What is deviation What is validation and its type in detail What is CAPA AND HOW IT is initiated Examples of incidences and how it is rectified Examples of preventive action and corrective actions Procedure for reprocessing of batch What isTap density bulk density. How bulk density calculated Principle of equipments like rmg fbd sifter multimillion Critical points of granulations Working principles of compression machine

Question

Accepted Answer

The questions are related to various topics including deviation, validation, CAPA, reprocessing of batch, tap density bulk density, equipment principles, and granulations.

Deviation refers to the divergence from a standard or expected value.
Validation is the process of establishing documented evidence that a system or process consistently produces results meeting predetermined specifications.
Types of validation include analytical method validation, process validation, cleaning validation, and computer system validation.
CAPA stands for Corrective and Preventive Action, which is a systematic approach to identify, investigate, and address the root causes of non-conformities or potential non-conformities.
Examples of incidents can include equipment malfunction, product contamination, or deviations from standard operating procedures.
Rectification of incidents involves identifying the root cause, implementing corrective actions, and verifying the effectiveness of those actions.
Preventive actions aim to eliminate potential causes of non-conformities before they occur, while corrective actions aim to address existing non-conformities.
Reprocessing of a batch involves repeating the manufacturing process for a specific batch to rectify any deviations or non-conformities.
Tap density is the density of a powder or granular material when tapped or vibrated under specific conditions.
Bulk density is the mass of a powder divided by its volume, typically expressed in grams per milliliter (g/mL) or grams per cubic centimeter (g/cm³).
The working principles of equipment like RMG (Rapid Mixer Granulator), FBD (Fluid Bed Dryer), sifter, and multimill depend on their specific design and functionality.
Critical points of granulations refer to the key factors that can significantly impact the quality and characteristics of granulated materials.
Compression machines are used to compress powders or granules into tablets or other solid forms, and their working principles involve applying pressure to the material to achieve desired compaction.

Popular interview questions of Executive Assistant

Top HR questions asked in Hetero Drugs Executive Assistant