|e yee evils set ny the 150 that define «af standant deseo pia woot isin a femaintain ancl 000 5.4.2 PURPOSE OF 150 9 = Fe comply with customers ho require 160 9! «Focal! inthe European Union market * Fampete in domestic mals « Foimprove the quality sysem aoe © Tominimize repetitive auditing by similar © Toimprove: subcontractors! performance 5.4.4 BENEFITS OF THE ISO 9000 SERIES OF STANDARDS: 1. Improved controls, discipline (e.g, prevents the use of short cuts and duplication of activities), procedures, documentation, communication, dissemination and customer satisfaction, quicker identification and resolution of problems, greater consistency Ge. the job is done the same way, time after time and best practices are shared). : 2, A reduction in errors, customer complaints and non-conforming ‘products, services and costs and the retention of customers. 3, Assistance with the liberalization of trade through common rules and language. 4, Responsibility for quality issues is placed firmly where it belongs, swith the supplier and, not the customer. 5, Reduction in the number of customer audits and assessments and also a reduction in the time taken, leading to a saving in resources need for such activities. 6, Identification of ineffective and surplus procedures and documents and other forms of waste. 7. Abetter working environme 5.4.8 REQUIREMENTS OF IS0 9003 LS aaa, «Customer Foous:By maki ‘understand need: making the custo : gem ‘Benerate customer the center of the business, Engagement of People: As with oly principle should indude al ta gay fitted to the venture’s success. Sane a ¢ Leadership:Good = ' interest wl employees. ‘an environment that a - Process Approach i ' , Tey Conia a en aed ee aii of processes, the big picture becames dear. Rather than fosing on“ «los or inspection at the fini . delivery. finish, the process reveals issues and. Seer Continual. Improvement: Oxgenizations ; Sea TOPS Sarr rae veead.te 4 Evidence-Based Decision Making-You a : ae: foundation for comparing itn sah ake dane . parent eamapaieanrs ‘ — others is cit See sa and providing feedback on sexvk ipa ae pares5.5.1 DEFINITION 150 14000 is a family of standards related to exvirummental management thet exits to bap organizations. It is an Intemational Volmtery Standards for providing exmmon framework for managing environmental issues. ISO 14000 is Product end Process oriented. Determines environmental impacts of products and services; estsbiich, meintsin end evelzate EMS. BO 14000 is a process but not a performance standard ISO 1£000 is sizdler to BO 9000 quality management. The requirements of ISO 1000 are en integral past of the Exropeen Union's Eco- Management and Audit Scheme (EMAS), 3 G2 FEATURES, ) 5556 IMPORTANCE OF ISO 14000 + Better Environment management ‘Reduces enviromental liability « Flexible and applicable to all natio. |. “+ Enhances pubic image and reputation Sden + Assures customers oe © Satisfies investor criteria *Eractieal Gyasefsl Meets your cients’ registration requirements + Reduces your consumption of materials and energy + Falitates permits & authorizations * Reduces the cost ‘Improve industry-government relations 5.5.7 AREA OF ISO 14000 ‘The series is divided into two separate areas: 1. Organizational evaluation standards 2. Product standards evaluation 557.4. Organizational evaluation standards: ape ‘The organizationoriented standards provide comprehensive guidance for establishing, ‘maintaining and evaluating an environmental management system (EMS), Ieovers— ‘Environmental maagenent items b. Environmental auditing, 2 ¢ Environmental performance erlaion 1. Environmental Management System (EMS) «1s tematic way of anagog organisa’ envionental fis» Addrees numa and long tm tof sm organisations product serves and pros of te environmen. vironmental aus & aug ronmental si «ris section asm nt conducting & for environmental adn aera quifiatons. Joped measures and goals revel + Co. must = tion in air emissior ; peormancs Ze such as the & reduc the Exton ecm i ny wae A SS ay Rearoue as SEEN jon in the ines nd Pena pecures consume 55:72. Producten eee he environmental impacts (of products and servicg, concerned with determifin6 UO ets and declarations. FS These are ith «environmental aspects rete ces snd ele assessment aspects ig, cavers 2 exssonmental product tact standard- Its purpose 1 to 1 Evonmenal apc a PL Aint of product standards 10 prey tring Mireneinpac ontheeniOe a onmental product advertising 2 Seay Se caries orSSS CQ... _ehofthe drier Photostability testing should be conducted on at