Semi-automatic inspection machine

GOOD DOCUMENTATION PRACTICE (GDocP) PQ (PERFORMANCE QUALIFICATION)
1

Hi all,

I have posted this question in the URS forum, but I don’t know which the correct forum is…

I would like to know if anyone is using a semiautomatic inspection machine with 18% grey background instead of black and white background and if FDA or EMEA find any trouble in this matter althougth there are studies that the yield is the same and the time of process is less with this color of backgroung.

Thanks in advance!

2

Various Regulatory guidance State their requirements in Different ways on this matter:

[COLOR="#0000CD"]WHO Requirement on this:

Vertical matte black panel

  • Vertical non-glare white panel next to black panel
  • Adjustable lamp holder with shaded, white light source and …a diffuser (…two 13W fluorescent tubes, each 525 mm (20.7 in) in length is suitable). …illumination at the viewing point is …between 2,000 and 3,750 lux for clear glass ampoules. Higher values are preferable for coloured glass and plastic containers.[/color]

]Parenteral Drug Association Suggestion:

Define visibility (of particulates) through reference inspection method

  • Manual, single container inspection - 500 lux, 18% gray background
  • No magnification[/color]

[COLOR="#000000"]Both Black and white panels and when ever there is a 18% grey back ground-- All are critical inspection parameters.

WHO recommends Black Panel.

There is large ambiguity in this area and the end user should talk to regulatory authorities directly to get clarification on subjects like these.[/color]

3

Thanks you very much for your quick answer! It has been very helpfull!