Utilising An Audit Checklist For Pharmaceutical Industry Standards

What is an audit in the pharmaceutical industry? For pharmaceutical businesses, an audit is an independent and systematic examination of various processes, documentary trails or systems to verify compliance with certain standards. These could include Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP) or Good Clinical Practices (GCP), depending on your niche and the scope of the audit.

The purpose of an audit is to ensure that a pharmaceutical business produces high quality, safe, and efficacious products at all stages of manufacturing, testing, storage and distribution. Audits are either internal – e.g. performed by the business itself – or external, carried out by a customer, third-party auditor, or regulatory agent. An audit will attempt to identify gaps in safety or compliance and suggest areas for improvement to protect customer safety and maintain compliance.

Audit Checklists For Pharmaceutical Industry

Audit checklists are important tools because they help businesses to systematically evaluate compliance requirements, identify risks, and streamline the audit process itself, so that all critical areas are reviewed.

Any audit will need to be tailored to the specific pharmaceutical standards relevant to your product and regulatory authorities. For example, an internal (tier 1 to 3) audit will probably look quite different to an external (e.g. second/third party or unannounced audit). However, most pharmaceutical audits aim to verify compliance with regulations such as ICH Q7  (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use) and EU GMP (European Union Good Manufacturing Practice); therefore, a checklist will include the following points.

Please note that this list is by no means comprehensive and, for reasons of space, does not include checklists for crisis management and corrective/preventative actions (CAPA), or for audit trail reviews. Further information about GMP audit checklists can be found here (GMP Audit Checklist For Drug Manufacturers), here (FDA), here (EMA), and here (EMA, FDA and ANVISA)

Documentation accuracy

• Check that all batch records are accurate, complete, and up-to-date
• Verify the presence of Standard Operating Procedures (SOP) for all processes
• Confirm that change control documentation is fully managed and approved
• Check for deviation reports and make sure that corrective actions are documented and implemented
• Review all training documentation

Facility

• Inspect the hygiene and state of maintenance of all production facilities
• Make sure that all manufacturing zones are designed to prevent or avoid the risk of cross contamination
• Calibrate and assess all environmental monitoring systems for functionality and safety
• Ensure that ventilation systems are working correctly, with the appropriate levels of air quality and pressure differentials for each zone
• Monitor storage conditions for temperature, humidity etc and keep records for both raw materials and finished products

Process controls

• Validate all critical processes
• Ensure that in-process safeguards and controls are followed according to the established procedures
• Review and investigate any process deviations
• Maintain equipment settings and production parameters in line with your process specifications

Equipment maintenance

• Maintain scrupulous calibration and maintenance records for all production equipment and assets
• Ensure that stainless steel equipment is passivated and cleaned on a regular basis
• Regularly check for signs of visible wear and damage on machinery and tools
• Review logs for planned and unplanned downtime and all remedial actions taken.

Staff training and hygiene

• Ensure  that all staff are trained on relevant GMP principles and SOPs
• Validate compliance with hygiene and gown-wearing protocols in ‘clean zones’ for staff, visitors, and contractors

Quality assurance

• Validate that all active pharmaceutical ingredients are tested and approved before use
• Check traceability for any raw materials, finished products, and intermediates in the supply chain
• Ensure that analytical testing aligns with validated methods
• Test all finished product before release to market
• Validate the accuracy and completeness of quality control data and laboratory records

Contamination control

• Implement the appropriate cleaning validation protocols for facilities, equipment, and utilities
• Ensure strict delineation between sterile and non-sterile areas in the facility

Contact us

The passivation process has several benefits for the pharmaceutical industry and is often deployed by organisations as part of their pharmaceutical audit checklist. To find out more, please contact the team at Inox Passivation today.