Audits are a critical pillar for the assurance of quality standards and should be designed to challenge pharmaceutical manufacturers and their related suppliers by asking “do you do what you say you do?”

Not surprisingly, regulatory agencies conduct detailed and robust audits in a variety of reasons including:

  • 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

Regulatory agency audits are often feared by pharmaceutical companies, but with appropriate, tailored preparation and management, audits can be conducted smoothly and be informative on a regulatory agency’s view of specific aspects of quality management.

Anticipating problems before they are highlighted by inspectors as well as ensuring corrective actions to address areas of weakness have been documented and ensuring corrective actions are in place can avoid potentially damaging regulatory action. All GMO manufacturers and licence holders are required to undertake periodic self-audits.

Self-audits ensure licence holders (MAA, GMP, GDP, etc) are prepared and audit ready. 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. Some of the more frequent types include:

System audits

These assess how a manufacturer 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.

Quality / compliance audits (or self-audits)

These allow companies to perform internal audits or regulatory inspectors to perform formal audits on manufacturing facilities and operations 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.

Self-audits can help manufacturers to continually improve and refine their quality systems and prepare for regulatory, GMP, or clinical audits, and for agency pre-approval inspections. Agency inspections form a critical part of product review and approval and include assessments such as pre-approval inspections.

Conformance audits or product conformance

These are 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

These 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 ongoing conformance.