API production and quality assurance interview questions

Fish Bone Diagram or Ishikawa diagram (Cause and effect diagram) : Ishikawa diagrams were popularized in the 1960s by Kaoru Ishikawa, who pioneered quality management processes in the Kawasaki shipyards, and in the process became one of the founding fathers of modern management. The defect is shown as the fish’s head, facing to the right, with the causes extending to the left as fish bones the ribs branch off the backbone for major causes, with sub-branches for root-causes, to as many levels as required. Analysis of Fish Bone diagram: Man: Educational Qualification Experience Association with Company Workload 2. Machine: Qualification Preventive Maintenance Breakdown Calibrations 3. Measurement: Inprocess checks Release testing Control sample testing Stability testing 4. Material: Raw material (API& Excipients) Packing materials Semi finished Goods 5. Method: Dispensing Sifting 6. Environment: D...

Process Validation in Pharmaceuticals Manufacturing : What is Process Validation: Process validation is defined as the collection and evaluation of data from the process design stage through commercial production, which establishes scientific evidence that a process is capable of consistently delivering quality product. Process validation involves a series of activities taking place over the lifecycle of the product and process. Process validation activities categorized in three stages, such as Stage 1 as Process Design: The process is defined during this stage based on knowledge gained through development and scale-up activities such as lab scale / trial batches and optimization / pre – validation batches. Stage 2 as Process Qualification: During this stage, the process design is evaluated to determine if the process is capable of reproducible commercial manufacturing with three consecutive validation batches. Stage 3 as Continued Process Verification: Ongoing as...

Health and Hygiene in Pharmaceuticals : Objectives : Review measures to ensure Good Sanitation in: Premises and Personnel Equipment and Apparatus Processes, Materials and Containers 2. To review measures to ensure Good Personal Hygiene Scope  : High level of Sanitation and Hygiene practiced – in every aspect of  Manufacturing.  It covers: Personnel Premises Equipment and Apparatus Production Materials and Containers Products for cleaning and disinfection All potential sources of cross-contamination General points to be Followed : Take daily bath Cut nails and comb hair neatly Use hair covers in all areas (Cap, beard cover, etc.) Do not keep open wounds Person having contagious diseases should avoid contact with other persons and product. Follow the Entry and Exit SOPs strictly while entering in each area Gowning of personnel shall be followed to maintain departmental hygiene Ornaments, Make up, Watches, Pe...

Definition used in Pharmaceuticals  : Batch Number  :  A distinctive combination of numbers or letters from which the complete history of  the manufacture, processing, packaging, coding and distribution of a batch can be determined. Documentation that provides the history of a batch from the raw material dispensing stage to completion of the batch or lot which include Dispensing of raw material, Granulation, Blending Compression, Capsule Filling, Coating, Inspection and yield at different stages. It also includes the details of the activity performed by whom, checked by whom, at what time activity was performed, at what date activity was performed and signature of the personnel involved in the batch or activity. Batch Packaging Record :  Documentation that provides the history of a batch from packaging material  dispensing, Blister packing, Bottle packing, Jar packing, Dry syrup Filling, labeling, Carton packing and shipper packing up to ...

Self Inspection or Internal Audit is a Quality System to check whether activities followed by all departments are according to the written approved procedures and complying with the cGMP and Regulatory Requirements. What are the Objective of Self Inspection : Promote awareness for Quality and CGMP  within plant Proactive approach to identify and correct the non conformance Assure the effectiveness and support continuous improvement of compliance to CGMP and Quality management system. Develop confidence to minimize and possibly to eliminate the scope for major or critical regulatory findings. To identify the non-compliance or Gap with respect to Manufacturing Practices of production, Quality Control systems, quality assurance procedures, engineering practices, environmental conditions etc. Procedure of Self Inspection: Internal audit shall be carried out by an organization of its own system, procedures and facilities It should be conducted in an independent and det...

WHAT IS THE ROLE OF CDSCO : The Central Drugs Standard Control Organization (CDSCO) is the national regulatory body for Indian pharmaceuticals and medical devices, and serves parallel function to the European Medicines agency of the European Union, the Japan, the Foods & Drugs Administration of the United states and the Medicines and Health care products Regulatory agency of the united Kingdom. The Central Drugs Standard Control Organization (CDSCO) is the Central Drug Authority for Discharging functions assigned to the Central Government under the Drugs and Cosmetics Act. CDSCO has a good track record with the World Health Organization (WHO) . CDSCO Reports to Drug Controller General of India (DCGI) Major Role of CDSCO: Under the Drug and Cosmetics Act, the regulation of manufacture, sale and distribution of Drugs is primarily the concern of the State authorities while the CDSCO Authoritie...

Consecutive meaning following closely with no gap or following one after another without interruption. The number of batches to be taken under validation depends upon the risk involved in the manufacturing Critical process parameters & critical Quality Attribute so  depends upon that manufacturer have to choose the number of batches to be validated. If we will consider less than two batches then the data will not be sufficient for evaluation of and to prove reproducibility of data  between batch to batch variation & if we consider more than three batches it can increase the time & cost of manufacturer which usually not preferred. Generally if we will require quality in the First batch, then it is accidental (co-incidental), Second batch quality is regular & third batch quality is Validation or Confirmation. Statistical evaluation cannot be done by considering two points, because two points always draw a straight line so minimum three points requir...

The demonstration that a particular instrument or device produces results within specified limits  by comparison with those produced by a traceable standard over an appropriate range of  measurements. list of instruments calibration in pharma industry: Thermo-Hygrometer Weight Box (E2 Class and coarser) Temperature controller / Indicator Autoclave Mapping Micro pipettes ORP Meter Temperature Mapping Weighing balance Data Loggers Humidity Mapping Glass wares Safety Valve Incubator Hydrometer Magnahilic Gauge Oven Measuring scale Manometer Glass thermometer Caliper Pressure gauges Thermocouples / Temperature Sensor Wobble meter Compound gauges Muffle Furnace Dial gauge Pressure recorder Anemometer Lux Meter Hot-Wire anemometer Temperature recorder Temperature transmitter Pressure Transmitter Humidity transmitter Test sieve Dial Gauge

1.   What is the role of Warehouse in Pharmaceuticals : Warehouse in pharmaceutical plays an important role which includes Receiving of Raw material, Packing material, Finished products, Storage of materials in required storage condition (Temperature and RH), Dispensing of Raw and Packing materials which are required for manufacturing of the batches , Dispatch of Finished (the products which completed all stages i.e. manufacturing and Final packing) products. 2.   What is Good Warehouse Practices (GWP): Good Warehouse Practices (GWP) includes Entry and Exit to warehouse with proper gowning, Receiving and storage of materials in required storage condition, Proper Labeling of Raw and packing materials, Systematic arrangement of materials in warehouse, Use of required personnel protective equipment during dispensing of materials, Storage of controlled drug substances, Training of persons working in warehouse, Verification of Incoming materials with respect to Quantity and...