Quality audits are integral to secure pharma compliance with pharmaceutical and healthcare industry regulatory prerequisites. These quality audits are conducted in the pharmaceutical space to ensure that your pharmaceutical company’s comprehensive system of processes and operations meets all industry standards. Compliance audits are an important aspect of pharmaceutical business development as they help ensure that companies are operating in compliance with relevant laws and regulations and protecting patients’ safety and well-being.
Quality audits can appear to be intimidating and complex. However, if you understand what needs auditing, have accurate documentation, and prepare for the auditor’s questions, you can make the process simpler and more systematic. In this article, we will help you achieve this simplicity. Let’s start with an introduction to pharmaceutical audits.
What is a pharmaceutical quality audit?
In simple words, a pharmaceutical audit is a systematic and independent examination. In this examination, you will find out whether the activities carried out by your company are following standard regulations. Dickson Data said that pharmacies are the last step in the cold chain. Therefore, to maintain the efficacy of pharmaceutical products, it is essential to build a robust and reliable environment in pharmaceutical warehouses and storage spaces.
Internal or external quality audits are crucial to an excellent pharmaceutical quality management system. With quality audits, your pharmaceutical company will effectively evaluate its pharma compliance with regulatory requirements and obtain the feedback needed for refinement.
What are the types of pharma compliance audits?
Pharmaceutical companies mostly face three types of audits.
Internal audits
Pharmaceutical companies audit their systems, facilities, and standard operating procedures (SOPs) in an internal audit process. Companies conduct these audits regularly. It is essential to have strategies and programs to conduct such audits. Depending on the complexity of the internal audit process, there are three major categories:
Level 1 internal audits
These audits are the minor complex of internal audits. The staff of the relevant department or section conducts them. These audits are usually short, frequent, and focused on auditing the management or documentation of a specific department or division. However, even in the case of a level 1 audit, the personnel responsible for conducting the audit must complete basic training before the audit.
Level 2 internal audits
Level 2 internal audits are more complex compared to level 1 internal audits. They are more system-focused, and the frequency is lower than level 1 audits. These audits will take longer, and auditors must have rigorous training emphasizing quality systems and techniques.
Level 3 internal audits
Tier 3 internal audits are the most complex and performed less frequently. The purpose of conducting them is primarily to assess a pharmaceutical company’s readiness for an upcoming regulatory audit. In addition, it is better to execute Level 3 internal audits before the commencement of a critical activity within the company.
Auditors for level 3 internal audits must have proficient expertise and knowledge of all regulatory requirements of the pharmaceutical industry, obtained through advanced training. As a result, outside consultants may perform these types of audits.
External audits
External audits include second and third-party audits.
Second Party External Audits
Interested parties in the audited company conduct second-party audits. They can be both customers and suppliers. Supplier audits fall under second-party audits because, as a manufacturer, you need to know your suppliers thoroughly. Companies can manage relevant information from supplier audits and other supplier-related activities with integrated audit management features. These activities include CAPAs, deviations, non-conformance reports, supplier corrective action requests, and quality information within a centralized location.
Third-Party External Audits
External independent organizations such as notified bodies or authorities carry out third-party audits. Third-party audits include audits performed by regulatory agencies. For instance, national regulatory bodies such as the FDA must carry out third-party audits.
In addition, one country’s regulatory authorities may audit manufacturers located in other countries. For example, the FDA audits European manufacturing facilities for drug suppliers to the US. Third-party regulatory inspectors receive comprehensive training and have advanced knowledge.
Unannounced audits
Manufacturers of pharmaceutical products often face regulatory agencies that may conduct random unannounced audits. Such audits may also include external suppliers who supply vital raw materials for their products. These audits commonly occur in the European Union and US pharma companies. The regularity of these audits depends on the manufactured product complexity and can range from 3 to 5 years.
How to prepare for a pharmaceutical audit?
A pharmaceutical company can prepare for a pharmaceutical audit by following the critical issues.
Check all documents
First, review documents from past audits and prepare a detailed list of relevant documents. Next, you must check these documents to ensure they are validated and up-to-date. Also, prepare all supporting documents and records.
Select Employee and Delegate Responsibility
You will have to select one or more people from each department as pivotal individuals for the upcoming audit. Delegate the responsibilities for various aspects of the audit who have the necessary knowledge of auditing, documents, records, systems, and protocols.
Prepare an audit plan
The third step in your action plan is for selected staff to prepare an audit plan that outlines the audit process. This activity plan will go to the control inspectors and note the strengths and weaknesses of departments. Ensure the most sorted departments are focused first to highlight your company’s strengths.
Do an internal audit
You must conduct an internal audit to ensure that all relevant staff is confident and will help rectify gaps. You may consider bringing in outside experts for this part of the audit process.
Be prepared for remote audits
The COVID-19 pandemic has necessitated remote auditing with file sharing, video conferencing, and screen sharing. Being prepared for inspection and informed of new or changing regulations is even more critical in light of COVID-19. The pandemic has changed the nature of how regulators interact with pharmaceutical companies. It is now a standard expectation for businesses to share their documents electronically. Electronic systems facilitate sending documents and their monitoring and updating when regulations change.
Audits and pharma compliance reviews are always stressful times for pharmaceutical companies. The concern is even more challenging to handle when the regulations are constantly transforming. Moreover, tracking and ensuring pharma compliance with requirements from various regulatory bodies is even more complex for companies that trade in global markets. But readiness for inspection and audit in the shortest possible time is not rocket science for companies willing to digitize their quality systems and adapt to the latest audit management technologies.
Facilitate planned internal audit activities by managing audit plans, creating regular tasks, setting deadlines, and automatically sending alerts to the right people at the right time with audit management solutions.
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