WHO Basic Training Modules On Good Manufacturing Practices

 

G ood Manufacturing Practices (GMP) WHO Basic Training Modules on Good

  Basic Principles of GMP: Module 1

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Introduct ion to the Introduction t he training course [1-2 hours] ho urs] Quality Qual ity managem man agemen ent [4 hours]  hours]   Sanitati Sani tation on and hygien hygi ene [3 hours] hour s]  

 

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Qualifica tion and Validation [3 hours] Qualification h ours] Complaints and recall s  s [4 hours]  hours]  Contract production and analysi s  s [3 hours]  hours]  Self-inspection Self-inspect ion and Quality Q uality udit ud its [3 hours] hour s] !ersonne !erso nne l [" hour hours] s]  

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!remise !rem ise s [4 hour hours] s]

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#$ui pmen t [" hours #$uipmen h ours]]  %aterial s [3 hours]  hours]  &ocumentation '1 '1( '2( [" hours] )ood !ractices !ractice s in !roduction !roductio n and Quality Contro l [* hours] hour s]   Sterile production  production  cti+e ct i+e !har harmac maceut eutica ical l Ing ngre redi dien entt [3 ho hour urs] s]

 GMP Inspection Process: Module 2

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Introduction [1 hour] ,he role of the inspector [2 hours]  hours]   !reparation !reparat ion for an inspection [2 hours] ,ypes of )%! inspection [3 hours]  hours]   ,he insp inspecti ection on [2 hour hours] s]

 

Trainer's otes ,hese notes complement the ./ training programmes 0asic !rinciples of )%! )%! Inspection !rocess and four ad+anced ad+anced modules modules 'supplementar 'supplementary y training training modules( ,hey should should e used to assi assist st in the preparation and deli+ery of courses using some or all of the modules from the to programmes ,he tr train aining ing pro progr gram ammes mes ha ha+e +e ee een n pre prepar pared ed to all allo o the cou course rses s to e gi+ gi+en en it ithou houtt fur furthe therr de+elopme de+e lopment nt of cour course se mate material rial .oe+ .oe+er er it is essential that the tra trainer iner has suff sufficient icient first-hand first-hand e5perience of the pharmaceutical manufacturing to e ale to pro+ide e5amples and case studies oth during the presentations and in the group sessions sessions It is also important that local issues are considered considered throughout the course ,he asis of all materials is the rele+ant ./ ,echnic ,echnical al 6eports  full list of these reports is gi+en at

 

the end of these notes In order to e5plain the te5ts te5ts different ords ords ha+e een used in the training training modules to illustrate each of the 7ey issues

  !ourse Material #ach module is ased on appro5imately $uarter day units of 2 hours each 'see ao+e regarding timings of modules( &epending on the su8ect there ill ill e 1 2 3 or 4 units to a module #ach unit is made up of a 39-:9 minute presentation a group session lasting 39-:9 minutes a plenary feedac7 session of appro5imately 39 minutes minutes depending on the numer numer of groups )roup sessions rely rely on rainstorming rainstorming ,he trainer should should e prepared to e5plain the techni$ue ,he modules also ha+e ha+e a short test to assess understanding y the trainees ,he course material is di+ided into to parts - the trainer;s inder and the trainees; inder

  Trainer's Binder  

,he trainer;s inder consists of the folloing items< •

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O8ecti+es of module  Transpar  T ransparencies encies and spea7er;s notes or7sheets ,est papers and ansers

Form for personal action !lan Form for e+aluation

,he o8ecti+es of the module are co+ered y the second transparency in each case ,he spea7er;s notes are not intended to e read aloud as a lecture 6ather they are pro+ided as resource material or as memory 8oggers as it is e5pected that the trainer should ha+e a good understanding of the )%! issues already ,he or7sheets consist consist of the group $uestions &iscussion points are are gi+en at the end of the spea7ers;  spea7ers;  notes ,he trainer and his=her his=her team should mo+e eteen the groups and and facilitate the discussion y raising the points if they ha+e not already een co+ered y the group themsel+es Since the trainers are li7ely li7 ely to +a +ary ry et etee een n e5p e5peri erienc enced ed ins inspec pector tors s and ne rec recrui ruits ts it ith h no ind indust ustry ry e5p e5peri erienc ence e the $uestions are +aried accordingly ,rainers should also thin7 aout cultural implications ,he test papers ta7e the form of multiple choice $uestions that can e mar7ed y the trainer in a short period perio d of time and can e used to ident identify ify areas that re$uire re$uire further further e5planation e5planation and discussion discussion >or good learning it is important to re+ie the $uestions and ansers ith all participants ,he training course should not stand in isolation ut should e seen as part of the ongoing de+elopment of the inspector .ence there is a form for a personal action plan that should e completed y each trainee during the course course s a result of the +arious modules modules indi+iduals ill identify specific o8ecti+es o8ecti+es that they ish to ta7e ac7 to thei eirr or7place /8ecti+ i+e es should e de+eloped in the "M#$T "M#$T format<  format< "pecific Measurale #ction-oriented $ ealistic ealistic and Time-related ,he columns for o8ecti+e and actions should e completed during the course and may need the help of  the trainer or other other memers of the training training team If possile the columns for responsiility and due date should also e completed although these may need to ait until the trainee has discussed the

