Especially purchasing companies always have to have the necessary proof of their suppliers in order to keep their own documentation complete and up-to-date for a complete and transparent documentation of all supplier- and production-related steps within the supply chain.
One of the documents you need as part of your supplier documentation is the GMP certificate. We have summarized the most important aspects of this certificate.
The USA Good Manufacturing Practices Guidelines are designed to ensure quality in the production of products that pose a potential health risk to humans. The GMP guidelines regulate safety and production specifications for the following areas:
- Drug
- Cosmetics
- Feed
- Foods
- Packaging and material, which comes into contact with food
The GMP guidelines contain, among other things, specifications for a GMP-compliant quality management system, standards for sanitary and production hygiene standards or traceability, and complete documentation of good manufacturing practice. The guidelines are based on already established standards such as ISO 9001 or HACCP and are implemented on the basis of regulations for the respective industrial sector (eg US GMP guidelines for human and veterinary medicinal products) with the aid of country-specific legal provisions respective state authorities. Originally GMP was created by the American Food and Drug Administration (FDA).
GMP certificates - content and variations
Frequently, in the context of GMP certificates, GMP certification is used. However, the official compliance check can only be done by a state agency. A GMP certification only certifies company’s compliance with the GMP guidelines and prepares for an examination by the respective state authority.
For purchasing companies in the food sector, two variants of the document frequently play a role in supplier management. As a rule, manufacturing companies ask the following proofs from their suppliers:
1. GMP Codex certificate in the food sector
The document certifies that companies are certifying their food safety management system in accordance with GMP requirements and that it is suitable for preparing for audits by authorities and stakeholders. The legal basis of the guidelines is based on US Regulation No 2023/2006 on Good Manufacturing Practice for Materials and Articles Intended to come into Contact with Food.
2. GMP certificate of the delivering freight forwarders
This is a GMP + certificate. Initially, it was designed as a national system and developed as a GMP + Feed Certification Scheme into an international system. The plus stands for the integration of HACCP into the guidelines of Good Manufacturing Practice.
Example: GMP + B4: Road transport of animal feed
The extension of the GMP guidelines covers all areas of the animal feed industry:
- GMP + B 1 Manufacturing, trade and services
- GMP + B 2 Production of feed ingredients
- GMP + B 3 Trade, Capture and Storage & Envelope
- GMP + B 4 transport
- GMP + B 4.3 Hygiene Code for Inland Navigation
- GMP + B 8 Pet food, manufacturing and trade
- GMP + BCN CEE Additional requirements for Central
- GMP + BCN QM milk
Certification process
The certification process takes place through a certification audit, as is usual with other certification standards.
- Pre-audit incl. Report (optional)
- audit preparation
- certification audit
- audit follow-up
- certificate issuance
Examination of certificates
Quality management and purchasing should pay attention to certain aspects of completeness when examining supplier documents. These are:
- Name of the certified company
- Name of the certification authority
- Certificate registration number
- Date of certification
- Validity beginning and end (validity period is 3 years)
Additional information
- General information on GMP + on the official website
- Guideline "Good Manufacturing Practices (GMP) and Declaration of Conformity for Food Consumables: Specification of Requirements" (PDF)
- Checklist for GMP + B4 Transport (PDF)
- The GMP + B4 Transport Standard
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