ISO/IEC 17025:2005 (NABL)

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1 ISO/IEC 17025:2005 (NABL) / An ISO 9001:2008 Certified Laboratory C 1385 & C 1386 Welcome Hyderabad, Telangana, India. 1

2 Company Profile SP calibration was established in 2012 as a specialist in independent calibration company based on the ethos of quality and service. Our long experience and knowledge of the demands of regulatory authorities such as FDA and others, enables us to provide a comprehensive high quality service to all users. This company formed as a professionally managed third party calibration with experience and exposure in complete calibration requirements of pharmaceutical industry. Calibration with services of accurate documentation is paramount importance in pharmaceutical industry. SP Calibration firm is running by Mr. Nagendra Kumar as a Quality Manager, who having 16 years above work knowledge in R&D and Formulation Pharma industry in terms of Engineering and Quality Assurance activities. Vendor Qualification exposure for API & Formulation Industries. Independent handling of Site Quality Assurance activities for the past 3 years. Where associated with Dr.Reddy's Labs, Gland Pharma, Hetero Drugs, Granules India, Appcure Labs (US based), Invagen Pharma (US) and also worked as a Vendor Audits consultant for few Pharma Industries (Formulation & API Plants) of inland as well as Overseas and his qualification back ground is M-Tech & MBA. SP Calibration Labs is a well-established name in the market for offering world class services to its huge clientele in the field of Mechanical Calibration, Thermal Calibration and Electro Technical Calibration. We are located at Sai Ram Nagar Colony, Nagole. Rangareddy Dist. Hyderabad, Telangana , INDIA. In the process of rendering these services we have a major focus in maintaining consistency and timely execution of all the works, bringing complete satisfaction to clients. Our commitment levels are very high and we ensure to train our all Laboratory personnel to be well aware in Quality Documentation. A special focus is given by management in ensuring all policies and procedures are implemented as per the guidelines of the industry. SP CALIBRATION LABS 2

3 Our Team We are having good technical skilled workers & they have attended the training classes as per in-house outline procedures as well as attended at Govt. calibration agencies. They are well aware of all organizational works and ensure each and every department runs in very smooth manner. We impart regular training to enhance their skills and there is no doubt in claiming the organization has highly benefited by doing the same. Our ethical policies ensure to take care of the interest of employees in a good manner. ORGANOGRAM DIRECTOR / QUALITY MANAGER ADMINISTRATION MANAGER TECHNICAL MANAGER BUSINESS DEVELOPMENT GENERAL OPERATIONS ACCOUNTS LAB-INCHARGE CALIBRATION ENGINEERS TRAINEE SP CALIBRATION LABS 3

4 Technical Competency Profile S.No. Employee Name Qualification Employee ID. Designation Experience 1. Nagendra Kumar. V M. Tech- Pharma, MBA SPCL-001 Quality Manager Having 16 years above work knowledge in R&D and Formulation Pharma industry in terms of Engineering and Quality Assurance activities. Vendor Qualification exposure for API & Formulation Industries. Independent handling of Site Quality Assurance activities for the past 3 years. 2. Pavani. N B.Tech Electronics & Communication Engineering 3. Chandra Sekhar. R M.Sc. Tech (Electronics & Instrumentation Engineering SPCL-012 Quality Executive 4. Shaik Nagoor Diploma (EEE) SPCL-009 Sr. Calibration Engineer Having 3 years work knowledge in the handling of Laboratory Instruments and Quality activities as per ISO/IEC 17025:2005 & ISO 9001:2008 norms. Previously associated with Sri Chakra Scientific Services. SPCL-022 Lab In-Charge Having 5 year above work knowledge in the calibration of Thermal validation activities. Previously associated with Simco Calibration laboratory and Savanth Enviro Tech Pvt. Ltd. Having 7 year above work knowledge in the calibration of Thermal validation activities. Previously associated with Dr. Reddy s, Granules India & Hetero Drugs Pvt. Ltd. 5. Kavitha. K B.Com SPCL-006 Executive Having 4 years work knowledge in the handling of Accounts. Previously associated with Airmech Validation Services. 6. Gowtham Kumar K. V B. Tech (Mechanical) SPCL-026 Administrative Having 4 years of experience in administration activities. SP CALIBRATION LABS 4

