Tftffft TMEQ TgT*-3M<M/99 irfrfBWl KEQD.N0iD.L.-33ttW9 (Hie (Baxette of 3ud\a EXTEAOWXNAAY 1PI H^W»¥ 3 — * * - W (f)
PART II—Section 3—Subjection (1) PUBLISHED BY AUTHORITY tf. 390| ^ ftwfrp # W T , TOST 10, 200a/WI^ 19, 1930 No. 5401 NEW DELHI, MONDAY, NOVEMBER 10, 20WKAKTIKA 19, 1930 1 — • - - • • " ' - . - M n r sftr f̂t*TT ^ n u r Tfcnm (MIW ftlHI) STfâ SPTI M feft, 10 W*T, 2008 w,^r,fa, 780( 30.—afafa 4 r imm îraft tor, 1945 ̂ 1 ^ tfritoi ^ ^ fan ^jfim ft*rif ^T 3fl^T, 3fafa 3̂ T TOt*H * r t SffafaiTO, IW0 ( lW0 3iT23)^t**HI 12 *fo 33 ^ ^ W ^ I R *nw*R*ER^^rrc**i afoTTft̂ R *^r"Ji Tt5fWT (^snwf^m) tff srfa^ntf. m^ifr. 63(30,inter 13 3*^ ,2006^ ^ ^ T O ^ ^ R ^ a ^ ! * ^ , ^ 1 1 , ^ 3 , ^ - ^ ( i ) , t T * t a I3 3W^T, 2006 B^T aipiiq^n^^raira^i ^t uf̂ qf ŝnar ̂ ^ i ? m ^ tf ^nft ^^?i#ra far*>t srafa ^TOifa 3^T, TF3N^ ^ Tlfalf ^rai ^ 13 3 1 3 ^ 2006 ^ Bq?W ^IF ft ^ *ff 3fa W ^ I HWTC 3 "3S?l HIF̂ T iwflf ^ Tfâ f̂ jRtn ^ UF̂ I aflifiNI afa y^nT ^ ERR ^T fa*n $ i ^ fe^ PlHfrlfyd f^PT ^!Rfr t , 3T*rf?I j — , i. (i > ^ fcpff ^i tff^r TO afafa sfa w t n (tffew f̂oftar) ft*i*r, 2008 £ i
(2)^ M 1-2010 ̂ H ̂ ^ft I 436* 01/200* fl) 2 THE Q AZFTTEOFINDCA; EXTRAORDINARY^ [PART ll—Ste; 3flil 2* afafe 3&T JTCIflH ^nnft P m 1945 % ($R* ?H*I ^ 1 * ISRuJ v3«f » j) F m 74 $ ^3 {̂ J ^ fl3flwT ^ $ ^TC^, PMfaRlKI ii) $m 78 % ^5 (a) % "wtim* w$ * q s ^ Pt^fcw iii) £m 150 s* $ iste fa) 3 1*m lso V ^ $ <ra^ ^ 3 1 ^ 3-1 * (ft*F? 74, 78 A t 150 3. H ) l* uran«i sflttrc :- 3TFWF l / # ^ q qi^'% 3TOrft $ fa? fate #T <TT 5flf̂ cT ?t #r i^t fito ^r A factor 3^mi T̂ *#TTI *r. «ar f^ *ra*n>, sniteiw ^ V3TPT Ji^wRir arcs* % far <w»## Ntaif 5TTT T̂PT ^ , ^T ^f l l^t TPf M&TCT * ^ B R 3*faft sto f̂c, «ift ato T ̂ T ^ ;
anarit 7̂ ;
iH) <mim iffiwft ^t ^ $ fair F R q Sl^HI^R % f?flj # T# *fap qpft, ft^ #7* % %fr ^TOtff * f^n 4 iv) &l tf 3IWIW R*lrfV * ^T-TfeT «HdM Î gfrH^cT $m a^WT #ft 3?ft *jfc 3TWR5 £t tft q*TT * ÎVlPfJl ^ *ft eq^ir 4 THE GAZETTE OF INDIA; EXTRAORDINARY IPAnrll—Sr.c.3tiM w H % ^i4 ^t ^ T T <TT srf̂ jer s m T̂ q%i *T. ? t t *fr <2J<CT ftf TOT ?tft $5 3fl% 3ftcT T^-T^FI 3 i ^ # AT ftam-Ttsft it cr«n ^?t tps w ?t ^ l^ft =r f&s T^T stfti ^n?R) $m t 1996 $ 3 ^ N t $ GFJflTT ^ *fiT l^T yTl̂ TTt ^. 3%?MT ^ 3J^T *(5TC*T 5S1TA ^ TTTO <#<r ?«Jff ^t aTOfl ^r^rtt Hprtf ^r ^ £ Urc AT SOT - S ^ F T tor 5TO?IT **H3> ^rt^FT *tor (^A.<ft.) ^nr ^t ^wft i ST. f%*fisRT A T 3|fa4fad i f r 3 ^ t ^ f t TT ^ i q t - ^ T *fil ST^TOT ST. ^ ^ :- ^ ^ ^gA ^ , j ^ T ^ ^t *Fmt 3 rf̂ rr was #t£t< tii.) ^ T T ^ J % T ^ *l 3fa?T ( ^ i q ^ I ^ ) ^ uTn̂ TT A T rvmn—^"rjfflj gKa*if*t*tnr:3WTOrc*t V.) <̂ J3lf % 5T3OT ^ ^ T f f i , TO-7^, WBlf *TT ^^(TT $ IcR ^ *$m STto cfaTT *ft W^ft ftfttf ^ # % Ffaft fatf SfacT 5FFRT $t ^ Wmi ?t ^ T ZW& PplPRT
