Seven Things You Need For Your GCLP Audit
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If you're looking for some suggestions or reminders to get you and your firm prepared for the scary GCLP audit, then you are going to need to read this document. Specifically, I'm going to give you some recommendations on how to ace the GCLP audit and the seven main things that you need to remember for the audit day.
After reading this article, you ought to be able to get all the preparations prepared for that GCLP audit that you've been having mixed feelings for. Excited but shocked at the same time? Do not be disturbed, I know how you feel. GCLP audits can be really scary because of the gravity of the GCLP certification.
The Seriousness of a GCLP Audit
In simple language everything inside and surrounding your hospital or laboratory is included in the GCLP audit. And this is just one of the explanations why a lot of lab and clinic executives get the shivers when they hear a "GCLP audit" is lined up.
Now, of course, everyone knows that a GCLP audit is essential. It ensures that your lab is fit for clinical trials and that your processes are all of top quality. It can often help you identify your strengths and make plans for improvement on your drawbacks.
GCLP Audit: Things To Test Out
Now, as I discussed, you should check out everything in your lab for the GCLP audit. But since that can be terribly hard, I've just picked seven of the most important things that will be checked in a GCLP audit. These are all taken straight from the GCLP guiding principle book released by WHO.
1. Independent auditing of the trial facility should be conducted to assure conformity with the trial protocol, analytical plan, standard operating procedures and these principles.
2. Facilities, systems, equipment, methods, QC procedures, staff, reports and paperwork should be audited at intervals following a prearranged program.
3. Audits should be conducted by an able person (s) delegated by trial facility management. This person (s) should be independent of the work being checked. Independent audits by external specialists can be exploited.
4. All audit results should be recorded. Reports of the audits should contain all the findings made during the audit and, where necessary, any remedial actions.
5. Analytical Project Managers and Trial Facility management should respond to these audit reports in a hurry.
6. Any curative actions indicated should be tracked to guarantee suitable implementation.
7. On the satisfactory completion of an audit, an audit certificate should be produced, which identifies the activities audited, and a suggestion of the compliance of those activities with this guiding principle.
Article Source: Articlelogy.com
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