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Internal Audit in Pharmaceutical Industry

internal audit in pharmaceutical industry

The ultimate guide for successful planning and execution of internal audit in the pharmaceutical industry

internal audit in pharmaceutical industry

ComplianceQuest’s internal audit software for the pharmaceutical industry is a very effective tool to improve the quality standards of any manufacturing unit. Learn how to conduct an effective internal audit program compliant with GMP and identify any critical, major, and minor defects during internal audits in pharmaceuticals.

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Best Practices while Performing Internal Audits in the Pharmaceutical Industry

Auditing manufacturing processes in the pharmaceutical industry is a standard part of most quality system plans today. An internal audit helps assess the internal control of a system and measure the effectiveness of the quality system.

Internal audit practices enable an organization to continually improve its operations by providing critical information about identified problem areas or preventing issues before they lead to non-conformance or compliance issues. To perform an internal audit, auditors must take a systematic, disciplined approach to assess and increase the effectiveness of risk control and governance processes. There are many different ways to complete internal auditing. To conduct an effective internal audit, follow these recommended steps.

  • Prepare a plan of action to avoid high-risk areas. Thus, a company can address them before a regulatory inspection and enhance the effectiveness of its business operations.
  • Develop a structure for the audit program that takes a risk-based approach.
  • Conduct periodic training for the audit team to keep up with regulatory changes, observation trends, and risk areas.
  • Have an opening meeting with all the functional teams at the beginning of the audit so that an auditee can get the time to prepare for the audit operationally.
  • Finish the audit with a close-out meeting to present the audit findings and conclusions.
  • Prepare an audit report to communicate the result of the investigation. This report also provides accurate data for addressing important organizational issues effectively.

How to Prepare for a GMP Audit?

GMP audit for the pharmaceutical quality system should be conducted to ensure that the company complies with federal regulations such as the Code of Federal Regulations (CFR). With a GMP audit, an organization can determine if there is complete control over the manufacturing processes and QMS. The audit also helps check the manufacturer’s compliance status and recommend improvements.

Typically, GMP audit includes gap analysis audits and mock inspections to evaluate the readiness level for GMP inspections. The objective of the GMP audit is to monitor the effectiveness of GMP implementation programs. Thus, an organization can ensure consistent GMP adherence across the entire supply chain, i.e., from procurement to distribution, complaint evaluation, and product quality reviews.

A GMP audit focuses on various aspects of the pharmaceutical unit, including equipment, raw materials, facility, operating processes, trained workers, completed products, and a different quality control department. To successfully conduct a GMP audit, you should consider the following actions.

gmp audit review

Review previous GMP audits to ensure that all the previously mentioned deficiencies are closed.

gmp audit examine

Examine your documents properly to ensure that all are updated.

gmp audit educate

Educate the personnel on the basics of whatever will happen during the GMP audit and how they should respond to questions asked by the auditors.

mock internal audit

Carry out a mock internal audit at regular intervals to ensure that the company adheres to the codes of GMP. This can help you find out the loopholes in current processes and equipment to rectify those at the right time.

  • gmp audit review

    Review previous GMP audits to ensure that all the previously mentioned deficiencies are closed.

  • gmp audit examine

    Examine your documents properly to ensure that all are updated.

  • gmp audit educate

    Educate the personnel on the basics of whatever will happen during the GMP audit and how they should respond to questions asked by the auditors.

  • mock internal audit

    Carry out a mock internal audit at regular intervals to ensure that the company adheres to the codes of GMP. This can help you find out the loopholes in current processes and equipment to rectify those at the right time.

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How to Conduct an Internal Audit in the Pharmaceutical Industry?

Over the years, internal audit has played an important role in the pharmaceutical industry. Internal audits can help organizations improve processes and build a better system by assessing the strengths and weaknesses of quality assurance processes. The pharmaceutical quality system ensures that the procedures and reimbursement mechanisms comply with the contractual and regulatory requirements by evaluating and reviewing all pharmacy programs.

Here is a step-by-step guide to conducting an internal audit in a pharmaceutical company

  • Notification

    Set the date and time for the audit.

  • Planning

    Before the audit, an auditor should develop a more detailed audit plan to identify key areas of risk and areas of concern. To do the same, they can use an audit checklist. Documentation of the audit plan is necessary as it acts as a record of the proper planning and performance of the audit procedures.

  • Opening meeting

    An organization should schedule a meeting between the auditing staff and senior management before the commencement of the audit.

  • Communication

    The audit team should communicate with the corporate auditor to clarify procedures and processes and gain access to documents.

  • Draft audit report

    After completing the audit, prepare a draft audit report that includes the details of the auditing process and the findings.

  • Management response

    Once the draft report is ready, the management will review, edit, and suggest changes, scrutinize areas of concern, and rectify errors. After reviewing, the management should state whether they agree with the problems mentioned, the plan to rectify the problem, and the expected date by which all issues will have been addressed.

  • Final meeting

    Once the audit is complete, the auditor discusses the management response and addresses the scope of the audit in the final meeting.

  • Report distribution

    The final audit report is sent to appropriate officials inside and outside the audit area.

  • Feedback

    In audit feedback, the audited company implements the changes suggested, and based on the auditor’s review, the company tests the quality, adherence, and effects of the adopted changes.

