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)

2 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.

3 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.

4 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. 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.

5 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.

6 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.

7 : 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? 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.

8 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.: containers are cleaned beforeand after sampling. Who carries outthe sampling?(Pls specify whether the sampling iscarried out as per the current SOP).

9 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?

10 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. 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.