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Showing posts from May, 2018

Table of contents (toc) for thailand

Table of contents for product registration (Thailand). Toc for thailand, toc formate for product registration Toc for thailand , toc formate for product registration

Table of contents (toc) for trinidad and tobago

Table of contents for dossier requirments (trinidad and Tobago). Toc for trinidad and tobago , toc formate for dossier

Table of contents (toc) for ukraine

Table of contents for product registration (ukraine) Toc for ukraine , toc formate for product registration

Table of contents (toc) for uruguay or paraguay

Table of contents for dossier requirments (uruguay or paraguay) Toc for uruguay or paraguay, toc formate for dossier

Temperature, transmitters, rtds, thermocouples sensors calibration

For Temperature Parameter covers the Range from -95 o +1200 Deg:  All type of temperature sensors, Gauges, Ultra Cool Deep Freezer - 192 to 50 Degrees. Using the High Stability Temperature Source of Fluke make 9190 and 9150 and High accuracy sensor IRTD sensor, 6 and a half DMM and Fluke indicator with best CMC started from 0.05, Nist Traceability by using Below Standards instruments Source Fluke, Master Irtd Sensor With Indicator Temperature , Transmitters, RTDs, Thermocouples Sensors Calibration

Air flow test & acph calculations

We conduct Air Velocity Measurement to determine the average filter face velocity and uniformity, and the average room airflow velocity and uniformity within a clean room. These test can be conducted by using anemometer or Capture wood. Air Flow Test & ACPH Calculations

Microbial air samplers calibration

Umed is an independent Calibration facility set up at Lab and providing services for the following parameters at its state of the art laboratories which is equipped with reference calibration standards from world-renowned brands like Fluke, WIKA. We do all types Microbial Air Samplers Calibration. Microbial Air Samplers Calibration

Sound level measurement

We perform noise level test that measures the sound pressure. The measurements will vary based on the occupancy state-of-the-art clean room. The purpose may vary but the procedures of testing are identical.          Sound Level Measurement

Breathing validation

Breathing Air Validation Breathing Air-The Quality of air is important to ensure that Respiration System will function properly and reliably. Clean, Natural Air is an odourless, colourless gas mixture Breathing Validation

Electro-technical

Digital Multimeter, Clampmeter, Universal Calibrator, RTDs, Decade Resistance box, all type of Electrical signal input, Temperature Indicator and Universal data logger. Also, other instruments like Digital Timer-Timer-Stop Watch-RPM Indicator Electro-technical

Containment test

We conduct Containment Tests for client's clean room facility. The test is carried to demonstrate that airborne contamination does not enter from a higher pressure area adjacent to the clean room by means of leaks in the construction materials. Containment Test

pure steam validation

Steam quality test equipment to qualify plant/utility/clean/pure steam generators, steam distribution systems and steam supplies to autoclaves in accordance with cGMP (Orange Guide), HTM 01, HTM 2010 (replaced by CFPP01-0l): 1994, HTM 2031 (replaced by CFPP01-0l): 1997, EN 285: 2006, DIN 58950, ISO14937:2000, AAMIST79, ISPEBase line Guide for Steam and Water, and PDA Technical Reports No.l&48 Non-condensable gases (inert gases), Dryness Value , Superheat Testing

plc validation

Umed is a leader in Regulatory Compliance & Validation Consulting & Services. umed also pioneer for Regulatory Compliance Services in India & the largest company that provides Software Categorization & other GAMPbased validation consulting in India & abroad. PLC Validation , CSV Validation, Excel Sheet Validation, Computer System Validation , BMS System Validation, SAP Validation

Gases (Oxygen, N2, CO, CO2)

Oxygen, N2, CO, C02 Calibration will be performed by using standard cylinders and Dewpoint Meter and Dew point sensors Calibration will be performed by comparison method. Oxygen , N2, CO, CO2, Dew Point Meter and Due Point Sensors Calibrations

Ware house mapping validation

Umed offers a complete Temperature & RH   mapping service for any finished product - Raw material warehouse -Production rooms - cold facility in compliance with regulatory guidelines to comply with current guidelines, mapping of a warehouse must be conducted seasonally. We use small wireless sensors which have the capabilities of monitoring temperature and RH simultaneously. Ware house Mapping Validation

Temperature & rh measurement

We conduct validation tests that include Temperature and Humidity Measurements for Production, Warehouse, to ensure that the clean room's HVAC system maintains the specified levels of temperature and humidity required for occupant comfort. The second level or the comprehensive level test identified that the clean room HVAC systems need to maintain the specified levels of temperature and humidity required for both occupant comfort and process temperature control . Temperature & RH Measurement

