GMP / GxP Audits

Audits are an integral part of supplier qualification. Good Manufacturing Practice (GMP) audits are essential to ensure manufacturers comply with regulatory standards pertaining to the production, control and release of active pharmaceutical ingredients and medicinal products. These audits cover all aspects of the manufacturing process, from raw material sourcing to staff training and product distribution. blue inspection body is the leading service provider of GMP audits, conducting high quality and independent audits worldwide.

The purpose of a GMP audit is to verify that the processes and systems used by the manufacturer adhere to the required quality measures, thereby safeguarding the end-users. GMP audits are thoroughly planned by the lead auditor and performed in accordance with an individual audit plan for each audit. In addition, a comprehensive checklist for GMP audits can be used as a tool, guiding auditors through a detailed review of all relevant aspects of production, from raw material sourcing to the final product release. The GMP audit report serves as a critical document, detailing compliance with the established regulations and identifying areas for improvement.

In line with our accreditation, we at blue inspection offer GMP audits at API and excipient manufacturers to all pharmaceutical companies in the supply chain including:

Marketing Authorisation Holders
Finished Dosage Form Manufacturers / Contract Manufacturers
Traders

Pharmaceutical companies face ever-changing market forces and statutory regulations. Hence, they must demonstrate increasingly systematical risk management and consistent GMP compliance. GMP audits need to meet the highest standards. Effective GMP training is crucial for auditors to understand the complexities of regulatory requirements and to conduct thorough audits. Our auditors are trained on a regular basis to keep up-to-date on specific regulations. At blue inspection, we select auditors who are most qualified to perform each audit, according to their expertise and experience.

We generate GMP audit reports according to our implemented quality management system and structured in accordance with the relevant EU GMP guidelines, intended for regulatory purposes and for inspections of authorities. We provide detailed and specific audit reports, including description of product related documentation, such as e.g., Product Quality Reviews, batch records, validation reports etc. as well as a detailed list of all deficiencies identified during the audit.

GMP Audits of APIs and Excipients

Good Manufacturing Practice (GMP) audits for Active Pharmaceutical Ingredients (APIs) and excipients are crucial to ensure the quality and safety of medicinal products.

When conducting GMP audits for APIs, auditors focus on the entire manufacturing process, from raw material sourcing, synthesis, purification, packaging processes, final product testing and distribution. Auditors evaluate the consistency of production operations, the reliability of analytical methods, and the robustness of quality system. They also review documentation for adherence to good documentation practices.

For excipients, the audits are similarly detailed; the appropriate audit criteria need to be established in accordance with a formalized risk assessment for ascertaining the appropriate good manufacturing practice for excipients of medicinal products for human use risk assessment (EU guideline 2015/C 95/02). Amongst others, auditors check for potential contamination, proper handling, and storage conditions, as well as the general performance of the quality management system and related documentation.

High Quality and Independent Audits by blue inspection

blue inspection is renowned for its commitment to high-quality and independent audits, ensuring regulatory compliance and fostering trust among clients and auditees alike.

Our rigorous audit process, based on a quality management system is designed to provide an unbiased and independent examination of a manufacturer's good manufacturing practice.

According to the EU Guidelines for Good Manufacturing Practice for Medicinal Products, audits should be of sufficient duration and scope in order to ensure adequate assessment of GMP. Dedicated to excellence, our highly-experienced auditors and project-management team adhere to applicable good manufacturing practices (GMP) requirements for the organization and performance of audits. Thorough auditing helps to maintain manufacturing excellence, to protect patients’ health, and to uphold integrity in the supply chain. Our audit reports fulfil regulatory requirements, demonstrate the GMP compliance of the audited suppliers and have a high acceptance by authorities worldwide.

Your blue inspection audit benefits:

Highest Quality GxP audits
Independent evaluation of suppliers
In-depth audit reports
Acceptance by authorities worldwide
Reduction of audit costs and work-load for in-house QPs
Organizational benefits (travel planning, VISA, translations)
Impartial audits
Confidentiality guaranteed

Key Elements and related documents of a GMP audit

At blue inspection we cover all key elements of the GMP audit in accordance with the relevant guidelines, from documentation review to the on-site tours covering warehouses, production, and QC laboratory. The following key elements, amongst others should be covered in GMP audits:

Change control
Deviation handling
Internal audits
Product quality review
Handling of OOS results
Training
Monitoring of clean rooms
Water supply and monitoring
Equipment qualification and cleaning
Supplier qualification
Batch records / batch record review
Contamination control
Validation
Computerized systems
Data Integrity
Laboratory controls
Complaints
Recalls
Outsourced activities
Reuse of materials

Good Manufacturing Practice (GMP) related documents are essential for ensuring that products are consistently produced and controlled according to quality standards. These documents serve as a foundation for building a robust quality management system. Adherence to GMP documentation is critical for regulatory compliance and to ensure the safety and efficacy of products.

Supported by our GMP audit checklist, our auditors perform a comprehensive review of various documents. GMP related documentation includes amongst others:

Standard Operating Procedures (SOPs)
Specifications
Batch Records
Validation and Qualification Reports
Training Records
Change Control Records
Quality Control Documentation

The GMP audit report is an essential document to verify the manufacturing facility's compliance with Good Manufacturing Practices (GMP). A predefined audit report template should be used to guide the auditor through the various aspects of an audit report. A well-structured GMP audit report template ensures that all relevant aspects of the manufacturing process are audited.

How to ensure a reliable third-party audit

The out-sourcing of GMP audits is a cost-efficient and practical way of qualifying your suppliers. When out-sourcing audits in such a responsible area of activity, it is essential to qualify your auditing service-provider in order to ensure consistency in the quality of the audits performed.