3. «lM+ :- ^ *Pft d^ l? ST^RR 3Tftfej<sl' T^T WWW *r. a^RiRir ^r sran g**r <*n™te #q?n *H*TT ajfar star ^ I # T i) TTOT 3*a**ffi 3ff*fil, 4feU f̂rM«l w f t SR^T ^ j t ii) *iii?tft jpn# ^ ^aHritar m ^FTT oik OTTÔ R- OT Hi) creM Rnsm^ ̂ 3 F ^ ; afft toifar^i sifaT s i te 5fan 6 THE GAZETTE Of INDIA: EXTRAORDINARY I PACT II—Sec,3ffll (*r.) OT*T OT**T fa TO zm-m ^r T̂PT m* ? ?&B W T *fPFTTI (*r.) ^ srerfaFT 3q^iu?l ^r frqfaw 3f?m# <TT sraraitsFT fc*TT Efa*rT3Tf % **q 3 M^rf ft^T ^ t I
(i) vjq^R / T # T / 3 W I ^ T̂*T ;
(ii) Wninf ^T T̂PT, 3f^r ^ r CM q r̂R =PT WRIT,
(iii) *R w
(iv) ^ ctrtfa to ^ sqrof ib srafiw *f sn̂ tor "PIT;
(V) <fifapT 3TWFT ;
(Vi) m ^ OTT T̂T (3STOT % t^r, ^TT, 3 q % tor Wj 5̂ : to tor w);
(vii) fcMfff $ f̂tqieFT ftM ^t SffrT
(viii) oq?nqH $i «II«IWI (JX) 7^-WR ^ 41'fcll WI
(xii) 3 W P R ^ ^
(xlii) snft̂ f S ^ N K M / T O M " ! ^ ^ t i
(xiv) fW *fr * , s^rit, wforr a m &*mt nv^
(xv) * fa?r ^T * k OTim *rfr ^ A, * ^ fh T. ? f ^ ^ * T F T %̂ ̂ qr ^ i j t t a^rof, 3<WTT <rc ^r <ra> SFJTCH ^r4 M ^JWMIHM S^R^K turn wf l teT am $3*IT s. sircta^ (*iro w *rat) 3>fr ^ M H , ^ i r ftfe Hf-wui nteait $ a THE GAZETTEOF INDIA: EXTRAORDINARY [pAHT|l^-SEC3(i)| mv\\<*> $K ^itor *rrc ̂ ^ ^T ^m 3 ^ w$\\ *p qar $ toll 4fe-Tmrcte y*ft ih, -afrr ? # ^ T 3 ftf^ ^nt ^ tori!, TIR^ fa^mf. 3Frf^ ton! $t <Wr ̂ ^ ^>
3. ?&$ tent ^ ^ ^ tonf % ^ r r qr frRf^?r ^ i. î vta^ Tw^^rt ^T r̂rc for^t ft^H ̂ nr tori in, s^E aTFRf̂i ton qr flrfcfr 7̂ i ^ spfrr ^ f?rc Ft ^t fo ^CR? % isftm qr ffafffo smr i [HWn—^U3(i)l MHA *i (wfi; wnuuui » Sfifo <b*klfffi ^t fttTT $ flraTTT ÎT ft$lT fafa<T ft&T W\ % H?ft̂ T fe «W$\ (^lif^I $ far, qh?T Jrafr, ^ OTTO q^rit îrcrit # t ii. sratTOffiTflf ^ < H ^ ^ T *gRIT ^ *fr ^FrfcT 1 * irffcpr %'?ei^ $ ^ # ^M?I*I ^rr^t ?mt%i ^3 6 0 * ^ - / 0 5 - ^ M THECAZETTEOFINMA: EXTRAORDINARY iPARTll^SECJ^| ^RTF^f, a#T W # T %T HTFfif ^l S % TOT .# vi) epfaift̂ t̂ w t o fatal n^M, 3TNOT#T tmm *THT ^ f e ; 3?TT vii) Slfaf %T ftrfefeff $ * f f iH Wft T̂HT ftqrff T̂ W T *OT 3Tfadl4 ePTT q**î lftf4 $ S l tofa TOT TT ̂ T̂PT (T) srit*ra»3ft 3 *rc# ^ 3i# ^TT g^nW:- i) 3%¥ncTT 3 3facT **lHf <TT ̂ Fft $ * p t ?FTT% ^ t I H) $%$& ft^tAfl^Tvft IT ^ f t^ fa W* fl^FT 3̂ T 5I#T fa^ ill) tffa frtf^T T ^t 5TT fl^ 31̂ 1 aStT *3"d<W Jlftft5*fl3Tf ^ San w^t 3fa ft stew ^ vsnfr ) %rprir, qmiftqf iv) * ^ ^i *ras% *rsrc*i # r Pmen $ t ^ sfa?r ^fciui 3'KW ^nft ^nttfti 3TO grl^f f̂ THR T̂ t ^ W 35T 4*W=fc $ <#M?T:
^H«fl(l ft Wrft 3HTffl^TT*f*frfa>*jft3lT ^> *R*t *r# 5Jn%^ gwir H M * I M $ ^ IT3 *ft wq> ̂ JIH*I{1 J $. s#mrar ^ jroto ^ ^ ^ wm OTqrft sroit sftr $Htt gpatf ^ T ^ îffcrif 3ww ^ M $ fcm afar ftfori fm tftom amnj sippft *fa gro faqfai *w % afeita* ttf faftr I I - W I ftpir SIFPIII WOT*FT ^ *it*irfli .
