变化3:大幅修改了稳定性考察的描述“ FDA recommends that sponsors minimize freeze-thaw cycles by appropriately aliquoting subjects’ samples because freezing and thawing such samples may also affect assay results. However, studies evaluating short-term stability, including, as relevant, freeze-thaw cycle ...
变化3:大幅修改了稳定性考察的描述“ FDA recommends that sponsors minimize freeze-thaw cycles by appropriately aliquoting subjects’ samples because freezing and thawing such samples may also affect assay results. However, studies evaluating short-term stability, including, as relevant, freeze-thaw cycle ...
Is it acceptable to use a bracketingapproach for the manufacture of the exhibit batches of a generic drug productwith multiple strengths produced from common bulk granulations (or blends)? Doall of these exhibit batches need to be put into the stability program?采用同一制粒工艺（或混合）得到的...
3. Your firm failed to establish and follow an adequate written testing program designed to assess the stability characteristics of drug products and to use results of stability testing to determine appropriate storage conditions and expiration dates (21 CFR 211.166(a)). 你们公司未能建立并遵循适当的...
Is it acceptable to use a bracketingapproach for the manufacture of the exhibit batches of a generic drug productwith multiple strengths produced from common bulk granulations (or blends)? Doall of these exhibit batches need to be put into the stability program? 采用同一制粒工艺(或混合)得到的...
The assessment should also determine whether test methods used in the stability program are stability-indicating. The scope of the assessment should encompass any tests conducted by your firm or its contract laboratories.对所有测试方法进行详细、独立的评估,以评估它们是否包含足够具体的说明以确保可重复性...
-Ongoing stability program was established; 建立了持续的稳定性研究项目; -Suppliers were adequately qualified; 供应商有充分的资格; -Out-of-specification (OOS) results were thoroughly investigated and written procedures were established for investigations; and, ...
The use of the word s 24、hould in Agency guidances means that something is suggested or recommended, but not required.II. GUIDANCE (2)A.Drug Substance (2.1)1.General (2.1.1)Information on the stability of the drug substance is an integral part of the systematic approach to stability ...
-Ongoing stability program was established; 建立了持续的稳定性研究项目; -Suppliers were adequately qualified; 供应商有充分的资格; -Out-of-specification (OOS) results were thoroughly investigated and written procedures were established for investigations; and...
Chemical stability in solid state and in solution: 固态和溶液中的化学稳定性: Stress testing (forced degradation) was carried out on acetriptan to study its impurity profile, degradation pathway and to facilitate the development of a stability-indicating method. In addition, knowledge obtained from ...