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