Good Manufacturing Practice (GMP) is the regulatory baseline for any facility that manufactures cosmetic products. In the European Union, Article 8 of EU Cosmetics Regulation 1223/2009 mandates that all cosmetic products must be manufactured in accordance with GMP, and it designates ISO 22716 — "Cosmetics — Good Manufacturing Practices (GMP) — Guidelines on Good Manufacturing Practices" — as the harmonised standard that provides a presumption of conformity. Compliance with ISO 22716 is not a competitive advantage; it is a legal prerequisite for placing cosmetic products on the EU market.
What ISO 22716 Covers
ISO 22716 provides guidelines for the production, control, storage, and shipment of cosmetic products. Unlike GMP standards in pharmaceuticals (such as EU GMP Annex 1 for sterile medicinal products), ISO 22716 is tailored specifically to the cosmetics industry. It addresses the unique characteristics of cosmetics manufacturing — the diversity of product types, the range of raw materials, the variety of packaging formats — while maintaining the core GMP principles of quality assurance, consistency, and traceability.
The standard is organised around several key areas, each of which has direct implications for how a manufacturing facility operates and how its operations are documented:
Personnel
ISO 22716 requires that personnel involved in manufacturing, quality control, and storage have adequate training and competence for their roles. Training must be documented and periodically refreshed. Responsibilities must be clearly defined, and there must be sufficient supervision to ensure that procedures are followed consistently.
Premises
Manufacturing premises must be designed, constructed, and maintained to prevent contamination, mix-ups, and errors. The flow of materials, personnel, and products through the facility must be logical and controlled. Adequate lighting, ventilation, and temperature control are required. Dedicated areas must exist for receiving, storage, weighing, manufacturing, packaging, quality control, and waste handling.
Equipment
All equipment used in production and quality control must be suitable for its intended purpose, properly installed, and maintained according to a defined schedule. Cleaning procedures for each piece of equipment must be established, validated, and documented. Equipment must be uniquely identified, and usage and cleaning logs must be maintained. This is one of the areas where manual record-keeping is most burdensome — and most error-prone.
Raw Materials and Packaging Materials
ISO 22716 requires that all incoming raw materials and packaging materials be inspected, tested (or accepted based on a certificate of analysis from a qualified supplier), and approved before use. Materials must be stored under defined conditions, with clear identification and status labelling (quarantine, approved, rejected). Full traceability must be maintained — from the supplier's batch number through to the finished product batch in which the material was used.
Production
Manufacturing operations must follow written instructions and procedures. Batch records must document every step of the production process: the quantities of raw materials weighed, the equipment used, the process parameters (temperature, mixing time, speed), in-process checks, and the identity of the personnel who performed each operation. Deviations from established procedures must be recorded, investigated, and resolved. Batch records must enable full reconstruction of the manufacturing history of any individual batch.
Quality Control
The quality control function must be independent of production. It is responsible for approving or rejecting raw materials, packaging materials, bulk products, and finished products based on defined specifications. Retained samples must be kept for an appropriate period. Out-of-specification results must trigger documented investigations. Stability testing programmes must be established to support shelf-life determination.
Why Paper-Based GMP Compliance Fails at Scale
Many cosmetics manufacturers still manage GMP documentation through a combination of paper batch records, standalone spreadsheets, and disconnected quality management systems. This approach creates several systemic risks:
- Incomplete batch records: When batch records are filled in manually, fields are missed, handwriting is illegible, and deviations go unrecorded. Auditors reviewing paper batch records frequently find gaps that cannot be retrospectively filled.
- Equipment cleaning logs: Paper-based cleaning logs for manufacturing equipment are difficult to cross-reference with production schedules. If a tank was used for Product A at 14:00 and Product B at 16:00, was it cleaned between uses according to the validated procedure? Paper logs make this verification slow and unreliable.
- Traceability gaps: Reconstructing which raw material batches went into which finished product batches requires linking purchase records, warehouse receipts, weighing records, and batch production records. When these exist in separate systems — or on paper — traceability exercises during audits or recalls become time-consuming and uncertain.
- Training documentation drift: Training records for personnel must be current and linked to the specific procedures they are qualified to perform. Paper-based training matrices quickly become outdated as procedures are revised and personnel change roles.
How Manufacturing ERP Software Embeds GMP Compliance
A purpose-built manufacturing ERP for the cosmetics industry — such as Labify® Factory — does not simply digitise paper processes. It embeds GMP requirements into the structure of every workflow, so that compliance is a consequence of normal operation, not a separate documentation exercise performed after the fact.
Electronic Batch Records
Labify® Factory generates batch records directly from the manufacturing order. When a production run is initiated, the system creates a structured record that captures every required data point: raw material identification and quantities (drawn from the formulation data in the platform), equipment assignment, process parameters, in-process check results, operator identification, and timestamps. Fields cannot be skipped. Deviations require documented justification before the batch can proceed.
Equipment Management and Cleaning Schedules
Every piece of manufacturing equipment is registered in the system with its associated procedures, operating instructions, and cleaning protocols. The platform tracks equipment usage across production runs and enforces cleaning schedules between batches. A production order cannot be started on a piece of equipment unless the system confirms that the required cleaning has been completed and logged. This eliminates the risk of cross-contamination from inadequate cleaning — one of the most common GMP non-conformances in cosmetics manufacturing.
Raw Material Traceability
Batch allocation — assigning specific raw material batches to specific manufacturing orders — can be performed manually or automatically within the platform. Either way, the traceability chain is unbroken: from supplier delivery note to warehouse receipt, from warehouse to weighing, from weighing to batch production, and from batch production to finished product. A vertical ERP designed for cosmetics maintains this chain natively, without requiring external traceability tools or post-hoc reconciliation.
Scheduling and Coordination
ISO 22716 requires that manufacturing, packaging, and cleaning operations are coordinated to prevent errors and contamination. Labify® Factory provides a scheduling dashboard that visualises all three activities across the facility, enabling production managers to identify conflicts, plan equipment cleaning windows, and ensure that the manufacturing sequence respects GMP constraints.
GMP as Infrastructure, Not Overhead
The shift from paper-based GMP compliance to embedded, software-enforced compliance represents a structural change in how cosmetics manufacturers operate. When GMP requirements are built into the platform that manages production, they cease to be a documentation burden imposed on top of manufacturing. They become the manufacturing process itself. Every batch record is complete because the system requires it. Every equipment cleaning is logged because the system enforces it. Every raw material is traceable because the system links it.
For cosmetics manufacturers preparing for regulatory audits, scaling production volumes, or managing contract manufacturing for multiple clients, this distinction is not academic. It is the difference between a facility that demonstrates compliance and one that struggles to prove it.