Jeast one primary batch of the drug product if appropriate. SELECTION OF BATCHES p Data from stability studies should be provided on at least three primary batches of the drug product. The primary batches should be of the same formulation and packaged in the same container closure system as proposed for marketing. CONTAINER CLOSURE SYSTEM . Stability testing should be conducted on the dosage form packaged in the container closure system proposed for marketing (including, as appropriate, any secondary packaging and container label). Any available studies carried out on the drug’ product outside its immediate container.or in other packaging materials can form a useful part of the stress testing of th dosage forin or.can be considered as supporting information, respectively. ¢ eT 45 gg : TESTING FREQUENCY For long term studies, profile of the drug prods frequency of testing at over the frst year, eve proposed shelf life ste Of testing should be sufficient to establish the stability thee Prodets with a proposed shelf fe of atleast 12 months, the ‘ong term storage condition should normally be every 3 months! *y 6 months over the second year, and annually thereafter through the + At the accelerated storage condition, a minimum of three time points, including thé initial and final time points (eg, 0, 3, and 6 months), from a 6month study is recommended, ‘Where an expectation (based on development experience) exists that results from. accelerated testing are likely to approach significant change citera, increased testing should be conducted either by adding samples atthe final time point or by including a fourth time point in the study design. ‘When testing at the intermediate storage condition is called for as a result of significant change at the accelerated storage condition, a minimum’of four time Points, including the initial and final time points (eg,,0, 6,9, 12 months), from a 12- month study is recommended. Reduced designs, ie, matrixing or bracketing, where’ the testing frequency is reduced or certain factor combinations are not tested ‘at all, can be applied, if justified. LIGHT SOURCES ‘The light sources described below may be used for photostability testing. The applicant should either maintain an appropriate control of temperature to minimize the effect of localized temperature changes or include a dark control in the same environment unless otherwise justified. For both options 1 and 2, a pharmaceutical manufacturer/applicant may rely on the spectral distribution specification of the light source manufacturer. 5 Option 1 Any light source that is designed to produce an output similar to the D65/ID&5 emission standard such as an artificial daylight fluorescent lamp combining visible and ultraviolet (UV) outputs, xenon, or metal halide lamp. D6S is the internationally recognized standard for outdoor daylight as defined in 1SO 10977 (1993). ID65 is the equivalent indoor indirect" daylight standard, For a light source emitting significant radiation below.320 nm, an appropriate filter(s) may be fitted to eliminate such radiation, sHGF HURSL/I.TF DOPOD) paENOY + FIST SH/I.TF DOE YONOMD,AINPIEIN « ms ‘99 ERE 9690/9.7* D,0€ 20 HR S69 FM ON/D.2F Dz COON ZL I) | Snopey ses wo supp 86720 a pms uosoyp spn jos 8u2 241 Pe SUELO rondde pp Aigeges OR 40 ammsou oy Ayanysuas st SEDNESE 3 PEE ps eet rradondde yu) suonppuo aso 29pun arenes 94 POH a ‘swouianoo 20vH015 -ponpoxd Sup Pos 21040. ex suoguedicoo op moe rr eb EO 2 ung $91 308)0 ET om : rowen sou payeseiuy we PUR EBON Te gps OES OL Teaio ue dupyoid agi 1 povodo 9 PRO = sunas00ud : wi0ir soppodasd wraSis #0 OE our 99 InEN® ANS Tans 0c OH VORA ‘1 one pe unu eo 0761 sPUEA WE ma ei OOF OF pny Pam ud de yas EEN Z URS 0g 01 pH zuondo -ongps Aapasny 933} < -spnpord pos pruodal por pedo oy eo sxpenidde sem 2900 aap mor pm a pga LS ‘anesos Aue sapun pojanpuco 2g ue sau aygeounday wy pais spnposd 2} spe Ages, wanos 20 amo >Moy {uoenyse Jad AsaAtTp sop ‘sup ung “msrp oped om spo “B3) 39 AUTOS pur ‘soinqsane peishyd ‘soueradde oj ey aoumdoooe ayy yaour o} aunyjer © ‘nonin aoaidae a} Suposoeaenposd uonepeidopAuy © ‘sampword pefojouninsy 2 89 Say wy Aoazod soy eyoyD soemdaoe ep ro} ame 20 ane HUT HY way Aes BUN SY © : ‘= pougep S| pnpaud Srup ej Bump yumgusis, e028 U epee O39 MES no E86 =p aey.ee ec repraopadare spre A a HUBS HI49/9.25 5.0020 ny 4¢3 bam 3001244 apSapo yeandde aq or dn ge Hyee gee oat ap 3 Es Bes fay dele ibs Hau $3: 32 gag Hs peebqjheg ey. seieia3 iil qebbiddl day Hun Ghana qadiiipedi R&P 22 Whig Baghi geet baie CHANGIOENEW/DRUGISUBSTANCES/ANDIPRODUCTSIQUA\(R2) The