﺽ ﺍﻝﺤﺎﻻﺕ ﺍﻝﺘﻲ ﻴﻤﻜﻥ ﺘﺒﺭﻴﺭﻫﺎ ﻋﻠﻤﻴﺎ‪.‬‬

‫ﻋﻨﺩﻤﺎ ﻴﺘﻡ ﺇﺠﺭﺍﺀ ﺩﺭﺍﺴﺔ ﺍﻝﺜﺒﺎﺕ ﻓﻲ ﺸﺭﻭﻁ ﻤﺘﻭﺴﻁﺔ ﻜﺤﺎﺠﺔ ﺒﺴﺒﺏ ﺤﺩﻭﺙ ﺘﺒﺩﻻﺕ ﺠﻭﻫﺭﻴﺔ‬
‫ﺃﺜﻨﺎﺀ ﻓﺘﺭﺓ ﺍﻝﺜﺒﺎﺕ ﺍﻝﻤﺴﺭﻋﺔ ﻝﺘﺤﻀﻴﺭﺍﺕ ﺃﻭﻝﻴﺔ )ﺘﺠﺭﻴﺒﻴﺔ( ‪ ،‬ﻴﻤﻜﻥ ﺍﺴﺘﻜﻤﺎل ﺇﺠﺭﺍﺀ ﺍﻝﺩﺭﺍﺴﺔ‬
‫ﺍﻝﺜﺒﺎﺕ ﻋﻠﻰ ﺘﺤﻀﻴﺭﺍﺕ ﻤﻠﺘﺯﻤﺔ ) ﺍﻝﺘﻲ ﺘﻡ ﺍﻝﺘﻌﻬﺩ ﺒﺘﻘﺩﻴﻡ ﻨﺘﺎﺌﺠﻬﺎ( ﺇﻤﺎ ﺒﺎﺘﺒﺎﻉ ﺍﻝﺩﺭﺍﺴﺔ ﻓﻲ‬
‫ﺸﺭﻭﻁ ﻤﺴﺭﻋﺔ ﺃﻭ ﻤﺘﻭﺴﻁﺔ‪ .‬ﻋﻠﻰ ﺃﻴﺔ ﺤﺎل ﺇﺫﺍ ﺤﺼل ﺘﺒﺩل ﻤﻬﻡ ﻓﻲ ﺸﺭﻭﻁ ﻤﺴﺭﻋﺔ ﻋﻨﺩﻫﺎ‬
‫ﻴﺠﺏ ﺍﺴﺘﻜﻤﺎل ﺍﻝﺩﺭﺍﺴﺔ ﺒﺸﺭﻭﻁ ﺘﺨﺯﻴﻥ ﻤﺘﻭﺴﻁﺔ‪.‬‬

