Shodhana Laboratories Interview Questions, Process, and Tips

A change control form is a document used to track and manage changes made to a process or system.

• It includes details such as the reason for the change, the impact of the change, and the approval process.

• It helps ensure that changes are properly evaluated, tested, and approved before implementation.

• Examples include software change control forms, manufacturing change control forms, and engineering change control forms.

Changes required when CCF is raised for production shift incharge.

• Batch size increase or decrease

• Facility change

• Specification change

• New facility arrangement

• SOP change

There are three types of process validation: prospective, concurrent, and retrospective.

• Prospective validation is done before the process is put into use.

• Concurrent validation is done during the use of the process.

• Retrospective validation is done after the process has been in use for some time.

• Validation can be done through various methods such as statistical analysis, testing, and documentation.

• Validation ensures that...read more

We use HEPA filters and pre-filters in our AHUs.

• HEPA filters are used to remove small particles from the air.

• Pre-filters are used to remove larger particles before they reach the HEPA filter.

• We replace the filters regularly to maintain air quality.

• Examples of particles removed by HEPA filters include dust, pollen, and bacteria.

MSDS stands for Material Safety Data Sheet and typically has 16 sections.

• MSDS is a document that provides information on the potential hazards of a chemical substance or product.

• It typically has 16 sections that cover topics such as composition, physical and chemical properties, health hazards, and emergency procedures.

• MSDS is required by law in many countries and is an important tool for ensuring workplace safety.

• Exam...read more