Laboratory Areas - GMP Spot check

1. Equipment Hygiene:
- Testing Equipment
- Fridges and incubators

Rate the standard of hygiene of the Equipment within the laboratory

Section 1: photo evidence / notes here:

2. Environmental Hygiene:
- Floor areas should be clean and not slippery under foot
- Evidence of 'clean as you go' to keep area hygienic
- Racking / Cupboards clean

Rate the standard of environmental hygiene within the laboratory

Section 2: photo evidence / notes here:

3. Personal Hygiene:
- Hands must be washed on entry / exit of micro lab.
- No personal possessions or jewellery.
- Blue plasters only.
- No eating of drinking permitted (exception water in product tasting areas).

Rate the level of compliance to the Personal Hygiene Policy demonstrated within the laboratory:

Section 3: photo evidence / notes here:

4. Clothing and PPE Requirements:
- Uniform worn correctly including micro coats in micro lab
- PPE available - Gerber area and autoclave
- Hairnets must be correctly worn by all, ears must be covered.
- Safety boots worn by all.

Rate the level of compliance to the Clothing and PPE requirements demonstrated within the laboratory:

Section 4: photo evidence / notes here:

5. Foreign Body Controls:
- Evidence of broken glass / brittle plastic
- Loose nuts and bolts found
- Pest control issues including anything stored under fly killers
- Miscellaneous foreign bodies in area - ripped cardboard, wood, broken equipment, peeling labels, cable ties etc.

Rate the level of foreign body control within the laboratory :

Section 5: photo evidence / notes here:

6. Engineering & Fabrication:
- Temporary fixes including any 'selotape' engineering.
- Damage to the lab equipment including rust and flaking paint
- Fabrication issues - focus on floor, walls, doors, ceiling.
- Lighting issues

Rate the level of engineering and fabrication issues:

Section 6: photo evidence / notes here:

7. Cleaning Equipment:
- Yellow equipment in use only.
- Single use cloths / green scourers discarded after use.
- Mop and mop bucket in good condition.
- Cleaning equipment clean and stored hygienically.

Rate the control / hygiene of cleaning equipment in use within the laboratory

Section 7: photo evidence / notes here:

8. Records & Document Control:
- Document control visible
- No evidence of poor photocopying (missing text etc)
- Factory pens in use
- Records correctly filled out, in good condition, no crossings out and legible
- No staples in use
- Signed off by supervisor as required

Rate the standard of records and document control in within the laboratory:

Section 8: photo evidence / notes here:

9. Packaging and Product Controls:
- No evidence of product packaging being used incorrectly (pen pot, storing liquids).

Rate the compliance to packaging and product controls within the laboratory

Section 9: photo evidence / notes here:

10. Chemical Controls:
- All chemicals correctly labelled
- Correct chemicals in use for application
- Chemical cabinets locked, chemicals stored correctly

Rate the compliance to chemical controls within the laboratory :