‫‪٢٠‬‬
 ‫‪ ٩,٢,٢‬ﺍﻝﺘﻘﻴﻴﻡ ‪Evaluation‬‬
‫ﻴﺠﺏ ﺇﻋﺘﻤﺎﺩ ﻤﻨﻬﺞ ﻤﻨﻅﻡ ﻓﻲ ﺘﻘﺩﻴﻡ ﻭﺘﻘﻴﻴﻡ ﻤﻌﻠﻭﻤﺎﺕ ﺍﻝﺜﺒﺎﺕ‪ ،‬ﻭﺍﻝﺘﻲ ﻴﺠﺏ ﺃﻥ ﺘﺘﻀﻤﻥ ﺒﺤﺴﺏ‬
‫ﺍﻝﺤﺎﻝﺔ ﻨﺘﺎﺌﺞ ﺇﺨﺘﺒﺎﺭﺍﺕ ﺩﺭﺍﺴﺎﺕ ﺍﻝﺜﺒﺎﺕ ﺍﻝﻔﻴﺯﻴﺎﺌﻴﺔ ﻭﺍﻝﻜﻴﻤﻴﺎﺌﻴﺔ ﻭﺍﻝﺤﻴﻭﻴﺔ ﻭﺍﻝﺠﺭﺜﻭﻤﻴﺔ‪ ،‬ﻤﻊ ﺍﻷﺨﺫ‬
‫ﺒﻌﻴﻥ ﺍﻻﻋﺘﺒﺎﺭ ﺍﻹﺨﺘﺒﺎﺭﺍﺕ ﺍﻝﻤﺘﻌﻠﻘﺔ ﺒﺎﻝﺸﻜل ﺍﻝﺼﻴﺩﻻﻨﻲ ) ﻤﺜل ﺴﺭﻋﺔ ﺍﻹﻨﺤﻼﻝﻴﺔ ﻝﻸﺸﻜﺎل‬
‫ﺍﻝﺼﻴﺩﻻﻨﻴﺔ ﺍﻝﻔﻤﻭﻴﺔ ﺍﻝﺼﻠﺒﺔ(‬
‫ﺇﻥ ﺍﻝﻬﺩﻑ ﻤﻥ ﺩﺭﺍﺴﺎﺕ ﺍﻝﺜﺒﺎﺕ ﻫﻭ ﻝﻠﺘﺄﻜﺩ ‪ ،‬ﺒﺎﻻﻋﺘﻤﺎﺩ ﻋﻠﻰ ﺍﻹﺨﺘﺒﺎﺭﺍﺕ ﺍﻝﺘﻲ ﺘﺠﺭﻯ ﻋﻠﻰ ﺍﻷﻗل‬
‫ﻝﺘﺤﻀﻴﺭﺘﻴﻥ ﺃﻭ ﺜﻼﺙ ﺘﺤﻀﻴﺭﺍﺕ ﻤﻥ ﺍﺍﻝﻤﺴﺘﺤﻀﺭ ﺍﻝﻨﻬﺎﺌﻲ ﻭﺘﻘﻴﻴﻡ ﻤﻌﻠﻭﻤﺎﺕ ﺍﻝﺜﺒﺎﺕ ) ﺘﺘﻀﻤﻥ‬
‫ﺒﺤﺴﺏ ﺍﻝﻀﺭﻭﺭﺓ ﻨﺘﺎﺌﺞ ﺍﻹﺨﺘﺒﺎﺭﺍﺕ ﺍﻝﻔﻴﺯﻴﺎﺌﻴﺔ ﻭﺍﻝﻜﻴﻤﻴﺎﺌﻴﺔ ﻭﺍﻝﺤﻴﻭﻴﺔ ﻭﺍﻝﺠﺭﺜﻭﻤﻴﺔ ( ‪ ،‬ﻓﺘﺭﺓ‬
‫ﺇﻋﺎﺩﺓ ﺍﻹﺨﺘﺒﺎﺭ ﺘﻨﻁﺒﻕ ﻋﻠﻰ ﺠﻤﻴﻊ ﺍﻝﺘﺤﻀﻴﺭﺍﺕ ﺍﻝﺘﻲ ﺴﻴﺘﻡ ﺘﺼﻨﻴﻌﻬﺎ ﻤﺴﺘﻘﺒﻼ ﺒﺎﺘﺒﺎﻉ ﻨﻔﺱ‬
‫ﻁﺭﻴﻘﺔ ﺍﻝﺘﺼﻨﻴﻊ ﻝﻠﻤﺴﺘﺤﻀﺭ ﺍﻝﺠﺎﻫﺯ ﻭﺘﺤﺕ ﺸﺭﻭﻁ ﻤﻤﺎﺜﻠﺔ ‪.‬ﺇﻥ ﺩﺭﺠﺔ ﺍﻝﺘﺒﺎﻴﻥ ﻭﺍﻹﺨﺘﻼﻑ ﻓﻲ‬
‫ﺍﻝﺘﺤﻀﻴﺭﺍﺕ ﺍﻝﻔﺭﺩﻴﺔ ﻴﺅﺜﺭ ﻓﻲ ﺍﻝﺜﻘﺔ ﺒﺄﻥ ﺍﻝﺘﺤﻀﻴﺭﺍﺕ ﺍﻝﺘﻲ ﺴﻴﺘﻡ ﺇﻨﺘﺎﺠﻬﺎ ﻤﺴﺘﻘﺒﻼ ﺴﺘﺒﻘﻰ ﻀﻤﻥ‬
