If there are some malfunctions in the equipment these things might happen.
They do not happen day in day out of production. Because machines are maintained and they will be kept in perfect condition to provide maximum output with minimum rejection of such capping or packing materials.
This is where Qualifying vendors come into picture.It makes sure that quality parameters of each supplied material meets the initial specifications that is mentioned in the quality agreement.
It does not fit into “V” diagram of process validation. You need to attach a new form by name “Risk based methods sheet”. In this all these thing will be entered properly.When ever you start up a batch – immediately after validation runs, you will run a batch size which is equall to production batch to show the shortest run time. In such an events you will note the pitfalls and lacunas of production and the production interruptions.Such interventions are noted in this document and they will also write CAPA. This will be available to topbrass of company management only.Most of parameters are given here.
I would like to understand that there is a lot of difference in quality, parameters and Regulatory restrictions between an Oral Bottle and a VIAL.
When ever you write a question please frame them properly and give the dosage form. I almost wasted some time about Vials.
Vials are different from bottles.