Audits in the Pharmaceutical Industry: Definition, Types, Formats, and Steps

An audit is a systematic and independent review process that uses documented evidence to objectively evaluate how well specific standards or compliance criteria are met. In the pharmaceutical industry, an audit is a structured assessment of an organization’s operations, systems, and documentation to ensure compliance with the applicable regulatory and customer requirements.

The main types of pharmaceutical audits include internal audits, second-party (customer or partner) audits, and third-party (independent or regulatory) audits. Pharmaceutical audits can be conducted in various formats, such as on-site audits, remote (virtual) audits, or self-inspection.

Pharmaceutical audits are governed by strict regulatory oversight. Organizations such as the US FDA (Food and Drug Administration), EMA (European Medicines Agency), MHRA (Medicines and Healthcare products Regulatory Agency), WHO (World Health Organization), and ICH (International Council for Harmonisation) define and enforce auditing requirements. They also oversee auditing services to ensure product safety, efficacy, and quality across global markets.

The auditing process typically follows a structured workflow involved in the auditing process, from planning and execution to reporting and corrective actions.

Pharmaceutical companies can ensure audit readiness through actions such as maintaining updated documentation, conducting regular internal audits, training staff continuously, mock audits, and using electronic Quality Management Systems (eQMS).

SimplerQMS is a QMS software designed for life sciences organizations, including pharmaceutical companies, with robust audit management capabilities to streamline compliance and quality assurance.

What Is an Audit in the Pharmaceutical Industry?

An audit in the pharmaceutical industry is a formal, systematic examination of a company’s processes, systems, facilities, and documentation. The purpose of the pharmaceutical audit is to ensure compliance with regulatory standards, pharmaceutical requirements, and internal procedures.

Pharmaceutical audits verify that pharmaceutical manufacturers, suppliers, and service providers meet all requirements to maintain product safety, efficacy, and quality.

Pharmaceutical audits can be conducted by internal quality teams, regulatory authorities such as the FDA or EMA, third-party organizations, or business partners like customers and suppliers.

What Is the Difference Between an Audit and Inspection in the Pharmaceutical Industry?

The main difference between an audit and an inspection arises from their objectives, who performs them, and how they are initiated.

An audit in the pharmaceutical industry is a scheduled, systematic evaluation conducted internally or externally to assess a company’s adherence to quality standards, regulatory requirements, and internal procedures. An inspection is an official review by regulatory authorities to determine specific operations or products to verify compliance with applicable pharmaceutical regulations.

For example, a pharmaceutical company may conduct an internal audit to evaluate the effectiveness of its Quality Management System (QMS) and identify areas for continuous improvement. Regulatory agencies like the FDA may conduct unannounced inspections to assess GMP compliance, including documentation, processes, and potential risks.

What Are the Different Types of Audits in the Pharmaceutical Industry?

Audits in the pharmaceutical industry are typically categorized into the following types.

• Internal Audits: Internal audits are conducted by a company’s internal team to assess compliance with industry regulations, quality standards, and internal procedures.
• External Second-Party Audits: External second-party audits are performed by customers or business partners to evaluate a supplier’s or contractor’s compliance with the terms outlined in quality agreements or contracts.
• External Third-Party Audits: External third-party audits are carried out by independent organizations or regulatory authorities to verify compliance with pharmaceutical regulations, international standards, and certification requirements.

Internal Audits

Internal audits are systematic evaluations conducted by a pharmaceutical company’s internal team. Internal audits assess compliance with internal procedures and regulatory requirements.

Internal audits are typically performed on a scheduled basis as part of the organization’s quality management system. These audits help identify gaps, mitigate risks, and drive continuous improvement within the organization.

External Second-Party Audits

External second-party audits are audits conducted by customers, clients, or business partners to assess a supplier’s processes and compliance. These audits are usually performed before establishing a business relationship or as part of regular supplier qualification processes.

Second-party audits help ensure that suppliers meet the expectations outlined in quality agreements or contracts.

External Third-Party Audits

External third-party audits are independent assessments carried out by external organizations that are not directly involved in the business relationship. These organizations include regulatory agencies like the FDA and EMA, as well as certification bodies.

