API production and quality assurance interview questions

HYGROSCOPIC MATERIAL :  A  hygroscopic  substance is one that readily attracts water from its surroundings, through either absorption or adsorption. Examples include honey, glycerin, ethanol, methanol, concentrated sulfuric acid, and concentrated sodium hydroxide  (lye). Hygroscopy  is the phenomenon of attracting and holding  water   molecules  via either  absorption  or  adsorption  from the surrounding  environment , which is usually at normal or room temperature. If water molecules become suspended among the substance's molecules, adsorbing substances can become physically changed, e.g. changing in volume, boiling point, viscosity, or some other physical characteristic or property of the substance. https://www.youtube.com/watch?v=srfsz9UsXSQ https://www.youtube.com/watch?v=RFcbJ15EqEM The word  hygroscopy  ( / h aɪ ˈ ɡ r ɒ s k ə p i / ) uses  combining forms  of  hygro-  and...

SULPHATED ASH : The  sulphated ash  test is an analytical test for determining the inorganic content of a sample by weight. The sample ( usually 1g) is accurately weighed into a platinum, silica  crucible that has been previously ignited, cooled and weighed. https://www.youtube.com/watch?v=SR5Ti89TP-Y

ROLL COMPACTOR : The features of roll compactor are it will improve the bulk density to achieve better granulation of sieve analysis improve product quality and reduce the process cost.

BUFFER SOLUTION : A buffer solution is an aqueous solution consisting of a mixture of weak acid or weak base ,it has the property that the ph of solution changes very little when small amount of strong acid or base are added. The majority of biological samples that are used in researcher are made in buffers especially phosphate buffer saline (PBS) at PH 7.4

DIFFERENT COUNTRIES REGULATORY BODIES : Major Regulatory Agencies World Wide Every country has its own regulatory authority, which is responsible to enforce the rules and regulations and issue guidelines for drug development,licensing, registration, manufacturing, marketing and labeling of pharmaceutical products. 1.  USA  : Food and Drug Administration (FDA) 2.  UK     :  Medicines and Healthcare Products Regulatory Agency (MHRA) 3. Australia : Therapeutic Goods Administration (TGA) 4. India :  Central Drug Standard Control Organization (CDSCO) 5.south africa : The medicine control council(MCC) 6.south korea : korea food and drug administration (KFDA) 7.European union :European medicines evoluation agency (EMEA) 8.Saudi: saudi food and drug authority  Country Name of  Regulatory Authority USA  Food and Drug Administration (FDA) UK Medicines and Healthcare Products Regulatory Agency (MHRA) Australia...

LINE CLEARANCE AND AREA CLEARANCE : What is Line Clearance : Line clearance is a process which provides a high degree of confidence or assurance that the said line or area is free from any unwanted residue or left over of previous processing’s before proceeding for next process. Quality assurance has to provide Line clearance before the start of any activity whether it is batch to batch change over and Product to product change over Criteria of Batch to batch change over : Change over from one batch to another batch of same product and same Strength or increasing in strength provided the excipients is same. Cleaning between batches of same product but in ascending or increasing strength. Criteria of Product to Product change over : Change over from one product to another product. Change over form one product to same product with descending or decreasing strength. Change over between batches / product with different colour/ Flavour / Excipients. Change over after ...

CAMPAIGN CLEANING : Manufacturing equipment campaign cleaning every 30 days once and powder processing area campaign cleaning every 15 days once.

PRODUCTION CONSUMABLE REGISTER (MICRON FILTER) : 1.Micron filters for nitrogen line ----> one year (0.5 micron) 2.Micron filters for process line -----> one micron

INTERMEDIATE TRANSFER SLIP :

PROCESS FLOW DIAGRAM OF THE PRODUCT :

SOP'S - ALL DEPARTMENTS :

DEPARTMENT ORGANOGRAM :

DEPARTMENTAL LAYOUT (PLANT LAYOUT) : 1. plant layout 2. equipment layout 3. fire escaping route plan 4. ahu zoning 

TYPES OF HEAT EXCHANGER   : Types of Heat Exchangers Based on the design characteristics indicated above, there are several different variants of heat exchangers available. Some of the more common variants employed throughout industry include: Shell and tube heat exchangers Double pipe heat exchangers Plate heat exchangers Condensers, evaporators, and boilers Shell and Tube Heat Exchangers The most common type of heat exchangers,  shell and tube heat exchangers  are constructed of a single tube or series of parallel tubes (i.e.,  tube bundle ) enclosed within a sealed, cylindrical pressure vessel (i.e., shell). The design of these devices is such that one fluid flows through the smaller tube(s), and the other fluid flows around its/their outside(s) and between it/them within the sealed shell. Other design characteristics available for this type of heat exchanger include  finned tubes , single- or two-phase heat transfer, countercurrent flow,...