Pharmaceutical GMP audits
Conducting internal and external audits of suppliers and outsourcing operations are key elements of the pharmaceutical manufacturers quality system. Audits are an effective means of evaluating compliance with the EU GMP regulations and guidelines, your internal company quality system and facilitate continuous improvement. Not only in the manufacturing of marketed products GMP Compliance is mandatory. Also in the manufacturing of investigational medicinal products (IMP) for human use, compliance with the applicable GMP Guidelines is obligatory, laid down in Commission Directives 91/356/EEC, as amended by Directive 2003/94/EC, and 91/412/EEC respectively, Volume 4.
It is the aim of AM Consultancy to offer our pharmaceutical audit management expertise to perform an independent and turn-key GMP compliance audit.
At AM Consultancy we audit the supply and distribution chain of your products and compare the GMP guidelines and applicable laws within and outside the European Union.
Initial Qualification and Due Diligence Audits or typical Surveillance and For Cause Audits can be ordered.
Based on the needs of the client, the purpose and Audit scope, AM Consultancy will conduct a facility or remote audit process to assess GMP/cGMP compliance. GMP Audits generally includes a production line and facility inspection, laboratory inspection, raw data and QA documentation inspection. A product conformity, system conformity and regulatory conformity check is performed.
Auditors apply the concepts of quality by design, process control, risk management, performance monitoring and other current quality systems models during their assessment. Audit checklist based on the regulatory GMP requirements are used as a guidance for completion of the audit process. From the beginning, the client is informed and consulted about the scheduled audit process.
A Service Agreement between both parties will be put in place.
- EU Regulation, EudraLex Volume 4 Good Manufacturing practice Guidelines of medicinal products for human use and investigational medicinal products for human use.
- US Food and Drug Administration: FDA 21 CFR Part 210 & 211: cGMP in Manufacturing, Processing Packing, or holding of Drugs and Finished Pharmaceuticals.
- IPEC-PQG Good Manufacturing Practices Guide for Pharmaceutical Excipients
- ICH Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
In addition to the ISO 9001 ‘Quality Management System- requirements’, ISO 15378 specifies ‘Good Manufacturing Practice (GMP) requirements applicable to primary packaging materials’ for a quality management system where an organization needs to demonstrate its ability to provide primary packaging materials for medicinal products, which consistently meet customer requirements, regulatory requirements and International Standards.
We assist you with the review and installation of the ISO 15378 GMP standard.
AM Consultancy can be your second pair of eyes, when performing internal Quality Management System (QMS) audits at your own premises. Verified by the selection of key processes and product samples, these assessments can help your organization to prepare for authority or customer inspections and is the perfect tool for the implementation of continuous improvement or certification.
Deviations and variances between regulatory requirements, applicable guidelines and current company policies are highlighted. Once these issues are found, appropriate actions can be taken to implement a more effective and efficient Quality Management System, to become fully compliant and reassure that the products meet the highest quality standards. Risk management principles will be applied.
Companies can benefit from our Interim Management service, leading high-level quality projects while we collaborate with your employees and bridge the compliance gap.
Due Diligence Audits
Within the Pharmaceutical Industry it is a common practice to partner with a contract manufacturing organization to provide specific expertise and support for the completion of your project. Deciding on the right partner for the contract manufacturing organization (CMO) can be challenging. Conducting a due diligence audit of the CMO’s facility and operations is essential before contract approval of the potential candidate.
AM Consultancy senior experts performs due diligence audits and provide an overview of strengths and potential weaknesses of the Quality Management System implemented at the selected candidate. The compliance assessment includes the following subsystems as a minimum:
- Quality System, including Personnel, Qualification & Validation, Quality Risk Management, Documentation, Computerized Systems, Continual Improvement
- Materials Control System
- Premises, Facility and Equipment System
- Production System, including Utilities
- Laboratory System
- Packaging System
- Warehousing and Distribution System
You can rely on our expertise and guidance during the complete due diligence process and bring in many years of experience. We ensure permanent confidentiality of documents and data in conjunction with GMP audit mandates. We deliver an accurate, impartial, and fair audit report with the indication of potential risks. It is our service to discuss these risks with you and provide an overview of the mitigation plans before contractual agreements are punt in place.
On-site audits to qualify your suppliers and contract acceptors might not always be possible. In this case, a risk-based supplier qualification process can be supported by a remote audit using IT-supported business and communication channels.
At AM Consultancy we have remote audit tools in place. Points to be considered in the audit plan are based on ICH-Q9 requirements and other important guidelines applicable to the type of industry. Specific customer requirements will be incorporated. On-site portions of routine surveillance such as plant tours will be replaced by interviewing subject matter experts and video channels.
Based on the review of critical GMP documentation and subject matter interviews, non-conformances will be raised and documented in the audit report to support the installation of corrective and preventive actions.
AM Consultancy ensures permanent confidentiality of documents and data and keep such information secret in the interests of our clients and the companies inspected.
As a licensed manufacturer, a company should always be ‘audit –ready’. Regulators can ‘drop-in’ any time.
Audits performed by AM Consultancy will be announced and will be performed within a specific time frame as agreed with the parties involved. The agenda will be sent in preparation of the audit.
The Auditee will be able to prepare for the audit.
The lead auditor, AM Consultancy or co- auditor will chair the opening meeting. The content of opening meeting is likely to include:
- introduction of the audit team
- confirmation of the audit scope and objectives
- presentation and brief discussion of the audit plan
- discussion of the methods and procedures to be used during the audit
- discussion of the communication links during the audit
- confirmation that the resources and facilities are available
- establish and confirm date and time for the closing meeting
During the opening meeting the auditor will be advised about :
- company policy on health, hygiene and safety
- company policy of photographs, video, collecting evidence
- normal operating hours
- times for lunch, breaks, etc.
A facility tour and documentation review will be performed and observations are documented and discussed.A summary session will be given at the end of each audit day. At the finalization of the Audit, possible observations will be discussed with company representatives, a written audit report will be provided to the client.
What customers say about us
Approximately 30 sponsor audits per year are challenging our Quality Management system as per supplier qualification requirements of different regulations. Some are perceived as standard ticking of the box audits and observations are not always helping us to fundamentally improve the quality of our services. In 2019 we were audited by Annemie for the first time challenging both technical and regulatory requirements of part of our GMP QC release activities. What we appreciated in particular were the open, pragmatic and risk based approach discussions which provided us as an auditee with an action plan which truely helped us to improve the quality of our services. Far from ticking of the box, but focused on the core quality, both from a technical as regulatory perspective.
On behalf of the team I wish to thank you again for conducting yesterday’s vendor audit. It gave us the opportunity to collect valuable information about this critical supplier. I appreciate the way we were able to interact in a seamless way, it certainly helped to cover many topics.
A special thanks from my Clinical Operations colleagues, they learnt much since it was their first audit. We’re looking forward to your observations summary!