Win-Win Solution

The processes of validation and qualification of the supply chain in the pharmaceutical industry involve different parties, which are the Stakeholders for the Association.

AFA aim is to gather all the necessities and became a Win-Win Solution for all of them.

PHARMACEUTICAL COMPANIES

Manufacturing Authorization Holders or Marketing Authorization Holders of Pharmaceutical or Veterinary products having the ultimate responsibility on the supplier compliance according to Directive 2004/27/CE amending Directive 2001/83/CE.

Economical
  • Best ratio quality / price.
  • Reduction of the audit cost by optimization (sharing).

In addition, for affiliated members:

  • 10% saving cost in all services (including the available audits).
  • Payback if the audits promoted (or co-promoted) by the affiliates are bought later by another company (half of the fee paid by the new company).

Confidentiality

  • Guaranteed confidentiality of any information received. Reports are personalized according the specific requirements of each sponsor.

Quality Proven Competence:

  • Qualified Auditors. AFA’s qualification program.
  • Intercompany protocol to regulate the audit activities.
  • More than 700 audits performed since 2005.
  • More than 400 audit reports available in AFA database.

Regulatory

  • AFA audit reports have been reviewed in many GMP inspections since 2005, always with successful results (EU, USA, Australia, and Canada among others).
  • Covering the complete life cycle of the supplier relationship. Follow up of CAPA derived from the audited companies and follow up audits after audit expiration date.
  • Taking advantage of AFA’s privileged position to interact with the authorities, regulatory bodies and other Pharmaceutical Associations.

SUPPLIERS

Any active substance (API), excipient and primary and secondary packaging material manufacturer responsible for the GMP compliance of supplied products, as well as analytical laboratories or carriers or any company giving service with GxP compliance.

Economical 

  • Reduction of the company resources dedication to develop the intensive audit plan required by clients, both to the initial and the renew audits.
  • Flexibility when planning audits.
  • Possible participation of several clients in the same audit.

Confidentiality

  • Guaranteed confidentiality of any information received. Reports are personalized according the specific requirements of each sponsor.

Quality · Proven Competence  

  • Qualified Auditors. AFA’s qualification program.
  • Intercompany protocol to regulate the audit activities.

Regulatory

  • AFA audit reports have been reviewed in many GMP inspections since 2005, always with successful results (EU, USA, Australia, and Canada among others).
  • Centralized follow-up of CAPAs derived from the audits and audit follow up after the expiration date.
  • Taking advantage of AFA’s privileged position to interact with the authorities, regulatory bodies and other Pharmaceutical Associations.

DISTRIBUTORS

All companies participating in the supply chain from the raw materials, pharmaceutical products to the delivery point including: Brokers, importers, carriers, etc. responsible for ensuring the supply chain security and the pharmaceutical product transportation conditions.

Economical

  • Reduction of the company resources dedication to develop the intensive audit plan required by clients, both to the initial and the renew audits.
  • Possible participation of several clients in the same audit.

Confidentiality 

  • Permanent contact with the distributor regarding the audit planning with its representatives.
  • Guaranteed confidentiality of any information received. Reports are personalized according the specific requirements of each sponsor.

Quality · Proven Competence 

  • Qualified Auditors. AFA’s qualification program.
  • Intercompany protocol to regulate the audit activities.

Regulatory

  • Facilitate to clients the access to reports from the representatives performed by AFA.
  • Bringing clients into contact with AFA for potential audits.
  • AFA audit reports have been reviewed in many GMP inspections since 2005, always with successful results (EU, USA, Australia, and Canada among others).
  • Centralized follow-up of CAPAs derived from the audits and audit follow up after the expiration date.
  • Taking advantage of AFA’s privileged position to interact with the authorities, regulatory bodies and other Pharmaceutical Associations.

HEALTH AUTHORITIES

Health Authorities are one of the key elements to prove the regulatory compliance from the API , excipients, packaging material manufacturers as well as those participating in the pharmaceutical products supply chain; and to prevent potential public health risks.

AFA guarantees the technical competence of auditors by means of a strict AFA auditor qualification program using a robust methodology that ensures a uniform approach with uniqueness criteria aiming to reach the highest rigor and quality in the audits performed.

Quality · Proven Competence

  • Technical Competence and demonstrated experience of auditors by means of a strict AFA auditor qualification program using a robust methodology in the execution of audits.
  • Uniqueness of acceptance criteria and criticality evaluation of the supply aiming to reach the highest rigor and quality in the audits performed.
  • Intercompany protocol to regulate the audit activities.

Regulatory

  • AFA audit reports have been reviewed in many GMP inspections since 2005, always with successful results (EU, USA, Australia, and Canada).
  • Expanding the Quality Assurance concept to the supplier-related processes.
  • Covering the complete lifecycle of the supplier relationship. Follow up of CAPA derived from the audited companies and audit follow up after the expiration date.
  • Taking advantage of AFA’s privileged position to interact with the authorities, regulatory bodies and other Pharmaceutical Associations.

Confidentiality

  • Guaranteed Confidentiality between sponsors, auditors and suppliers by means of Confidentiality Disclosure Agreements (CDAs).
  • Impartiality

  • The impartiality and absence of conflict of interest with the audited companies are guaranteed.