*r. stafar ^ "Ofciwi faro ^ ?m ^r fofar # ffcqafttf MfaMH flfan ^ afeitaT aiggjfr 5nft*wiraF ara N I T tar TOfti SR^ u41«ivtMi am ^ sram #r '^> N I T ^ ^iMti
8. *tot 4IIHQl4f :- ^ faft ^ amr &mft anraT 3W°r ^ 3F*T gpatf $ ( HfteFT 3W*T 4i3fll4H ftfa HMI4W WRI TKOTT $ ^ 1 3 nffiGAZETTEOFINDUiEXTRAORDlNAltY ^ J P A B T H—SEC 3 ^ | *ft aim ̂ t sn^fti ^s ^ r srfaflcr tor wpn #? sraHror % ^ f <TCT (L) TOJ qSI ^T;
(iii.) snfa ^ ?nftw ;
(V.) OTF TTFT, q^fr ̂ HT̂ T 3PRT ^ l ^ T OT& ^ 3*r&
(vii) aram ^ nrtia, ^ qftf A ^ r fifa* arfta flft *fa $ snspft < * ^ gffi^Rr tar *n B $ ft *T3rc°i $ tf^TOT ift zm&Fm 3T# Wflft ^ ^ 3 ^ 7 3 TOT VJTFFTT I ^ t Rm>iR*i 3>t ̂ rft *?mft ^ wfi ^ fen tartan i SITT ;wm$ ^r TTO MIVWIH Biter §m ^ wfti isr. f̂e ^ tf* s t e m *n 3?te# £t ^ t # ft# (snfâ r ^ife) $ 3T#T ^FT fa^H 5PT *ft ^fe %f ^r OTfr ^ WPCJUH (^iMRf'i) SRT ,TC ^ $ fa? f̂%icT siffcn
10. q?nl^ sm t̂ > ^ i M sFiRft P N I t e 3^rf ^ ^ f t t e ^ * fan sffafcr 5̂. TOT * OTt^R *fr ^mri% sfarctf % £»fa: 3ppT tPIT 14 ^ T T O Q M E T r a O F l N P l A : EXTRAORDINARY [PART II—Stc 3HH ^ • • — " — M J ^ ^ ^ 11* artcifai ^ t M $FTT# ^ ^n-<ritar > 3>. i^^Tt *ft fliflFtol ^ r f ^T ^ ^ ^ STRIDE ^IHTte $ ^ i t 3ftr ^ t t̂aT-<rftem* sqg^ ^ra-^it % arc ĉ4iî <i ^?T^ ^ ^m ^t ^ r S & ft^ ^ 31^ +i4«Hi4l' ^ for JIHT ^rft % i ^/dft^ ^ r i ^ ^n-^ffe?pi ^ aftite sftr ^riW qfa STCT ^t *TT^ f̂ R r̂ ^r-^r to fe ^ ^ t H^R cTC ^ vtf̂ fr t% 5 T ^ ^ / f e j N $ cfc3T-iT%T ^ 3 T. ^i-qffeTT^t ark JM^KW* ^nkr^ ^ HM^T 3 ^ R ft7!!!
