GMP 22716: Quality Standards in Professional Perfume Production

Good Manufacturing Practice (GMP) refers to a system of requirements and procedures that ensure products are consistently produced according to the quality standards defined for them. GMP is not a one-time event, but an ongoing quality management system.

In the cosmetics industry, the relevant GMP standard is GMP 22716:2007 — Cosmetics — Good Manufacturing Practices (GMP) — Guidelines on Good Manufacturing Practices. This international standard was developed in collaboration with the cosmetics industry.

Legal basis: Article 8 of the EU Cosmetics Regulation (EC) No. 1223/2009 explicitly requires that cosmetic products be manufactured in compliance with GMP. Without demonstrable GMP compliance, a CPSR cannot be obtained.

GMP 22716 structures the GMP requirements into eight essential areas:

1. Personnel: Qualification requirements, hygiene, training, protective clothing, health rules for production employees.

2. Premises: Requirements for construction, size, condition and cleaning of production rooms, laboratories, warehouses and sanitary facilities.

3. Equipment: Requirements for machinery and devices — design, material, maintenance, calibration and validation.

4. Raw materials and packaging materials: Incoming goods inspection, quality certificates from suppliers, release processes, storage, shelf life.

5. Production: Production instructions, batch records, controls during production (in-process controls), contamination prevention.

6. Finished products: Testing and release of finished products by quality control (QC) before dispatch.

7. Quality controls: Internal audits, deviation management, corrective and preventive actions (CAPA).

8. Documentation: Basic GMP principle: "If it's not documented, it didn't happen." Seamless documentation of all processes, tests and releases.

One of the most important GMP principles is complete traceability of each product batch. In the event of a safety incident, a customer complaint or an official recall, a manufacturer must be able to reconstruct at any time exactly:

• Which raw materials (which batch, which supplier) went into a product batch
• At what time and by whom which production steps were carried out
• Which quality controls were performed and with what result
• Which customers the product batch was delivered to

At NEROPI, each production batch is fully documented in our ERP system. The batch record contains all relevant data and is archived electronically.

GMP requires that all measuring and production equipment is regularly calibrated and all production processes are validated.

Calibration: Scales, volumetric measuring devices, temperature measuring devices and other precision measuring instruments are checked at regular intervals against certified reference standards and documented traceably.

Process validation: The filling process, mixing instructions and cleaning procedures are initially validated (proof that the process reproducibly delivers the desired results) and revalidated upon significant changes.

Cleaning validation: Particularly relevant for multi-product systems: proof that after a product change, no impermissible cross-contaminations occur.

GMP certification is awarded by an accredited certification body (e.g. TÜV, Bureau Veritas, SGS, Intertek) after an audit procedure.

Process:
1. Document audit: Review of the quality management system based on documents (SOPs, records, training evidence)
2. On-site audit: Inspection of the production facility by the auditor
3. Audit report: Documentation of findings and any deviations (Non-Conformances)
4. Corrective measures: Remediation of identified deficiencies with obligation to provide evidence
5. Certificate issuance: After successful assessment, the GMP certificate is issued, valid for three years with annual surveillance audits.

NEROPI is GMP certified and provides our customers with the current certificate on request.

The GMP certification of your contract manufacturer is not just a legal requirement — it has direct effects on your business success:

CPSR prerequisite: No safety assessor will sign a CPSR without proof of GMP-compliant manufacturing.

Trade access: Larger retailers (perfumery chains, department stores, international distributors) require GMP certification as a basic prerequisite in supplier qualification.

Insurance coverage: Product liability insurance for cosmetic products generally requires GMP-compliant manufacturing.

Export markets: Many third countries (e.g. Saudi Arabia, UAE, USA) require GMP proof from the manufacturer for import approval.

Consumer trust: The GMP certificate is a communicable quality mark that demonstrates the manufacturer's professionalism and reliability.