industrial 4 job

  CHROMATOGRAPHY INTRODUCTION  Chromatographic separation techniques are multistage separation methods in which the components of a sample are distributed between two phases, of which one is stationary and the other is mobile. The stationary phase may be a solid or a liquid supported on a solid or a gel. The stationary phase may be packed in a column, spread as a layer, distributed as a film, or applied by other techniques. The mobile phase may be in a gaseous or liquid form, or a supercritical fluid. The separation may be based on adsorption, mass distribution (partition), or ion exchange; or it may be based on differences among the physicochemical properties of the molecules, such as size, mass, and volume. This chapter contains general procedures, definitions, and calculations of common parameters and describes general requirements for system suitability. The types of chromatography useful in qualitative and quantitative analyses employed in USP procedures are column, gas (...

                              warehouse 1.What do you mean by warehouse? Warehouse is the department in pharmaceutical industry where Raw materials (Active & Excipients) and Packing materials which are stored at required storage condition. 2.What are the major responsibilities of warehouse department? - Processing material orders/reservation. - Maintain raw material and packaging material stock. - Operating mechanical and IT systems. - Liaising with production planning, production, quality control, supply chain, transport, suppliers and other related departments. - Training, supervising and appraising staff. - Maintaining statistical and financial records. 3.What do you mean by FIFO & FEFO? FIFO = First in first out FEFO = First expired first out 4.Mention the ICH stability zones? Zone I: Temperate (21°C/45%RH) Zone II: Mediterranean/Subtropical (25°C/60%RH) Zone III: Hot, Dry (30°C/35%RH) Zone IVa: H...

 Quality Risk Management: A systematic process for the assessment, control, communication and review of risks to the quality of the drug products across the product lifecycle (ICH Q9). Quality Target Product Profile (QTPP); A prospective summary of the quality characteristics of a drug product that ideally will be achieved to ensure the desired quality, safety and efficacy of the drug product. Reference Listed Drug (RLD), RLD is an approved drug product to which new generic versions are compared to show that they are bioequivalent. Rheology: is the study of the flow of matter, primarily in a liquid state. It describes the interrelation between force, deformation and time. Robustness: refer to the ability of an analytical method to remain unaffected by small, but deliberate variations in method parameters and provides an indication of its reliability during normal usage. State of Control: A condition in which the set of controls consistently provides assurance of continued process p...

 Acceptance criteria: Numerical limits, ranges or other suitable measures for acceptance of test results. Acceptance quality limit (AQL): The quality level that is the worst tolerable process average when a continuing series of lots is submitted for acceptance sampling. Accuracy: The degree of agreement of test results with the true value or the closeness of the results obtained by the procedure to the true value. Action limit: The action limit is reached when the acceptance criteria of a critical parameter have been exceeded. Results outside these limits will require specified action and investigation. Air-handling unit (AHU): The air-handling unit serves to condition the air and provide the required air movement within a facility. ALCOA: A commonly used acronym for “attributable, legible, contemporaneous, original and accurate”. ALCOA+: A commonly used acronym for “attributable, legible, contemporaneous, original and accurate” that puts additional emphasis on the attributes of be...

 1.What is Out of specification (OOS)? Defined as those results of in process or finished product testing that does not comply with the pre-determined acceptance established in drug applications, drug master files (DMFs), official compendia, or by the manufacturer. 2.What is Out of trend (OOT)? result that does not follow the expected trend, either in comparison with previous results with other stability batches or with respect to previous results collected during a stability study. 3.What is Bioassay? is an analytical method to determine the concentration or potency of a substance by its effect on living cells or tissues. 4.What is Biomarker? is defined as a measurable indicator that can be used to a particular disease state or some other biological state of an organism. 5.What is Precision? The precision of an analytical procedure refers to the closeness of agreement between a series of measurements obtained from multiple sampling of the same homogeneous sample under the prescrib...