Chirag Khatri
Beginner
Posts: 5
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Dear Friends,
Would like to know whethter QA can authorize the SOPs of a CRO which is GCP and GLP compliant? Is there any regulatory reference
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chidambara Joshi
Beginner
Posts: 1
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In response to Chirag Khatri
Dear Chirag,
It depends upon the policy of the organization. In most of the organizations QA will approve the SOPs
Joshi
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Kevin at Sanyo
Beginner
Posts: 40
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In response to Chirag Khatri
While I believe that the QA department may be useful in helping to generate the SOPs, it's main function is to verify that the SOP is written to established standards such as GLP or GMP. That said...I have often worked with QA departments who were responsible for creating a companies SOPs. They key is in the review and approval process. When one person generates (authors) an SOP, it is necessary to have another Review it. Once reviewed, the SOP gets edited accordingly and possibly reviewed again. Once the final SOP is generated it gets submitted for Approval. No one person can have more than one position in the process.
Kevin Loomis
Validation Engineer
Sanyo Biomedical Solutions
(630) 694-8218
(800) 858-8442 x8218
kloomis@sss.sanyo.com |
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complianceguru
Beginner
Posts: 23
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In response to Chirag Khatri
There is no regulatory reference, however, the predicate rules do require a quality assurance unit as i am sure you are aware. 
As far as approving a CRO's SOPs, QA can participate in the review and approval of their company's selected CRO.
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Guerra Parafino
Beginner
Posts: 6
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In response to complianceguru
I agree with Kevin and Micheal.
As a Sr. QA/Lead, I wrote IT SOP, Validation Plan and Request for Changes Process including Flowcharts. But QA do not approve IT SOP. QA can author SOP, addendums and other IT policy. IT policies are approved by IT Management depending upon upper executives that governs IT department.
On the last page of each the above documents, should have an IT Signature’s Block that may sound like: “By signing this document I certify that I have read the above items” this is signed by all IT staff to insure that they have read and understand the department policy. further, all IT new higher starts with reading the above materials, sign and date.
Parafino
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11-13-09 03:41 AM -