范例：
6．批检验报告 说明三个连续批次（批号：***、***、***）的检验情况，提供样品的生产时间、地点、批量等信息。 7．稳定性研究 以文字或列表的方式提供与参比样品或变更前样品的稳定性数据（如方法学适用）的比较研究情况。说明变更前后样品批号和批量。对关键项目，如有关物质、含量等，列出具体检测数据，比较变化趋势。 提供变更后样品的内包装材料、贮藏条件、有效期，并结合变更后样品的稳定性研究情况、变更前后样品的稳定性比较研究情况、已上市产品的贮藏条件和有效期等，说明变更后样品的内包装材料、贮藏条件、有效期的确定依据。 六、参考文献 （一）FDA有关指导原则 1.Guidance for Industry. BACPAC I：Intermediates in Drug Substance
Synthesis Bulk Actives Postapproval Changes：Chemistry，Manufacturing，and Controls Documentation.
FDA. February 2001. 2.Guidance for Industry. Changes to an
Approved NDA or ANDA，Revision 1，dated April 2004. FDA. November
1999. 3.Guidance for Industry. Changes to an
Approved NDA or ANDA：Questions and Answers，FDA. January 2001. 4.Guidance for Industry. CMC
Postapproval Manufacturing Changes Reportable in Annual Reports. FDA. June
2010. 5.Guidance for Industry. CMC
Postapproval Manufacturing Changes To Be Documented in Annual Reports. FDA.
March 2014. 6.Guidance for Industry. Established
Conditions：Reportable CMC Changes for Approved Drug and Biologic Products. FDA.
May 2015. 7.Changes to an Approved NDA or ANDA;
Specifications – Use of Enforcement Discretion for Compendial Changes，FDA. November 2004. 8.SUPAC-IR：Immediate-Release
Solid Oral Dosage Forms：Scale-Up and Post-Approval
Changes：Chemistry，Manufacturing
and Controls，In Vitro Dissolution Testing，and In Vivo Bioequivalence Documentation （I）. FDA. November 1995. 9.SUPAC-IR：Questions and Answers
about SUPAC-IR Guidance，FDA. February ，1997. 10.SUPAC-IR/MR：Immediate Release and
Modified Release Solid Oral Dosage Forms Manufacturing Equipment Addendum，FDA. January 1999. 11.SUPAC-MR：Modified Release
Solid Oral Dosage Forms：Scale-Up and Postapproval
Changes：Chemistry，Manufacturing，and Controls，In Vitro Dissolution Testing，and In Vivo Bioequivalence Documentation （I）. FDA. October 1997. 12.SUPAC-SS：Nonsterile Semisolid
Dosage Forms；Scale-Up and Postapproval Changes：Chemistry，Manufacturing，and Controls；In Vitro Release Testing and In
Vivo Bioequivalence Documentation （I）. FDA. June 1997. 13.SUPAC-SS：Nonsterile Semisolid
Dosage Forms Manufacturing Equipment Addendum，FDA.
December 1998. 14.Dissolution Testing of Immediate
Release Solid Oral Dosage Forms. U.S. Department of Health and Human Services.
FDA. 15.Extended Release Oral Dosage Forms：Development，Evaluation，and Application of In Vitro/In
Vivo Correlations. U.S. Department of Health and Human Services. FDA. 16.Guidance for Industry：Bioavailability and
Bioequivalence Studies for Orally Administered Drug Products—General
Considerations. U.S. Department of Health and Human Services. FDA. March 2003. 17.Waiver of In Vivo Bioavailability
and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms Based
on a Biopharmaceutics Classification System. U.S. Department of Health and
Human Services. FDA. （二）EMEA有关指导原则 18.Guideline on Dossier Requirements
for Tyle IA and Type IB Notifications. European Commission. July 2003. 19.Guideline on Stability Testing for
Applications for Variations to A Marketing Authorisation. CPMP December 2003. 20.Note for Guidance on The
Investigation of Bioavailability and Bioequivalence. CPMP/EWP/QWP/1401 /98. 21.Guidelines on the details of the
various categories of variations，on the operation of the procedures laid down
in Chapters II，IIa，III and IV
of Commission Regulation （EC）
No 1234/2008 of 24 November 2008 concerning the examination of variations to
the terms of marketing authorisations for medicinal products for human use and
veterinary medicinal products and on the documentation to be submitted pursuant
to those procedures （2013/C 223/01）. 22.Concerning the examination of
variations to the terms of marketing authorisations for medicinal products for
human use and veterinary medicinal products. COMMISSION REGULATION （EC） No 1234/2008. （三）TGA有关指导原则 23.Appendix 12：Changes To
Pharmaceutical And Quality Information Of Registered Medicinal Products：Notification，Self-Assessment And Prior
Approval. Australian Regulatory Guidelines For Prescription Medicines 24.Appendix 11b：Policy On When To
Request Bioavailability Data （Or A Justification As To
Why Such Data Are Not Required）. Australian Guidelines
For The Registration Of Drugs . 25.Appendix15：Biopharmaceutical
Studies. Australian Regulatory Guidelines For Prescription Medicines . （四）ICH有关指导原则 26.ICH Q6a. Specifications：Test procedures and
acceptance criteria for new drug substances and new drug products：Chemical substances. Draft ICH Consensus Guideline. 27.ICH Q3A（R2）. Impurities in new drug substances. 28.ICH Q3B（R2）. Impurities in new drug products. 29.ICH M7. Assessment and Control of
DNA reactive （mutagenic） Impurities in Pharmaceuticals to
limit Potential Carcinogenic Risk （五）其他 30.《已上市化学药品变更研究的技术指导原则（一）》 31.《化学药物原料药制备和结构确证研究的技术指导原则》 32.《化学药物制剂研究的基本技术指导原则》 33.《化学药物杂质研究技术指导原则》 34.《化学药物残留溶剂研究技术指导原则》 35.《普通口服固体制剂溶出度试验技术指导原则》 36.《化学药物（原料药和制剂）稳定性研究技术指导原则》 37.《原料药生产工艺变更主要研究信息汇总模板》 38.《注射剂处方工艺变更主要研究信息汇总模板》
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