Key differences between GLP, GCP, and GMP audits

Understanding the differences between Good Laboratory Practice (GLP), Good Clinical Practice (GCP), and Good Manufacturing Practice (GMP) audits is key to achieving and maintaining regulatory compliance and operational readiness.  Each of these audits focuses on a specific stage of drug development: GLP oversees preclinical, GCP governs clinical, while GMP evaluates commercial manufacturing. 

Therefore, every audit has distinct implications for pharmaceutical manufacturers, lab scientists, and regulatory specialists and each audit type has different goals, documents, and risks attached to it. This article breaks down how these audits are different from one another and their implications for pharmaceutical teams.

What is a Good Laboratory Practice (GLP) Audit?

Good Laboratory Practice (GLP) audits focus on demonstrating the ability of a laboratory to fulfill strict quality and integrity standards. GLP audits are applicable to non-clinical labs such as facilities that test drugs, cosmetics, food additives, medical devices, biocides and detergents.

GLP audits analyze accurate reporting, data archiving methods and laboratory management. By doing so, it ensures that the evaluated research is scientifically valid, reproducible and traceable. 

In preparation for a GLP audit, pharmaceutical leaders should:

• Promote a culture of documentation, in which research archives are constantly updated and  changes are tracked for all nonclinical studies. 

• Ensure there are SOPs for test systems, subject management, specimen management, data integrity, and equipment maintenance.

• Guarantee that the analytical instruments and software used to handle data are qualified to do so.

• Check that all the team members involved in a study have the necessary credentials, training and experience to perform their roles.

• Verify that testing facilities have an adequate size, design, and construction.

• Study conduct and documentation: Every observation must be attributable, legible, contemporaneous, and original.

An on-site GLP audit takes around one day, with duration according to the size of the facility evaluated and the complexity of the analyzed processes. Once the audit is finished, evaluators send a report with detailed findings. GLP deficiencies (ex. inadequate data archiving, incomplete SOPs, poor facilities, invalid data software, etc.) can cause reputational data, disqualify data findings, and even cause the revokal of licenses. Thus, it is critical that issues are resolved as soon as they are found.

What are Good Clinical Practice (GCP) audits?

Good Clinical Practice (GCP) audits ensure that trials that involve human subjects fulfill design, recording, and reporting standards. By doing so, it ensures that the rights, safety, and wellbeing of trial participants are protected and that the data produced is reliable. 

GCP audits are helpful to evaluate specific systems, third-party vendors, and/or sites currently participating in a clinical trial. To prepare for a GCP audit, pharmaceutical leaders should:

• Ensure the integrity of their data management, electronic medical records (EMR), and electronic data capture (EDC) systems.

• Check that documents fulfill regulatory and data management requirements throughout the study.

• Guarantee that the consent process is properly completed both at the documentation and at the practical level.

• Verify that protocol and/or study changes are properly documented and shared within the organisation.

• Promote an adherence to proper product and documentation handling.

When a GCP audit is completed, a report is generated with all the observations collected. Subsequently, a corrective and preventive action (CAPA) plan is created in response. GCP deficiencies (ex. incomplete consent documentation, unreported adverse events, protocol deviations, etc.)  can derail an NDA submission or require exclusion of entire data sets, which is particularly costly for small sponsors operating single pivotal trials. In an industry where there is a push towards patient-centric studies, GCP audits help pharmaceutical sponsors to understand their level of compliance and how they can improve their clinical processes involving human subjects.

What are Good Manufacturing Practice (GCP) audits?

Good Manufacturing Practice (GMP) audit evaluates if pharmaceutical products are consistently manufactured, effective in their intended use, and comply with quality standards. GMP audits often review the maturity of a Quality Management System (QMS), batch production records, material management, supplier qualifications, facility design, equipment validation, process validation and quality oversight.

To prepare for a GMP audit, pharmaceutical leaders should:

• Establish GMP assessment checklists for production, materials, facilities and equipment, packaging and laboratory controls.

• Review the feedback from past audits and FDA inspections.

• Ensure everyone in the organisation is familiar with GMP standards.

• Communicate which documents and processes need to be kept in order to comply with GMPs.

Deficiencies found during a GMP audit (ex. improper maintenance of equipment, poor supplier management, incomplete documentation, etc. ) can lead to recalls and import alerts. Therefore it is critical for pharmaceutical leaders to establish a structured quality strategy to build, maintain, and improve compliance.

Preparing for GLP, GCP, and GMP audits

Navigating the requirements of the audits described above can seem a daunting process for sponsors. Pharmaceutical leaders can ease the burden gradually, by implementing measures that promote a culture of self-assessment and regulatory readiness. 

Oversight duties, documentation processes, and regulatory expectations must be clearly defined. In addition, mock audits and internal audits can be conducted in order to evaluate the current level of readiness. By working proactively instead of reacting to audit results, pharmaceutical teams can eliminate deficiencies over time and increase their audit success chances.