gmp plant layout gmp jbk 001 2012

1

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!^=)^=@)^&, la/u+h, g]kfn02.10.2010 GPANGMPQSTNEP JBK 1001

02.10.2010 GPANGMPQSTNEP JBK 1001 2

p4]Zox? (Objectives)

hLPdkLsf cfaZostfx? Aff/]df hfu?ktf Nofpg] (Develop awareness on GMP requirements)

hLPdkLsf] k|efasf/L sfo{Gjogdf ck]6/x?nfO{ pT;flxt ug]{

(Motivate operators for effective implementation of GMP)

hLPdkLsf] k|efasf/L sfo{Gjogu/L u'0f:t/Lo cf}iflw pTkfbg Ifdtf clea[lw ug]{

(Improve capability for manufacturing quality medicine with effective implementation of GMP)


u'0f:t/af/] rlr{t kl/efiffx? cfa:ostf cg'?k ePsf] "conformance to requirements"

(Crosby)

ahf/sf] dfu adf]lhdsf] ul/Psf] k|efasf/L pTkfbg “efficient production of the quality that the market expects" (Deming)

Kf|of]usf]nflu ldn]sf]M a:t' sfdsf] / v/faL gePsf] "fitness for use"; "product performance and freedom from deficiencies" (Juran)

;dfhnfO{ xfgL gug]{ "does not impart loss to society" (Taguchi)

cfaZostf cg'?ksf ;du| rl/q ePsf a:t' jf ;]jf "the totality of features and characteristics of a product or service that bear on its ability to satisfy a given need" (American Society for Quality

Control)

u'0f:t/ (Quality):


u'0f:t/Lo cf}iflwsf rl/qx? (Characteristics of a drug quality)

;lx ;ls|o tTj ePsf] (Identity): correct active ingredient is present

xfgLsf/s kbfy{ /lxt ;'4 ePsf] (Purity): not contaminated with potentially harmful substance.

cfaZos dfqfsf] ;ls|o tTj ePsf] (Potency): correct amount of active ingredient is present (95-110%)

cfaZos u'0fx?df ;dfgtf ePsf] (Uniformity): no variation in consistency, colour, shape and size of dosage form

Zfl//leq cfaZos sfd ug]{ u'0f ePsf] (Bioavailability): consistent to provide predictable therapeutic result

Dofb eP;Dd sfd ug]{ u'0f ePsf] (Stability): ensured expected activity until stated expiry

kmdf{sf]lkof cg'?ksf] :tl/otf ePsf] (Pharmacopoeial Standard): meets standards described in a widely accepted pharmacopoeia


u'0f:t/ k|Tofe"t [Quality Assurance (QA)]

c;n pTkfbg cEof; [Good Manufacturing Practices (GMP)]

u'0f:t/ lgoGq0f [Quality Control (QC)]

u'0f:t/ Aoa:yfkg [Quality Management (QM)]

The concepts of QA, GMP and QC are interrelated aspects of Quality Management

u'0f:t/ ;DaGwx? (Quality Relationships)


c;n pTkfbg cEof; -lhPdkL_ u'0f:t/ k|Tofe"ltsf] Tof] c+z xf] h;n] k|of]u ;'xf+pbf] -u'0f:tl/o, c;/o"St, hg;'/lIft_ / cf}iflw Joj:yf ljefun] tf]s]sf] cfaZostf k'/f ePsf] u'0f:tl/o cf}iflwx?sf] b[9tfsf;fy pTkfbg / u'0f:tl/otfsf] lgoGq0fsf] k|Tofe"lt ub{5 . Good manufacturing practice is that part of quality assurance which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use (quality, efficacy and safety) and as required by the marketing authorization.

c;n pTkfbg cEof; -hLPdkL_ (GMP) ?


hLPdkL d'Vo?kdf cf}iflw pTkfbgsf] bf}/fgdf cfOkg]{ vt/fx?nfO Go"lgs/0fsf] sfo{df nlIft 5 . GMP are aimed primarily at diminishing the risks inherent in any pharmaceutical production.