‫ﺍﻝﻤﻭﺍﺼﻔﺎﺕ ﻁﻴﻠﺔ ﻓﺘﺭﺓ ﺇﻋﺎﺩﺓ ﺍﻹﺨﺘﺒﺎﺭ‪.‬‬
‫ﺇﺫﺍ ﺃﻅﻬﺭﺕ ﺍﻝﻨﺘﺎﺌﺞ ﺘﺨﺭﺏ ﻗﻠﻴل ﻭﺍﺨﺘﻼﻑ ﻗﻠﻴل ﺠﺩﺍ ﻴﻤﻜﻥ ﻤﻼﺤﻅﺘﻪ ﻋﻨﺩ ﺍﻝﻨﻅﺭ ﻓﻲ ﻨﺘﺎﺌﺞ‬
‫ﺍﻝﺩﺭﺍﺴﺔ ﺒﺤﻴﺙ ﻴﺘﻡ ﻤﻨﺢ ﺍﻝﻤﻭﺍﻓﻘﺔ ﻋﻠﻰ ﺘﺎﺭﻴﺦ ﺇﻋﺎﺩﺓ ﺍﻹﺨﺘﺒﺎﺭ ﺍﻝﻤﻁﻠﻭﺏ ‪ .‬ﻓﻲ ﻤﺜل ﺘﻠﻙ ﺍﻝﺤﺎﻻﺕ‬
‫‪ ،‬ﻓﺈﻨﻪ ﻤﻥ ﻏﻴﺭ ﺍﻝﻀﺭﻭﺭﻱ ﻹﺠﺭﺍﺀ ﺘﺤﻠﻴل ﺇﺤﺼﺎﺌﻲ ؛ﺇﺫﺍ ﺜﺒﺕ ﺒﺄﻥ ﺍﻝﺤﺫﻑ ﻤﻘﻨﻌﺎ ‪.‬‬
‫ﺇﻥ ﺍﻝﻤﻨﺤﻰ ﻝﺘﺤﻠﻴل ﺍﻝﻨﺘﺎﺌﺞ ﺒﺸﻜل ﻜﻤﻲ ﻝﻠﻤﻭﺍﺩ ﺍﻝﺘﻲ ﻴﻤﻜﻥ ﺃﻥ ﺘﺘﺒﺩل ﻤﻊ ﺍﻝﺯﻤﻥ ﻭﺫﻝﻙ ﻝﺘﺤﺩﻴﺩ‬
‫ﺍﻝﺯﻤﻥ ﺍﻝﺘﻲ ﺘﺸﻜل ﻓﻴﻪ ﺍﻝﺜﻘﺔ ﻓﻲ ﺍﻝﻨﺘﺎﺌﺞ ﺒﺎﺘﺠﺎﻩ ﻭﺍﺤﺩ ﻨﺴﺒﺔ ‪ %٩٥‬ﻭﺒﺄﻥ ﺍﻝﻤﻨﺤﻨﻰ ﺍﻝﻭﺴﻁﻲ‬
‫ﻴﺘﻘﺎﻁﻊ ﻤﻊ ﻤﺘﻁﻠﺒﺎﺕ ﺍﻝﻘﺒﻭل ﺍﻝﻘﻴﺎﺴﻲ‪ .‬ﺇﺫﺍ ﺒﻴﻨﺕ ﺍﻝﻨﺘﺎﺌﺞ ﺒﺄﻥ ﺍﻹﺨﺘﻼﻓﺎﺕ ﻤﻥ ﺘﺤﻀﻴﺭﺓ ﻝﺘﺤﻀﻴﺭﺓ‬
‫ﺼﻐﻴﺭ ﻋﻨﺩﻫﺎ ﻴﻜﻭﻥ ﻤﻥ ﺍﻝﻤﻔﻀل ﺠﻤﻊ ﺍﻝﺒﻴﺎﻨﺎﺕ ﻝﻠﻭﺼﻭل ﻝﺘﻘﺩﻴﺭ ﺇﺠﻤﺎﻝﻲ‪ .‬ﻴﻤﻜﻥ ﺘﺤﻘﻴﻕ ﺫﻝﻙ‬
‫ﻤﻥ ﺨﻼل ﺘﻁﺒﻴﻕ ﺇﺨﺘﺒﺎﺭﺍﺕ ﺇﺤﺼﺎﺌﻴﺔ ﻤﻨﺎﺴﺒﺔ )ﻤﺜل ‪ ،.‬ﺤﺩﻭﺩ ﻗﻴﻡ ﺍﻝﺭﻓﺽ ﺫﻭ ﺍﻷﻫﻤﻴﺔ ﺇﺫﺍ ﻜﺎﻨﺕ‬
‫ﺃﻜﺜﺭ ﻤﻥ ‪.( ٠,٢٥‬‬
‫ﺇﻥ ﺃﻱ ﺘﻘﻴﻴﻡ ﻴﺠﺏ ﺃﻥ ﻴﻐﻁﻲ ﻝﻴﺱ ﻓﻘﻁ ﺍﻝﻤﻌﺎﻴﺭﺓ ‪ ،‬ﺒل ﻴﺠﺏ ﺃﻥ ﻴﻐﻁﻲ ﺃﻴﻀﺎ ﻤﻭﺍﺩ ﺍﻝﺘﺨﺭﺏ‬
‫ﻭﺍﻝﻌﻭﺍﻤل ﺍﻝﻤﺸﺎﺭﻜﺔ ﺍﻷﺨﺭﻯ ‪.‬‬

