Annexure-1 GMP CHECKLIST

1 SOP No.: EP-INS-004 Page1 Annexure-1 GMP CHECKLIST (Based onWHO Good manufacturing Practices (GMP) for active pharmaceutical ingredients stated as perAnnex 2-WHO Technical report Series(TRS), No. 957, 2010; Good manufacturing Practice guide forActive Pharmaceutical Ingredients ICH Harmonised Triplicate Guidelinestated as per ICH Q9; and GMPrequirements as per Directives No. 2001/83/EC latest amended vide Directive 2011/62/EU)1 Location and surroundings:Self appraisal tobe filled by themanufactureralong with alldetails (yes or notype reply will notbe acceptable)Observations tobe noted by theinspecting teamat the time factory building is situated andcontrolled to avoid risk ofcontamination from externalenvironment including open sewage,drain, public lavatory or any otherfactory which produces disagreeableor obnoxious, odors, fumes,excessive soot, dust, and smoke,chemical or biological specify industries /establishments adjoiningmanufacturing and the building has been designedconstructed and maintained to suitthe manufacturing operations so asto produce drugs under specify nature of constructionused in the facility in respect of itsmaintenance and the building confirm to theconditions laid down in the FactoriesAct.

2 1948 Pls attach valid factory certificate/license issued by the how the premises used formanufacturing operations andtesting purpose preventscontaminations and crosscontamination is:a) Compatible with other drugmanufacturing operations that maybe carried out in the same oradjacent specify any special criteria forSOP No.: EP-INS-004 Page2the product manufacturered. , humidity, air classrequirements maintained for asepticproducts, ) Whether adequate working spaceis provided to allow orderly andlogical placement of equipment,materials and movement ofpersonnel so as to avoid risk of mix-up between different categories ofdrugs and to avoid possibility of thecontamination by specify space left around themachines. Pls attach equipment layout, men and material movement,waste movement if ) Describe the pest, insects, birdsand rodents control system followedin the copy of pest / rodent controlschedule along with contractagreement if ) What measures have been takento make Interior surface of (walls,floors, and ceilings) smooth and freefrom cracks, and to permit easycleaningSpecify material of construction andfinish for walls, ceiling, floor, covingetc.

3 Whether Epoxy or PUcoated, kota / granite stone withepoxy sealed joints, solid / GI /gypsum / cal. Silicate board ceilingwith epoxy, PU or any other pre-fabricated panel (GRP, powdercoated SS or Aluminum etc.) ) What measures have been takenso that the production anddispensing areas are well lighted andeffectively ventilated, with aircontrol specify the luxlevel maintainedin various parts of the specify the air handling systemused in various areas like stores,production, packing, QC areas No.: ) Specify drainage system whichprevents back flow and entry ofinsects and rodents into thepremises.(pls specify number and location ofdrains installed)3 Water the unit has validatedsystem for treatment of water drawnfrom own or any other source torender it potable in accordance withstandards specified by BIS or localmunicipal specify source of raw water andgive details of treatment processes,sampling points, distribution andstorage system for raw and bio burden in purified watercontrolled / water tank are cleanedperiodically and records maintainedthereof.

4 How water distributionsystem is sanitized to controlmicrobial of the system of disposal ofsewage, and effluents (solid, liquid,and gas) from the manufacturingsite.(Enclosed the copy of NOC obtainedfrom State Pollution Control Boardin this regard). provision for disposal ofbio-medical waste made as per theprovisions of the Bio Medical Waste(Management and Handling) adequate areas have beenallocated for warehousing of RawMaterials, intermediates, PackagingMaterial, products in quarantine,finish products, rejected or these areas marked specify the total areaprovided for the warehousing areas beingmaintained to have good storageSOP No.: EP-INS-004 Page4conditions. Are they clean and dryand maintained within acceptabletemperature limits? the storage arrangementprovided for materials whichsensitive to temperature, humidityand light and how the parameters cold room or deep freezersrequired for storage of goods?

5 If yes,how the temperature is proper racks, bins andplatforms have been provided for receiving and dispatch baysare maintained to protect in comingand out going incoming materials are treatedand cleaned before entry into specify the cleaning systemfor the outer surface of quarantined materials aresegregated from other access to quarantined area separate sampling area foractive Raw Materials and Excipientsis provided and yes, what is the control on entry ofmaterial and men into the reverse LAF havebeen provided for log book for samplingbooth not what provision has been madefor sampling so as to preventcontamination, cross contaminationand mix-ups at a time of the arrangementsprovided to sample the primarypackaging materials foils, bottles,etc which are used as specify sampling plan type of sampling tools areused and how they are cleaned, driedand No.

