Is the criterion of having a direct contact with product/semiproduct/raw material sufficient to perform IQ of the device/machine/system?
Please, take under consideration non-sterile production of:
I believe the criteria should be whether or not it affects quality. For example, if you have some software that tracks the product, that likely has a potential for affecting quality and should be validated.
Yes, I believe so.
The problem is that the whole factory (API manufacturing - e.g. plant extraction) is based on rather old equipment, some machines are e.g. 20-30 years old (there’s no computer system, so no sign of software). It works great, but it’s hard to gather data required to qualification.
I know that planning should be based on risk analysis, which we of course performed. But the result was: there’s no critical element in this system (!). There’s only a danger of smaller efficiency but there is no possibility to threaten the product quality.
So - my question (indirectly) was: if a device has direct contact with product, should we consider it a quality affecting element?
Dear Val,
In any Pharmaceutical Manufacturing process there will be impact spectrums. This is classified under Good Engineering Prcatice as : NO IMPACT, INDIRECT IMPACT & DIRECT IMPACT.
This is classified and added in your qualification documentation from the Start of your URS.
A direct impact system is one which comes into contact with the Drug or Product under consideration, can alter the qulaity properties of the product under manufacturing if its quality parameters are not set or defined or not monitored.
For Example: In oral Solid Dosages and Oral liquids the quality of DM or even Purified water (Note: DM and Purified water are totally different) is classified as Direct Impact systems. That means any Dissolved solids or particulates or Microbial load(Bioburden) will affect the product quality during manufacturing.
In such casses you need to know the quality parameters and design your URS, Sechematic Design and Later your functional design based on regulatory requirements given for compendial waters.
The whole qualification procedure starting from URS to PQ based on the Direct Impact system procedure.
You cannot skip out of this boundary as it alters the quality of product. From the day you think about a praticular machine for a praticular manufacturing process you must know how it works, where it works and how it has impact on your product. Then you will classify in any one of the 3 classifications given in above and then lay the system boundaries.
Regards