Why GIF?
GMP/GDP regulations, as well as any other applicable standards in the pharmaceutical and cosmetic sectors, require all supply chain partners to produce or provide services in compliance with quality and legal requirements.
Pharmaceutical and cosmetic companies relying on such partners must periodically verify their ability to meet these standards through audits of processes, services, and documentation, as part of an overall quality system.
GMP regulations applicable to medicines, cosmetics, food supplements, medical devices, and similar products require periodic audits at supplier sites that impact product quality, to assess the quality systems in place and verify compliance. These audits are governed by:
- EU GMP Part I and Part II
- ISO standards
- Other international references (IPEC, PIC/S, APIC, etc.)
The issuance of GMP certification and manufacturing authorization by a regulatory authority does not exempt the Marketing Authorization Holder (MAH) from conducting systematic audits of suppliers involved in the production of the finished product.
GIF aims to support the execution and maintenance of these inspection activities by promoting joint audits among member companies and sharing the resulting audit reports.
What is GIF?
GIF is an association of companies operating in the pharmaceutical, cosmetic, and related sectors that have voluntarily decided to pool their expertise, resources, and skills to conduct joint audits of suppliers.
- Audits are carried out by specialized personnel provided and trained by the companies and GIF.
- Member companies can access audit reports free of charge, even for inspections not directly conducted by the interested company.
- GIF represents a unique model in the Italian pharmaceutical and auditing landscape, fostering collaboration and shared exploration of common topics among companies with similar goals.
What is the GIF scenario and what does it offer?
Considering that each company typically conducts 10–15 audits per year, and GIF includes around 80 member companies, each contributing 2 auditors, the GIF model allows:
- Active participation in joint audits
- Access to 800–1,200 shared audits per year
- Annual savings of €18,000 to €36,000 per company
- Total system-wide savings of €1.4 to €2.9 million per year
What benefits does GIF bring to member companies?
Beyond economic and operational advantages, GIF:
- Promotes professional growth of auditors
- Expands their knowledge and areas of expertise
- Provides ongoing training sessions on various topics relevant to supplier audits
What are the benefits for suppliers subject to joint audits?
The GIF system also offers significant advantages to suppliers:
- Reduction in the number of audits to be faced
- Avoidance of overlapping and production slowdowns
- More objective and harmonized evaluations
- Concrete operational savings due to fewer audits to prepare, undergo, and follow up
- A single well-organized inspection recognized by multiple clients