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Design Quality: Connecting Design to Documentation
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Challenges with Triage and Investigation in Complaints Management Process
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Frost Radar for Quality Management Systems Names ComplianceQuest Leader
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The ultimate guide for successful planning and execution of internal audit in the 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.
A quality audit in the pharmaceutical industry systematically examines a company's processes, procedures, and systems to verify compliance with regulatory standards and quality control measures. These audits are essential for evaluating and improving the quality and safety of pharmaceutical products. They encompass various aspects, such as
Essentially, they serve as a quality assurance mechanism to identify and rectify deviations from established quality standards. A regulatory audit in the pharmaceutical industry is a specific quality audit conducted by regulatory agencies like the FDA to ensure compliance with national and international regulations.
The pharmaceutical industry conducts various types of audits, including:
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Internal audits are an integral component of quality management within pharmaceutical companies. These audits are conducted by the company itself to evaluate its own operations, identify non-compliance issues, and implement corrective actions. They ensure that processes align with established quality standards and are a proactive approach to avoid regulatory non-compliance, product recalls, and potential harm to patients. Internal audit software for pharma companies is increasingly used to streamline this process, making it more efficient and effective.
As the pharmaceutical industry evolves, the complexity and frequency of audits increase. This is where audit management software comes into play. Such software offers several advantages, including:
With CQ’s AI-enabled EQMS it is possible to drive efficiency into the audit lifecycle by automatically prioritizing audit findings.
To meet the growing demands of the pharmaceutical industry, specialized pharmaceutical audit management software solutions have emerged. These solutions are tailored to the unique needs of pharmaceutical companies, with features such as integrated regulatory standards, audit scheduling, and risk assessment tools.
In conclusion, audits in the pharmaceutical industry are a critical component of quality assurance and regulatory compliance. Whether they are internal or regulatory audits, they play a pivotal role in ensuring that pharmaceutical products are safe, effective, and meet the highest quality standards. With the adoption of audit management software, pharmaceutical companies can streamline their audit processes, enhance efficiency, and maintain the highest levels of quality and compliance in a highly regulated 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.
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.
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:
In addition to these risks, there are also financial audits and IT audits conducted from time to time.
Customer Success
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
Design control
We have rolled-out CQ across our company to automate various elements of QMS requirements such as Document Management, Complaints, Non-conformances, Corrective Action (8D and A3), Supplier Management and Audit Management. We have been using the software for more than 2 years. We are glad to see how well the system is being used across the company. We have several thousand users on the system currently and working to scale the usage further. CQ solution has been configured to meet our needs, works elegantly across languages, across time zones, and business verticals. With integration between CQ and SAP to exchange critical data, the process automation provides a lot of productivity.
CQ configuration team and support have worked hard to ensure that our needs continue to be met. They consistently go above and beyond. We cannot be more pleased with our use of CQ QMS capabilities and would definitely recommend to anyone who is looking for a modern cloud based EQMS solution especially if you want a scalable EQMS solution.
Lia Budiman,Solution Consultant
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.
Review previous GMP audits to ensure that all the previously mentioned deficiencies are closed.
Examine your documents properly to ensure that all are updated.
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.
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.
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.
With CQ’s AI-enabled, data-driven, collaborative audit management solution, your end-to-end audit workflow will become streamlined.
Pharmaceutical Quality Management System – An Effectiveness Review (Part – A)
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Pharmaceutical Quality Management System – Continual Improvement (Part – B)
Pharmaceutical CGMP Regulations with Quality System Part 3
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Pharmaceutical CGMP Regulations with Quality System Part 2
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Pharmaceutical CGMP Regulations with Quality System Part 1
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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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