purpose of stability testing is to.provide evidence on how the quality of a drug substance or drug product varies with time under the influence of a variety of environmental factors such as temperature, humidity, and light, and to establish aretest Period for the drug substance or a shelf life for the drug product and recommended storage conditions. The choice of test conditions defined in this guideline is based on an analysis of the effects of climatic conditions in the three yegions of the EC, Japan and the United States. The mean Kinetic temperature in any’ part of the world can be derived from climatic data, and the world can be divided into four climatic zones, I-IV. This guideline addresses climatic zones I and Il. : Stress testing Stress testing of the drug substance can help identify the likely degradation products, which can in turn help establish the degradation pathways and the intrinsic stability of the molecule and validate'the stability indicating power of the avialytical procedures used, The j. eI ate of the tres esting Wl pent ch of . eas vo be cased out ona sing Bs testing J indole °c increments (6 50°C; 60°C, ei above that fy . Te ect of tempers (eg, 73% RH or preted where appropri, eae substance. | otto a ne to hydrolysis across a wide range of piy_| ity of the © The susceptbility of ‘alae when in ane ser ategral part of stress testing. The standag peer i 1B. Phoebe aay esting are deste in ICH na conditions for phot ‘ander streis conditions is useful in establishing Bamining degradation Produce jing and validating suitable analytical procedures” degradation pathways and develoPg Tn ecifcally for certain degradation products iy SE a eer een lms, ~ phasen demented that hey an OUT gl arto the information prove a ae SEs pETuns . sake navidaat rag substance ad the yyy gy ° Sf the drug substance, Tt shoutg FREQUENCY OF TESTING , f For longterm studies, frequency of oft dig ste For dn 12 months, the frequency of esting a the} cre 3 ent vt Sat Js ee the proposed retest period. uo ae nae minimum of three time points, including the inital . in tea ponte (eg, 03nd 6 mons), froma é-monthstudysrecommended, When fet at thse stage condone fer result of sgn change it imum of four time points, including 1 the accelerated storage condition, a minimum o! rita end Ga ine pont (06,9, T2monts), roma 12-month study i recommended, esting thould be suficent to establish the stability substances with a proposed re-test period of at least the longterm storage condition should riormally be | ‘6 months over the second year, and annually STORAGE CONDITIONS ' In general, a drug substance should be evaluated under storage conditions (with appropriate tolerances) that test its thermal stability and, if applicable, its sensitivity to moisture. The storage conditions and the lengths of studies chosen should be sufficient to cover storage, shipsient, and subsequent use.ontery HD. * uauadopeaad MPO snontpuoDeid * seormsang snug soseueernh aD * spanporg 3rd PUP oe quousdeuep ap OUT oe warndopand 11 * gna jo anesnuen Pt : sooueysang 800 es Aen remsneeese ‘ ora RL AITO aSeso pareapaoe ag ye Sup] sAAWOU E FY aq UNAM Emo00 aBueYD yweDgTS JL sormmya®D, * ; 159d TOD” uoqypuo oSeys wo Buoy 4 messaeen POD sae ogee ep arp et 249 uo poseg oq prnoys pop soar posodoud ay) oped HP VD fens rrenpooe ag ve ans) Uo 9 pur ¢ wanaq Ea sue weg a a wou a ; suou 9 EPA 09 gonpn 292000" i = soueyuo ayy wo pase ssuopo] ss0je8 751 ©y ‘rede par mE POE eros wy aSes8 Japmoys ep so1are pur wopeuon Ara a 205 EONS PAP ata -voptoypads sy y0u oy amy se pauyep Hs0uesGNs rsp ‘momenta a pape -woprpuoo sero aepouay a y Apis yuo 4 svoppuoo quayque, syns su, Buz) ae YOBUE THT SATAN gO 9 jo umoupa © apnpMY proys woREDRadE TEAR aH, -poyRsnl een oypads ayqendde ayy SURES ;papysoud 94 PINUS ee enone a, sarees / URES Te apo proys woppuce sess aepauUDIN 2 supe payenqeaa pur poponpuos 2q pt ge 00 Faced APN soy paUSTge? 