What are GMP Auditing & Inspections?

Ensuring Good Manufacturing Practice (GMP) compliance.

GMP Auditing & Inspections are mandatory procedures designed to provide evidence that human and veterinary medicinal products adhere to specified quality standards, align with current industry best practices, and meet the relevant regulatory requirements and guidance documents of national health authorities.

GMP guidelines ensure proper manufacturing and controls are in place throughout the entire manufacturing process, and the continued GMP Certification of the manufacturing site.

With the ongoing evolution of regulations, authorities are inevitably placing greater emphasis on Risk Management and the Quality Management Systems in place to monitor, control, and minimize risk. Independent GMP Auditing, and potential authority inspections are therefore essential safeguards to maintain consistently safe products and manufacturing processes.

Manufacturers also have a requirement to conduct regular GMP audits on their suppliers as they are responsible for compliance across the entire manufacturing process, from raw materials through to finished products.

GMP Auditing can also provide useful management insights into current processes and highlight improvements in line with a culture of continuous improvement.

Click here for the European Commission GMP guidelines.

Because official site inspections can be initiated at any time, regular planned audits create a consistent record of compliance, assuring inspection-readiness. The planning of audits and Audit Program Management are therefore critical elements in maintaining safety and operational efficiency.

When conducting GMP audits, it is essential to employ appropriate risk-based sampling and testing methods. These methods enable the identification and assessment of specific risks in the area under review, with the audit findings methodically documented in an audit plan.

Risk is assessed at the following audit planning levels:

Strategic Level Audit Planning: This phase involves the development of a long-term audit strategy requiring endorsement from senior management.

Tactical Level Audit Planning: The tactical level focuses on creating an audit program that outlines audit objectives and the scope of audits within that program.

Operational Level Audit Planning: At the operational level, the focus is on crafting an audit plan for individual audit engagements. This involves prioritizing audit tasks based on a risk-based methodology, reporting audit findings in alignment with their relative risk levels and providing ranked or graded audit recommendations.

GMP Auditing must therefore gather essential evidence, including pertinent documentation and statements, which can subsequently undergo objective evaluation against the applicable compliance and risk criteria.

Common areas within a GMP safety audit.

A GMP audit should be a methodical, independent, and well-documented review that includes:

Validating that facilities are suitable for the manufacturing processes involved, with adequate space, equipment, and environmental controls to prevent contamination.
Ensuring that personnel are adequately trained and qualified for their roles, and that they follow appropriate hygiene and dress code standards.
Ensuring that all equipment used in the manufacturing process is properly designed, calibrated, and maintained to meet quality standards.
The quality control of raw materials, intermediates, and finished products, including testing and sampling procedures to verify the quality of materials and products meet required specifications.
The maintenance of accurate and complete documentation for all aspects of the manufacturing process, including procedures, records, and reports.

Conducting validation studies to ensure that processes, equipment, and systems are capable of consistently producing products that meet predetermined specifications.
The system for managing and documenting Change Control for processes, equipment, and systems to prevent unintended consequences on product quality.
The procedures for handling customer complaints and managing product recalls.
The ongoing training records for personnel to ensure they are aware of and comply with GMP requirements.
Ensuring that any outsourced activities, such as contract manufacturing or testing, comply with GMP standards.
The Quality Management System in place to identify, assess, and mitigate risks to product quality, and procedures for CAPAs and Deviation Management.

Why choose Aegisana for your GMP Auditing?

Our collaborative approach.

Our GMP Compliance team is thoroughly experienced in the full scope of GMP requirements, and the auditing services required to keep your entire manufacturing process safe, compliant, and inspection ready.

Through a collaborative approach, our process focuses on:

Audit planning and defining audit scope and objectives. Developing an audit plan outlining the areas to be assessed, audit methods, and the audit schedule within your Audit Program.
On-site inspections of facilities involved in the manufacturing process, including personnel interviews and process observations/assessment.
Documentation review including standard operating procedures (SOPs), records, and quality management system documents.
Data collection for key performance indicators, incidents, and deviations related to manufacturing activities.
Awareness through interviews and assessment of personnel at different levels on the knowledge of GMP requirements.
Communicating of findings and observations with relevant stakeholders.
Comprehensive audit reporting detailing observations, non-compliance issues, and recommendations for improvement.
Prioritizing of findings based on their impact and risk.
Developing CAPA plans for identified issues.
Conducting follow-up audits to verify the implementation of Corrective Actions.

Communication, reliability, trust.

Our internal and external GMP auditors are experienced and qualified and understand the latest in regional legislation changes and requirements.

Supported by a robust Quality Management System (QMS), we can seamlessly and efficiently adapt to the compliance needs of your manufacturing site.

Our goal is to provide you with peace of mind and confidence by thoroughly reviewing and assessing all your manufacturing compliance processes, with all levels of risk clearly identified and communicated in our audit findings.

Through effective communication, reliability, and trust, we aspire to establish a successful and robust strategic compliance and auditing partnership throughout the entire life cycle of your human and animal products.

All of our services adhere to the regulations and principles of the EMA’s guidelines on compliance.