TUV India Pvt. Ltd. Audit reportOrganisation:Audits (ZA):TORRENT PHARMACEUTICALS LTD.Safety Audit as per IS 14489Master Data of OrganisationName of OrganisationStreetTORRENT PHARMACEUTICALS LTD.Survey No:36,37 & 46.Plot No:77, JNPC, Thanam(V),Parawada(M), Visakhapatnam , Pin - 531021Postcode / Town / CountryContactPhone/FaxLanguageScope DescriptionVisakhapatnam District, Andhra Pradesh, Pin - 531021, IndiaMr Akash PatelMs. N. Rajya orrentpharma.com9898035317/9642715236English & HindiManufacturing of API and IntermediatesIndustry / Scope (EA)13E-MailAudit ProfileAudit typeAudit SiteProcess AuditedSafety Audit as per IS 14489PithampurAll the Processes associated with Manufacturing API andIntermediates,Processs, Utility & CanteenAudit team LeaderAudit team MemberArun Kumar SrivastavaJagdish HardasaniDetails for AuditAudit TypeDuration Stage 1Date Audit on siteOn site visit5 person-day(s)29.01.2020-31.01.2020Organisation Introduction & Site Work DetailsM/s Torrent Pharmaceuticals Limited is a public limited company. It is one of the companies under theflagship of TORRENT GROUP which also has its major presence felt in the power generation anddistribution in India. It is a force to reckon with both in the local and in the international business.Products manufactured by Torrent Pharmaceuticals Limited are marketed in India and also exportedto various countries in many parts of the world. Torrent Pharmaceuticals Ltd., Visakhapatnam issituated at JNPC Pharma city at Lankelapalem; PARAWADA and 7 Km away from NH-16.ANDHRAPRADESH State, India. Torrent Pharmaceuticals Limited Visakhapatnam division was acquiredfrom M/s Glochem industries in the year Sept’2016. Plant was engaged in manufacturing of API andIntermediates.Torrent Pharma Vizag division is accredited with USFDA and ISO 14001 & OHSAS 18001.The plant is designed in such a way that materials have unidirectional flow for manufacturing fromstart to end and ensures safety and protects health and environmental. The plant has excellent & safefacility for storage of raw materials with proper segregation of hazardous materials and packagingmaterials for manufacturing of API. Materials are stored as per specific and recommended guidelines.The facility has state of the art QC laboratory for testing raw materials, packing materials, in-processsamples and finished products. The laboratory is equipped with modern analytical instruments andNormal.dotPage 1 of 5Rev. 04/01-2014

TUV India Pvt. Ltd. Audit reportOrganisation:Audits (ZA):TORRENT PHARMACEUTICALS LTD.Safety Audit as per IS 14489managed by qualified, experienced and competent personnel and strict controls are enforced for eachactivity. Torrent has social and environmental commitment. The emission from the factory and liquiddischarge, complies with the norms of Central and State Pollution Control Boards.The HSE department is managed by Qualified, experienced and competent personnel and strictcontrols are enforced for each activity.TPL provides PPE to operating personnel (as per requirement)for carrying hazardous activities. All the employees are regularly trained on Safety & Fire Fighting. Theplant is having an Occupational Health Centre with full time doctor, trained First aid team, Ambulancevan, Regular health checkup of staff is carried out as per norms. Health reports are made available tothe staff for the information. Torrent is highly committed for continual improvements in the area ofquality, health, safety and environment through set objectives and targets. The company has a Fixed& Portable firefighting equipment & Installation is various places. The systems are maintained bytrained & experience Fire & safety crew round the clock duty in TPL.Audit ResultRelevant areas of the organisation were visited during a tour of the site and individual employeeswere asked about their activities and the management system on a random sample basis in order togain an impression of Safety Mangement System .Site Mangement system are in general meeting the set requirement .If individual requirements have been assessed as "Audit Finding ", are described in detail in the"detailed audit results" section.TotAl 38 Audit FindingsThe Audit finding are Mainly Categarised as Critical, Major, Minor & Recommendation based on theSeverity.Below are the Summary of talNumbers17111938Person InterviewdNo. Name1. Akash Patel2. Suresh Nath Roy3. Rajyalakshmi. N4. Sheshagiri Rao .T5. K. Vijay Ram sekhar6. M.Deepak7. Mrinal Kanti Das8. T.Madhusudhana RaoNormal.dotArea / ProcessManufacturingHRHSEHSEHSEEngg. (Maint.)Engg. (Proj.)Engg. (Elect.)Page 2 of 5Rev. 04/01-2014