The EU GMP guideline sets basic requirements for the approval and maintenance of suppliers of active substances and excipients. Furthermore, an industry guidance for performance of 3rd party GMP audits has recently been developed (Peither et al., Pharm. Ind. 86, Nr. 3, 224–228 (2024)). Adequate audit duration is of great importance in order for auditors to be able to cover all aspects of a GMP audit and to deliver a detailed audit report as required by authorities.

We at blue inspection have a well-established auditing process in place for third-party audits. The key to a successful audit is in the preparation by the project-management team internally in advance of the audit. Clients can submit their queries and issues to be addressed in our audit questionnaires. Our project-management team carefully select the appropriate auditors, especially when specialized knowledge is required, for example for the audit of sterile products. Safe-guarding confidentiality for all parties involved is paramount. Confidentiality should be guaranteed both during audit preparation and in the aftermath of an audit when requesting approval from manufacturers to pass on audit reports and documents to clients. Non-Disclosure or confidentiality agreements should be put in place between the third-party audit service provider and the manufacturers / auditees in order to protect the information acquired during the audit process. Furthermore, contracts should be in place between the audit report provider and clients, also to safeguard the confidential information in the audit report.

Why choose an accredited audit?

Choosing an accredited audit service provider ensures that your audits are performed by a company who has been evaluated for its independence and impartiality in compliance with international standards. The EMA Guidance on good manufacturing practice and good distribution practice (Questions and answers) recommends that there is no commercial relationship between the organization performing the audit and manufacturer to be audited. Accreditation signifies a mark of quality and reliability, providing assurance that the audit is carried out impartially and with professional diligence.

An accredited service provider and its quality management system is inspected and monitored by a state accreditation body, covering all aspects, from the qualification of the auditors to the compliance of audit processes. It enhances the credibility of the audit findings and can facilitate acceptance by clients and authorities worldwide. blue inspection is accredited according to ISO 17020 for “inspections of excipient and active pharmaceutical ingredient manufacturers for pharmaceutical products and determination of the conformance with international GMP rules”. Our accreditation is granted by the German Accreditation Body (Deutsche Akkreditierungsstelle, DAkkS).

The excellent quality standard that an accredited system provides, includes a mandatory training schedule for all our auditors, including annual re-trainings. These trainings cover all relevant GMP-aspects in detail. Product-specific audit reports as oppose to only a general audit report on the audited site is a key component of a thorough audit. This facilitates clients to receive in-depth information on their specific product, while protecting confidential information for the manufacturer surrounding other products. Accreditation ensures trust, integrity and confidentiality in the area of third-party GMP audits.

Mandatory Re-audits

Pharmaceutical companies must re-audit Active Pharmaceutical Ingredient producers for GMP compliance every three years. These mandatory re-audits confirm adherence to current GMP requirements and allow for ongoing improvements, risk identification, and necessary corrective actions.

At blue inspection our services include the timely re-audit scheduling of your suppliers, securing the optimum re-audit date and preparing the audit comprehensively in order to reduce delays in receiving the re-audit report on time.

During a mandatory GMP re-audit, auditors systematically review the organization's procedures, records, and operations under consideration of the results of the previous audit. They assess the effectiveness of corrective and preventive measures, risk management practices, and adherence to regulatory requirements. The findings from these re-audits provide valuable insights for enhancing operational efficiencies and strengthening internal controls. Manufacturers can prepare for mandatory re-audits by maintaining up-to-date documentation and conducting regular internal audits.

Tracking of Corrective and Preventive Actions (CAPA)

The identification of deficiencies or non-conformities need to be clearly and precisely documented in the audit report. The implementation of corrective measures, as described in the CAPA (Corrective and Preventative Actions) plan is a pivotal component after the audit. It ensures that non-conformities are addressed, and potential issues are pre-emptively mitigated.

The knowledge gained by our auditors from the annual auditor trainings we provide enables them to identify non-compliance issues. Effective CAPA follow-up requires meticulous documentation to facilitate the evaluation of action effectiveness over time. It is essential to verify the root of the issue and the rationale behind the chosen corrective actions. Preventive actions, on the other hand, involve analyzing trends and data to identify and eliminate possible causes of non-conformities before they occur.

To maintain the integrity of the CAPA process, regular monitoring and review are crucial. This includes verifying the implementation of actions, and assessing their impact on quality and compliance. Continuous improvement is a core objective, and the CAPA system plays a central role in achieving it. Successful close-out of CAPA in a GMP audit not only helps in regulatory compliance but is essential for customers evaluation of their suppliers.

Third-Party Shared Audits

blue inspection offers clients the possibility of joining shared audits organized by their partner. The company Diapharm GmbH & Co. KG is our partner for the organization of high quality third-party shared audits, offering a one-stop address for your audit requirements. This trustworthy partnership combines the accreditation of blue inspection and the expertise in audit project-management of Diapharm. Over 15 years of experience together in the field of GMP audits has been recognized by both clients and auditees worldwide as a reliable and trustworthy partnership.

Third-party shared Good Manufacturing Practice (GMP) audits are a cost-effective and efficient approach to ensuring compliance within the pharmaceutical industry. These audits are conducted by independent auditors who assess multiple suppliers or contract manufacturers against the EU GMP guidelines. The shared nature of these audits allows clients the opportunity to join a professionally organized and comprehensive audit at reduced cost.

Auditees benefit from shared GMP audits as these provide a collaborative verification of manufacturing regulation compliance, help reduce the number of multiple individual customer audits and streamline quality assurance.