The reference, if any, to a The reference, if any, to a pharmacopoeial pharmacopoeial monograph; monograph; The approved suppliers and, if The approved suppliers and, if reasonable, the reasonable, the original producer of the original producer of the material; material; A specimen of printed materials; A specimen of printed materials; Directions for sampling and testing; Directions for sampling and testing; Qualitative and quantitative requirements with Qualitative and quantitative requirements acceptance limits; with acceptance limits; Storage conditions and precautions; Storage conditions and precautions; The maximum period of storage before The maximum period of storage before 4.15 Specifications for intermediate and bulk products 4.12 Specifications for intermediate and bulk products should Rewrite to allow Nil should be available for critical steps or if these are be available if these are purchased or dispatched, or if data a risk based purchased or dispatched. The specifications should be obtained from intermediate products are used for the approach to similar to specifications for starting materials or for evaluation of the finished product. The specifications should requirement to finished products, as appropriate. be similar to specifications for starting materials or for have specs for finished products, as appropriate. bulks and intermediates 4.16 Specifications for finished products should include 4.13 Specifications for finished products should include: Increasing Nil or provide reference to: flexibility by The designated name of the product and the code moving a “or The designated name of the product and the reference trial applicable; reference to” code reference where applicable; from b) only to The formula or a reference to; the core text to The formula; A description of the pharmaceutical form and package details;
The reference, if any, to a pharmacopoeial monograph; The approved suppliers and, if reasonable, the original producer of the material; A specimen of printed materials; Directions for sampling and testing; Qualitative and quantitative requirements with acceptance limits; Storage conditions and precautions; The maximum period of storage before The reference, if any, to a pharmacopoeial monograph; The approved suppliers and, if reasonable, the original producer of the material; A specimen of printed materials; Directions for sampling and testing; Qualitative and quantitative requirements with acceptance limits; Storage conditions and precautions; The maximum period of storage before 4.15 Specifications for intermediate and bulk products should be available for critical steps or if these are purchased or dispatched. The specifications should be similar to specifications for starting materials or for finished products, as appropriate. 4.12 Specifications for intermediate and bulk products should be available if these are purchased or dispatched, or if data obtained from intermediate products are used for the evaluation of the finished product. The specifications should be similar to specifications for starting materials or for finished products, as appropriate. Rewrite to allow a risk based approach to requirement to have specs for bulks and intermediates Nil 4.16 Specifications for finished products should include or provide reference to: The designated name of the product and the code reference where applicable; The formula; 4.13 Specifications for finished products should include: The designated name of the product and the code reference applicable; The formula or a reference to; A description of the pharmaceutical form and package details; Increasing flexibility by moving “or a reference to” from b) only to the core text to Nil trial