Good Manufacturing Practice (GMP) Certification

GMP (Good Manufacturing Practice) defines the basic production conditions ensuring a product is manufactured consistently and at its intended quality — facility and equipment design, hygiene, personnel, documentation, records and traceability. It is not a single standard but an approach given concrete form by different regulations by sector (pharmaceutical, food, cosmetics, feed).

• Food and food-additive manufacturers
• Food-supplement manufacturers
• Cosmetics manufacturers (ISO 22716)
• Pharmaceutical and medicinal-product manufacturers (pharmaceutical GMP)
• Feed manufacturers (GMP+)

It varies by sector. GMP is legally mandatory in pharmaceutical manufacturing and is audited by the competent health authority; this audit is a licensing requirement, not a certification. In food and cosmetics, GMP is generally embedded within hygiene legislation and sector standards (e.g. ISO 22716). Whether it can be certified depends on which GMP framework applies.

• Facility and area design: separation of flows, prevention of cross-contamination
• Equipment design, maintenance and cleaning
• Personnel hygiene, clothing and training
• Raw-material and packaging control
• Production process control and process parameters
• The cleaning and disinfection programme and its validation
• Documentation: batch records, deviation management, change control
• Traceability and recall
• Storage and shipping conditions
• Complaint management and internal audit

1. 1ApplicationThe organisation's field of activity, headcount, number of sites and scope boundaries are determined. The number of audit days is calculated from this information.
2. 2Document Review (Stage 1)The management system documentation, scope definition, risk assessment and internal-audit/management-review records are examined; readiness for the on-site audit is assessed.
3. 3Certification Audit (Stage 2)It is verified on site that the system is implemented and effective. Findings are classified as major/minor nonconformity or observation.
4. 4Closing NonconformitiesThe organisation submits a root-cause analysis and corrective action plan. The certificate is not issued until major nonconformities are closed.
5. 5Issuing the CertificateThe certificate is issued after review by an independent decision-maker. The audit team cannot make the certification decision.
6. 6Surveillance AuditsA surveillance audit is carried out at least once a year during the certificate's validity. The first surveillance cannot exceed 12 months from the last day of Stage 2.
7. 7RecertificationAt the end of three years, the entire system is re-audited; it must be completed before the certificate expires.

Management system certificates are valid for three years. At least one surveillance audit is carried out per year during this period; the certificate is suspended if surveillance is not carried out. A recertification audit is completed at the end of the third year.

• Trade registry record and operating licence
• The organisation's organisation chart and headcount
• The list of sites/branches within scope
• The management system manual or process documentation
• Internal audit and management review records
• Legal permits, licences and operating documents, if any

There is no fixed list price; the cost is calculated based on the following variables and provided in writing in the quote.

• The headcount within scope (directly determines the number of audit days)
• The number of sites and branches; whether multi-site sampling applies
• The activity's risk level and process complexity
• The number of standards to be certified — an integrated audit reduces the number of days
• The three-year cycle: certification + two surveillance audits

Management system certification is carried out within the scope of ISO/IEC 17021-1. The certification body is accredited by an accreditation body party to the IAF multilateral recognition agreement (IAF MLA); This agreement establishes a chain of international recognition that ensures that a document issued in one country is accepted in other countries. EUROLAB has internationally recognized accreditation from IAF member accreditation bodies within the scope of ISO/IEC 17021-1.

The scope under which this scheme can be offered varies according to your product and activity; it is confirmed in writing at the quote stage.

• ISO 22000Food Safety Management
• FSSC 22000Food Safety System
• HACCP
• GMP+Feed Safety
• BRCGS Food
• BRCGS Packaging
• IFS Food
• IFS Logistics