5 Our Infrastructure The organization has a good infrastructure which has been the driving force behind our success. Our all business procedures are followed in a very orderly and synchronized manner. We have made sure our every organizational activity takes us closer towards providing world class services to our huge clientele. Highly advanced equipment and machines help us invariably in achieving our set goals and targets. Handling of works: We have a customized software development for track and trace of the calibration activities for better quality management System and customer support as a part of Regulatory compliance. Work identification, allocation, monitoring and issuance of certificate shall be routed by usage of customized Software Application. SP CALIBRATION LABS 5

6 Quality Policy/ Processes The laboratory is committed to good laboratory practices and to producing reproducible and reliable results. The laboratory service is prompt and reliable. All laboratory personnel understand the management system for all operations. All personnel familiarize themselves with the quality policies and documents and implement the same at all times. All the laboratory personnel are well trained in both laboratory techniques and as well the quality system procedures The laboratory management is committed to comply with the International Standard ISO/IEC 17025:2005 and also to continuously improve the effectiveness of the management system. SP CALIBRATION LABS 6

7 Client Satisfaction Serving the clients with best service has been our primary aim since our inception. Our popularity in market is a clear indicator of our excellent services. We have gone a long way in achieving client s satisfaction which has resulted in our enormous growth in market. It feels great when we see happy and satisfied clients in market, their satisfaction is an important measure of the work we are doing in the industry. Timely achievement of work at appropriate price brings joy to the clients. Our Services SP calibration has exclusive to take care of accurate documentation. We execute for all types of calibrations/validation activities and details are furnished as under SP CALIBRATION LABS 7

8 Calibration /Validation Services Thermal Pressure Temperature Gauge Diff. Pressure Gauge, Pressure Indicator Digital Thermo Hygrometer/ Digital Thermometer Vacuum/ Magnehelic/ Pressure/Compound Gauges Thermocouple Diff. Pressure Transmitter Temperature & RH Sensor Pressure Switch, Pressure Transmitter Glass /Thermometer Differential Pressure Switch Thermostats Manometer Safety Thermo Stats Digital Pressure Gauge Electro Technical Mass, Volume & Dimensional Ammeters SS Scale Digital RPM Indicators / Tachometer Dial Indicator Timer Leak Test Operator Conductivity Transmitter Weighing Balances up to 5Kg Temperature Transmitter Radius gauge Conductivity Meter Punch Gauge Level Transmitter Go No-go Gauge RH Transmitter Incremental gauge Digital Clamp meter Measuring Tape Digital Multi meter Digital Micrometer Digital Anemometer Digital Vernier Caliper Temperature & RH Controller SS Button Voltmeter SS Weights (Each) UV Intensity Meter Analytical Weight Box Digital Clock Primary /Secondary weights ( based on certification) Data Logger Centring Jig Velocity Transmitter Flow meter Temperature Controller Digital Protractor ORP Transmitter Plunger Dail Indicator, Hgauge Block Temperature & RH Indicator Vernier depth Gauge, Centring Device Digital Sound Level Meter Rectangular Weight (5 Kg) Lux Meter Machanical Tablet ( 10 Kg) ph Meter Torque Test Weight box v Digital Stop Watch Laboratory Glassware Calibration SP CALIBRATION LABS 8

9 Calibration / Validation Services Thermal services Note: Protocol / Reports shall be provided for all Thermal services on chargeable basis. CALIBRATION / VALIDATION Hot Air Oven Water Bath Vacuum Oven Cooling Chamber BOD Incubator Clean Rooms Mapping Bacteriological Incubator Thermal mapping Areas of Warehouse, Cold Room & Retention Room Refrigerator Muffle Furnace Deep freezer Digital Hot Plate Stability Chamber Challenging Studies Walk-In- Chamber SP CALIBRATION LABS 9

