31.What are the sampling techniques used in the cleaning validation?
Swab sampling: Areas which are reasonably accessible & hardest to clean can be evaluated, leading to level of contamination or residue per gives surface area.
Rinse sampling: Large areas or parts of equipments which could not be swabbed should be rinse sampled or directly extracted by solvent. Tubes, nozzles, pipes or containers with surface those are not reasonably accessible for direct surface sampling have to be rinsed with solvent.
In addition, inaccessible areas of equipment that cannot be routinely disassembled can be evaluated.
32.What is OOT and define?
"OOT" stands for Out Of Trend. It means any test results obtained for a particular batch that is markedly different the results of the batches in a series obtained using a same validated method.
33.What is calibration?
The demonstration that a particular instrument or device produces results within specified limits by comparison with results produced by a reference or traceable standard over an appropriate range of measurements.
34.What is the micron size of HEPA filter?
The micron size of HEPA filter is 0.3µm
35.What is the abbreviation of CAS Number?
CAS Number: Chemical Abstract Service Number
36.What is in-process control?
Monitoring the manufacturing process at different stages is called in-process control. In-process control of the process provides an acceptable and achievable level of built in quality assurance for the product. This is possible through appropriate GMP during all manufacturing steps.
37.What do you mean by market complaint?
Any communication, written or verbal, received regarding the quality, packing directly from any traders or product manufacturer and marketing staff or any other such complaints shall be considered as a Market Complaint
38.Describe the categories of the market complaints?
Market complaints are categorized into three types
and are as follows:
Critical: Complaints related to suspected contamination, adulteration and mislabeling.
Major: Complaints related to the product not meeting its pre-determined critical specifications and damage to primary packaging.
Minor: Complaints related to the product not meeting non-critical quality attributes, or damage to secondary packaging or shortages etc.
39. What do you mean by re-validation?
A repeat of the process validation to provide an assurance that changes in the process/equipments introduced in accordance with change control procedures do not adversely affect process characteristics & product quality.
40. What is the QMS?
It is the quality management system to direct and control an organization with regard to quality.