External third-party audits may be scheduled or unannounced and aim to verify compliance with national and international pharmaceutical requirements. Successful completion may result in certifications, regulatory approvals, or operational licenses.

What Are the Types of Quality Audits in the Pharmaceutical Industry?

Quality audits in the pharmaceutical industry can be categorized into three main types listed below.

• System Quality Audits: System quality audits evaluate the overall effectiveness of pharmaceutical quality systems, including documentation control, employee training, deviation handling, change control, and CAPA.
• Process Quality Audits: Process quality audits focus on specific processes to ensure they are performed according to approved procedures and consistently meet predefined quality criteria.
• Product Quality Audits: Product quality audits examine finished pharmaceutical products or medical devices by examining batch records, test results, and compliance with product specifications and release requirements.

System Quality Audits

System quality audits are comprehensive evaluations of an organization’s QMS.

System quality audits assess whether key quality elements such as document control, employee training, deviation management, change control, and CAPA are properly implemented and maintained.

These audits are usually scheduled periodically or conducted during certification and re-certification processes to maintain QMS integrity and compliance.

Process Quality Audits

Process quality audits are targeted evaluations of specific processes within a pharmaceutical company.

Process quality audits aim to verify that operations are conducted according to approved procedures and consistently meet established quality standards.

These may be initiated due to internal reviews, procedural changes, or observed deviations.

Product Quality Audits

Product quality audits are assessments focused on the final product.

Product quality audits verify that each product batch meets required specifications, complies with test results, and satisfies release criteria.

These audits may be performed routinely or in response to customer complaints, product recalls, or other quality concerns. The primary goal of product quality audits is to confirm that the final product is safe, effective, and compliant with regulatory and internal quality standards.

What are the Advantages and Disadvantages of Pharmaceutical Quality Audits?

Pharmaceutical quality audits provide several benefits for companies.

• Improve Regulatory Compliance: Quality audits help verify that internal processes and systems align with current industry requirements.
• Identify and Mitigate Risks: Early detection of compliance gaps or process failures enables timely corrective action, reducing regulatory and operational risks.
• Enhance Product Quality: Regular audits help maintain product safety, efficacy, and consistency throughout the product lifecycle.
• Optimize Processes: Audits uncover inefficiencies and redundancies, creating opportunities to streamline operations and reduce costs.
• Boost Stakeholder Confidence: Audits reinforce trust among stakeholders by demonstrating strong internal controls and quality assurance.
• Promote Continuous Improvement: Audits support ongoing enhancements in operations, driving greater efficiency and effectiveness over time.

Pharmaceutical audits come with several disadvantages, as listed below.

• Consume Resources and Time: Audits can require significant time, staffing, and financial investment, especially for smaller firms.
• Disrupt Daily Operations: Audits may interrupt normal workflows and demand significant time and attention from staff.
• Create Staff Stress or Resistance: The audit process can increase employee stress or resistance, especially if perceived as overly critical or intrusive.
• Reveal Costly Issues: Identifying non-compliance or inefficiencies may require substantial investments to resolve.
• Depend on Auditor Expertise: Audit outcomes can vary depending on the auditor’s knowledge, experience, and objectivity.
• Pose Data Confidentiality Risks: External audits may expose sensitive information, increasing the risk of data breaches or misuse.
• Expose Companies to Negative Outcomes: Major non-compliances found during audits can result in penalties, warning letters, or regulatory actions.

What are the Different Formats of Pharmaceutical Audits?

Pharmaceutical audits can be conducted in different formats, depending on the audit’s objective, regulatory expectations, and operational constraints. The most common formats of pharmaceutical audits are listed below.

• On-site Audits: An on-site audit involves auditors physically visiting the pharmaceutical facility to review documentation, inspect manufacturing areas, assess quality systems, and interview staff. On-site audits are commonly performed during regulatory inspections, supplier qualification assessments, or when seeking approval to enter a new market. On-site audits are often required for high-risk processes or when full visibility is essential.
• Remote Audits: Remote audits, also referred to as virtual audits are conducted using digital platforms such as video conferencing, secure document-sharing tools, and electronic Quality Management Systems (eQMS). Remote pharmaceutical audits are often used when travel is restricted or for follow-up assessments, offering a flexible and cost-effective way to verify compliance with industry requirements.
• Self-inspections: Internal audits or self-inspections are carried out by a pharmaceutical company’s own quality assurance or compliance team. Internal audits are regularly scheduled as part of the company’s QMS to proactively identify gaps, ensure ongoing compliance, support continuous improvement, and prepare for third-party or regulatory inspections.

