In the pharmaceutical world, quality is paramount: it governs everything from research and production to patient care. Audits play an important role in this process; every product that reaches a patient must comply with the highest safety and regulatory standards. An ISO 9001 audit verifies that a company’s Quality Management System (QMS) is adequate and complies with ISO 9001 clauses and Good Manufacturing Practices (GMP).
Auditing can be challenging, but knowing how to get it right makes all the difference. QMS, Audit Management, and Document Management Software by AmpleLogic streamline the audit preparation process with automated compliance tracking and easy document control. Our APQR software makes audit readiness even easier.
Learn the essentials of ISO 9001 audit, including ISO 9001 checklist, frequency, and factors to achieve compliance that helps companies ace audits with confidence.
ISO 9001 Audit: Meaning and Stages
Audit certification ISO 9001 is an internationally recognised standard for quality management systems (QMS), which helps organisations meet customer needs and exceed their expectations by improving their processes. The ISO 9001 audit takes place in three distinct phases, each covering different aspects of the organisation and processes.
| Stages | Stage Name | Purpose |
|---|---|---|
| Stage 1 | Documentation Review | Evaluate compliance |
| Stage 2 | On-Site Assessment | Inspect processes |
| Stage 3 | Surveillance Audit | Ensure improvement |
- Documentation Review: Review of quality policies, standard operating procedures (SOPs), and related compliances.
- On-Site Assessment:Â Evaluation of manufacturing, quality control, and distribution processes.
- Surveillance Audit: Regular audits are conducted after certification to ensure continued conformity and enhancement.
The use of AmpleLogic’s QMS software reduces overhead by automating documentation, audit trails, and compliance tracking that various government agencies generally require.
Audit ISO 9001: Components and Clauses
The ISO 9001 audit entails critical regulatory and quality control aspects. The components are provided below:Â
- Regulatory Compliance: Compliance with pharmaceutical regulations, including FDA, EMA and WHO guidelines
- Good Manufacturing Practice (GMP): Ensuring that production is in accordance with international GMP standards.
- Quality Risk Management: Understand how risks are identified, mitigated, and controlled.
- Supplier Qualification: Evaluate the raw material suppliers’ selection, approval, and performance.
- Process Validation: Confirm that the manufacturing processes are capable of producing a product according to the specifications at any time.
- Document Control: Ensuring that records for batches, SOPs, and other quality documents are properly maintained.
- Training and Competency: Reviewing employee training programs and employee competency evaluations.
- Deviation & CAPA Management: Evaluating ways of handling deviations and implementing CAPA actions.
An ISO 9001 clause in the pharmaceutical industry is a detailed list to ensure that all aspects of the quality management system are implemented and are working properly. These important ISO 9001 clauses are:
| ISO 9001 Clause | Clause Name | Description |
|---|---|---|
| Clause 4 | Context of the Organization | Understanding the organisation’s context and stakeholders |
| Clause 5 | Leadership | Demonstrating leadership commitment to the QMS |
| Clause 6 | Planning | Identifying risks, opportunities, and quality objectives |
| Clause 7 | Support | Ensuring resources, competence, communication, and documentation |
| Clause 8 | Operation | Managing processes like design, production, and service |
| Clause 9 | Performance Evaluation | Monitoring, measuring, and evaluating QMS performance |
| Clause 10 | Improvement | Addressing nonconformities and driving continuous improvement |
Within the pharmaceutical industry, companies like AmpleLogic offer innovative solutions that can help minimise these bottlenecks to align with regulatory standards, such as those mandated for audit certification ISO 9001.
Pharma companies can use AmpleLogic‘s AI integrated Audit Management Software to monitor their processes in real-time to ensure they remain compliant.
How Often is ISO 9001 Audit in Pharma?
The frequency of an ISO 9001 audit in the pharmaceutical industry varies depending on the type of audit:
| Type of Audit | Frequency |
|---|---|
| Internal Audit | At least once a year |
| Certification Audit | Depends on the certification cycle |
| Surveillance Audit | Annually (within the 3-year certification cycle) |
| Re-Certification Audit | Every 3 years (before certification expires) |
Pharmaceutical companies must conduct internal audits frequently to ensure compliance, while external certification bodies perform audits as part of the ISO 9001 certification process.Â
Also Read – QMS in Pharma: How AI is Transforming Quality Management
Audit ISO 9001 Checklist and Documents
Pharmaceutical companies must maintain specific documentation for ISO 9001 audits, below are some of the ISO 9001 checklists and documents:
| Sl No. | Document Type | Purpose |
|---|---|---|
| 1 | Quality Manual | Outlines QMS structure and compliance strategy |
| 2 | Standard Operating Procedures (SOPs) | Documents critical manufacturing and quality processes |
| 3 | Batch Manufacturing Records (BMRs) | Records details of product batches produced |
| 4 | Corrective Action Request (CAR) Forms | Logs non-conformities and corrective measures |
| 5 | Internal Audit Reports | Documents internal audits, findings, and actions |
| 6 | Supplier Audit Reports | Evaluates supplier compliance and quality performance |
| 7 | Change Control Records | Tracks modifications in processes or equipment |
| 8 | Training Records | Verifies employee training on quality and compliance |
AmpleLogic’s Document Management System (DMS) provides a secure, automated, and version-controlled documentation system for pharmaceutical companies, reducing errors and audit risks.
