Successful USFDA Audit.

To understand how to do successful USFDA audit we must is understand why pharmaceutical companies are not able to cope up with the expectations of USFDA and land into the serious 483 observations.

For successful USFDA audit.

Following are the key points that a pharmaceutical manufacturing company is required to adapt so that the regulatory expectations are met without facing any hurdles.

Define what is the objective of the pharmaceutical business.

Define the cost of running the business as per the expectations of USFDA.

Arrive at the profit and loss after the considerations of above two points is the company going to make profit or losses.

If after adapting the policy to run the company as per the expectations of US FDA guidelines, UK MHRA and EU guidelines, is the company making profit?

If yes, then formulate a perfect policy by considering following things to achieve successful USFDA audit.

In order to meet the compliance and regulatory stringent compliance expectations of US FDA UK MHRA and EU, etc. following things which are necessary should be given priority in the operational policy of the pharma company.

Objective of the business: To do pharmaceutical business without violation of regulatory laws and guidelines, produce quality pharmaceutical.

Ethical policy: to achieve above objective all ethical ways will be adapted, in operations in facility care will be taken to comply the good manufacturing practices guidelines issued by US FDA.

To achieve this expert people with positive and appropriate attitude will be employed, they will be encouraged to follow ethics, in order to achieve this, they will be rewarded monitory so that they maintain the approach. There will be no tolerance for false and manipulations, data integrity violations.

Quality policy: To produce quality medicine by adhering to the above policy.

Training of the ethical policy and objective to management and employees.

Decide on at which points management will never compramise to meet the expectations of US FDA and other regulatory agencies.

Training to management and staff who are key in the operations.

Reward and Punishment policy to clearly define on the violations those done in deliberation will not be tolerated.

Handling Errors occurring due to unintentional manner will be treated with proper management of personnel with training and education and monitoring policy.

To achieve successful USFDA audit companies should have honest objectives and goals to achieve with honest operations. Companies should define the employee’s behavioral expectations through policy defining important aspects of behavior and encourage inculcation of honesty.

Written Procedures are important for successful USFDA inspections:

483 form issued by USFDA
483 observation of USFDA

One of the important aspect of compliance of US FDA is a prompt and correct perfect practicable written documents, like SOPs Methods, and other procedures.

Company should encourage employees to follow the written instructions and procedures, one must not do anything beyond the written documents, and write the report about what they have done, the observation made in actual, as per written instructions, procedure followed as per written instructions, and that to be concurrent to the operations, follow data integrity principles.

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