PIC/S审计清单(Audit Checklist)是PIC/S对药品监管机构进行GMP监管体系评估的指标体系,该指标体系共有11个模块,细分为38项亚指标[3],其中模块5检查程序包含6项亚指标,围绕实施检查的过程展开评估,包括检查策略、检查前准备、检查报告格式和内...
GMP Audit Checklist Improve GMP compliance by inspecting processes and operations using GMP audit checklists. Explore templates Template FDA Inspection Checklist Prepare for FDA inspections and improve GMP compliance for food and drug products with a digital checklist. ...
Good Manufacturing Practices (GMP) andcurrent Good Manufacturing Practices (cGMP)are, in most cases, interchangeable. GMP meaning the basic regulation promulgated by the US Food and Drug Administration (FDA) under the authority of theFederal Food, Drug, and Cosmetic Actto ensure that manufacturers ar...
Make sure they're easy to access so you don't have to go searching for them during the audit. Have a checklist of everything needed for GMP compliance in your facility at all times. For example, checklists for equipment maintenance and cleaning schedules can be very helpful in ensuring tha...
Audit Trail: 审计追踪An audit trail is a process that captures details such as additions, ...
in the same manner as the validity period of other manufacturers and importers who have been previously audited. However, in the case of a regular examination, it can be applied only when a valid certificate of conformity of another business operator is issued throu...
consequences. As a result, manufacturers must comply with both Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP) regulations to protect consumer safety and ensure preparedness in case of an audit. AComputerized Maintenance Management System(CMMS) software simplifies GMP and GLP ...
The APIC Audit Program has been completely revised to bring it in line with EMEA's guidance on the responsibility of auditing active substances manufacturers by the Manufacturing Authorization Holders for medicinal products in Europe. This audit programme now provides a third party option for auditing...