vt/fx? Ps cf}iflw;+u csf]{ cgfaZos cf}iflwsf] ld;fj6 cross-contamination (in particular of

unexpected contaminants)

Ps cf}iflw csf]{ cf}iflw;+u ldl;g' / Ps cf}iflwnfO csf]{ cf}iflwelg n]an ul/g' mix-ups (confusion) caused by, for example, false labels being put on containers and

cfsZos dfqf eGbf clt sd jf clt a9L ;ls|o tTj eO k|efasf/L pkrf/ gx'g' jf grflxbf] c;/ x'g' insufficient or too much active ingredient, resulting in ineffective treatment or adverse effects

c;n pTkfbg cEof; -hLPdkL_ (GMP) ?


hLPdkLsf] ;fwf/g k[i6e"ld (GENERAL BACKGROUND OF GMP)

hLPdkLn] cf}iflwsf] u'0f:tl/otf, sfo{ Ifdtf / ;'/lIfttfdf 7'nf] e"ldsf v]Nb5 h'g hg :jf:Yodf k|ToIf ;/f]sf/ /fVb5 GMP plays vital role in quality, efficacy and safety of drugs - a matter of concern for the public health

hLPdkLn] d'Vo?kdf cf}iflw pTkfbgsf] bf}/fgdf cfOkg]{ vt/fx?nfO Go\lgs/0fsf] sfo{df nlIft ub{5 h'g tof/L a:t'sf] kl/If0faf6 yfxfkfpg ;lsb}g GMP rules - directed to diminishing risk, inherited in drug production, that cannot be prevented by end product testing

hLPdkLsf] cawf/gf cg'?k cf}iflwsf] u'0f:tl/otf ;'?b]lv agfOPsf] x'g' kb{5 gsL kl5 yKg ;lsG5 Quality must be built into the product, Quality cannot be inspected into the product

hLPdkL u'0f:tl/o cf}iflw pTkfbgsf] sl; xf] GMP compliance - a criteria to judge for quality


hLPdkL]sf] ;fwf/g k[i6e"ld (GENERAL BACKGROUND OF GMP)

hLPdkLn] la/fdLn] u'0f:t/lxg cf}iflw slxNo} gkfcf]; eGg] cawf/gf /fVb5

hLPdkLn] cf}iflw lbg] / pTkfbgug]{ ;+:yfk|lt la/fdLsf] bl/nf] laZjf;sf] lasf; ub{5

hLPdkLsf] cawf/0ffn] cf}iflwsf] hf+r k|ls|ofdf /x]sf l;ldttfaf6 u'0f:t/df kg{ ;Sg] gsf/fTds k|efasf] Go"lgs/0fdf dxTjk'g{ e"ldsf v]Nb5


hLPdkLsf] cawf/0ff s;/L z'?jf6 eof] < (How GMP Initiated ?) OlynLg UnfOsf]n nfO{ k|f]kLnLg

UnfOsf]n elg n]an ul/bf To;sf] k|of]uaf6 gfO{h]l/ofdf !)( hgf aRrfx?sf] d[To' x'g' (Mislabeled ethylene glycol as

propylene glycol-death of 109 infants in Nigeria)

Kff/fl;6fdf]n cf}iflwdf 8fOlynLg UnfOsf]nsf] laifflwd'ns k|efan] To;sf] k|of]uaf6 xfO{6Ldf *( hgf aRrfx?sf] d[uf}nf v/fae} d[To' x'g' (Diethylene glycol poisoning in paracetamol product-death of 89 children form kidney failure in Haiti 1996)

Ps cf}iflw csf]{ cf}iflw;+u ldl;Psf] -S|m; sG6fldg]zg ePsf]_ sf/0fn] ePsf c;/x? h:t}M cGo cf}iflwdf Kf]gLl;lngsf] ld;fj6n] ePsf cnlh{sf ;+s]6x? (Cross contamination causes serious effects- Penicillin

contamination)


hLPdkLsf cfwf/e"t cfaZostfx?

