In this week’s edition of Devine Guidance , Dr. D will complete (it’s about time!) the review of section 820.70 of the Quality System Regulation (QSR), and focus on subsection (h) manufacturing material, and (i) automated processes.
In this week’s edition of Devine Guidance (DG), Dr. D will continue down the production and process controls path by examining the requirements for subsections (f) buildings, and (g) equipment. Buildings and equipment fall into Dr. D’s not rocket science category.
As promised, in the week’s edition of Devine Guidance (DG) Dr. D will continue with analyzing the requirements associated with 21 CFR, Part 820 – Section 820.70; subsections (c) environmental control, (d) personnel, and (e) contamination control.
The identification and traceability (sections 820.60 and 820.65) for products and finished medical devices, throughout the entire manufacturing process, including raw materials employed during the manufacturing process, and the subsequent sale and distribution of medical devices, are critical elements of the Quality System Regulation (QSR).
If you are a returning visitor, welcome back to this 4th installment of Devine Guidance. If this is your first time, I hope you have a chance to read the first-three installments of my blog. In this installment, I will continue with the defensive-receiving inspection theme, a process that I feel “has limited-value.” That said,…
To those who have decided to return for another episode of Devine Guidance , thank you! Once again, I hope you find some reading enjoyment and value in this third installment. For this adventure, I plan to dive into the importance of a clear and concise specification to support the design, development, and procurement processes.