Industrial Pharmacy-II

Pilot Plant Scale-Up Techniques

• Laboratory to pilot-scale

• Pilot-scale to industrial-scale

  
  

• Industrial to pilot-scale

• Laboratory to industrial-scale

Pilot plant can be used for ……

• Evaluating results for laboratory studies

• Product and process correction

• Shelf life and stabilities studies

• All of above

The filling method of a pharmaceutical liquid depends on the following factors

……

• Viscosity of the liquid

• Surface tension of the liquid

• Compatibility with the material used in the construction of the filling

  machine

• All the above

Quality control is defined as ……

• Sampling and documentation

• Sampling, specification and documentation

• Sampling, specification, testing, documentation and release procedures

• None of these

Quality management system deals with ……

• Quality for their products and services

• Safety for their products and services

• Quality and safety for their products

• Quality and safety for their products and services

ICH guidelines involve ……

• Quality, Safety

• Quality, Safety and Efficiency

• Quality control and Multidisciplinary guidelines

• Quality, Safety, Efficiency and Multidisciplinary guidelines

Carcinogenicity and Genotoxicity study is a …… aspect of ICH guidelines.

• Safety guidelines

• Efficiency guidelines

• QSEM guidelines

• All of these

Key components of TQM are ……

• Consumer/Customer focus

• Continuous improvement

• Involvement of employee

• All of these

Six sigma concept includes …….

• Define, Measure, Analyze, Improve and Control

• Design, Measure, Analyze, Improve and Control

• Define, Manage, Analyze, Improve and Control

• All of these

The basic principle of ISO 9000 is ……

• Customer focus and Engagement of people

• Relationship management and Leadership

• Evidence based decision making and Continuous improvement

• All of these