The document outlines 55 training criteria for a pharmacist quality assurance officer in a quality assurance department. The criteria include in-process checks, final product checks, sampling procedures, complaint handling, calibration processes, documentation maintenance, validation activities, and ensuring compliance with good manufacturing practices, ISO standards, and regulatory requirements. The training is designed to provide expertise across the full quality assurance function.

1. Training criteria of pharmacist QA officer in QA department:
1. In process checks. ( startupprocess,dispensedmaterial checkswithquantity,line
clearance,areacleaning,equipmentcleaning etc)
2. F.G checks. ( final productlabel withmfg.date andExp.Date, outerpackingcondition,weight,
volume,quantity, shipperconditionetc)
3. Incoming material checks. ( verificationof incomingmaterial asperlist,physical condition,
identification,documentsetc)
4. Sampling process. samplingof material aspersop,log bookfillingprocess
5. Dispensing process. dispensingof processasper sopand logbookfillingprocess
6. Inprocess sampling. Inprocesssamplingateverybatch
7. Inprocess complaints. Inprocesscomplaintsatanystepof manufacturingprocess,
fillingorweighingprocess,overprintingprocess,packingprocess,analysisprocessetc
8. Proof reading.Checkingprocessof printingmatterof labels,unitboxes,leaflets,alu.foils,
shippers,all documentsrelevantinBMRand for products
9. Retained samples receiving and entry. Retainedsample receivingprocess,
entry,areamaintaining,expiryrecord,destructionrecordof retainedsamplesafterone yearof
expiry
10. Sale return. Sale returnupdatesfromstore,production,QC,checkphysicallyandchemically
process,redressing,destruction
11. Market complaints and recalls. Market complaints in written form from
supply chain,sample,justificationof complaintfromPM,QCM, and finallyQAM,CAPA with
relevantdocuments,if outof specs,or managementdecision,recallsthe products,check
physically&chemicallyprocess,verificationof samples,R&D process,redressprocessor
destruction
12. CAPA. Corrective andpreventive actionof eachcomplaint
13. Training of workers and officers. Trainingof workersat time of need andnew comers
and as perannuallyschedule andalsotrainingof new comingofficersingeneraland
departmentrelevantandatthe time of needandtroubleshoot
14. Sop writing. Standardoperatingprocedure ineachandeveryprocessinthe plant
15. BMR checking. Checkingof BMR as per all practicallyprocessandspecs.
16. Stability studies. processof stabilitystudies,asperschedule,atacceleratedtemp,real
time,R & D productsand also FG products,trouble shootinproductsalsoinstabilitystudies
17. Calibration process. all the machineryandequipmentinproductionandQCdeptt,will
processof externallycalibrationaftereachfourmonth,andalso some have internally
calibrationdailybasis
18. Fumigation process. fumigationprocessonce in amonth
19. Best team process. as per criteria,processof bestteam
20. Sop revision process. revise the sopas perrequirement
21. Supplier evaluation process. supplierevaluationprocesswithlistof approvedsupplier,
certificateswithvalidity,COAs, annually internal andexternal audit,criteriaforapproval of new
supplier

2. Training criteria of pharmacist QA officer in QA department:
22. Indent checking process. indentcheckingprocessasperapprovedsupplierlist,withvalid
certificates,andexternal audit
23. Master file making process. for making of master file, data collection from the relevant
deptt.,verificationof MO,POand submittedinfile withsignatures
24. Renewal updates process. Renewal of all productswithintime afterregistrationof 5
years,update andtransferto relevantdeptt.
25. Registered product list updation process. updatesthe registeredproductlistaspernew
registrationof productsorany change in products
26. Registration letter updation process. all productsregistrationlettersshouldsoftand
hard recordand updation
27. Dossier record updation. Dossierrecordfollow upinmakingprocess,submission
process,andfinallyassetinQA deptt.,update listinsoftform of all dossier
28. MO checking with label claim. CheckMO as perlabel claimmentionedinregistration
letter
29. Temperature and humidity process in sections. In all section maintainedthe
temp.humiditypracticallyasperspecification
30. Hvac process and pressure in the relevant areas. Hvac processin all sectionattime of
batch processingandpressure of relevantareashouldmonitoredandwithinspecifications
31. Filter washing process. all hvac pre filterswashat everyFridayandalsocleaningof bag
filtersandhepafilterscheckbyDOPtestonce in a year,preventive maintenance of eachhvac
unitinevery6 month.
32. Cleaning of whole plant documents training. For cleaningof plant,like corridorand
each section,changingroom,outerside of productionarea, roof of plant
33. Product review. Productreview of everyproductandeachbatch of annuallybasis
34. Validation. Validationprocess,VMP,processvalidation,cleaningvalidation,equipment
qualification,methodvalidation,hvacvalidation
35. IOM and flow charts process in MS word and MS excel. Processof iomand flow
charts, graphs,and otherdocumentsrelatedmswordandms excel
36. IPQC test training. IPQCtestat starts of compression
37. Section wise training about process of products. Sectionwise trainingabout processof
products withrelevantprocessandprocedures
38. Stores process. all storesprocesslike temperature,settingof material,ledgers,
bincards, release slips,identificationslips,undertest,sampledslips,conditionof material,
closingof material,
39. Engineering process relevant production and QA corrective and preventive
maintenance. engineeringrelatedwork,correctiveandpreventiveprocess,projectsinrunning
form
40. Procurement work process , RM, PM material . procurementrelatedworklikeimport
and local raw material,packagingmaterial ,general material etc
41. PD deptt related process new designing printing matter process. printingmatterof all
runningproductsandnewdesigningof new registeredproducts

3. Training criteria of pharmacist QA officer in QA department:
42. RO plant process. RO plantflow process,manufacturingprocedure of ROwaterand WFI
and theirstorage
43. Security process. trainingof securityaboutinand out andtheir relevantwork
44. Supplychain process. all marketcomplaintsand samples,theirresponse letterandfeedback
aboutproducts
45. Marketing process relevant training. Anycomplaintfrommarket, all stepsin
productionaboutqualityof productsandtargetsfrom marketingteam
46. ERP training. ERP software trainingaboutall steps,like incoming,qcrelease,batchdefine,
material issuance,analysisreleaseorrejected,confirmation,bill payingprocess
47. Presentation process training. All pharmacistinplantpresentationprocessindifferent
processes heldfromQA
48. ISO certification and its relevant documents training. Isocertificationprocessand
preparation aboutisoauditrelevantdocuments
49. CGMP process and training. cGMP trainingtoall workersand technical staff andapplyat
everyprocessinmanufacturing,analysisetc
50. FID inspection preparation and process training at QA end. Preparationof CGMP
inspectionfromFID,renewal inspectionandapproval of new sectiontrainingandpreparation
51. GMP performa. Study and follow upandimplementthe GMPperformaat every
process
52. Whole department Sops one by one training. All departmentsQA relatedsopsandall
QA sopstrainingone byone
53. Handling of troubleshoot in any product, process, material, personnel, premises etc.
trainingof handlingof troubleshootinanyprocessinthe whole plant
54. Meeting details. Trainingandfollowupprocessaboutmeetingslike weeklycoordination
productionmeeting,isomeetings,departmental meeting,CEOweeklymeeting,all staff
meetingsonce inmonth,suppliermeetings,troubleshootmeeting, withagenda
55. Feedback processes. Supplychainwill give feedbackupdate fromall distributorsand
customeraboutproduct annuallybasis
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