T/GDCQMA 006-2024 Guidelines for the validation of cosmetic production processes
T/GDCQMA 006-2024 Guidelines for the validation of cosmetic production processes
Basic Information
Scope
Scope: This document provides guidance on the validation of key process parameters and critical control points in cosmetics production processes, including the formulation of validation plans, validation records, and validation report specifications. This document is applicable to the guidance of cosmetics production process validation work. Main Technical Content: 1. Scope: This document provides guidance on the validation of key process parameters and critical control points in cosmetics production processes, including the formulation of validation plans, validation records, and validation report specifications. This document is applicable to the guidance of cosmetics production process validation work. 2. Normative Reference Documents: The content of the following documents is an integral part of this document through normative reference in the text. Among them, the referenced documents with a specified date apply only to the version corresponding to that date; the unreferenced documents apply to the latest version (including all amendment sheets) of the document. - Announcement of the National Medical Products Administration on the Issuance of the "Good Manufacturing Practice for Cosmetics" (No. 1 of 2022) - Announcement of the National Medical Products Administration on the Issuance of the "Inspection Points and Judging Principles for Good Manufacturing Practice for Cosmetics" (No. 90 of 2022) - Good Manufacturing Practice for Pharmaceutical Production (Revised in 2010) (Decree No. 79 of the Ministry of Health) 3. Terms and Definitions 3.1 Process Validation 3.2 Critical Quality Attribute 3.3 Key Process Parameter 3.4 Critical Control Point 3.5 Verification Batch 4. Abbreviations The following abbreviations are applicable to this document: - CQA: Critical Quality Attribute - KPP: Key Process Parameter - FMEA: Failure Mode and Effects Analysis - SOP: Standard Operating Procedure 5. Requirements 5.1 The main production p