‫‪ ١٠,٢,٢‬ﺘﺼﺭﻴﺢ‪ /‬ﺍﻝﻌﻨﻭﻨﺔ ‪Statements/Labelling‬‬

‫ﺸﺭﻭﻁ ﺍﻝﺘﺨﺯﻴﻥ )ﺤﺭﺍﺭﺓ ‪ ،‬ﻀﻭﺀ ‪ ،‬ﺭﻁﻭﺒﺔ( ﺍﻝﻤﺼﺭﺡ ﺒﻬﺎ ﻴﺠﺏ ﺃﻥ ﺘﺴﺘﻨﺩ ﻋﻠﻰ ﺩﻝﻴل ﺘﺼﺭﻴﺢ‬
‫ﺸﺭﻭﻁ ﺘﺨﺯﻴﻥ ﺍﻝﻤﺴﺘﺤﻀﺭﺍﺕ ﺍﻝﺩﻭﺍﺌﻴﺔ – ﺍﻝﻤﻭﺍﺩ ﺍﻝﻔﻌﺎﻝﺔ‪.‬‬
‫ﺇﻥ ﺍﺴﺘﻌﻤﺎل ﺘﻌﺎﺒﻴﺭ ﻤﺜل ﺍﻝﺸﺭﻭﻁ ﺍﻝﻁﺒﻴﻌﻴﺔ ﺃﻭ ﺤﺭﺍﺭﺓ ﺍﻝﻐﺭﻓﺔ ﻫﻭ ﻏﻴﺭ ﻤﻘﺒﻭل‪.‬‬

