It is the aim of AM Consultancy to offer our audit management expertise to perform an independent and turn-key GMP compliance audit.

The ISO 22716 standard ‘Cosmetics – Good Manufacturing Practices’ is globally acknowledged and used as our backbone for cosmetic GMP audits in Europe. It gives guidelines to produce cosmetic final products, control, storage, and shipment. It also states general requirements for production facilities, equipment, hygiene, personnel, laboratory evaluation, labelling, documentation, complaint, and recall handling.

By audit, we measure the effectiveness of the quality system implemented, provide objective evidence that adequate controls are in place and assure that products and processes conform to specifications. You can rely on our knowledge for the manufacturing of products that are safe and pure. We establish continuous improvement when needed.

A GMP Compliance Audit according to ISO 22716 principles will allow you to avoid delays in bringing product to market, minimize cost and time associated with regulatory or customer re-audits if compliance is not maintained. Furthermore, with the implementation of the quality standard ISO 22716 you meet the legal requirements established in the European Cosmetic Regulation (EC) 1223/2009 and provide high quality products to your customers.

As a cosmetic manufacturer or cosmetic ingredient supplier, the quality and safety of your raw material is key. The Good Manufacturing Practice published by the European Federation for Cosmetic Ingredients (EFfCI) is our manual while assessing the production, control, packaging, storage, and distribution of cosmetic ingredients. The ISO 9001 ‘Quality Management System’ certification program is the basis for the implementation of EFfCI GMP compliance. We assist you with the review and installation of this quality standard.

Within the Cosmetic Industry it is a common practice to partner with a contract manufacturing organization to provide specific expertise and support for the completion of the 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 (QMS) implemented at the selected candidate.

The quality 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 whole due diligence process and bring in many years of experience. We ensure permanent confidentiality of documents and data in conjunction with GMP audit mandates. Audit reports are accurate, impartial, and fair and further commented and discussed with our client before the final distribution to the auditee.

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.

Audits are performed based on an audit plan, referring to the applicable audit standard and the defined audit scope. The approved plan is sent to the auditee two (2) weeks before the audit execution.

An audit report will be provided to the client. AM Consultancy may assist with the review and implementation of the audit corrective and preventive action (CAPA) plan when appropriate.

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.