ST. ^ r ^ ^r srci ^ T T M f̂tfa STSRI ^r%€t 5P»n#, tifcH $ ftrctf qfterr jm t̂, fr^vr r̂ *w, SF srfte ^ fts^q*r tof w , âfitl̂" "#qfei $ft\ ctar qfan ŝ r SRF ^ *rr Tfc faf*FT ^ ^ m t ti^fr gro ^af *& sitor *fr ^r^t
12. JwrgsfH^r:-
(i) sifafaj ^r-qttaiT ^ fcft£ $ m ftfe ;
(ii) fts# J ^ ^ H H $ ^ ^ wti ;
(iii) 17̂ T ̂ T vf&Rtft ^ M£, qfc 3&i Ft ;
(iv) ftroftftqtf*^?*;
(v) irfHm r̂fteTT $ tft"TPT ;
(vi) 3#ITOT r̂rat $ aq^ta^ ^ jn^ tei^ sftgfe ;
(vii) simfa? wi^t tem ^ £ «̂ ft ;
(ix) WZ **ftflR$t cpr 5|^T HfiRPT # T
(x) a^RIRIT ^ ^ 3PT ^Blltt I j< _ TH^AZETTEOFI>TOA: EXTRAORDINARY | PABTJ .[—SgC- 3(t)j 13* W& vUsm tifcm :- i) ^?i ^ S^OT #c Jxi^ito ;
ii) snfa g s ^ WTT, ftsw CPH v%m ? ttm ^tft ill) ^ 3 f f 351 aiWM^I+i^, Rvrt^T, W ° T ^ JT: Slfa (WM;
iv) faf*FT 3WP?f *& f̂itf̂ T, ^wjifl^' &\ Mjft % (nurn—^pnr3(i>] <iK<rgrTnnft: Brown*? n vi) d<H/ulT ^ W$it VM-V3R, Sffa, Sfefl^T oftT viii) ftifctaulcH* a f e r MsifcWf ;
ix) srsrater srraii ;
x) f̂Mf m wtm 3 *tem *ft 3^ snftr ;
xi) R̂«2T ̂ *JTOT tfwr ;
xii) <TCJ ^ r ^ ffaTT 3>HT ;
xiii) ^ ^3*TM ;
xv) ^ i ^ M w *m ix vsi-vm ( 3 ^ ^targ^r SRT, ^T ^ ^ C | | ^ J ) H fafa ^ fatcTT ^ 75HT ^ xvii) *T5Rf t ^ gq^R ifr H M ^ f f ;
xviii) W$ % ^ T T ^ f^Rpft *OT ;
xix) ^ T̂ ftq *R ^ f f =Pt f f t 7GF\, \ J # WFT M H , . xx) <*<Al f^FT ;
xxi) d * W 1$MWdl 3* *wraK ;
xxii) S13tf 3Stffi?r ;
xxiii) ^mi<hH% $K P^mm * I < M ;
xxiv) ^ * q i (qftOT q^TTf} ;
» TtfECAZETTE OF INDIA: EXTRAORDINARY |PAATH—SEC,3{IJ| xxv) ®m& m-$$RX $K ;
xxvi) tfSrem w-gj^m ;
^. JT^& STOWTOT *fl ^ i^??H aiftstapirc star aftr siftf^m atfc ^H% tftffr SRA *tf forot wn 7T*sfc Sf ^fc t^P *fl̂ ^ f e r̂f̂ ^pft ^t ^ tn7T3Ti ^ 5?#T # j) *TOT ^ 1 - tftoSRT ̂ ^ t !
m £ T^TT HT M^TT^q ^ ^ Ft l ^ t ^ T * sfafa 5TCT ĉ TT ^t ^ *TFT q%m ^ E M ^WTT, ^ T ! , . ^ :
swr TOT, Frar; "bmft $K mm, tfifc i% Tin# 3
15. 3jqfts|5 * > | :- fafita0! gfe, aiNteii, srm, t^PTt *™f 3*f i TTRRT tfcraf ^RrT, ^«^T terras, &*$$ ^ , fe*£*R fe ^ ^ q ^ sjqfogff sliest $ snftw ^cdf , * snfa ^ flfa^ta, ^?^T ^jf 3Jtrri ^ f t t scfasr nsm s°n# % *ra% f̂,- Sfrfe ^ *J*te TOT flfotf 11 T. aifast eft q^firei 3k $TOT TO? x# ^?ft ak fr# »fr is. aifaWf *r *terc«r ak *Rftra<foy»i :- , $ f t w , g^infa *mw, w-^mcr sk terc % %** fl^r ak tffcm fcqtf *HI% j& *$&\ wm sroflftfcr sq*m TO^ ^ 3 *̂ft # r g=r: * r % Rut tJiftftmu 20 THEfiAZETTEOFlNDIA; EXTRAORDINARY IPABT H—SEC, 30)1 S, ^ far <TT ^ OT^<*^ tfftt *m $ flTC jq^ ^ TO* !̂ CT. U W - ' l D L 4 / 3 / 2 0 0 6 - ^ . t ^ ^ f t . ] ^TCJfa ^ s r #fW Tlfa* ^ft^rn:.—^^m^rrai^ *rsm3«fa^n *rcsrra?m 28-10/45 T ^ snfx^rcr^if^n^r, 1945 MINISTRY OF HEALTH AND FAMILY WELFARE (Department or Health) NOTIFICATION New Delhi, the 10th November, 2008 G.&R. 780(E).—Whereas a draft of certain rules further to amend the Drugs and Cosmetics Rules, T$4$ were published, as required by sections 12 and 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940), in the G&cette of India Extraordinary, Part II, Section 3 Sub-section(i) dated the 131K October.2006, under the notification of the Government of India in the Ministry of Health and Family Welfcre (Department of Health), Number G-S.R.
634(E), dated the 13* Ocstober\2006 inviting objections and suggestions from all persons * likely to be affected thereby, before the expiry of a period of forty-five days from the date on which copies of the Official Gazette containing the said notification were made available to the public;
And whereas copies of the said Gazette were mad? available to the public on 13* October, 2006;
And whereas, objections and suggestions received from the public on the said draft nites have been considered by (Jw Central Govemjnent;
Now, therefore, in exercise of the powers conferred by sections 12 and 33 of the said Act, the Central Government, after consultation with the Drugs Technical Advisory Board, hereby makes the following rules further to amend the Drugs and Cosmetics Ruk&,1945, mmely:- 1, <])Theie njlcj may be called the Drugs and Cosmetics (Thin) Amendment) Rules, 2008.