‫‪٢١‬‬
 ‫ﻤﻠﺤﻕ ‪Annex I‬‬

‫ﺘﻌﺘﺒﺭ ﺍﻝﻤﺎﺩﺓ ﺍﻝﻔﻌﺎﻝﺔ ﺜﺎﺒﺘﺔ ﺇﺫﺍ ﺒﻘﻴﺕ ﻤﺤﺎﻓﻅﺔ ﻋﻠﻰ ﺍﻝﻤﻭﺍﺼﻔﺎﺕ ﺍﻝﻤﻌﺭﻓﺔ ﺃﻭ ﺍﻝﺼﺎﺩﺭﺓ ﻋﻥ‬
‫ﺍﻝﺴﻠﻁﺎﺕ ﺍﻝﺼﺤﻴﺔ ﻝﻤﺩﺓ ﻻﺘﻘل ﻋﻥ ﻋﺎﻤﻴﻥ ﻋﻨﺩ ﺘﺨﺯﻴﻨﻬﺎ ﺒﺸﺭﻭﻁ ‪ 25°C /60% RH‬ﺃﻭ‬
‫ﺒﺸﺭﻭﻁ ‪ 30°C /65% RH‬ﻭﻜﺫﻝﻙ ﻝﻤﺩﺓ ﺴﺘﺔ ﺃﺸﻬﺭ ﺒﺸﺭﻭﻁ ‪. 40°C /75% RH‬‬

‫ﻤﻠﺤﻕ ‪Annex II‬‬

‫ﺍﺴﺘﺨﻼﺹ ﺍﻝﻨﺘﺎﺌﺞ‬

‫ﺇﺫﺍ ﻜﺎﻨﺕ ﻨﺘﺎﺌﺞ ﺍﻝﺯﻤﻥ ﺍﻝﺤﻘﻴﻘﻲ ﺍﻝﻤﺩﻋﻤﺔ ﺒﺩﺭﺍﺴﺎﺕ ﻗﺩ ﺘﻤﺕ ﺒﺸﺭﻭﻁ ﺘﺨﺯﻴﻥ ﻤﺴﺭﻋﺔ ﺃﻭ‬
‫ﻤﺘﻭﺴﻁﺔ ‪ ،‬ﻓﺈﻥ ﻓﺘﺭﺓ ﺇﻋﺎﺩﺓ ﺍﻹﺨﺘﺒﺎﺭ‪/‬ﻋﻤﺭ ﺍﻝﺩﻭﺍﺀ ﻋﻠﻰ ﺍﻝﺭﻑ ﻴﻤﻜﻥ ﺃﻥ ﺘﻤﺩﺩ ﻝﻔﺘﺭﺓ ﺃﻁﻭل ﻤﻥ‬
‫ﺩﺭﺍﺴﺎﺕ ﺍﻝﺯﻤﻥ ﺍﻝﺤﻘﻴﻘﻲ‪ .‬ﻋﻤﺭ ﺍﻝﺩﻭﺍﺀ ﻋﻠﻰ ﺍﻝﺭﻑ ﺃﻭ ﻓﺘﺭﺓ ﺇﻋﺎﺩﺓ ﺍﻹﺨﺘﺒﺎﺭ ﺍﻝﻤﺴﺘﺨﻠﺼﺔ ﺃﻭ‬
‫ﺍﻝﻤﺴﺘﻨﺘﺠﺔ) ﺍﻝﻤﺘﻭﻗﻌﺔ( ﻴﻤﻜﻥ ﺃﻥ ﺘﻜﻭﻥ ﻀﻌﻑ ﺍﻝﻔﺘﺭﺓ ﺍﻝﺯﻤﻨﻴﺔ ﻭﺫﻝﻙ ﺒﺎﻻﻋﺘﻤﺎﺩ ﻋﻠﻰ ﺯﻤﻥ‬
‫ﺍﻝﺘﻐﻴﻴﺭ‪ ،‬ﺍﻻﺨﺘﻼﻑ ﻓﻲ ﺍﻝﻨﺘﺎﺌﺞ‪ ،‬ﺸﺭﻭﻁ ﺍﻝﺘﺨﺯﻴﻥ ﺍﻝﻤﻘﺘﺭﺤﺔ ﻭﻜﻤﻴﺔ ﺍﻝﺘﺤﺎﻝﻴل ﺍﻹﺤﺼﺎﺌﻴﺔ‬
‫ﺍﻝﻤﻨﺠﺯﺓ‪.‬‬

