Audits should be designed to challenge pharmaceutical manufacturers and their related suppliers by asking “Do you do what you say you do?” Regulatory Agencies conduct detailed and robust audits in a variety of cases such as:-
• Before a Marketing Authorisation is granted
• To identify any cGMP compliance issues or concerns and to ensure adequate remediation prior to granting a licence authorisation
• As a “for cause” audit to investigate concerns over the control, compliance and conformance of a manufacturer.
Regulatory agency audits are often feared by pharmaceutical companies, but with appropriate, tailored preparation and management, audits can be conducted smoothly. Anticipating problems before they are highlighted by inspectors, and ensuring corrective actions to address areas of weakness have been documented and corrective actions are in place, can avoid potentially damaging regulatory action.
Self-Audits ensure companies are prepared and ready for a formal audit, they are independently performed by qualified vendors in order to assess whether the appropriate systems and processes have been implemented and are being followed to provide satisfactory pharmaceutical, biopharmaceutical, healthcare and medical devices products. These audits ensure that an organisation is following the legal and regulatory requirements as laid down by the The Food and Drug Administration (FDA) in the US, The European Medicines Agency (EMA) in the EU or any other relevant competent authority.
Types of Audits
There are many different types of audits including;
System Audits – these assess how a company operates using processes and systems. Each company has a range of systems designed for their specific business operations. These can be IT / IS systems including databases, Quality Systems, etc.
Product / Departmental Audits – these assess the wide range of departments involved in the manufacture, testing and release of a product within a pharmaceutical company. Regular auditing ensures on-going compliance to company and regulatory systems and procedures. Post-marketing surveillance for pharmacovigilance is performed to confirm that a product continues to be free from any unknown side-effects and complies with the regulations laid down by the FDA or EMA.
Compliance / Quality audits (or Self-Audits) – these allow companies to perform internal audits on their manufacturing facilities and operations in order to confirm compliance to cGMP. These audits assess all areas mandated by cGMP regulations including; Quality Systems (Change Control, OOS, Deviations, Training, etc. ), manufacturing processes, facilities, utilities, equipment, method validation, etc. These self-audits help companies prepare for Regulatory, GMP, or clinical audits, and in particular for agency Pre-Approval Inspections.
Conformance Audits or Product Conformance is the on-going maintenance of the Marketing Authorisation (MA) and the avoidance of Registration Drift. A key element to the maintenance of the MA is the robust implementation of Change Control throughout the business to ensure appropriate controls are in place for on-going product conformation. Registration Drift occurs when there is a loss of synchronicity between an MA and the manufacturing, testing and release activities.
Regulatory Audits or Regulatory Self-Audits, demonstrate adequate levels of control over Regulatory Systems, such as MA visibility, MA Change Control, Regulatory Commitments Tracking, License Variations Tracking, and other bespoke systems and procedures designed around the company’s business operations.
How Woodley BioReg can help with Audits
Woodley BioReg holds and maintains its own GMP licence and provides on-going support to companies with a full range of tailored internal self-audits. WBR always works to the latest legislations and regulations and our highly experienced Regulatory Affairs and Quality Assurance consultants have a strong track record of delivering pragmatic solutions to ensure problems are quickly identified and fixed.
Woodley BioReg also provides assessment on the level of Product Conformance and Registration Drift, through Gap Analysis, offering full license remediation services and tailored sustainable maintenance solutions, to ensure on-going Conformance.
For more help and advice on Audits please contact us.