(2) They shall come into force on the 1 si day of November, 2010.
2, bi die Drugs and Cosmetics Rules, 1945, (hereinafter referred to as the said rules>
(i) in rule 74, in clause (o), after the words, "requirements o f the following shall be inserted, namely; - "Good Laboratory Practices as laid down in Schedule L4 and";
(U) In rule 78. ta claurc (p), afto the w c ^ "requirem inserted, namery:- "Good Laboratory Practices as laid down in Schedule L-l and";
fin) In rule 150 E, in clause (a), after the words "Rule 150 C \ the following shall be inserted, namely:- "and Schedule L-T.
3. La the said rules, after Schedule L, the following Schedule shall be inserted, namely:- "SCBEDULE L-I (see rules 74,78 and 150 E) Good Laboratory Practice* and Requirements of Pretuows aad Eqnipaesti
1. Geftcral RequinmeBti:-
(a) The laboratory or the organisation of which it is a part must be an entity that is legally authorised to function and can be held legally responsible.
(b) It is the responsibility of the management to ensure that the laboratory carry out its testing, calibration, validation, and all other technical activities in such a way as to meet Good Laboratory Practices (GLP) requirements.
(c) Laboratory management shall have a qualified individual to be known as quality manager or technical manager for carrying out all technical activities and for the Implementation of documented quality system and shall report to the top management directly.
(d) The quality manager shall prepare a schedule for technical audit of the laboratory for GLP compliance by an expert or experts appointed by the top-management other than the in-charge of the laboratory and shall ensures the maintenance of documented quality system as per quality, manual
2. Premises:-
(a) (i) the laboratories shall be designed, constructed and maintained so as to prevent entry of insects and rodents besides cross contamination;
(ii) interior surface (walls, fbor, and ceilings) shall be smooth and free from cracks, and permit easy cleaning and disinfection;
(ill) adequate provision is made not only for space and equipment for carrying out necessary test but also for utilities like water, power and gas;
(iv) air ventilation system shall ensure dust free environment » THE GAZETTE OF INDIA: EXTRAORDINARY | PART 11—Stc.3(l)|
(b) The laboratories shall be provided with adequate lighting and ventilation and if necessary, air- conditioning to maintain satisfactory temperature and relative humidity that will not adversely affect the testing and storage of drugs or the accuracy of the functioning of the laboratory equipments or instruments.
(c) The drainage system facilities shall be such as to facilitate proper maintenance and prevent water logging in the laboratory.
(d) Tanletops shall be constructed with acid, alkali and solvent resistant material and shall be smooth arid free from crevices as far as posstble,-
(e) All bio-medical laboratory waste shall be destroyed as per the provisions of the Bio- Medical waste (Management and Handling) Rules, 1996.
(f) Adequate space with proper storage conditions in the laboratory shall be provided for keeping refensnce and working standards and be maintained by the quality control department. Standard Operating Procedure (SOP) for the maintenance of reference standards and evaluation of Working and Secondary standards shall be prepared by the laboratory,
(g) The air circulation is maintained in the area where sterility test is carried out as per Schedule 'M\
(h) Bio-burden shall be routinely maintained in the controlled and uncontrolled area. (eg. air locks)
(i) Animal House;-
(i) Animal House shall have the approval of the Committee for the Purpose of Control and Supervision on Experiments on Animals (CPCSEA).
(if) Designed in such a way that there is an arrangement to quarantine die new animals procured or purchased arid have a provision for clean corridor and dirty corridor.
(iii)ln case of a diseased animal proper diagnosis shall be done and proper record of treatment shall be maintained.
(iv) Different types of animals shall be housed separately witii proper identification.
(v) A Standard Operating Procedure shall be prepared for breeding and care of animals, maintenance, cleaning or sanitation with suitable schedule for cleaning of animal cages, racks, floor and other equipments,
(vi)The animal bouse shall have proper air-conditioning (temperature and humidity) with proper lighting and be monitored regularly and documented periodically.
3. Personal:-
(a) Staff in the laboratory shall possess necessary qualification, proper training and shall have adequate, experience for the assigned duties.
(b) A training record of all the personnel shall be maintained.
(c) Head of the laboratory must be of high professional standing with experience in drug analysis and laboratory management who is responsible for:
[ win—wtXi) ] wrer^rTnrq?: aTOrogpT__
(i) ensuring the control and maintenance of documents including the quality system as per the requirements of regulatory authorities which involves all raw data, SOPs, documentation exhibits, protocols, training charts, etc;
(ii) planning and organising the audit of the quality system and initiation as well as follow up action of the corrective actions, if any;
(iii) investigation of technical complaints;
(ivj taking final responsibilities for recommending any regulatory action in the event of noncompliance of tested samples.
4, Equpmcnts:-
(a) The laboratory shall be furnished with all types of equipments as may be necessary for carrying out the different activities within the laboratory.
(b) The analytical instruments shall be housed in dust-tree environment and whenever required, conditions of temperature and humidity shall be maintained and periodic checks on temperature and humidity be made and recorded.