(BASIC REQUIREMENTS FOR GMP)!=:ki6?kdf k/Leflift, k|0fflnut?kdf n]lvPsf] pTkfbg lalw Clearly defined, systematically reviewed manufacturing processes

@=oGqx?sf] of]Uokg / pTkfbg oGq jf sfo{ lalwsf] pko'Sttf l7s 5 elg ul/g] k|ls|of Qualification and validation

#=;\xfpbf] >f]tx?M dflg;, pTkfbg If]q, oGq, ;fdfg, k|ls|of / lgb]{zg Appropriate resources: personnel, premises, equipment, materials, procedures and instructions

$=:ki6?kdf lnlvt k|ls|of Clearly written procedures

%=tflnd k|fKt ck/]6/x? Trained operators


hLPdkLsf cfwf/e"t cfaZostfx?

(BASIC REQUIREMENTS FOR GMP)^=k'0f{ clen]v k|0ffnL Complete record system

&=pko'St e08f/0f / lat/0f k|0ffnL Proper storage and distribution

*=pTkfbg lkmtf{lng] k|0ffnL Recall system

(=l;sfot ;DxfNg] k|0ffnL System for complaint handling


!=;/;kmfO{ / :j:Yotf (Sanitation and hygiene)

pTkfbgsf] x/]s s'/fdf pRr:tl/o ;/;kmfO{ / :j:Yotfsf] cEof; ug'{ kb{5 . ;/;kmfO{ / :j:Yotfsf] cEof;sf] bfo/fleq AolStut ;/;kmfO{, pTkfbg If]q, pTkfbg oGq, pTkfbgdf k|of]u ul/g] kbfy{x? / at{gx?, ;/;kmfO{ / lhafg'gf;ssf] nflu rflxg] a:t'x? / cgfaZos ld;fj6sf] >f]taGg] s'g}klg lrh cflb kb{5 . A high level of sanitation and hygiene should be practiced in every aspect of the manufacture of drug products. The scope of sanitation and hygiene covers personnel, premises, equipment and apparatus, production materials and containers, products for cleaning and disinfection, and anything that could become a source of contamination to the product. Potential sources of contamination should be eliminated through an integrated comprehensive programme of sanitation and hygiene.

hLPdkLsf] d"Vo c+zx? (PRINCIPAL COMPONENTS OF GMP)

hLPdkL dflyNnf] Aoa:yfkg tyf pTkfbg / u'0f:t/ lgoGq0f Aoa:yfkg kIfsf] ;+o"St lhDd]jf/Lsf] sfd xf] . Joint responsibilities of top management and of production and quality control management)


@=of]Uokg / pko'Stkg (Qualification and validation)

hLPdkL cg'?k k|To]s cf}iflw sDklgn] pTkfbg sfo{ k4tLsf] ;+a]bglZfn kIfx? cfaZostf cg';f/ lgolGqt 5 elg l;4 ug{ cfaZoskg]{ of]Uokg / pko'Stkg ;DalGw sfo{sf] klxrfg ug'{ kb{5 . sDklgsf] of]Uokg / pko'Stkg ;DalGw sfo{s|dsf d"Vo tTjx? :kI6?kdf kl/eflift ug{'sf] ;fy} pko'Stkg u'? of]hgfdf clen]lvt ul/Psf] x'g' kb{5 . In accordance with GMP, each pharmaceutical company should identify what qualification and validation work is required to prove that the critical aspects of their particular operation are controlled. The key elements of a qualification and validation programme of a company should be clearly defined and documented in a validation master plan

hLPdkLsf] d"Vo c+zx? PRINCIPAL COMPONENTS OF GMP


#=l;sfot Aoa:yfkg (Complaint Handling)

;a} l;sfot / cf}iflwsf] v/flakg ;DalGw ;"rgfx?nfO{ lnlvt sfo{lalw cg'?k /fd|f] tl/sfn] 5fglag ul/ ;Rofpg] sfd ug{' kb{5 .All complaints and other information concerning potentially defective products should be carefully reviewed according to written procedures and the corrective action should be taken.

