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”?