(c) The instruments, instrument bench and surrounding areas shall be kept clean and tidy at all times,
(d) Instruments requiring calibration shall be calibrated at regular intervals and records of such calibration or maintenance be maintained and there shall be written instructions in the form of Standard Operating Procedures for the operation, maintenance and calibration of instruments*
(e) Equipment records shall be maintained and such records shall contain the following:-
(i) name of equipment or machine or apparatus;
(ii) manufacturer's name, model number and type of identification;
(iii) serial number;
(iv) dtttt on which equipment was received in laboratory;
(v) current location;
(vi) condition when received (e.g, new, used, re*conditibned);
(vii) copy of the manufacturer's operating instructions;
(vi i i) frequency of cali oration;
(ix) frequency of maintenance',
(x) tog Book (day to day entry including status of the equipment)
(xi) staff responsible for monitoring the calibration-and maintenance status of the equipment;
(xii) calibrating records;
(xiii) list of authorised users or operators, if any;
(xiv) history of any damage, malfunction, modification or itpgradation, repair and calibration;
(xv) list of spares and TOcsssories, if any.
ff) A progress register for non-functional equipments and action for procurement of spares and accessories, monitoring thereof, shall be maintained.
24 THE GAZETTE OF INDIA: EXTRAORDINARY [?*HTP—SBC.3Q)1
(g) A Standard Operating Procedure for preventive maintenance of machine of equipment or apparatus shall be prepared by the laboratory,
(h) Other equipments such as burettes, pipettes, volumetric flasks, weight boxes;
thermometers, etc., shall be thoroughly checked for accuracy of calibration before acceptance for use.
(i) Maintenance procedure in the form of Standard Operating Procedures must be prepared and regular servicing must be performed by the maintenance eng.neer or specialist
(j) Equipments, instruments giving anomalous results or defective must be labeled as 'out-oforder' till they are repaired and after instrument is repaired it should be calibrated before use.
(k) The maintenance of equipments for services like electricity, gas* water, steam, and compressed gas shall be handled by competent person.
(1) Autoclaves must meet the requirements described for operations, safety and validation procedures, and the validation carried out by the laboratory shall be recorded,
(m) Fume Cupboards.- Work involving me evolution of harmful and obnoxious vapours shall be carried out to ft fume cupboard. The exhaust system of the fume cupboard shall be checked fHqucotiy to ensure that it is in order. There should be a water drainage system inside the fume cupboard and shall be checked frequently to ensure that there is no water logging and it is in order.
5. Chemicals and Reagents:
(a) The storage and handling of chemicals and reagents shall be done in a manner considering the physicochemical properties of these substances arid the hazards involved in their use,
(b) All reagents and solutions in the laboratory shall be properly identified with a label.
(c) A standardisation register shall be maintained by the laboratory along with its raw data and Standard Operating Procedure for preparation and standardisation on stock solution^ standard solutions, volumetric solutions must be prepared for the guidance of staff.
(d) Containers of stock solutions and of standard solutions shall bear the folio wmg details:- •
(i) name of analytical chemist who prepared the solution;
(ii) date of preparation;
(iii) Each volumetric solution shall have "use before date" depending upon the stability of the solution; and
(iv) standardisation records,
(e) The transfer of hazardous chemicals and regents from one container to another container shall be carried out with suitable equipment by taking the care of safety and no make-shift or hazardous methods must be resorted to.
6. Good bouse keeping and saiety.-
(a) General and specific written down instructions for safety stall be circulated to each staff member and the instructions be revised periodically as appropriate (eg., poster displays, audio-visual material and by seminars/conferences),
(b) Standard Operating Procedure for safety, house-keeping and loss prevention shall be prepared in accordance with the various rules, and regulations of the Government of India and include the following requirements, namely:-
(i) safety data sheets must be made available to staff before lestmg is carried out;
(ii) drinking, eating and smoking shall not be permitted in the laboratories; food for human consumption shall not be kept in working or storage areas; food meant for test animals shall be handled by the workers under the guidance of a veterinary doctor or qualified person. In the animal house, the facilities for collection and disposal of animal waste or safe sanitary storage of waste before removal from testing be provided;.
(ui) staff must wear laboratory coats or other protective clothing including gloves and face masks and eye protection wherever required;
(rv) the laboratories shall have adequate first aid kit and fire righting equipments located at the right places and the staff must be familiar and trained with the use of tut fighting equipment including fire extinguishers, fire blankets and gas masks,
(v) operators carrying out sterility tests shall wear sterilised garments including headgear, face masks and shoes;
(vi) the staff must be educated in the first aid techniques, emergency care and use of antidotes; and
(vii) safety rales in handling cylinders of compressed gases must be observed and staff must be familiar with relevant colour identification codes;
(c) Protective Precautions to be taken in Laboratories:
(i) water showers shall be installed at appropriate places in die laboratory;
(ii) rubber suction bulbs must be used on manual pipettes and siphons;
(iii) warnings, precautions, and written instructions must be given for work with violent, uncontrollable or dangerous reactions (e.g. mixing water and acids, biological such as infectious agents, etc.);
(iv) appropriate facilities for the collection, storage, and disposal of wastes shall be made available.
(v) staff must be aware of methods for safe disposal of corrosive or dangerous products' by neutralisation or deactivation and of the need for complete disposal of mercury and its sate.
