Services


Audit Services

Audit stamp

Based on the needs of the client, the purpose and Audit scope, AM Consultancy will conduct a facility Audit to access 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.

From the beginning the client forms part of the team. There is a communication line between the clients responsible person and AM consultancy from the start of the audit preparation until the audit reporting and closure.

Typical Regulated Audits, Quality Management System Audits, Specialty Audits or Host Audits of your own manufacturing site, sub-contracting manufacturers or suppliers can be ordered.

A Service Agreement will be put in place.

Compliance

Regulated Audits

  • Drug Finished Product manufacturing, audits are performed on the basis of:

    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.

    Medicinal products in blister

     

  • Cosmetics or Cosmetic/ Drug combinations that are both:
    Cosmetics

    EU Cosmetic Regulation (EC) No 1223/2009.

    ISO 22716 – Cosmetics Good Manufacturing practice.
    Considered as the backbone of many other cosmetic GMP initiatives.

    US Food and Drug Administration, Cosmetics : FDA 21 CFR Part 700&701 : Cosmetic General and Cosmetic Labeling.

    US Food and Drug Administration : FDA 21 CFR Part 210 & 211 : cGMP in Manufacturing, Processing, Packing, or holding of Drugs and Finished Pharmaceuticals.

  • Ingredient and Active substances

    Ingredient and Active substance (API) manufacturing can be verified as well, for API preferably hosted by a technical specialist of the clients company.

    Quality Systems Audits are performed on the basis of:

    • IPEC-PQG Good Manufacturing Practices Guide for Pharmaceutical Excipients
    • ICH Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
    • EFFCI GMP Guide for Cosmetic Ingredients

Quality Management System Audits

Derived from normative standards as ISO 9001 , GMP and ICH Q9 guidelines, AM consultancy offers QM System Audits, going into detail in the different ISO or GMP Management chapters, verified by random selection of implementation on process and product samples. These mock Audits of the QM system can help manufacturers to prepare for authority inspections and is the perfect tool for implementation of continuous improvement. Furthermore, an independent quality overview is given and the client can verify his own Quality Management performance or can compare the internal quality level to that of external partners and applicable regulations

Specialty Audits

For some reasons a more specific Audit can be requested to focus on one certain GMP process or product. These Audits are custom tailored and provides the second pair of eyes on top of the customer expert view. This often reveals previously unidentified GMP compliance gaps or risks.

Host Audits

On the customer request AM Consultancy can host your own company Auditor(s) as a Lead Auditor, co-Auditor or Audit trainer for internal or external Audits. Preparation of the Audit report can be performed by AM Consultancy and discussed with the client, if preferred.

Audit Plan

Audit Plan

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.

Audit Satisfactory Report

Consultancy Activities

GMP Training

As a result of an Audit outcome or in preparation of a regulatory inspection, AM Consultancy can evaluate the current adopted compliance standard and procedures of the company or assist with the implementation of corrective and preventative actions or additional SOP’s subject to compliance. An on site GMP training can be provided.

AM Consultancy will follow up with detailed documentation on the facility, proceed to establish Quality Assurance (QA) mechanisms and oversee the completion of documents and GMP requirements.

If requested, an Interim Management role may be in the scope of the project.