全球质量经理的培训教材.ppt

* * * * * * * * * * Procedures are given. Create signed sheet audit and report was completed * * * * * * * * * * Medical Device cGMPsSubpart L – Handling, Storage, Distribution Installation §820.150 Storage Establish procedures for storage areas that address prevention of the following: Mixups Damage Deterioration Contamination Other adverse effects Procedures shall ensure no obsolete, rejected, or deteriorated product is used or distributed. Stock rotation. Procedures for receipt from and dispatched to storage areas. * Medical Device cGMPsSubpart L – Handling, Storage, Distribution Installation §820.160 Distribution Establish procedures for distribution of only released devices. Distribution records are maintained. Name Address of consignee Identification and quantity shipped Date shipped Control numbers * Medical Device cGMPsSubpart L – Handling, Storage, Distribution Installation §820.170 Installation Provide device installation and use instructions. * Medical Device cGMPsSubpart M – Records §820.180 General Requirements Records required by part 820 shall have reasonable accessibility, readily available for the FDA, properly stored, and if automated shall be backed up. Confidentiality Records may be marked confidential to aid FDA in disclosing. Record Retention Period Time equivalent to design expected life, not less than 2 years from the date of release. K-C Record Retention Policy Exceptions Management Review Reports Quality Audits Supplier Audit Reports * Medical Device cGMPsSubpart M – Records §820.181 Device Master Record Maintain a device master record (DMR) that includes or references location of: Device specifications – drawings, composition, formulation, component specifications, software specifications. Production process specifications – equipment specifications, production methods, production procedures, production environment specifications. Quality assurance procedures, specifications, and acceptance criteria * Medical Device cGM