99 PROGS KHSINS aSesons Vv. uoprppe ‘vonrpua>aSeio%s paespane ueaajar ya aouepsosze uy SUPA Sujoqer/swawares dump wegndss, pur Hy SF HE %09/9.25: pa aqqucsy snes SR008P TH TS wo sourydane 4) SIS 98TD yeoun an ounuasayap 01 $3 9p A Sores 20 wproudde WY - fano 2u0 OWE TIF yous 1 se ‘UGS HU HS8/D.25 3,00 = pauopad ae spe Anges 2, uo 2a334n apap o HUGS HY %52/9.25 D,0p squuc ‘HUGS HU %99/9.2% D,0¢ syuow eau ayy soy ypu] souepyUe? PPP! 8ueyp o} popadxa sy 4 INAH 671 H59/025 240-0 HH SFI HO9/D.e= D5 YANO 50009 85 wonIpEED po smn Jo ponod © 2p pan 99 poy pu vom an 2] 8 wo NORE suow zo wn g QIA - QIF Stability Q2 Analytical Validation Q3A - Q3D Impurities Q4-Q4B Pharmacopoeias11.1 DEFINITION OF GLP FDA defines GLP as, “A set of principles intended to assure the quality and intearity of non-clinical laboratory studies that are intended to support research or marketing permits for products regulated by government agencies.” The term non-clinical laboratory study refers to the in-vitro or in-vivo experiments where iter being tested is studied in systems under laboratory conditions to evaluate how safe it will be. Thus, GLP ensures that testing facilities comply with the minimum requirements the FDA expects with respect to the planning, conducting and reporting of safety studies related to non-clinical testing. By providing a framework for a well-controlled study, GLP assure an overall accountability. 411.8 PROTOCOL FOR AND CONDUCT OF NON-CLINICAL LABORATORY STUDY 11.8.1 Protocol Written and approved protocols must exist for each study, and they must indicate the purpose of the study and methods to be adopted in conducting the study. The following formation must form a part of the protocol: + Title and purpose statement for the study. 116 ‘© Test and control articles identified by name, code number or chemical abstract number. '* Study sponsor name, and testing facility name and address. ‘= Test system being used - number, sex, age, body weight range, species, strain, substrain and supplier details. test system * Experimental design description, methods used for bias control. ‘* Description of items to be used in study — diet of animals, solvents or emulsifiers, and limit values for contaminants likely to be found in these that may interfere with study © Dosage levels (in mg/kg body weight) of control and test articles; the frequency and method of administration. * Tests, measurements, analyses to be performed and their frequency. ‘= _ Information regarding the statistical methods that will be used in the study. ‘+ Date when study protocol was approved by sponsor, and signature with date by study director. ‘+ Any changes/revisions in an approved protocol must be documented along with the reason; it must be signed and dated by the study director and this document must be kept along with the protocol. 11.8.2 Conduct of the Study The non-clinical laboratory study must be conducted according to the protocol. All specimens must be labeled with details of study, test system, nature and date of collection. If a specimen is to be examined histopathologically by a pathologist, the gross findings from post-mortem examination must be also available. Data generated during the course of a study (except automatically collected data) must be recorded at once, directly, and in legible ink. Dates and initials of the person making the entry should be affixed. If any change is to be made, it shall be done in a manner to not deface the original entry. The reason for the change must be documented, and dated and signed. In case of automated data collection systems, the person responsible for data input ‘must be identified. 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The warehousing department must maintain records of batches released for distribution in a systematic manner. For every batch of product, it is important to maintain distribution records in sufficient detail to be able to trace to which places the product has been sent. This is critical in the event of a problem with the product batch that necessitates a product recall from the market. Distribution record details: Some of the important details required include: «Name of the product, its strength, and description of dosage form. ‘© Batch number/lot number of shipped product. © Name and address of consignee. ‘Shipping date and quantity shipped. ‘+ Besides warehouse inventory records, distribution records also include invoices, receipts from customers and bill of lading. The February 28, 2019 edition of Pharma Times Now provides a review of data collected regarding the “Top 20 Reasons for Drug Recalls in the USA". The topmost category cited is the violation of cGMP which was the cause for the highest number of recalls ~ 238. In the pharmaceutical industry, compliance with cGMP is the basic quality requirement that ensures the production of safe and effective medicines. While there is increasing awareness of the need to adopt quality systems, the pharmaceutical industry still has a long way to go to make sure all personnel involved in the manufacturing of drug products understand the criticality of following practices as laid down in the written documents of the company.