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introduction bpharm pci syllabus classification sixth semester size and shape definition objectives disadvantages advantages content uniformity weight variation organoleptic characterisation receiving complaints preformulation in solid dosage forms waste disposal methods compression machines unit 2 compression problems dry granulation preparation maintenance excipients percentage of weight gain in coated tablets benefits types of quality control of tablets hardness wet granulation tablet coating coating equipments coating defects drug recall organisation and personnel equipments quality assurance principles importance facilities accreditation areas approaches to obtain nabl accreditation accreditation procedure introdution test and control articles elements target product quality profile general provisions conduct reporting critical quality attributes protocol regulations unit 1 accreditation nabl material management gdp data storage gwp who guideline characters of a good warehouse types of warehouses disqualification maintenance of stores for raw materials steps of purchasing raw materials purchase specifications of raw materials raw materials purchase specifications of equipments pharmaceutical brief overview of qsem study on q series guidelines stability testing guidelines secondary packaging materials closures goals physical properties chemical properties containers bcs application of preformulation pka ph densities angle of repose bulk characterisation material attribute critical process parameter design space nonclinical study control strategy risk assessment steps of qbd tools of qbd glp design of experimentation doe process analytical technology pat purpose of ich participants of ich process of harmonization disposal types of waste six types reasons nine methods regulatoy guidelines record keeping waste management strategy minimization unit4 returned products general requirement types of documents master formula record batch production record distribution record standard operating procedures statutory recall system recall team stages procedure standard recall letter complaints voluntary handling complaints types technical investigation corrective actions trend analysis documentation of report complaint record book regulatory guidelines personal hygiene authorized person approval and release of finished product location design construction testing facility operation sanitation sanitation in sterile areas maintenance in sterile areas testing facility utilities environment control contamination control air cleanliness selection criteria control tests waste quality audit quality review quality documentation redords documents unit 4 chapter 2 deifinition gmp personnel responsibilities personnel training training system training plan personnel records head of production nucleation state funicular state capillary state droplet state pelletization techniques direct pelletization agitation layering compaction compression extrusion spheronisation globulation spray congealing spray drying cryopelletization pharmacy pharmacist history reciprocating die process accogel machine in process and final quality control tests stability testing packaging storage of capsules gelatin properties hard gelatin capsules soft gelatin capsules nature of the capsule shell and capsule content production of capsules filling and finishing special techniques of hard capsules quality control of hard and soft gelatin capsules packaging and storage of capsules pellets mechanism of pellet formation and growth education and training drug dosage form sterility dose accuracy physical form route of administration solid dosage form powders capsules pills dusting powders insufflation snuffs tooth powder effervescent granules tablets liquid monophasic industry pharmacy career parenterals routes preformulation factors essential requirements vehicles additives isotonicity production facilities production procedure production controls container selection closure selection paranteral products svp lvp injections sticking tablet granulation ideal characteristics of a tablet classification of tablets granulation methods tablet equipment tooling types of coating coatig composition methods of coating quality control of tablets identification markings organoleptic properties types of tablet coating coating materials coating composition evaluation test non -official tests of tablets official tests of tablets head of quality control hydrolysis oxidation reduction racemisation polymerisation solubility profile bb tooling capping compression machine tooling d tooling direct compression dry cota tablet machine importance of granulation lamination multi station rotary press picking single punch machine general appearence pan finishing cloth dusting brushing special techniques of formulation of hard capsules quality control of capsules paracetamol aspirin granules quality control tests of tablets rotary punch machine applications nature of capsule shell nature of capsule content base adsorption factor minim/gram fcator production plate process rotary die process legibility of markings friability api tests thickness of film in coated tablets disintegration dissolution production of hard gelatin capsules size of hard gelatin capsules filling of capsules filling machines capsule finishing punch method hand operated method semi automatic method automatic method dosator principle dosing disc principle finishing methods biphasic