Find out how to efficiently prepare for regulatory agency audits at a pharmaceutical company and learn about best practices for ensuring compliance.

Pharmaceutical companies play a crucial role in society, making drugs that save lives and make people healthier. To ensure the safety and efficacy of these products, it is essential that these companies comply with the rules and regulations set forth by regulatory organizations. One fundamental part of this process is the audit, where the regulatory agency assesses whether the company is appropriately following good manufacturing practices.

Nevertheless, an audit can be a critical moment for pharmaceutical companies, since failure to comply with regulations can result in sanctions and even in authorization being suspended for the manufacture and sale of products. It is therefore extremely important that these companies make appropriate preparations to be audited by the regulatory agency.

Yet how can pharmaceutical companies get prepared for a regulatory agency audit?

Here are some important tips:

Know the regulations:

The first step in preparing for an audit by a regulatory agency is to have in-depth knowledge of relevant regulations and guidelines. Pharmaceutical companies should be up to date on the latest guidelines and regulations, such as good manufacturing practices (GMP) and drug safety. This will provide a solid basis for evaluating compliance and identifying possible gaps in the company’s operations, guaranteeing that all records and licensing requirements are in order.

Implement robust quality management systems:

Organizing and documenting processes and procedures are essential aspects when preparing for an audit. Pharmaceutical companies should implement robust quality management systems that include document control policies, a master validation plan, periodic reviews of the quality system and of products, and employee training. These systems ensure that processes are consistent and they help to demonstrate compliance during the audit.

Keep documents updated and organized.

Documentation is the basis of an audit, since it provides evidence of the activities performed by the company, from drug development to distribution. That is why it is important to keep updated and organized records, according to the standards required by the regulatory agency. Documents also need to be easy to access to facilitate their consultation during the audit.

Keep precise and updated records:

Maintain precise and updated records is another vital element when preparing for an audit. Detailed records of manufacturing, packaging, distribution, and quality control activities should be kept and easily accessible. Records should include dates, times, signatures, and any other relevant information. This allows for appropriate traceability and shows transparency during the audit.

Review internal processes and procedures:

The audit also assesses whether the company’s internal processes and procedures are aligned with the regulatory’s agency’s rules. That is why it is important to periodically review them, to check whether they are appropriate and up to date. If nonconformances or opportunities for improvement are found, the necessary corrective or preventive actions need to be implemented.

Guarantee product traceability:

Product traceability is a fundamental requirement in ensuring drug quality and safety. It allows the entire product lifecycle to be tracked, from raw materials to the end consumer. To do this, you need to have a system for lot identification and control that lets you record and consult relevant information on products, such as the date of manufacture, expiration, origin, destination, etc.

Perform regular internal audits:

Before the regulatory agency’s audit and periodically, it is important to carry out internal audits to help identify and correct system deficiencies. These internal audits allow the company to assess its performance in relation to regulations, identify possible nonconformances, and take corrective actions prior to the regulatory agency audit. This can involve adjusting processes, updating procedures, or additional employee training. Performance of internal audits moreover helps to continually improve the processes and the culture of compliance within the organization.

Be prepared for the audit:

Before the audit date, it is important to train and prepare the entire team to guarantee a smooth and successful experience. The team should be aware of audit procedures, they should understand their roles and responsibilities, and they should be prepared to answer the auditor’s questions. In addition, the company should designate a representative who can accompany the auditor during their visit, providing information and answering any questions that may arise. Also, guarantee that every area is clean and organized, while quickly and precisely providing the auditor with all information requested.

By following these tips, pharmaceutical companies can better prepare for regulatory agency audits, increasing their chances of having a satisfactory result and remaining credible in the market. But keep in mind that these are generic suggestions and each pharmaceutical company should consider the regulations and requirements specific to their country or region.

Learn about the SoftExpert Suite

SoftExpert offers the most complete software for the pharmaceutical industry, meeting the sector’s specific needs in every respect, from product lifecycle management to monitoring of performance indicators and process optimization, simplifying compliance and quality management.

With the SoftExpert Suite increase their success and productivity, reducing risks and complying with a variety of regulations. Some functionalities include:

  • Management of quality deviations, documents, change control, supplier management, customer complaints, product quality reviews, risk management, and other processes essential to a robust Quality Management System.
  • Prepare and revise necessary documents, such as procedures, records, reports, and evidence.
  • Plan and schedule audits, defining objectives, scope, criteria, and the audit team.
  • Execute audits according to applicable rules and regulations, keeping notes, nonconformances, and recommendations on record.
  • Track and monitor corrective and preventive actions, verifying efficacy and whether deadlines are met.
  • Create and send reports, with results, conclusions, and action plans.
  • Store and file data, ensuring the integrity, confidentiality, and traceability of information.
  • Monitor and guarantee compliance with good manufacturing practices (GMP), according to the quality, safety, and traceability standards and rules required by the market.
  • Manage and enhance validation, qualification, calibration, and maintenance processes for the pharmaceutical company’s equipment, systems, and installations.

The SoftExpert Suite is a solution to help pharmaceutical companies undergo regulatory audits with more confidence, agility, and transparency, making processes more efficient and effective, resulting in greater reliability and compliance within the pharmaceutical sector.

Learn about the SoftExpert Suite

Daiane Loeffler


Daiane Loeffler

Daiane Loeffler is a Business Analyst at SoftExpert. She holds a degree in Chemical Engineering from UNISOCIESC, a specialization in Process Engineering from Sustentare Business School, and a specialization in Pharmaceutical Engineering from Instituto Racine. She is experienced in the Processes and Quality Systems areas and has expertise on Good Manufacturing Practices, Risk Management, Audits, Root Cause Analysis, CAPA, FMEA, PPAP, APQP and Six Sigma.

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