A regulatory auditor in the pharmaceutical business is critically responsible for ensuring that pharmaceutical products and manufacturing businesses follow all applicable regulations, guidelines, and standards. Their primary role is to evaluate the company’s operations, systems, and processes for compliance with regulatory standards and good manufacturing practices (GMP).
If we discuss their position, responsibilities, qualifications, and professional scope, the role of a regulatory auditor in pharma is that a regulatory auditor assesses pharmaceutical businesses.
This ensures that they follow required local and international regulatory requirements, such as those established by the FDA (USA), EMA (Europe), CDSCO (India), WHO, or MHRA (UK). Along with this, they focus on product quality, documentation accuracy, regulatory compliance, operational efficiency, etc.
The important elements you should consider when facing a regulatory auditor are as follows:
Meeting with a regulatory auditor for any pharma company can be a scary endeavour, but rigorous preparation, professionalism, and excellent communication can help ensure a successful audit. Here we have given some important points on how to tackle it:
- Preparation for the audit: Firstly, examine the regulations governing your facility (e.g., GMP, FDA, ISO standards). Also, understand the auditor’s primary focus (e.g., production, quality control, documentation).
Moreover, you should always ensure that all records are up-to-date, full, and easily accessible. The list of key documentation includes batch manufacturing records, standard operating procedures (SOPs), training records, and certificates of analysis (COAs).In addition, you have to make sure that all staff understand their roles and responsibilities, and they conduct training workshops on how to manage auditor enquiries and ensure compliance. Along with this, maintain a clean, orderly, and compliant facility and also check the storage conditions.
- Audit professionalism: Greet the auditor politely, provide a designated workstation, and also appoint a skilled team to accompany the auditor. Moreover, for effective communication, give accurate, factual responses without over-explaining or providing extraneous details.
Moreover, be open about processes and issues, and also avoid withholding facts or misleading the auditor. The following procedures include displaying adherence to SOPs and regulatory norms and also demonstrating consistency between documented and actual processes. Most importantly, documents should be provided as soon as possible and must be related to the request.
- Managing non-conformities: Accept the auditor’s observations without arguing with him/her, and if necessary, seek clarification to fully understand the situation. Furthermore, explain any deviations with supporting evidence (for example, corrective measures taken or incident reports).
Even with this, assure the auditor that any findings will be addressed swiftly and also take notes to ensure nothing is overlooked during the post-audit process.
- Post-audit actions: Verify and examine the auditor’s observations carefully. Then identify crucial, major, and minor discoveries to prioritise. Also, in developing corrective actions, develop a corrective and preventive action (CAPA) plan with specific dates and responsibilities.
Lastly, for the document, all steps are taken, and the report is submitted to the auditor if it is required.
- Continuous improvement: You can use audit findings to enhance your high-quality manufacturing processes and avoid repeated issues. Also, schedule regular internal audits to ensure continued compliance.
What are the important certifications for regulatory auditors?
- CQA (certified quality auditor) by ASQ.
- GMP auditor certification by NSF or PDA.
- Certified pharmaceutical GMP professional (CPGP) by ASQ.
- ISO 9001 Lead Auditor Training.
How is Knors Pharma fully capable of facing the regulatory auditor?
Our company’s several years of experience and knowledge in the pharma industry allow us to have huge expertise in quality assurance, compliance, or auditing within the pharmaceutical or life sciences industries.
Because of this, we have established our special team of auditors that are fully skilled and qualified in their fields and also have bachelor’s or master’s degrees in pharmacy, chemistry, biotechnology, or a related subject.
Even they have various certifications in quality auditing (e.g., ASQ CQA). In addition, we understand the importance of technical skills, and we follow all the norms of the GMP, GLP, GDP, and ISO 9001/13485 standards. We are even familiar with regulatory guidelines (e.g., FDA, WHO GMP, ICH Q10). This proves our many years of experience with pharmaceutical production procedures, validations, and quality control.
Besides all of this, we believe in the importance of soft skills. This allows us to do analytic and critical thinking and have effective communication and interpersonal abilities.
