tag:blogger.com,1999:blog-4223777401798869681.post3850134652968729336..comments2024-03-16T09:06:28.316-04:00Comments on The QA Pharm: When All Else Fails, Lower Your Standards John E. Snyder (The QA Pharm)http://www.blogger.com/profile/16731163138908986936noreply@blogger.comBlogger2125tag:blogger.com,1999:blog-4223777401798869681.post-46375123243914862632010-10-21T12:54:43.241-04:002010-10-21T12:54:43.241-04:00You are absolutely correct, Malcolm.
QA ensures ...You are absolutely correct, Malcolm. <br /><br />QA ensures that an appropriate system exists whereby specifications are not just sucked out of R&D's thumb. But R&D typically sets specifications. In fact, R&D can even write the procedure(s) that describe the system for establishing specifications--but QA approves.<br /><br />And---correct again. It is not unreasonable for specifications to evolve over time as more data accrues with operational and experimental experience. The change control system gives QA the opportunity to review the justification.<br /><br />In these cases, one wonders what QA's role was in reviewing the 483 response. The FDA response was certainly a predictable.<br /><br />Thank you, Malcolm. John E. Snyder (The QA Pharm)https://www.blogger.com/profile/16731163138908986936noreply@blogger.comtag:blogger.com,1999:blog-4223777401798869681.post-423892556216288242010-10-21T02:23:02.137-04:002010-10-21T02:23:02.137-04:00I would make one comment-QA is indeed the guardian...I would make one comment-QA is indeed the guardian of specifications BUT QA does not set specifications! If R&D sets a specification it is their job to justify it and not QA's responsibility. Remember that when one is talking about quality risk management in terms of lifecycle it is not unreasonable to have a change in specifications. What went wrong in the cases you quote is that the companies incorporated these changes-not via change controls but as a response to an audit. That is the real issue hereMalcolmhttps://www.blogger.com/profile/13379077740821244842noreply@blogger.com