CCS指南-附件2：CCS内容表的例子.docx

Attachment 2: Example of a CCS Table of content 附件2：CCS内容表的例子 Purpose and scope of the document Definitions and abbreviations List of the GMP sites Brief description of the plants and facilities (refer to SMF) Brief description of product currently manufactured CCS and sites objective CCS cross-functional team Roles and responsibilities CCS communication and decision-making process QRM scope in regard to the CCS requirements Reference to gap assessment vs. the CCS requirements Elements to consider for the CCS Facility layout Cleanroom classification Cleanroom Pressure, temperature, humidity, etc. HVAC layout Maintenance program v. Control access to the defined area Intermediate, product, material Personnel Flow Utilities Water QRM and controls Preventive maintenance program Qualification (reference) and routine monitoring Compressed gas QRM and controls Preventive maintenance program Qualification (reference) and routine monitoring Steam QRM and controls Preventive maintenance program Qualification (reference) and routine monitoring Equipment Process equipment cleaning validation Qualification (reference) QRM and controls Premises Cleanroom qualification Cleaning and disinfection Maintenance program Material transfer and disinfection Process contamination risk assessment Product A List of the QRM List of the routine sampling and controls Product B Aseptic manipulation and intervention risk assessment Visual inspection Single Use Systems Particulate monitoring Integrity monitoring Third party management I. Personnel Training and qualification CCS Evaluation Overview of the critical controls Contamination residual risk threshold List of the QRM part of the CCS (See Annex C) Routine KPI and target (see Annex B) Periodic review of the CCS Elements that trigger the CCS review Continuous improvement and governance decision (see annex A) Conclusion References Document history Annexes List/link of QRM related to CCS List/link of the procedures/policies related to CCS