What Are the Key Organizations Defining Requirements for Pharmaceutical Audits?

Below are the key organizations that outline requirements for pharmaceutical audits.

• US FDA (U.S. Food and Drug Administration): The FDA is a regulatory authority that enforces GMP regulations to ensure that pharmaceutical products are safe, effective, and manufactured to high-quality standards. FDA audit requirements apply to companies that manufacture, distribute, or export pharmaceutical products to the United States.
• EMA (European Medicines Agency): The EMA is a European regulatory body responsible for GMP and Good Distribution Practices (GDP) compliance across the European Union. EMA audit requirements apply to pharmaceutical manufacturers and distributors operating within EU member states.
• MHRA (Medicines and Healthcare Products Regulatory Agency): The MHRA is the UK’s national regulatory authority for medicines and medical devices, ensuring compliance with quality and safety standards. MHRA audits are required for pharmaceutical companies manufacturing or marketing products in the UK.
• WHO (World Health Organization): The WHO is an international public health organization that provides global GMP guidelines emphasizing quality audits, documentation, and process reviews. WHO audit requirements apply to manufacturers that supply medicines to global health programs or operate in countries following WHO standards.
• ICH (International Council for Harmonization): The ICH is a global standard-setting body that develops harmonized guidelines such as ICH Q10, which focuses on pharmaceutical quality systems and audit controls. ICH standards are adopted by regulatory authorities in the U.S., EU, Japan, and other participating countries.
• Ph. Eur (European Pharmacopoeia): The European Pharmacopoeia is a scientific reference standard maintained by the European Directorate for the Quality of Medicines (EDQM), setting binding quality standards for medicines and raw materials. Ph. Eur requirements apply to manufacturers in the EU who must comply with official pharmacopoeial specifications.
• ISO (International Organization for Standardization): ISO is an independent international standard-setting organization that develops standards, such as ISO 9001 for QMS and ISO 13485 for QMS specific to medical devices. ISO certification applies to pharmaceutical and medical device companies seeking global recognition of their quality systems.
• EU MDR (European Union Medical Device Regulation): The EU MDR is a regulatory framework implemented by competent authorities in EU member states, governing the safety, performance, and audit requirements for medical devices. EU MDR compliance is mandatory for manufacturers marketing medical devices in the EU.

What Are the Key Steps Involved In the Pharmaceutical Auditing Procedure?

The pharmaceutical auditing procedure follows a structured sequence of steps designed to evaluate compliance with regulatory and quality requirements. Below are the main steps involved in the pharmaceutical audit process.

1. Audit Planning and Preparation: The audit process begins with clearly defining the audit scope, objectives, format, and schedule. During this phase, the audit team reviews relevant documents such as SOPs, previous audit findings, risk assessments, and applicable regulatory guidelines. An audit checklist is prepared to guide the assessment. Proper planning ensures that the auditors have a comprehensive understanding of the facility, its operations, and its compliance landscape. The auditor should also be trained or informed on the auditee’s official audit SOP.
2. Conducting the Audit: During this stage, auditors perform the actual evaluation, either on-site or remotely. This involves facility walkthroughs, interviews with staff, and detailed reviews of records, procedures, and quality systems. The goal is to verify whether the company’s operations align with regulatory expectations, industry standards, and internal requirements.
3. Identifying & Documenting Findings: Deviations, non-conformities, observations, and areas for improvement are identified during the audit. Each finding is categorized by severity and documented with supporting evidence to ensure transparency and facilitate effective corrective actions.
4. Closing Meeting: A closing meeting is held with the organization’s management team to present findings, clarify issues, and discuss preliminary conclusions. This meeting ensures mutual understanding and agreement on the required follow-up actions and expected timelines.
5. Audit Report & CAPA Implementation: Following the closing meeting, the auditor prepares a detailed audit report summarizing all findings, conclusions, and recommended CAPAs. The audited organization is responsible for reviewing the report, addressing each finding, and implementing the required corrective and preventive measures.
6. Follow-Up & Closure: The auditor reviews the CAPA responses and verifies the effectiveness of implementation. Once verification is complete, the audit is officially closed, confirming that the organization meets required quality and regulatory standards.

