Tips and Techniques for Conducting Internal Audits of Pharmaceutical Facilities in Low- and Middle-income Countries

Pharmaceutical facilities are subject to strict regulations and requirements, as they deal with the production and distribution of medicine. To ensure that they are meeting these standards, it is essential to conduct regular internal audits. These audits are meant to evaluate and assess the facility’s compliance with regulations, identify areas of improvement, and implement corrective actions. This article provides guidance on how to conduct an effective internal audit of a pharmaceutical facility.

1. Planning the Audit

Before conducting an internal audit, it is essential to plan the audit. The planning phase involves defining the purpose and scope of the audit, defining the objectives, identifying the audit team, and preparing the audit checklist. The audit team should consist of experienced auditors who understand the regulations that apply to the facility. The audit checklist should be developed based on the applicable regulations and standards.

Key Considerations

1. Identify the scope of the audit: Establish and define the scope of the internal audit and ensure the scope is approved by the stakeholders. It is important to establish an audit plan that clearly defines the goals and objectives of the audit.
2. Develop a plan: Develop a detailed audit plan which outlines the objectives, timeline, and resources needed for the audit process. Select an internal audit team that is knowledgeable and experienced in pharmaceutics.
3. Information Gathering: Gather information about the facility, such as its location, legal documents and equipment used. Collect all relevant documentation, such as existing protocols, standard operating procedures (SOPs), reports, and other documents related to the operation of the facility.
4. Review the facility’s previous internal audits, if any. This should include details of the corrective and preventive actions taken, timelines, and post actions effectiveness assessment.
5. Develop an audit checklist to be used during the audit process and ensure that all areas of concern are properly addressed.

Internal auditors play a crucial role in ensuring that companies are adhering to these standards and best practices. To achieve this, it is essential to have a detailed questionnaire that covers all areas of the business and its operations. This questionnaire should include a comprehensive list of activities and audit areas that the auditor should focus on during the audit process. Read more here!

2. Conducting the Audit

The audit should be conducted in a systematic and objective manner. The audit team should gather evidence to support their findings and recommendations. They should review documents, observe processes, interview employees, and perform testing as necessary. The auditors should evaluate the compliance of the facility with applicable regulations, good manufacturing practices (GMPs) and other regulatory standards in the country or region. The auditors should also identify any potential non-conformance issues, document them, and report them to the management team.

Key Considerations

1. Conduct an Onsite Inspection: Begin the audit by visiting the pharmaceutical facility and observing the operations. Check for signs of contamination, verify storage temperatures and assess the general work environment.
2. Review Corporate Policies and Procedures: Ensure that all corporate policies, procedures, and guidelines are in compliance with applicable laws and regulations.
3. Review Quality Management System Documents: Verify that all relevant documents (e.g., quality management system, standard operating procedures (SOPs) are up-to-date and properly maintained.
4. Evaluate Good Manufacturing Practices (GMP): Analyze GMP compliance with respect to facility design, personnel qualifications, documentation, equipment usage, production processes, and validation criteria.
5. Assess Supply Chain Processes: Analyze the sourcing of raw materials and their supply chain management, labor practices and final product distribution to ensure they are compliant with applicable regulations. Examine the facility’s inventory management systems and raw material dispensing processes to ensure that quality standards are met.
6. Observe and document the physical conditions of the facility, such as cleanliness and maintenance of equipment. Verify that all equipment is properly maintained in accordance with GMP requirements.
7. Evaluate Quality Control Practices: Confirm that all quality control practices are consistent with established quality standards and that any non-conforming products are properly identified and disposed of in accordance with appropriate regulations.
8. Review the facility’s documents related to health and safety regulations and compliance with Good Manufacturing Practices (GMP).
9. Test Records and Reports: Review documentation to ensure it is complete and accurate, including raw material records, production records and laboratory tests reports, etc.
10. Perform Risk Assessment: Review existing risk management processes for the facility, along with any emergency response plans in place. Assess the potential risks associated with the operation of the facility and identify areas which require further investigation and/or improvement.

3. Developing the Audit Report

After conducting the audit, the audit team should develop an audit report that outlines their findings and recommendations. The report should contain a summary of the audit findings, the scope of the audit, the auditors’ observations, and the corrective actions required. It should also include details of the audit team, the audit methods used, and any limitations encountered during the audit process.

Key Considerations

1. Prepare a report based on the findings of the audit and develop recommendations for improving operations at the facility.
2. The final audit report should summarize findings and observations for corrective and preventive actions.

Summary

Internal audit should follow a systematic process. The following steps should be considered for conducting a successful internal audit:

1. Create a comprehensive audit plan – This should include the objectives of the audit, the scope of the audit, timelines and resources needed.
   
   A sample audit plan may include:
   Objectives: To assess compliance with laws, regulations, and standards pertaining to pharmaceutical facility operations in low- and middle-income countries.
   Scope: This audit will cover all aspects of the facility’s operations, from production to warehouse to sales and distribution.
   Timelines and Resources Needed: The audit should be completed within three months and will require 3-4 auditors with expertise in pharmaceutical facility operations.
   
2. Collect evidence – Collect documentation such as records, reports, procedures, etc., to better understand how the facility is being managed and operated. Additionally, conduct interviews with personnel to gain further insight into their processes and systems.
   
3. Set expectations – Outline the standards that need to be met in order for the facility to pass the audit. Make sure to include country-specific requirements that may apply in addition to industry-wide standards.
   
4. Observe operations – Take note of any observations that may be relevant for the audit and make sure to document them. This includes safety measures, quality control practices, inspections, operation of equipment and other relevant activities that occur at the facility.
   
5. Test samples – Sample products or processes to ensure compliance with standards and procedures. Make sure to document any discrepancies or non-conformances that may be found during testing.
6. Analyze data – Review all the evidence collected during the audit to identify areas of concern or non-compliance. Conduct a risk assessment.

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Disclaimer: The views and opinions expressed on PharmaRead are those of the authors and do not necessarily reflect the official policy or position of any agency or organization. PharmaRead articles are provided for information only with a focus on global health, pharmacy practice, and healthcare systems in Low- and Middle-income Countries (LMICs). Readers should seek expert opinion for use, implementation or application of this knowledge based on their individual circumstances.