In short
GMP Annex 1 (Good Manufacturing Practice, new version effective 2023-08-25) is the strictest norm for pharmaceutical production and sterile compounding. It requires materials approved for the cleanliness regime, full visual control in classes B and C, and traceability of personal equipment (e.g. OHS prescription glasses per pharmacist). From a procurement perspective this means a specific dispenser choice: INOX of the appropriate grade for the given room class, transparent fronts where visual control without opening is needed, technical documentation in PL+EN. Back to 6 standards →
The regulator starts the audit. Inspector enters through Class D → C → B airlock and observes control points: are gowns accessible, are FFP3 masks accessible, are prescription glasses identified per pharmacist, does every PPE element have visual control without opening the container. With a plastic basket: 5 protocol remarks, "no full visual control". With MedicLine configuration: transparent Maxi 12 with 12 named pharmacist labels, transparent Maxi for gowns, Mini × 5 at each airlock stage, Easy Saver before Class B. Inspector: "exemplary", moves on.
What the GMP Annex 1 auditor checks
4 typical GMP control points for PPE dispensers
- Materials approved for GMP zones — INOX 304 for C/D, INOX 316L for A/B (cytostatic and biological contact), HDPE/ABS FDA-approved 21 CFR Part 175
- Full visual control (Annex 1 §8.3) — in classes B and C the ability to inspect content without opening the container is required. Transparent fronts are mandatory
- Per-employee identification — pharmacists' prescription OHS glasses MUST have named identification. SecuBox Maxi 12 with 12 named labels
- Cleaning and disinfection — material must withstand aggressive pharma-grade agents (70% IPA, IPA + 0.5% H₂O₂, sporal A) without corrosion or surface change
How to choose dispensers per GMP room class
Room classification is set by your pharmacy / manufacturer based on the production profile. The map below shows which dispenser features to prefer for each class — these are educational hints, not the final clean-room designer's decision:
- Class D (entry airlock) — INOX 304 usually sufficient. Blue SecuBox Mini for standard gloves, INOX 392 mm mask dispenser
- Class C (preparation / packaging) — INOX 304 + transparent fronts (visual control). Transparent SecuBox Midi, 392 mm dispenser with PETG acrylic
- Class B (sterile compounding) — consider INOX 316L (greater chemical resistance to aggressive disinfectants). Transparent SecuBox Maxi 12 with named labels, transparent Maxi for sterile gowns
- Class A (laminar) — only laminars and isolators; PPE dispensers do not enter Class A and are placed in the adjacent Class B
- Cytostatic preparation room — INOX 316L or ABS, transparent fronts, plus EN 15154-4 Eye Wash
Confirm the final choice with your clean-room designer and QA owner — the above are typical paths, not a technology mandate.
Documentation available with a B2B order
What we can attach to the offer / delivery
- Steel mill certificate 3.1 per EN 10204 — on request (grade 304 or 316L)
- Technical data sheet with material identification and surface smoothness
- Notes on disinfectant compatibility (70% alcohol, IPA, H₂O₂) — per manufacturer documentation
- Product card PL + EN
- Installation manual and cleaning procedure
- SecuBox Maxi 12 — physical slots for 12 pharmacist name labels (to be completed on your side)
If your QA dossier requires a specific document (e.g. pharmaceutical-zone material declaration for a given model) — let us know directly and we will check with the manufacturer what is available.