How Pharmaceutical Audits Differ Compared to Medical Device Audits?

Pharmaceutical audits differ compared to medical device audits in their focus and scope. While both pharmaceutical and medical device audits prioritize safety, efficacy, and compliance, the specific areas of emphasis vary.

Pharmaceutical audits concentrate on GMP compliance, process validation, contamination control, raw material traceability, batch record accuracy, and robust quality management systems.

Medical device audits emphasize design controls, risk management, software validation, usability engineering, and post-market surveillance, following standards like ISO 13485 and EU MDR. To explore this topic further, check out our in-depth guide to medical device audits.

How to Ensure Audit Readiness In a Pharmaceutical Company?

Audit readiness in pharmaceutical companies means being consistently prepared to demonstrate regulatory compliance during inspections or audits. Listed below are the essential steps to maintain audit readiness in the pharmaceutical industry.

1. Maintain Up-to-Date Documentation: Ensure that all SOPs, batch records, validation protocols, and quality documents are current, accurate, and easily accessible.
2. Implement a Robust Pharmaceutical QMS: A strong QMS ensures process consistency, regulatory compliance, and effective handling of deviations and CAPAs.
3. Conduct Internal Audits Regularly: Internal audits help identify compliance gaps early and reinforce a culture of continuous improvement within the organization.
4. Provide Continuous Employee Training: Regular and role-specific training ensures staff understand procedures, regulatory expectations, and responsibilities during an audit.
5. Establish a Clear Audit Response Protocol: Develop predefined procedures for managing audits, including team roles, communication strategies, and document presentation processes.
6. Perform Mock Audits: Simulated audits help test audit preparedness, reveal potential weaknesses, and train personnel on effective audit engagement.
7. Ensure Facility and Equipment Compliance: Perform regular inspections to verify facility and equipment cleanliness, calibration, maintenance, and adherence to current standards.
8. Maintain Effective Communication Channels: Foster collaboration between departments through regular cross-functional meetings to align objectives and proactively address potential compliance risks.
9. Leverage Digital Tools for Compliance: Implement electronic systems for document control, CAPA management, and audit tracking to improve efficiency, data integrity, and real-time access during inspections.
10. Adhere to Regulatory Standards: Remain up to date with global pharmaceutical regulations (e.g., FDA, EMA, WHO) and ensure all processes, records, and practices comply with evolving requirements.
11. Prepare an Audit Readiness Checklist: Develop and maintain a comprehensive audit checklist covering documentation control, employee training records, equipment qualification, and supplier approvals to ensure systematic audit preparation.

How Does QMS Software Enhance Pharmaceutical Audit Management?

QMS software enhances pharmaceutical audit management by automating key processes, centralizing quality documentation, and ensuring compliance with pharmaceutical requirements.

QMS software offers essential functionalities such as document control, audit scheduling and tracking, risk management, and CAPA to streamline audit management activities and reduce compliance risks. Key capabilities such as quick document retrieval, traceability through interlinked records, automated workflows, and real-time audit trails further improve efficiency and accuracy during audits.

An audit management module is often a core component of QMS solutions like SimplerQMS, which is specifically designed for the life sciences industry, including pharmaceuticals. With built-in process support for requirements such as FDA 21 CFR Part 210/211, ISO 9001:2015, ICH Q10, and GMP guidelines, SimplerQMS enables pharmaceutical companies to maintain continuous audit readiness.

The system includes fully integrated modules for document control, change management, training management, CAPA, deviation handling, complaint management, and more, making it a comprehensive pharmaceutical QMS software.

SimplerQMS helps pharmaceutical companies maintain compliance with strict regulatory standards, including FDA 21 CFR Part 210/211, ISO 9001:2015, GMP guidelines, ICH Q10, and others.