6 : containers are cleaned beforeand after sampling. Who carries outthe sampling?(Pls specify whether the sampling iscarried out as per the current SOP). precautions are taken duringsampling of photosensitive,hygroscopic materials? provisions have been made forsegregated storage of rejected,recalled or returned materials is the access to these highly hazardous, poisonousand explosive materials, narcotics,and psychotropic drugs are handledand these areas are safe and there certification from competentauthority for handling of explosivesetc. If any. Pls attach the certificateissued by the competent printed secondary packagingmaterials are stored in safe, separateand secure the arrangement providedfor dispensing of starting is the control on entry ofmaterial and men into the dispensingarea? Whether reverse LAF havebeen provided for dispensing withback ground clean air pressure differential ismaintained between the dispensingand adjacent type of dispensing tools areused and how they are cleaned, driedand containers are cleaned beforeand after dispensing.

7 Who carriesout the dispensing?(Pls specify whether the dispensingis carried out as per the currentSOP). and where sampling of sterilematerials carried steps are taken againstspillage, breakage and leakage ofcontainers? provisions have been made toprevent the entry of rodents, insects,SOP No.: substance is used for pestcontrol and how it is handled.(Pls specify whether the pest controlis carried out as per the SOP). record of master labels ismaintained for comparision toissued labels?6 Production specify the design of themanufacturing area which allow uni-flow and logical sequence ofoperations so as to prevent productcontamination/ mix there any criss cross of flow ofmaterials and the position of IPQC lab inthe manufacturing area .Please specify whether non storageareas used for storage of separate dedicated and self-contained facilities have beenprovided for the production ofsensitive pharmaceutical productlike Penicillin,Biologicalpreparation with like micro-organism, Beta lactam, SexHormones and Cytotoxic yes pls explain how and attachcopy of plan of premises of eachcategory of specify the provisions ofstorage of dirty, washed and cleanedequipment parts, tool room, inprocess storage areasetc.

8 Which provide sequential /logical manner so as to preventcontamination and crosscontamination? specify how service lines likepipe work, electrical fittings,ventilation openings etc. areidentified by colors for nature ofsupply and direction of the service lines in productionareas are through service not, how they are placed so as toavoid accumulation of areas:-SOP No.: specify the position of restand refreshment rooms and mentionwhether they are separate and notleading directly to the manufacturingand warehouse there general change rooms inplant?Are toilets, change room separatefrom mfg. Area? Pls specify numberof washing station & toiletsprovided for number of change facilities separatedfor both many sets of protectivegarments provided for eachpersonnel entering production there in house general laundry forgarment washing / cleaning?

9 If nothow garments washing are carriedout and maintenance workshop isseparate and away from animals for production ortesting are housed in the facility if sowhether areas housing animals areisolated from other specify the provision of airconditioned and ventilation systemfor the animal quarantined, under test andtested animals housed animal carcass are disposed attach copy of Control QC area is independent ofproduction QC carries out its own: physico-chemical testing, biological testing, microbiological testing & sterilitytesting and Instrumental firm is outsourcing yes names of the testinglaboratories contacted or give list of test case of contractual testing whatare the responsibilities of contractgiver and contract acceptor. (Copyofthe contract should be enclosed)SOP No.: EP-INS-004 Page8 Are there safety installation such asshower, eye washer, fireextinguisher etc in the there separate area for humiditychambers for stability studies.

10 Howmany humidity chambers have beenprovided. Pls attach specify the arrangementprovided for handling and storage oftest samples , retained samples ,reference standards / cultures, retained samples are storedfor a period of 1 year after expiry or3 years after distribution whicheveris earlier?Whether separate area for storage ofreagents and glassware separate records room hazardous or poisonousmaterials are stored and environmental conditions aremet during the course of storage andtesting of grade of glassware are usedin assay separate AHU's areprovided for biological,microbiological and radio iso-topestesting areas withHEPA filter separate areas provided forsterility testing within support areas are double door autoclaveprovided for sterilization entry to the sterility area isthrough three air lock is the air class of these testingareas and whether pressuredifference is maintained in theseareas?