 

o8ecti+e his=her super super+iso +isorr and colleagues colleagues ,hese action action plans should then e transferred transferred onto o8ecti+e ith his=her e+aluation forms and used to monitor progress o+er time ,hey can e used as part of formal appraisal meetings y the super+isor of the participants if appropriate

  Trainees' Binder ,he trainees; inder consists of the folloing materials<

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O8ecti+es of module .andouts including space space for personal personal notes ,est papers !roforma for !ersonal ction !lan Course e+aluation and feed ac7

,he o8ecti+es of the module are co+ered co+ered y the first couple of transparencies transparencies in all cases cases ,he handouts include copies of all transparencies ithout the spea7er;s notes ith space for the trainee;s on notes ,hey also include copies of ./ te5ts on )%! 'See 0iliography( If felt to e appropriate the complete spea7ers; notes can e handed out as a reference document %ut t&is s&ould onl %e done after t&e odule is copleted and not in adance adance  ,he test papers are the same as those pro+ided in the trainer;s inder e5cept that the ansers ha+e een remo+ed from the te5ts ,he forms for !ersonal ction !lan and #+aluation >orm >orm are identical to those pro+ided in the trainer;s inder

  "c&edule of Modules ,he modules that ma7e up each training shon ao+e #ach module stands alone alone and training programme are shon hence a course can e made up in any order .oe+er it is recommended that the Basic Principles of GMP e GMP  e presented efore GMP Inspection Process Process dditional training modules on .VC Validation Inspecting Quality Control ?aoratories and ater for !harmaceutical !harmaceutical @se are also a+ailale If the latter is presented alone a asic understanding of )%! should e a pre-re$uisite for attending the course

  ote &epending on the numer of trainees on the course ,he numer of groups and hence the time re$uired for the feedac7 sessions ill ill +ary +ary ,he shorter time ill e appropriate for up up to 2" participants and the longer time for up to "9 participants ,imes gi+en for the presentations are appro5imate ,ra ,rainers iners should present the materials y adding practical e5amples here possile

  Bi%liograp& ,he folloing documents ha+e een used as the asis of the course material< Quality assu Quality assuranc rance e of phar pharmace maceutica uticals ls – A comp compendiu endium m of guideli guidelines nes and related mate materials rials Volume 1, )ene+a orld .ealth /rganiAation 1BB*

 

  Quality assurance of pharmaceuticals – A compendium of guidelines and related materials Volume 2: Good manufacturing practices and inspection, )ene+a orld .ealth /rganiAation @pdated edition 2994   WHO !p !per ertt "om omm mit itttee on #pe pec cif ific ica ati tion ons s forr fo $harm rma aceu euti tic cal $rep epa ara rati tion ons s  %hirty&'inth (eport  )ene+a orld .ealth /rganiAation 299" './ ,echnical 6eport Series o B2B(   nne5 2< )ood %anu %anufactu facturing ring !ra !ractic ctices< es< re$ui re$uiremen rements ts for the samp sampling ling of star starting ting mate materials rials 'amendment(   nne5 3< ./ )ood %anufacturing !ractices< ater for pharmaceutica pharmaceuticall use   WHO !per !pertt "omm "ommittee ittee on #pec #pecifica ifications tions for $ha $harmac rmaceutic eutical al $rep $reparat arations ions )ort )ortieth ieth (epo (eport  rt  )ene+a orld .ealth /rganiAation 299: './ ,echnical 6eport Series o B3*(   nne5 nne 5 2< Suppl Supplement ementary ary guidel guidelines ines on )%! for heat heating ing +ent +entilati ilation on and airair-cond condition itioning ing systems   nne5 3< )ood manufacturing practices practicesa5 '41 22( *B1 4D9: #-mail< oo7 oo7orde orders rs Eho Ehoint int

 

$elated lin+s •

)%! Supplementary ,raining %odules< Validation ater ir .andling Systems