TUV India Pvt. Ltd. Audit reportOrganisation:Audits (ZA): PHARMACEUTICALS LTD.Safety Audit as per IS 14489Piyush PatelJagdeesh GE. RameshPrakash PandaB. Vykunta RaoManufacturingManufacturingWare houseQCQADetailed Audit ResultsNo. Good PointsArea / Process1. Knowledge & Experience of Employees2. Management Commitment for Safe OperationSr.No12345678910Audit FindingsArea / LocationThe drain water pipe and cable were at same pointcrossing the road through same Pipe , Electrical Cable Tobe separatedThe pump switches were not identified w.r.t. which thepump to be operated. To be suitably identifiedThe HDPE pipe line for going to ETP was found hangingon other pipes at height without proper supports.Proper supports are to be made to route the HDPE pipeline and clamps are to be placed.HDPE pipe line for the building utilitiesare laid without supports and are not in vertical orhorizontal direction causing stress on the joints may failin due course of time. To be surveyed all over the plantand rectified.Outside utilities equipment’s, AHU foundations arecorroded, valves and gaskets are found badly corroded.To be identified and replaced or rectifiedPipe lines supports and U clamps are missing at manyplace. To be surveyed all over the plant and rectifiedOne pipe line on pipe rack was in disconnectedcondition with open end . To be identified andconnected if not required to be removedIn washing area N2 line is provide to flush theequipment .There is no outlet for discharging in toatmosphere at proper height. The SOP for flushing to bereviewed and to ensure that operator is not exposed toN2.Many of the drain points are open to floor or at height.To be provided with proper plugsThe lift provide in the area not interlocked and door wasgetting open when lift going up or down. All lifts usedfor material are to be marked Material lift withidentification No. & safe Load.Normal.dotManagementManagementPage 3 of 5ProductionBuilding DCategory ofObservationCriticalProductionBuilding DProductionBuilding DMinorProductionBuilding DMinorProductionBuilding DMajorProductionBuilding DProductionBuilding DMinorProductionBuilding DRecommendationProductionBuilding DProductionBuilding ERecommendationMajorRecommendationMinorRev. 04/01-2014

TUV India Pvt. Ltd. Audit reportOrganisation:Audits (ZA):111213141516171819202122232425262728TORRENT PHARMACEUTICALS LTD.Safety Audit as per IS 14489Some Fire Hose boxes were not having nozzles .To besurveyed and provided the sameThe pumping system was tested but was tripping andnot stabilised the electrical pump was on manual mode.All three pumps jockey ,electrical main pump and dieselpump are to be kept on auto mode at different settings6.5 ,5.5 and 4 bar respectively and tested every weekThe capacity of fire water tank is 360m3 against 542 m2required for 2 hrs operation of main pump .To bedesigned and rectified to satisfyCapacity of tanks and logic of staring stopping are notdisplayed .To be displayed prominentlyNear diesel tank foam type Fire Extinguishers are notprovided. At least 22.5 litre capacity FE to be provided atall such points like DG sets and wherever diesel is storedFire extinguisher are not placed with identificationnumber and type of Fire extinguisher required .To bereviewed for proper application as per requirement andFire extinguisher Number to be displayed with locationAviation light available on the Stack for boiler, Aviationlight replacement SOP not available.Pressure vessels to be identified with capacity,identification No, pressure rating and due date of testing.To be identified prominently.The dyke wall slope is to wards road in case of anyleakage while unloading can come to road .Slope to berectifies or other arrangement may be madeFire water monitor is not available near the tank farm.To be relocatedIn N2 storage area some pipe lines at the corner werenot identified and one line was found disconnected .Thelines are to be identifiedBottom portion of N2 tank found lot of corrosion. To becleaned and paintedPeso licence not displayed prominently To be displayedat all tank farmsThe drums are cleaned or to be cleaned are not labelled,All drums coming for cleaning and after cleaning to belabelled and record to be maintained.PPE matrix not displayed at Detoxification areaAll nitrogen purging points to be provided with positiveisolating flange connection only be used when requiredand to be disconnected after purging.All over the plant survey to be done for all stair casesand platform for toe guards and rail condition .To berectified accordinglyFactory revised plan approvals are not available as perNormal.dotPage 4 of 5Fire systemMinorFire systemMajorFire systemMajorFire systemRecommendationFire systemRecommendationSafetyRecommendationUtilities blockRecommendationUtilities blockRecommendationTank farmRecommendationTank farmRecommendationN2 storageMinorN2 storageMinorN2 inorDocumentationMajorRecommendationRev. 04/01-2014

TUV India Pvt. Ltd. Audit reportOrganisation:Audits (ZA):29303132333435363738TORRENT PHARMACEUTICALS LTD.Safety Audit as per IS 14489factory rule. To be processed immediatelyRenewed Stability certificate is not available. To beprocessed immediatelyIndividual toxic and dust inhalation monitoring as perform 37 is not done. To be done for all involved in thehazardous chemicals handlingTrainings are given to individuals butRecord for all persons as per the plan given or not andhow many hours HSE training is given is not identifiedMagnesium Sulphate, Pharma Grade to Be Used in OHCCentre.The First Aid Box content to be ensure as per AP FactoryRulesScaffolding should be constructed & Inspected as per IS4014 also ensure that contractor follow the same.The approach to all overhead water tanks to beEstablished. Ensure Tank Lid are placed & PeriodicCleaning of Water Tanks.All Emergency Numbers to be prominently displayed atSecurity & Other relevant Places .Emergency ControlRoom to Be definedAll the Fire Alarms Generated including false alarmshould be recorded for compliance & AnalysisGlass Bottle Handling Protocol/SOP to be made &Training to be provided to all relevant Staff.Stabilizing Service Area , Piping to be corrected for TripHazard & Approach to Electrical Control ributionOrganisation, audit team, audit documentation,EditorDate:31.01.2020Name:Arun Kumar ShrivastavaSignature Audit team leaderAnnexure : Health , Safety & Loss Prevention Audit Checklist as per IS14489Normal.dotPage 5 of 5Rev. 04/01-2014

Audit Site Pithampur Process Audited All the Processes associated with Manufacturing API and Intermediates,Processs, Utility & Canteen Audit team Leader Arun Kumar Srivastava Audit team Member Jagdish Hardasani Details for Audit Audit Type On site visit Duration Stage 1 5 person-day(s) Date Audit on site 29.01.2020-31.01.2020