(vi) staff must also be aware about the safety precautions to be adopted while handling potassium cyanide and cyanogen bromide.
(vii) a Standard Operating Procedure for handling, collection, disposal of chemical and biological wastes be prepared.
7„ Maintenance, calibration aad validation of equlpmeafi;-
(a) All equipments, instruments and other devices used in the laboratory shall use appropriate methods and procedures for all tests or calibrations and they shall be regularly calibrated and validated. The frequency of calibration may differ from instrument to instrument THE G AZETTEOF INDIA; EXTRAORDINARY [FAKT II—Sec, 3<i>l
(b)The original equipment manufacturer's recommendations along with the experience of the laboratory staff and the use of equipment per day may also be considered while fixing the frequency of calibration,
(c)For most of the equipments and instruments. Standard Operating Procedures for calibration and calibration schedule be prepared by the laboratory and a logbook shall also be prepared by each laboratory for proper documentation of calibration results.
& Reference materialst-
(a) Reference materials are necessary for the testing and, or calibration, validation or verification of a sample or of equipment, instruments or other cevices and all such materials shall be traceable to agency authorised by Government of India or any other International body.
(b) The laboratory shall prepare working standard by comparing with the reference standards and shall be routinely checked for their purity by selecting parameters such as identity, loss on drying or on water, impurity and assay, etc.
(c) Whenever, any new reference material is received by the laboratory, a code number shall be assigned and this code number shall be quoted on the labora:ory note book and analytical worksheet The working standard shall also be provided with identification code.
(d) A register pertaining to reference and working materials must be maintained by the laboratory. The following details may be mentioned in the register:
(i) source of supply;
(vi) code number of the reference material;
riii) date of receipt;
(ivj batch number or identification number of the supplying agency;
(v) details like assay value, water content or any other information provided;
(vi) storage condition of the material; and
(vii) date of expiry, if any and date of manufacturing if possible
(e) All working standards shall be checked at appropriate intervals or before use to ensure that it has not deteriorated or decomposed during storage. These observations be recorded in a register. All the reference and working standards shall be stored at appropriate storage condition; those requiring storage between 2-S°C shall be stored in a refrigerator. Wherever recommended the material may not be allowed to be frozen.
9. Microbiological CuHnres;-
(a) Standard Operating Procedure for maintenance of microbial culture and sub-culture must be prepared by the laboratories.
(b) If the cultures have become non-viable or mutant, proper procedure shall be followed to destroy these cultures by autoclaving underan authorised personnel for biological testing.
Preferably not more than five passages may be prepared.
(c) All activities be carried out in a aseptic area by autiwrised person.
(d) The laboratories shall perform standard biochemical tests on die sub-culture as given in literature to ensure their viabi lity.
10. Quality lystem.- The quality system shall be designed to ensure the following objectives: -
(a) the measurements and calibrations shall fully conform to the poropewtial requirements and the methods demonstrably based on validation protocols are followed.
(b) R snaD be effective in providing necessary assurance that the activities or processes or techniques or practices comply with planned amngemeats,
(c) It helps in early deflection and correction of nonconformities.
(d) Remedial action on die observations by internal and external audits are taken appropriately and
(e) It shall have a documented quality policy for the organisation.
11. Infernal qnafity system •ndfev-
(a) Internal audits are done to assure me integrity of the analysis and such audits shall be conducted periodically with a predetermined schedule and procedure with appropriate checklist, to verify mat die operations continue to comply with me requirements of quality system and requirements of regulatory authorities. Internal quality audits shall be carried out by trained and qualified personnel who are mdependecAoftheactivhytobeaudhed.
(b) The periodicity of quality audit shall be fixed by the Head of the laboratory so that each acrivfty Is audited at leart once m a year.
(c) Head of the laboratory will be responsible for fartiation of the corrective action arising from audits and verification of corrective action,
(d) Whenever any non-compliance or any diversion is noticed by the team in implementing quality policy or quality system, protocols, die same will be attended by the Quality Manager.
The problem will be analysed and necessary actions vriU be t a t a wim praper oV^
(e) The Quality Manager shall maintain all the records of me analysis being conducted which includes test system, the type of analysis, date on which analysis is done, etc and quality Manager shall also maintain copies of all protocols pertaining to different activities being checked by die audit team.
12. Management review - Quality system reviews shall be conducted by die top management atleast once in every twelve months and die agenda of review shall generally cover the following:* "(t) report or input of internal audits;
(ii) matter arising foam previous reviews;
(iii) report of external audits, if any;
(iv) surveillance reports if any; , ,
(v) result of proficiency testing;
L136o Gijjo^ - 5 38 TH E GAZETTE OF INDIA: EXTRAORDIN AKY IPART 11—SEC 3<i)1
(vi) complaints or feedback received from users of laboratory services;
(vii) details of in-house quality control checks;
(viii) need of amendment of the quality system and documentation;,
(ix) induction training of new staff; and
(x) any other requirements of the laboratory.
13, Standard Operating Procedures:-
(a) Standard Operating Procedures are written procedures for different activities being conducted in a laboratory and shall include the fol lowing characteristics:
(i) they shall be written in a chronological order listing different steps leading to an analysis of drugs or calibration of an instrument;
(ti)testing laboratories shall have Standard Operative Procedure manuals and have its periodic review;
(iii) it shall be user friendly documents and shall include designation of the person responsible for intended activity.
