Thread Content
What are the external documents in the laboratory? How to obtain and manage it? 1 Types of external documents 1) Testing technical standards: including **standards, industry standards, pharmacopoeias, and documents issued by relevant ministries and agencies such as the drug regulatory authorities ； 2) CNAS/CMA documents: including standards, regulations, application instructions, guideline documents, etc ； 3) Calibration and verification certificates for instruments and equipment ； 4) Certificates of reference materials, instructions for reagents and consumables ； 5) Equipment manual ； 6) Industry conferences, notices from regulatory authorities, letters, etc ； 2 Methods of obtaining external documents, channels, and usage requirements 1) Testing technical standards: Purchase legitimate versions from reputable publishers or download them from official websites. Documents need to be under control, regularly updated, and older versions should be replaced promptly with the latest ones ； Maintain the files in an up-to-date state; destroy expired files or mark them clearly. Keep the files readily accessible at the location where they are stored, issue them under controlled conditions, and assign unique identifiers to them. 2) CNAS/CMA documents, which can be downloaded from the CNAS/Market Regulation Bureau website or purchased as genuine copies from authorized publishers. Documents need to be under control, regularly updated, and the older versions should be replaced promptly with the latest ones. Maintain the files in an up-to-date state; destroy expired files or mark them clearly. Keep the files readily accessible at the location where they are stored, issue them under controlled conditions, and assign unique identifiers to them. 3) The calibration and verification certificates for instruments and equipment are obtained from calibration institutions with CNAS accreditation whose scope of competence covers the calibration of the instruments in this laboratory. It is necessary to verify the calibration certificate; if there are correction values or correction factors listed in the certificate, these must be updated on the corresponding equipment. 4) The certificates for reference materials, as well as the instructions for reagents and consumables, should be obtained from the producers or sellers of those reference materials. Controlled storage certificates; there must be a correspondence between the certificates and the corresponding reference materials, reagents, and consumables. 5) The equipment’s manual can be obtained from the equipment manufacturer or seller. Archive the equipment manuals in a manner that makes them easily accessible to those who use the equipment; the manuals can be managed as non-controlled documents ； 6) Industry conferences, notices from regulatory authorities, letters, etc., are obtained from the departments that issue such notices and letters. Public notification letters are sent to the relevant personnel in a timely manner; such notifications and letters are managed as non-controlled documents.