Bioequivalence and Bioavailability Forum • QA statement signature

jlanteigne
☆

2011-03-02 17:24
(5182 d 09:56 ago)

Posting: # 6686
Views: 6,371

QA statement signature [GxP / QC / QA]

Hello,

I'm working for a CRO as a QA specialist and my question is the following. The QA statement is signed by the QA management for now in our company but we are reevaluating this practice and we are wondering if there is some regulatory requirements (FDA, EU, Japan...) to have the management siging this statement? We are planning to ask the auditor to sign it. What is the responsibility of the person signing this document?

Regards
Johanne

Edit: Category changed. [Helmut]

Ohlbe
★★★

France,
2011-03-02 18:00
(5182 d 09:21 ago)

@ jlanteigne
Posting: # 6687
Views: 5,362

QA statement signature

Post reply

Dear Johanne,

- for the clinical part of a trial, the Glossary of the ICH GCP guideline defines an audit certificate as A declaration of confirmation by the auditor that an audit has taken place.

- for the bioanalytical part of a trial, OECD GLP § 2.2.1.f states under Responsibilities of Quality Assurance Personnel:
prepare and sign a statement, to be included with the final report, which specifies types of inspections and their dates, including the phase(s) of the study inspected, and the dates inspection results were reported to management and the Study Director and Principal Investigator(s), if applicable. This statement would also serve to confirm that the final report reflects the raw data.
§ 9.2.4. on the contents of the final report also states:
A Quality Assurance Programme statement listing the types of inspections made and their dates, including the phase(s) inspected, and the dates any inspection results were reported to management and to the Study Director and Principal Investigator(s), if applicable. This statement would also serve to confirm that the final report reflects the raw data.

So no specific requirement in the parent documents to have the statements signed by QA management rather than by the auditors themselves.

Regards
Ohlbe

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Regards
Ohlbe

jlanteigne ☆ 2011-03-02 18:45 (5182 d 08:35 ago) @ Ohlbe Posting: # 6688 Views: 5,352	QA statement signature Post reply
	Thanks for your reply. That's what I've seen in the ICH and OECD guidance. I wanted to know if it's the common practice in the industry. Johanne

Helmut
★★★

Vienna, Austria,
2011-03-02 18:58
(5182 d 08:23 ago)

@ jlanteigne
Posting: # 6689
Views: 5,376

QA statement signature

Post reply

Dear Johanne!

❝ That's what I've seen in the ICH and OECD guidance. I wanted to know if

❝ it's the common practice in the industry.

Cough... Common practice is to add as many signatures as possible - 'just to be sure'. :cool:

Did you ever come across the term 'dissipation of responsibility'? = the misconception that the more people sign a document, the less errors it will contain. :not really:

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Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz

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