What Is ICH Q7?

International Council for Harmonisation guideline on good manufacturing practice for active pharmaceutical ingredients (APIs), covering facilities, materials management, packaging, storage and distribution.

Detailed Definition

ICH Q7, Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients, sets out GMP expectations for making APIs, the active substances in medicines. It covers quality management, personnel, buildings and facilities, equipment, documentation, materials management, production controls, packaging and labeling, storage and distribution, laboratory controls, validation, change control and complaints and recalls. FDA has adopted Q7 as guidance for industry. Finished dosage forms fall under drug CGMP rules such as 21 CFR Part 211 instead.

Where pallets meet API GMP

Q7 does not specify pallets, but its sections on materials management, storage and facilities set the expectations that pallets must support. Materials should be stored in conditions that do not harm their quality, in a way that allows cleaning and inspection, and with clear identification and status. For finished drugs, 21 CFR 211.80 similarly requires bagged or boxed components to be stored off the floor and spaced to permit cleaning and inspection, which in practice is often done with pallets.

Pallet practices API sites commonly adopt

• Plastic or dedicated pallets inside production and sampling areas.
• Transfer of incoming materials from wood pallets at a defined point.
• Inspection of pallets for debris, mold, pests and damage.
• Labels on each pallet showing material identity, batch and quarantine or release status.
• Written procedures for cleaning and reuse of pallets.

These are site decisions based on risk assessment, often using ICH Q9 tools, rather than rules written in Q7 itself. A supplier serving API plants should ask for the customer's pallet specification and expect it to be part of a supplier approval process.

Related Glossary Terms

• GMP (Good Manufacturing Practice) - Good Manufacturing Practice: quality rules for how products are made, enforced by FDA as current good manufacturing practice (CGMP) for drugs, food and other products; pallets are covered as equipment and materials in those facilities.
• ICH Q10 - ICH guideline describing a model pharmaceutical quality system across the product lifecycle, including oversight of outsourced activities and purchased materials such as packaging and pallets.
• ICH Q9 - ICH guideline for quality risk management in pharmaceutical manufacturing and distribution.
• 21 CFR Part 211 - FDA regulation establishing current good manufacturing practice (CGMP) for finished pharmaceuticals.
• GDP (Good Distribution Practice) - Good Distribution Practice: guidelines, such as the EU GDP guidelines and WHO guidance, that set quality standards for storing and distributing medicines, including temperature control, handling and traceability.
• Plastic Pallet - Plastic pallets are non-wood pallets typically used in food, pharmaceutical, and pool applications.
• Sanitary Pallet - A sanitary pallet is a clean, dry, undamaged pallet suitable for carrying food, in line with the FSMA Sanitary Transportation rule's requirement that transportation equipment be kept in sanitary condition.
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