AUDITS


Pharmaceutical GMP Audits

GMP compliance is required by OECD countries and cGMP is required by the United States FDA to ensure that proper guidelines are followed in the manufacturing of active pharmaceutical ingredients (APIs), excipients and finished drug formulations.

AM Consultancy assists in the review and implementation of GMP/cGMP compliance.

Cosmetic GMP Audits

If your organization wants to sell cosmetic products anywhere in the world you need to meet the appropriate Cosmetic Good Manufacturing requirements. Cosmetics are regulated by the Federal Food, Drug and Cosmetic Act (FD&C Act) for the United States and have to comply to the European Regulation (EC) No 1223/2009 if sold in Europe.

AM Consultancy offers services to the cosmetic and personal care industry.

Is it a Drug, a Cosmetic or Both ?

Whether a product is a drug or cosmetic by the law is determined by a product’s intended use and the marketing authorization of the product into a specific market. Different laws and regulations apply to each type of product and market to be sold in. Also for combination products, for example antiperspirants, makeup marketed with sun-protection claims, anti-dandruff shampoo etc. are specific guidelines and regulations in place.

Is it a Drug, a Cosmetic or both? This question has to be answered first before an audit against the applicable guidelines and regulations can take place.

Audit Services

Audit stamp

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 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 client's responsible person and AM consultancy from the start of the audit preparation until the audit reporting and closure.

A Service Agreement between both parties will be put in place.

Compliance

Regulated Audits

  • Drug Finished Product manufacturing, audits are performed based on:

    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 based on:

    • 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 applicable GMP regulations and normative standards as ISO 9001, ISO 22716 and ISO 13485, AM Consultancy offers QM Assessment Audits verified by random selection of process and product samples. These Audits of the QM system can help manufacturers to prepare for authority inspections and is the perfect tool for implementation of continuous improvement or certification purposes.

Remote Audits

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.

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