simple ways to prepare for an fda audit

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Simple Ways to Prepare For an FDA Audit

MANAGERS IN PHARMA COMPANIES ARE USUALLY QUITE WORRIED ABOUT FDA INSPECTIONS AND AUDITS

IT’S OBVIOUS AS MILLIONS OF DOLLARS ARE INVESTED IN PRODUCT DEVELOPMENT AND IT’S ALL AT STAKE WHEN A PRODUCT IS AWAITING FDA APPROVAL

IN THIS PRESENTATION WE WILL GIVE YOU SOME TIPS AND SUGGESTIONS TO ENABLE YOU TO IMPROVE THE PROCESSES IN YOUR COMPANY SO THAT YOU CAN EASILY PASS THE FDA INSPECTION/AUDIT.

THESE TIPS WILL NOT QONLY HELP YOU IN THE FDA AUDIT BUT ALSO IN THE OTHER AREAS OF OPERATIONS AND PROCESSES.

FIRST OF ALL LET’S KNOW WHAT IS FDA AND WHAT ARE ITS RESPONSIBILITIES.

The chief role of the FDA is to make sure the health of the US citizens is protected. They also keep tabs on the products available in the market specially with regard to their effectiveness and any probable side-effects.

FDA is the US government watchdog that controls the food and drugs being sold

in the states.

FDA INVESTIGATORS' FOCUS

Sanitation

Purity and specific identity of the product

Quality

ABOVE ALL FDA MAKES SURE THAT NO COUNTERFEIT OR DIVERTED DRUG IS DEVELOPED AND SOLD IN THE STATES.

DON’T BE SCARED OF AN FDA INSPECTION AS WE ARE GOING TO SHARE WITH YOU SOME TRIED AND

TRUSTED METHODS YOU CAN USE TO NOT ONLY PASS THE AUDIT BUT ALSO ENHANCE THE QUALITY OF YOUR

INTERNAL PROCESSES.

AUDIT YOURSELF AND HIRE AN INTERNAL AUDITING TEAM

ASK YOUR INTERNAL AUDITORS TO SUPERVISE AND MONITOR THE PROCESSES.

ASK THEM TO GO BEYOND MAKING RECOMMENDATIONS.

AUTHORIZE THEM TO CHANGE/TWEAK PROCESSES

Internal auditing processes can go a long way towards improving the overall

processes.

Hire third party auditors from outside and arrange fierce mock audits to expose your teams to real life

FDA audit scenarios

IT HAS DUAL BENEFITS:

First, the analytics of the overall processes will be easier for you and you will be able to measure the performance of

your company and the procedures ;

Secondly, the training of your team would be an added bonus

for real-life FDA audit.

If you claim something, be ready with its evidence

If the investigator asks for any specific document, be ready with that document

Stay away from false statements

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