Types of ISO 9001 Audits
There are different types of ISO 9001 audits that can take place in any organisation. Here are the types of ISO 9001 audits:Â
- Internal Audit
Conducted by the company’s internal audit team to assess compliance before an external audit.
- Certification Audit
Performed by an accredited certification body to grant audit certification ISO 9001 to a pharmaceutical organisation.
- Surveillance Audit
Annual audits are conducted to ensure continuous compliance during the certification cycle.
- Re-certification Audit
Conducted at the end of the certification period to renew ISO 9001 compliance.
Internal Audit and External Audit
The difference between internal audit and external audit for audit certification ISO 9001 are:
| Characteristics | Internal Audit | External Audit |
|---|---|---|
| Objective | Improve internal controls and efficiency. | Validate ISO 9001 compliance. |
| Conductors | Organization's employees. | Third-party auditors. |
| Scope | All operations (finance, compliance, etc.). | ISO 9001 standards compliance. |
| Frequency | Quarterly/Semi-annually. | Annually/Every 3 years. |
| Reporting Structure | Internal use. | Certification agencies and external stakeholders. |
| Independence | May lack objectivity. | Independent and objective. |
| Methodology | Tailored processes. | Standardized methodologies. |
Steps in an ISO 9001 Audit in Pharma
- Opening Meeting – The auditor explains the scope, objectives, and methodology of the audit.
- Document Review – Examination of SOPs, batch records, and compliance documentation.
- Facility Inspection – On-site evaluation of manufacturing, storage, and quality control areas.
- Employee Interviews – Discussions with key personnel to verify process understanding.
- Process Evaluation – Assessment of production, quality control, and risk management processes.
- Findings and Reports – Identification of non-conformities, opportunities for improvement, and corrective actions.
- Closing Meeting – The auditor presents findings and discusses necessary corrective actions.
Must Read – Quality Management Systems (QMS) for Medical Devices
Audit Management Guidelines
Effective audit management is crucial in the pharmaceutical industry. It involves identifying gaps, improving processes, and ensuring adherence to regulatory standards like ICH Q10. Key aspects of audit management include:
- ICH Q10: Provides a comprehensive model for a pharmaceutical quality system, emphasising audit management
- Documentation: Maintaining clear and accurate records is essential for audit success.
- Corrective Actions: Promptly addressing non-conformities is vital for maintaining compliance.
Common Non-Conformities in ISO 9001 Audit in Pharma
Pharmaceutical companies often encounter the following non-conformities during an ISO 9001 audit:
- Inadequate documentation of quality processes.
- Failure to adhere to Good Manufacturing Practices (GMP).
- Incomplete or outdated Standard Operating Procedures (SOPs).
- Lack of evidence for training and competency of employees.
- Poor deviation management and corrective action implementation.
- Ineffective risk assessment and quality control measures.
To avoid these issues, AmpleLogic’s QMS software helps pharma companies automate quality processes, maintain compliance, and generate real-time audit reports.
Conclusion
To make sure you are ready for an ISO 9001 audit in Pharma, implement a comprehensive Quality Management System backed by well-documented policies and procedures, and follow the ISO 9001 checklist. Routine in-house audits, adherence to GMP protocols, and active risk management practices ensure smooth certification and ongoing quality control. Having an efficiently operated and compliant QMS will result in better compliance with regulatory norms and increased customer trust in pharmaceutical companies.
As the leading QMS, DMS, and Audit Management software provider, AmpleLogic helps pharmaceutical companies meet ISO 9001 audits effortlessly. Digital solutions allow organisations to drive compliance, mitigate risks, and improve operational efficiency.Â
Explore AmpleLogic today to see how it can transform your software experience. Also, you can visit our page for other such informative articles – AmpleLogic Resources!
