Visual Inspection of Lyophilized Product Parenterals

SUBJECT Visual Inspection of Lyophilized Product Parenterals 

The purpose is to provide a procedure for checking and conhrming that lyophilized parenterals are passing the following test and can be packed  

It is the responsibility of the quality assurance (QA) inspector stationed in the parenterals area to follow the SOP. The QA manager is responsible for SOP compliance. 

Divide into two portions one should have white background and the other black. The illumination should be from a shielded 100-W bulb daylight-quality light source, which provides an intensity of illumination of not less than 100 and not more than 350 fc, at a point 25.4 cm (10 in.) from its source. 

Collect a representative sample per the single sampling plan (general level B) and inspect. Record the observation in the attached format. Following is the sampling plan. 

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Area clearance procedure for parenterals QA inspector responsibilities in injectable area Particulate matter in injectables, DSP criteria Visual inspection of lyophilized products parenterals... 

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