‫ﻤﻠﺤﻕ‪Annex III‬‬
‫ﻤﺭﺘﺴﻡ ﺸﺠﺭﺓ ﺍﻹﺤﺘﻤﺎﻻﺕ‬

‫ﻴﻭﻀﺢ ﺍﻝﻤﺭﺘﺴﻡ ﺍﻝﻤﺭﻓﻕ ﺍﻹﺤﺘﻤﺎﻻﺕ ﺍﻝﻤﺨﺘﻠﻔﺔ ﺍﻝﻤﺘﻭﻗﻌﺔ ﻝﺘﻘﻴﻴﻡ ﺍﻝﻨﺘﺎﺌﺞ ﻝﺘﻘﺩﻴﺭ ﻓﺘﺭﺓ ﺇﻋﺎﺩﺓ‬
‫ﺍﻹﺨﺘﺒﺎﺭ ﺃﻭ ﻋﻤﺭ ﺍﻝﺩﻭﺍﺀ ﻋﻠﻰ ﺍﻝﺭﻑ ﻝﻠﻤﻭﺍﺩ ﺍﻝﻔﻌﺎﻝﺔ ﺃﻭ ﺍﻝﻤﺴﺘﺤﻀﺭﺍﺕ ﺍﻝﻨﻬﺎﺌﻴﺔ )ﺒﺎﺴﺘﺜﻨﺎﺀ‬
‫ﺍﻝﻤﺴﺘﺤﻀﺭﺍﺕ ﺍﻝﻤﺠﻤﺩﺓ(‪.‬‬

‫‪٢٢‬‬
 ‫  ول أو أر   درات ات‬
‫('& ‪#$%‬؛  ة إدة أو  اواء  اف‬

‫ا‪ ,- ).‬؛‬ ‫‪ )*+‬وا‪  $‬ا  ‪  .5%‬ة ‪/0' /12 )34‬‬

‫ا ‪ :*1‬ا‪ )'&. 789‬ا‪/*' 46‬‬
‫‪$'*%‬‬
‫ا  ‪&B%‬د إ آ) ‪A‬وط ا ?>'‪ /‬و‪ *+‬آ‪)*;< :‬‬
‫‪:C D4 :02-‬‬

‫‪%‬ل '  ا‪2‬وط ا‪ )D‬ة ‪ ٦‬أ‪,A‬‬

‫(‬
‫أ‪,F‬ت ا‪  $‬ا‪ )'&.‬ا‪:46‬‬
‫‪ -١‬م و&د ‪ *5%‬أو ‪ 4 :*+ *5%‬ا>‪/4‬‬
‫‪ -٢‬م و&د ا< ‪L‬ف أو ا< ‪L‬ف ‪:*+‬‬
‫‪/*$3M B‬‬
‫أ‪,F‬ت ا‪  $‬ا‪:)D‬‬
‫‪ -٣‬م و&د ‪ *5%‬أو ‪ 4 :*+ *5%‬ا>‪/4‬‬
‫‪ -٤‬م و&د ا< ‪L‬ف أو ا< ‪L‬ف ‪:*+‬‬
‫‪/*$3M B‬‬
‫ا ‪ :*1‬ا‪ 789‬دة ‪ *Q‬وري‬
‫‪Y= up to 2X,but not exceeding‬‬
‫‪X+12 months ,‬‬
‫‪Or if refrigerated,‬‬
‫‪Y= up to 1.5X, but not exceeding‬‬
‫‪X+6 months‬‬
‫‪  =Y‬ة إدة ا‪ <9‬ر أو  اواء  اف‬
‫‪ =X‬ا‪ S‬ة ا  ‪   ,*.5%‬ارا) ا‪ )'&.‬ا‪46‬‬

‫‪%‬ل ‪  ,4‬ا‪2‬وط ا‪L< )D‬ل ‪ ٣‬أ‪,A‬‬

‫‪B‬‬

‫‪B4‬ة  ?>'‪  /‬ااد‬

‫‪٢٣‬‬