Auditing is an absolutely necessary function within a pharmaceutical company which will help to review and evaluate the quality system of an organization.

International organization for standardization (ISO) defines the audits as "Systematic, independent and documented process for obtaining audit evidence and evaluating them objectively to determine the degree to which the verification criteria are met". In simply terms audit can be defined as an inspection wherein an organizations ensures that their processes and system meet the requirements of its intended use.

Every pharmaceutical organization should have GMP compliance regulations to ensure that the safety of the product. A quality team consisting experienced and skilled members should be formed who will focused on improving quality and complying with GMP regulations. Their main aim will be analyzing and identifying the problems, its root cause and develop appropriate improvement measures. The best way to ensure GMP compliance is to educate and train the staff on the importance of Good Manufacturing Practice

An internal audit of every department gives you an idea about activities carried out in a facility and the level of GMP compliance. The audit finding will helps to identify the real sources of non-compliance and appropriate measures to curb the situation before it depreciate. This type of audit is also known as first part audit. An organization should have a standard operating procedure (SOP) to carry out internal audit process.

Apart from internal audit, there are two more types of audit-External Audit and Regulatory Audit. External audit, also known as second party audit is carried out by a company on the supplier to ensure that they meets the requirement specified in their contract and are GMP compliant.

Regulatory Audit is also known as third party audit and is carried out by regulatory agency for the purpose of compliance or certification or registration. All regulatory inspectors are extensively trained and competent. Failure to pass a regulatory audit can result in revocation of import/export license. To avoid this situation, an organization should have defined process and system along with trained staff. Internal audits can provide valuable opportunities to face the regulatory audits.

The audit is characterized by various principles such as integrity, fair presentation, due professional attention, confidentiality, independent of the activity and evidence-based approach. These principles help to establish audit as an effective and reliable tool by providing information on how an organization can improve its performance.

The audit is characterized by various principles such as integrity, fair presentation, due professional attention, confidentiality, independent of the activity and evidence-based approach. These principles help to establish audit as an effective and reliable tool by providing information on how an organization can improve its performance.

Planning is the second step of audit where the audit will identify the key areas of risk and concerns. The third step is opening meeting which take place between the auditing staff and senior management and administrative staff of the auditing organization.

The forth step, field work begins with notifying the employees about the audit, activities of the audit staff are scheduled, investigation begins by studying the organization’s procedures, interviewing the key staff members, reviewing the various rules and practices followed in the organization.

In the fifth step, the audit team consistently remains in contact with the auditor to clarify processes and procedure and to provide documentation proof.

The sixth step is to prepare the draft audit report which details the audit finding and list of concerns. In the seventh step the report is handed over to the management for their review, suggest changes and to probe area of concerns. Management is requested to response to the audit report by stating whether they agree with issue mentioned in the report, plans for the corrective actions and the expected time by which all the issue will be addressed.

In the eighth step, the final meeting is taken to close loose ends and to discuss the management response.

Distribution of report is the ninth step of audit process. The final audit report is distributed among the appropriate officials inside and outside the audit area.

The tenth and last step is the audit feedback whereby the audited company implements the changes recommended by the auditor and this changes is again reviewed by the auditor. This cycle continues until all issues are addressed and the next audit process cycle begins.

The tenth and last step is the audit feedback whereby the audited company implements the changes recommended by the auditor and this changes is again reviewed by the auditor. This cycle continues until all issues are addressed and the next audit process cycle begins.

On-site audits take place on the site while remote audits utilize different techniques and technology to evaluate organization’s processes, systems, and procedures remotely. Remote auditing has proven to be a valid way of doing things for many reasons like saving money and hassle, cutting down on travel and allowing audits to be run efficiently. Communication skill is of paramount importance to support an effective remote audit.

But there are some disadvantage of remote auditing like maintenance data security, time zone difference, poor Wi-Fi connections and the lack of a personal touch. It is not an option for site certification audits; also it is not accepted by all Health Authorities. If these problems are overcome then remote auditing be the best method for the future audits.