10 List of Master Equipment s details S.No. Equipment Name Make Equipment Id. Range Accuracy THERMAL: Temp.& RH Data logger (Qty:87 No s) EBRO SPCL/T/DL to 60ºC & 0.5 ºC, 1.0 to 0 to100%rh SPCL/T/DL087 3% RH Temp.& RH Data logger Testo SPCL/T/DL088 to SPCL/T/DL to 60ºC & 0 to100%rh 0.5 ºC, 3% RH Temperature Data logger (24-Channel) G-TEK SPCL/T/DL to 400ºC ± 0.5 % FSD ± 1 digit Data logger (16-Channel) ACE SPCL/T/DL ºC to 1200 ºC Data logger (16-Channel) ACE SPCL/T/DL ºC to 1200 ºC 6.0 Data logger with Sensor Microcubs SPCL/T/DL to 250 ºC 0.5 ºC Temperature Indicator with Sensor (K-Type) PPI SPCL/T/TI001 0 to 600ºC 0.5 ºC 0.5 ºC 0.5 ºC 7.0 Temperature Indicator with Sensor (PT 100) -50 to 250ºC 0.5 ºC Hygro Thermometer with sensor Radix SPCL/T/DH to 60ºC 1 ºC, 0 to100%rh 3 % RH Digital Thermometer UDIAN SPCL/T/DT to 1000ºC 0.05 ºC 10.0 Digital Hygropalm Rotronics SPCL/T/HP001 0 to 100%RH 0 to 80 ºC 0.1ºC, 1 % RH SP CLAIBRATION LABS 10

11 List of Master Equipment s details S.No. Equipment Name Make Equipment Id. Range Accuracy Humidity Chamber Indeecon SPCL/T/HC001 5 to 50 ºC Dry Bath Divya Process Instruments 20 to 98 % RH 0.1 ºC 1%RH SPCL/T/DB to 600ºC Uniformity : 0.1 ºC Stability : 0.1 ºC 13.0 Cool Bath Divya Process Instruments SPCL/T/CB to 100 ºC Uniformity : 0.1 ºC Stability : 0.2 ºC Temperature Data logger (24-Channel) G-TEK SPCL/T/DL to 400ºC ± 0.5 % FSD ± 1 digit Temperature Data logger (24-Channel) G-TEK SPCL/T/DL to 400ºC ± 0.5 % FSD ± 1 digit Temperature Data logger (24-Channel) G-TEK SPCL/T/DL to 400ºC ± 0.5 % FSD ± 1 digit Digital Thermometer UDIAN SPCL/T/DT to 1000ºC 0.05 ºC Digital Thermometer UDIAN SPCL/T/DT to 1000ºC 0.05 ºC 19.0 Dry Bath Indeecon SPCL/T/DB002 Ambient to 1200 C Uniformity : 1 ºC Stability : 2 ºC 20.0 Cool Bath Indeecon SPCL/T/CB to 50 C Uniformity : 0.1 ºC Stability : 0.5 ºC SP CALIBRATION LABS 11

12 List of Master Equipment s details S.No. Equipment Name Make Equipment Id. Range Accuracy ELECTRO-TECHNICAL: Digital Tachometer Equinox SPCL/E/DT001 1 to 0.05% FSD + 1 digit RPM Digital Multimeter Fluke SPCL/E/DM001 As Per Manual As Per Manual Universal Calibrator BTH C9 SPCL/E/UC001 As Per Manual As Per Manual Digital Stop Watch TF SPCL/E/DS001 As Per Manual As Per Manual 5.0 ph and ORP Simulator HANNA Instruments SPCL/E/pH001 0 to 14 ph mv to 1900 mv 0.1 ph 5 mv Conductivity Simulator Jumo SPCL/E/CS001 0 to 250 KΩ As Per Manual Digital Multimeter EEE-TECH SPCL/E/DM002 As Per Manual As Per Manual Digital U.V Light Meter Lutron SPCL/E/UV001 As Per Manual 1 % FSD 9.0 Lux Meter Lutron SPCL/E/LM001 AS PER MANUAL As Per Manual Universal Calibrator Radix SPCL/E/UC002 AS PER MANUAL As Per Manual Sound Level Meter Lutron SPCL/E/SL to 130 db As Per Manual Vane Type Anemometer Lutron SPCL/E/VA001 AS PER MANUAL As Per Manual 13.0 Digital Tachometer Lutron SPCL/E/DT002 1 to RPM 0.05% FSD + 1 digit SP CALIBRATION LABS 12

