Define Bio burden?

The level & type (i.e. objectionable or not) of microorganisms that can be present in raw materials, API starting materials, intermediates or APIs. Bioburden should not be considered contamination unless the levels have been exceeded or defined objectionable organisms have been detected.

 It means the bioburden is the number microbes present in the raw material or water sample. Bioburden does not claim any specific microorganism.

Describe the method of testing for checking of MOC of SS material (Molybdenum test)?

Procedure:

1.   Put one drop of the electrolyte solution of molybdenum test kit on the clean metal surface, which is to be tested.

2.       Switch on the detector and touch the metal tip of the detector on the metal surface & carbon point in the electrolyte solution.

3.       Do not pass the current for more than 3 to 4 seconds.

4.       If the red color appears and is stable for more than 2 seconds then it can be concluded that MOC of the part being tested is SS-316.

5.       If the solution remains colorless or green color appears then it can be concluded that MOC of the part being tested is SS-304.

6.       If the black color appears & is stable for more than 2 seconds then it can be concluded that MOC of the part being tested is SS-302.

What are the test parameters in the nitrogen gas validation?

Test parameters during validation and its frequency are given below:

a) Test for oil mists - Every 6 months once

 b) Test for moisture content - Every 6 months once

c) Particulate count (Non-viable) - Every 6 months once

d) Sterility test (Aseptic area locations) - Every 6 months once

e) Bioburden test (Controlled area locations) - Every 6 months once

The purity of nitrogen gas (Based on manufacturer COA)

 * Perform the nitrogen gas sampling & testing for three consecutive days.

What do you mean by Critical Quality Attributes?

A critical quality attributes is a physical, chemical, biological or microbiological property or characteristic that should be within an appropriate limit, range, or distribution to ensure the desired product quality.

It defines that critical quality attribute is to maintain the product quality within the predefined limits.

What are the possible reasons for the Non-conformities?

Non-conformities are the deviations from the predefined standards. Generally, these are findings in a requlatory audit.

 The following are the possible reasons, but not limited:

·         Management attitude

·         Ineffective documentation

·         Lack of trained personnel

·         Lack of co-ordination/ co-operation within or among departments.