Importance of Auditing in the Pharmaceutical Industry

Pharmaceutical Industry

The job of a pharmacist is one of the most challenging jobs. The usual Pharmaceutical Industry is always busy, and with the ongoing global pandemic, it has been difficult for this community to maintain fully stocked shelves and a fully staffed counter.

Although these are some of the significant difficulties that a pharmacist has to face in their day-to-day life in the recent period, in addition to the staffing issues and the pandemic worries, the pharmacist also has to worry about their pharma audit reports.   

Pharmaceutical audit consultancy is one of the essential factors to meet the guidelines to keep the pharmacy needed intact.

In this article, we will be discussing the pharma audits in detail.

What do you mean by a pharmacy audit?

A pharma audit is a formal review of the various processes and operations to ensure that the pharmacies are compliant enough with the given pharmaceutical rules and regulations and the other related agreements by the governments. 

The pharma audit report library can include various forms such as the onsite, desktop, and investigational pharmacy audits, along with the prepay claim reviews. 

What are some of the different types of pharmaceutical audits?

The audits are mainly classified into three different groups, understanding the pharma Industry audit types:

  • First, internal audits- this type of audit is the first–party audit and generally involves using a systematic methodology.
  • External audits- are the second-party audit and thus typically refer to the audit by a customer upon the contractor or supplier.
  • Regulatory audits- are third-party audits and are typically under the governance of a regulatory agency or an independent body.

What are the benefits of managing a pharma audit report by the pharmacist?

The pharma audit reports generally have a low influence on the regulatory inspections. Still, they form an essential management tool for assessing a given pharmaceutical company in–house management system for the quality. Some of the significant benefits of managing a practical pharma audit report library are as follows:

  • Proper management of a quality management system by the company.
  • Through the various identification methods of the unsatisfactory situations or trends, detecting weak points in advance becomes possible.
  • Based on the quality data review, preventing quality failures has become easy.
  • Informs the senior management team about the quality levels of the operations and the facilities.
  • By standardising the required audit reports, the pharmacist will be able to optimise the quality level and the outputs of their audits which will, in turn, help them in a continuous improvement loop.
  • By establishing a high-quality audit system in the pharmaceutical industry, we will be able to increase compliance. As a result, there will be an improved relationship and confidence between the required partners.

Conclusion

A pharma audit is one of the essential factors that a pharmaceutical company remains intact. In addition, they serve as a method that typically uncovers the required information regarding the company’s quality management system. This helps the pharmacist meet the required guidelines generated by the government.

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    Audit Report Package

    Our Audit Report Package is very thorough and includes all of the following which is sufficient enough to qualify the supplier:

    • Full Audit Report.
    • Auditor’s CV.
    • Auditor’s non-conflict of interest declaration.
    • CAPA plan with evidence, as applicable.
    • Audit closure signed by Lead Auditor, with CAPA review confirmation.
    • Attachments including lists, certificates, licenses, layout etc.
    • Additional documents such as SMF, SOP index, Site presentation etc. as available.