FDA 关于 CGMP 要求的问答（Docket No. FDA-2017-D-6821）
Q&A on CGMP Requirements
FDA 发布关于 CGMP 要求的问答资源，用于就人用、兽用及生物制品药品的 CGMP 含义与应用提供及时解答，并明确其属于 Level 2 指南。该资源由 CDER、CVM、CBER 和 OII 共同发起，一般澄清 21 CFR part 211 现行 CGMP 法规，公众可随时就 Docket No. FDA-2017-D-6821 提交意见。
As part of the Current Good Manufacturing Practice (CGMP) initiative announced in August of 2002, and to help FDA be more transparent with CGMP policy, we have developed this question and answer resource on current good manufacturing practice. We intend to use this format to provide timely answers to questions about the meaning and application of CGMP for human, animal, and biological drugs, and to share these widely. These questions and answers clarify statements of existing requirements or policy that are minor in nature, and as such, are considered Level 2 guidance. You may submit comments on this guidance at any time. Submit comments to Docket No. FDA-2017-D-6821 (see the instructions for submitting comments in the docket). This resource is being cosponsored by CDER, CVM, CBER, and OII. The Q&As generally clarify the existing CGMP regulations for finished pharmaceuticals: 21 CFR part 211
Questions and Answers on Specific Topics:
- General Provisions
- Buildings and Facilities
- Equipment
- Control of Components and Drug Product Containers and Closures
- Production and Process Controls
- Holding and Distribution
- Laboratory Controls
- Records and Reports
- Returned and Salvaged Drug Products
Contact for Further Information:
来源：FDA Pharmaceutical Quality Documents · fda.gov