A QA consultant I know made the case that SOPs are not always needed for QSR compliance. As an example, his client is a small Class II Medical Device contract sterilization services company which has executed the validation of the computerized system controlling its sterilization line with a validation plan, test protocols, and a validation report. There is no SOP in place to ensure the consistency of validation for similar systems; however, the company seems to have passed all its FDA audits in the past 6 years with no major or minor findings.
GAMP-5 specifies: “It is the responsibility of regulated companies to establish policies and procedures to meet applicable regulatory requirements”
§ 820.75 Process validation from 21 CFR Part 820 specifies: “(a) Where the results of a process cannot be fully verified by subsequent inspection and test, the process shall be validated with a high degree of assurance and approved according to established procedures”, and
§ 820.3 Definitions from 21 CFR Part 820 further clarifies: “(k) Establish means define, document (in writing or electronically), and implement.”
What do you think?
GAMP-5 specifies: “It is the responsibility of regulated companies to establish policies and procedures to meet applicable regulatory requirements”
§ 820.75 Process validation from 21 CFR Part 820 specifies: “(a) Where the results of a process cannot be fully verified by subsequent inspection and test, the process shall be validated with a high degree of assurance and approved according to established procedures”, and
§ 820.3 Definitions from 21 CFR Part 820 further clarifies: “(k) Establish means define, document (in writing or electronically), and implement.”
What do you think?
Hi,FDA 21 CFR Part 820 compliance require controls in design, document, purchase, and production process. This entails establishment of processes to ensure that a medical device conforms to specifications. Requirements emphasize maintenance of records of document changes, documentation of instructions of production processes and SOPs, and monitoring of process parameters.Thanks to all!!!
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Majakel