$=pTkfbg lkmtL{ (Product recalls)u'0f:t/df v/fla5eGg] yfxf ePsf jf ;+vf:kbePsf cf}iflwx?nfO{ ahf/af6 t'?Gt} lkmtf{ lng] Aoa:yf x'g' kb{5 . There should be a system to recall from the market, promptly and effectively, products known or suspected to be defective.



%= Zjlg/LIf0f / u'0f:t/cl86 (Self-inspection and quality audits)

Zjlg/LIf0fsf sfo{s|dnfO{ lgoldt ;dosf] cGt/fndf lhPdkL nfu''ug]{s|ddf x'g] sldsdhf]/Lx? kQfnufpg] / cfaZos cg?k ;Rofpg] sfo{sf] l;kmfl/; ug]{ ul/ l8hfO{g ul/Psf] x'g' kb{5 . The purpose of self-inspection is to evaluate the manufacturer’s compliance with GMP in all aspects of production and quality control. The self-inspection programme should be designed to detect any shortcomings in the implementation of GMP and to recommend the necessary corrective actions with regular interval.

u'0f:t/cl86 eGGffn] u'0f:t/ clea[lw ug]{ x}l;otn] u'0f:t/ k|0ffnLsf k'/f jf cf+lZfs efusf] kl/If0f ul/g] sfo{nfO hgfpb5 . u'0f:t/cl86 ;fwf/gtof Aoa:yfkgn] ;+:yf aflx/sf :jtGq la1x?nfO{ ;dfa]; ul/ agfOPsf] ;d'xJbf/f u/fO{G5 . It may be useful to supplement self-inspections with a quality audit. A quality audit consists of an examination and assessment of all or part of a quality system with the specific purpose of improving it. A quality audit is usually conducted by outside or independent specialists or a team designated by the management for this purpose



^= cfaZos AolStx? (Personnel)

pTkbsn] lhDd]jfl/k'a{s ug{'kg]{ ;Dk'g{ sfdsf]nflu cfaZosdfqfdf of]Uo AolStx?sf] Aoa:yf x'g' kb{5 . k|To]ssf] AolStut sfo{;+Dkfbg lhDd]jf/L{ :ki6?kdf kl/efliftul/Psf], ;DalGwt AolStn] /fd|/L a'em]sf] / lnlvt clec]v /flvPsf] x'g' kb{5 . There must be sufficient qualified personnel to carry out all the tasks for which the manufacturer is responsible. Individual responsibilities should be clearly defined and understood by the persons concerned and recorded as written descriptions.

&= k|lzIf0f (Training)

pTkfbg sfo{df ;+nUgx'g] ;Dk'0f{ AolStx?nfO{ cfaZos 1fg / l;kaf/] pTkfbsn] lnlvt sfo{s|d cg'?k ;do ;dodf k|lzIf0f k|bfg ug'{ kb{5 . The manufacturer should provide training in accordance with a written programme for all personnel whose duties take them into manufacturing areas or into control laboratories (including the technical, maintenance and cleaning personnel) and for other personnel as required.



*= AolStut :jf:Yo Personal hygiene

pTkfbg sfo{df ;+nUgx'g] ;Dk'0f{ AolStx?nfO{ sfdug{ clw / sfdul//x]sf] ;dodf :jf:Yo kl/If0f u/fpg' kb{5 . cf}iflwsf] b[li6ut k/Lif0f ug]{ AolStx?sf] ;fdlos g]]q kl/If0f u/fpg' kb{5 .All personnel, prior to and during employment, as appropriate, should undergo health examinations. Personnel conducting visual inspections should also undergo periodic eye examinations.

(= pTkfbg If]q Premises

pTkfbg If]qsf] :Yffg lgwf{/0f, 9f+rfsf] agfj6, ejg lgdf{0f, dd{t;Def/sf sfo{x? ;+rfng ;'xfpbf] ckgfpg' kb{5 . Premises must be located, designed, constructed, adapted, and maintained to suit the operations to be carried out.


Premises

02.10.2012 19CIST PHT303 JBK PM 1203

Premises

02.10.2012 20CIST PHT303 JBK PM 1203


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gmp plant layout gmp jbk 001 2012

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