13 List of Master Equipment s details S.No. Equipment Name Make Equipment Id. Range Accuracy PRESSURE: Digital Pressure gauge Keller SPCL/P/PG001-1 To 30 bar 0.1% FS Digital Pressure Gauge Ashcroft SPCL/P/PG002 0 to 160 kg/cm² 0.25% FS Digital Manometer Testo SPCL/P/DM hPa 0.01% Hand Held Pressure Pump Keller SPCL/P/HP001-1 to 30 bar Std.Source High Level Pressure Pump Nascon Instruments SPCL/P/HP002 0 to 1000 bar Std.Source Hand Held Pressure Pump Keller SPCL/P/HP003-1 to 30 bar Std.Source Analog Pressure Gauge Mass SPCL/P/PG003 0 to 40 kg/cm² 0.5% FS Digital Pressure gauge Keller SPCL/P/PG004 0 To 700 bar 0.1% FS Digital Manometer Testo SPCL/P/DM hPa 0.01% Digital Pressure Gauge Ashcroft SPCL/P/PG005-1 To 30 bar 0.25% FS Digital Pressure Gauge Ashcroft SPCL/P/PG006-1 To 30 bar 0.25% FS Pressure Comparator Nascon Instruments SPCL/P/HP002 0 to 400 bar Std.Source SP CALIBRATION LABS 13

14 List of Master Equipment s details S.No. Equipment Name Make Equipment Id. Range Accuracy Mass & Volume /Measurement 1.0 Analytical Weight Box Wensar SPCL/M/AW001 1 mg to 220 gm As per Manual SS weights Wensar SPCL/M/SS004 5 Kg As per Manual SS weights Wensar SPCL/M/SS003 2 Kg As per Manual SS weights Wensar SPCL/M/SS002 1 Kg As per Manual SS weights Wensar SPCL/M/SS gm As per Manual Digital Vernier Caliper Mitutoyo SPCL/M/VC001 0 to 300mm Std. Certificate Digital Micrometer Mitutoyo SPCL/M/MM001 0 to 25 mm Std. Certificate Measuring Tape Hi-Lock 16 SPCL/M/MT001 5 Meters Std. Certificate SP CALIBRATION LABS 14

List of Customers Major esteemed customers details mentioned as Under: Shantha Biotecnics Pvt.Ltd. Aurobindo Pharma Ltd. RA Chem Pharma Ltd. ( Hyd.) RA Chem Pharma Ltd. ( JPT.) CR Bio. ( Hyd.) RA Chem Pharma FRD (Hyd.

15 List of Customers Major esteemed customers details mentioned as Under: Shantha Biotecnics Pvt.Ltd. Aurobindo Pharma Ltd. RA Chem Pharma Ltd. ( Hyd.) RA Chem Pharma Ltd. ( JPT.) CR Bio. ( Hyd.) RA Chem Pharma FRD (Hyd.) Airis Pharma Pvt.Ltd. Epione Labs Finoso Pharma Pvt.Ltd. Newtronic Life Sciences India Pvt.Ltd. Hetero Labs Ltd. Hetero Drugs Ltd. Sami Labs Ltd. MSN Laboratories Ltd. Honour Labs Ltd. VKT Pharma Pvt.Ltd. Kekule Pharma Pvt.Ltd. Vibrant Pharmachem Pvt.Ltd. Annora Pharma Pvt.Ltd. SP CALIBRATION LABS 15

16 ISO/IEC 17025:2005 (NABL) / An ISO 9001:2008 Certified Laboratory NAGENDRA KUMAR.V Director/Quality Manager Cell: , Ph# For Enquiry: Text us: Info@spcalibrationlabs.com nagendra@spcalibrationlabs.com SP CALIBRATION LABS 16

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