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.

What are the types of DMF?

Drug master files are regulatory submission requirements.

There are four types of DMF. They are referred to by their numbers in Roman numerals:

Type-I: Is an obsolete number once used for a category that no longer exists because it was found to easily fit into and overlap with the other four categories.

 Type-II: DMF is for companies who supply drug substances, drug products, intermediates & material used in their manufacture.

Type-III: DMF is for companies who supply packaging (container closure system) for human drugs & biologics.

Type-IV: DMF is for companies who supply excipients

Type-V: DMF is for companies who supply clinical services, sterile manufacturing etc.

What is a DMF?

A Drug Master File (DMF) is a submission to the Food and Drug Administration (FDA) that may be used to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs.

A DMF is a package of proprietary information filed voluntarily by a company with the FDA. If it held by them in confidential closed files until such time as an FDA reviewer requests a review of the DMF.