ComplianceQuest Audit Management solution offers end-to-end quality visibility to pharmaceutical and biotech organizations that can be leveraged to quickly and easily verify compliance from design to delivery. The cloud-based, cross-platform, mobile-enabled Audit Management Solution helps quality leaders know gaps, take preventive action, and comply with all regulations.



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What are the types of Internal Audits in the pharmaceutical industry?

The quality management team conducts several types of internal audits, to enable continuous improvement of the organization’s Quality Management System (QMS). Some of the types of internal audits include:

  • Operational Audits: These are process audits to ensure that the overall process design and workflows are robust. When gaps are identified, it is important to initiate a change process, involve relevant stakeholders, and implement the process change.
  • Compliance Audits: These audits are scheduled on a periodic basis to ensure that all regulatory requirements are met. From a compliance perspective, there will be changes needed because of new requirements or because the pharma company has entered into a new market.
  • Risk Audits: These audits are performed to ensure that the company is taking all necessary steps to identify and mitigate potential risks. These could include risks identified in past audits, data from customer complaints or even a risk identified from an inspection. It is important to ensure all risks – people, process, product and equipment-related risks are handled proactively with agility.

In addition to these risks, there are also financial audits and IT audits conducted from time to time.

Are you a quality leader looking to streamline your internal audit workflow? Workflow.

With CQ’s AI-enabled EQMS it is possible to drive efficiency into the audit lifecycle by automatically prioritizing audit findings.

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Is it Necessary to have an Audit Checklist for the Pharmaceutical Industry?

The pharmaceutical audit checklist is intended to guide the auditor with detailed entries during an audit. Before performing the audit, it is advised to plan it and review the past audits for any indications of potential problem areas and items. To that end, it is important to have a checklist to ensure all parameters are met. According to GMP requirements, the most effective pharmaceutical audit checklist should include sections addressing the following:

  • General controls that check if the facility operates per GMP regulations

  • Organizational and management responsibilities, including corporate quality policy, QA procedures

  • Employee orientation, quality awareness, and job training

  • Plant safety and security

  • Internal quality and GMP audit program

  • Quality cost program

  • Design control

  • Facility control

  • Equipment control

  • Material/component control

  • Operational control

  • Finished product control

  • General controls that check if the facility operates per GMP regulations

  • Organizational and management responsibilities, including corporate quality policy, QA procedures

  • Employee orientation, quality awareness, and job training

  • Plant safety and security

  • Internal quality and GMP audit program

  • Quality cost program

  • Design control

  • Facility control

  • Equipment control

  • Material/component control

  • Operational control

  • Finished product control

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ComplianceQuest pairs the user-friendly tools of SalesForce with a very capable and responsive development / support team resulting in a full QMS application that was adapted to our processes and very easy to implement. Our large, global organization is not an easy group to please. From their patient participation in our configuration workshops to their quick responses to every email and crazy request, the CQ team has proven to be a true partner in our implementation. Their website and demos show how user-friendly and well integrated the modules are. The REAL win is getting this functionality with a team who is truly invested and has gone over and above to make our implementation a success!

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Quality Director

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How to Prepare for a Quality Audit in a Pharmaceutical Company?

A pharmaceutical quality system helps an organization improve effectiveness and efficiency in the workplace. ComplianceQuest Audit Management software empowers quality leaders to choose between complex, stringent, or streamlined audits flexibly. The solution can be used to identify gaps and predict quality performance in the future. To execute a quality audit, have the following points in mind.

  • Enable open communication between all participants and encourage employees to ask questions and share suggestions.
  • Have proper documentation of all processes explaining all the required steps to perform a task.
  • Prepare a list of personnel auditors can talk to during the audit.
  • In case of deficiencies, the auditor should retain the evidence, and a copy should be made and maintained until the audit closure.
  • The auditor should discuss non-compliance-related issues with the management to avoid misunderstanding and keep the records and support documents.
  • Once the audit process is complete, the auditor should have a meeting to discuss the findings of each day of the audit and can get information related to it.
  • Close the audit and deliver the report and other necessary documents with recommendations and CAPA, where required.

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Quality-centric Companies Rely on CQ QMS

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  • lifescan mono
  • janssen mono
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  • qlik mono
  • csa group mono
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  • fluence mono

Frequently Asked Questions

  • In a highly competitive and fast-evolving environment, you can optimize internal audit practices in pharmaceutical companies by enhancing shareholder value, increasing efficiency, containing costs, and managing risks. With the help of ComplianceQuest’s audit software, your organization can focus on its core activities by providing access to a range of skills that a complex, global business demands. ComplianceQuest Audit Management solution offers enterprise-wide transparency and collaboration in managing quality initiatives and compliance processes. The solution facilitates collaboration between stakeholders during different stages of an audit and helps the enterprise build a QMS workflow that is data-driven and enables Continuous Improvement (CI).

  • An effective internal audit system helps:

    • Manage the quality management system as well as identify weak points by analyzing unsatisfactory trends or situations

    • Prevent quality failures by reviewing quality data

    • Standardize audits and optimize the output, thus increasing the quality level of audits for continuous improvement

    • Improve company’s performance by educating and enhancing employees’ knowledge in terms of quality-related aspects

    • Increase the level of compliance by establishing a high-quality audit system

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