USP chapter 〈1790〉 titled ‘Visual Inspection of Injections’, is the most efficient document that describes every single aspects which should be taken care while performing the validation of visual inspection process for the sterile injectables.
Pharmaceuticals Sterile Injectable Manufacturing and Filling Line produces a variety of products including liquid and lyophilized types, therefore a risk based rationale should be adopted with permutations and combination of Batch size, fill volume, filling speed, filling duration, container closure type, process or steam sterilization, product form (liquid or lyophilized), mode of product sterilization (filtration, terminal sterilization, aseptic process etc.), Inert gassing after filling of containers, equipment trail etc.
USFDA release the guidance documents on Process Validation titled “Process Validation: General Principles and Practices” in January 2011. However the approach laid down in this document is still being not adopted completely by the industries till date. The concept laid down was to transfer the complete process optimization activities to R & D from manufacturing instead of struggling during the Production phase. This would lead to cost saving and reduces the chances of failure of the product when it has been transferred to the manufacturing phase.
Fate of your decision lies in data accuracy. When you take a decision, it may be a good decision or a bad one. However the same is completely dependent on the accuracy of the data being evaluated by you, same applies to the Management Information System also.
The decision of the management may go wrong in case there is inaccurate data and inadequate Management Information System.
These are the two sides of the same coin, however, they are taught to us in different way.
Air Flow Pattern or Smoke studies have been one of the interesting areas for the Inspectorates, nowadays. There is very low amount of attentions being paid by the organization when we are designing the smoke pattern protocols and reviewing the videotapes. Sometime situations are there companies do not understand how to review the Air Flow Pattern or Smoke study recordings. This article shall explain everything on the topic and bring the clarity on each segment of Air Flow Pattern. It will make Smoke Study so simple.