What do you mean by “performance qualification

How many phases are in performance qualification of purified water system?

What are the types of non-compliances in the internal audit?

Describe the categories of the market complaints

What do you mean by “Reference standard” and “Working standard

Define stability study and its necessity?

Stability study is defined as “stability testing is to provide evidence how quality of product varies with time under influence of temperature, humidity & light”.

Stability study is essential because it helps to:

·         Establish a re-test period for drug substance 

·         Establish a shelf life for drug product

·         Recommend storage conditions for products

What precautions are to be observed while working in the powder processing room?

 Following precautions should be observed while working in the powder processing rooms:

·         Absolute discipline w.r.t complete uniform

·         Bunny suit, clean shoe covers, hand loves, snoot mask etc. and SOPs compliance

·         Positive pressure in the area

·         Housekeeping in the area Avoid foreign objects (pens, pencils, tools etc.)

·          Identification / status card on materials

·         Stage slips on equipment

·          Adequate Temperature (less than 25°C)

·         Avoid extraneous contamination from dust, insects, micro-organism, foreign particles etc.

·          Check the condition of sieves used in multi mill and sifter

·         Cleaning and calibration of weighing balances

·          Usage of fresh, clean drums and poly bags for the final packing of the product.

What is in-process control?

What are cGMP requirements for building and facilities?

 Following are the cGMP requirements for building and facilities:

• ·         Suitable size, construction and location of the facility
• ·          Facilitate cleaning, maintenance and proper operation
• ·         Adequate space for manufacturing and storage
• ·         Defined areas of adequate size for all activities
• ·         Water supply: continuous and of good quality of purified water or WFI
• ·         Power supply: continuous and uninterrupted power supply
• ·         Adequate lighting, ventilation, air filtration, plumbing sewage, toilet facilities.

What is mean by “Clean-in-Place” and “Clean-out-Place”?

What is the difference between dedicated and non-dedicated equipment?

What parameters considered during performance qualification of HVAC?

What are the sampling techniques used in the cleaning validation?

What do you mean by reconciliation?

What is Master validation Plan (VMP)?

What do you mean by product recall?

What do you mean by residual solvent?

What will happen if cGMP are not followed?

What is retention sample & why retention sample is preserved?

What is As-built clean room (facility)?