(b) Standard Operating Procedures in addition to those recommended under various activities shall also be prepared to the minimum in respect of the following:
(i) sample handling and accountability;
(ii) receipt identification, storage, mixing and method sampling of the lest and control articles;
(iii) record keeping, reporting, storage and retrieval of data;
(ivj coding of different studies, handling of data including use of computerized data system;
(v) operation of technical audit personnel in performing and reporting audits, inspections and final report reviews;
(vj) routine inspection of cleaning* maintenance, testing, calibration and standardisation of instruments;
(vii) action to he taken in respect of equipment failure;
(viii) analytical data methods;
(ix) the raw data;
(x) data handling and storage retrieval;
(xi) health and safety protection;
(xii) animal room preparations;
(xiii) animal care;
(xiv) storage and maintenance of microbial cultures;
(xv) maintenance of sterility room (i.e. constant maintenance and monitoring of Aseptic condition of sterility room);
(xvi) use and storage of reference standards
(xvii) procurement of stores and equipment;
(xviii) monitoring of testing of samples;
(xix) method of retention of unexpended samples, their location, maintenance and disposal;
(xx) document conirol,-
(xxi) redressal of technical complaints;
(xxii) housing-keeping;
(xxiii) corrective and preventive action;
[nm 11—^nTj(i)] Mnff^^wrt; anrorcgr ;_ i*
(xxiv) working procedure (test methods);
(xxv) calibration Manual; and (xxvj) train i ng manual.
14. Protocols and specifications archive.-
(a) Every.laboratory shall have a specification archive and current versions of aJI necessary specifications shall be kept as per the requirements of the Act and the roles made thereunder and the National Pharmacopoeia (Indian Pharmacopoeia).
(b) All updates and corrections must be noted in the master volumes of Pharmacopoeias to prevent the use of obsolete sections; supplement and addendum shall also be made available in the laboratory.
<c) The specification archive shall contain the following: -
(i) list of all the pharmacopoeias;
<ii> a file on patent and proprietary medicines (non^ihamiacopoeial) test methods to specifications prepared and validated by the manufacturer or by the laboratory itself The test methods shall be submitted to the concerned Drug Control Authority. The validated test methods developed by the manufacturer or the laboratory shall stand to the requirem^ts of comperi^l pafametera in regard to its precision, accuracy, reproducibility, specificity, linearity, and ruggedness etc
15. Raw data:-
(a) Raw data refers to the laboratory work sheet, note books or analysis sheet records, memorandum, notes or extract copies thereof that may be (he results of general observations and other activities and such raw data shall include handwritten notes, photographs, software, drawings, computer printouts, spectral charts, dictated observations or recorded data from automated eqiupmeMs. The raw date also inidudes tecord on receipt of animals, result of envfrotaneoltu' rfioflitoring, calibration, records of equipments, integrator output from analytical equipment, including work-sheet used to read • note, information from Light Emitting Diode (LED) display of any equipment
(b) A single line shall strike tfcrougb the data being changed; the correct mSormatkm shall be recorded along with the old data and the reason ofcliange. The analyst mating the change shall be identified by his signature with date. In case, of automated data collection system, the person responsible shall be klentifisd at the time of data output The original enay must be saved and the system shall have audit tiaii for all (he data.
(c) Data integrity and security shaft be maintained and the data shall not be acceodbfe to any unauthorised person.
16. Storage mi arehfoaL-
(a) The residual sample shall be retained in proper storage condition far a period of one year afkr the final report
(b) The laboratory must establish and maintain procedures for the identification coUectkn, indexing, retrieval, storage, inaintetiance, arid disposal of all quality documente, 34 THEGA2ETTE OF INDIA.- EXTRAORDINARY JPAWTII—Su,3(ijf
(c) All the raw data, documentation, Standard Operative Procedures, protocols, and final reports are to be retained and there shall be archives for orderly storage and expeditious retrieval of all taw data, documentation, protocols, interim and final report. The archive shall provide a suitable environment that will prevent modification^ damage, or deterioration and/or loss
(d) The condition under which the original documents are stored must ensure their security and confidentiality,
(e) Paper documents shall not be kept for long periods under high humidity and raw data in the form otftape and discs are to be preserved with care.
(f) In case of storage of only optical disc, the life of disc shall be longer than the stooge time,
(g) RAW data on thermal paper might fade away whh time- therefore, a photocopy of the thermal paper shall also be retained in the archive.
(h> Time for which records are retained shall be prescribed in the documents."
(F.Na. X-l 10W3GO06-DFQC] DEBASISH PANDA, Jt. Secy- Foot Notfc—The Principal lbule$ were published in ihe Gazette of India vide notification No. F. 28- IQ/45H0), dated 21st December, 1945 and was last amended vide notification GSR- 592(E), dated 1343D0& Pf IrtflJ fry to Mtmapt, Owt of fedi* Pies, Ring R«d, Miyiport, New DetW-llMM **d PUWubed by It* CAIUMUM of PuWtCimooi, Ddhi-I HW54.