Nitrogen gas validation

Nitrogen Gas is a critical component in the production of pharmaceutical industry and effects on the quality of the end product. Therefore it should be monitored to ensure that desired quality of the compressed air is using in production. So, Umed labs are giving you the best service with sophisticated Equipment-Gas Analyzers to monitor the Nitrogen. Nitrogen Gas Validation

Light intensity measurement

The purpose of the lighting level tests is to verify that the installed light levels and uniformity meet the specified requirements. We make use of modern testing instruments for assessment of lighting lux levels and intensity. Light Intensity Measurement

lux meter, uv meter

Calibration of all type of Lux meter and UV meter, UV transmitter by comparison method LUX Meter , UV Meter

Hvac validation

Clean room Validation/HVAC Validation is performed for a variety of reasons. To ensure that the design of the facility is fit for its intended purpose; to ensure that the facility, equipment, and environment meet to ensure that the facility, equipment and environment meet defined regulatory requirements; to ensure that the facility, equipment and its environment function together as a system to meet defined standards. Air Velocity , PAO Test, NVPC, Recovery Containment Test, Air Flow Pattern Test , Light Intensity, Sound Level

Non-viable particle count test

We are UMED a reputed name in offering clean room validation services. Our Particle Count Test provides complete airborne particle count cleanliness classification. The test identifies particle count on basis of As-Built, At-Rest, or Operational as per ISO14644, EUGMP.  Non-Viable Particle Count Test

Air flow pattern test ( using water fogger )

We offer Airflow Visualization Test as a part of the validation process. Visualization is carried out by using water fogger and taking Video Graph. The purpose of the airflow visualization test is to show the actual airflow pattern throughout the unidirectional clean room.  Air Flow Pattern Test ( using water Fogger )

QA/QC EQUIPMENT

We perform the validation of Incubators- BOD Incubators-CO2 Incubator-Stability Chambers- Orbital Shakers- Refrigerators-Deep Freezers- Ultra Low Deep- Freezers, Water Baths- Hot Air Ovens- Muffle Furnace- Vacuum & LOD Ovens- Cold Chambers, HPLC, GC Incubators Validation , BOD Validation, Stability Chambers Validation

UMED Pharma Lab Pvt. Ltd

The recording, reproducing, or broadcasting of moving visual images. a recording of moving visual images made digitally or on videotape Clean Room Validation, Compressed Air Qualification, Pure Steam Quality Test, IQ, OQ, PQ Qualification, Thermal Validation , PLC/Computer System Validation, Indoor Air Quality, Calibration Services

Table of contents (toc) for us and europe

Us-toc format for and a products. module 1: administrative and prescribing information. module 1.1: forms application form (356h). module 1.2:  cover letter Us toc format , and a products

Table of contents (toc) for venezuela

table of contents for dossier requirements (  venezuela ). Authority: ministerio de salud y desarrollo social. Toc for venezuela , toc formate for

Table of contents (toc) for vietnam

Table of contents for product registration (Vietnam. Authority:  drug administration of Vietnam moh. Toc for Vietnam , toc format for product registration

Table of contents (toc) for Yemen

table of contents for dossier requirements (Yemen). Toc for Yemen , toc format for dossier

Technical document index

Common & nbsp; technical document for technical document index Technical document

Clean room system in pharmaceuticals

Clean room is defined as an area with specified conditions which is designed to reduce microbial contamination and control of particulate contamination. There are many criteria that should be considered while designing a clean room or clean zone. some of the factors that tend to have impact on cleanliness of the room are building structure, air flushing rate and filtration Cleanroom , microbial contamination, airflow, air pressure

Rationale of copyright protection

 copyright is a right given by the law to creators of literary, dramatic, musical and artistic works and producers of cinematograph films and sound recordings. In fact, it is a bundle of rights including, inter alia ,  rights of reproduction, communication to the public, adaptation and translation of the work. There could be slight variations in the composition of the rights depending on the work. Rationale , copyright protection, literary , dramatic, Musical, artistic work

Geographical indications

a geographical indication (gi) is a sign used on products that have a specific geographical origin and possess qualities or a reputation that are due to that origin. In order to function as a gi, a sign must identify a product as originating in a given place. In addition, the qualities, characteristics or reputation of the product should be essentially due to the place of origin. Since the qualities depend on the geographical place of production, there is a clear link between the product and its original place of production. Geographical indications , ip mountains, guranse tea, specific geographical origin

Alphabetical list of intellectual property offices

alphabetical list of intellectual property offices Alphabetical , list of intellectual , property offices

Summary of the paris convention for the protection of industrial property 1883

Summary of the paris convention for the protection of industrial property 1883. The paris convention applies to industrial property in the widest sense, including patents, trademarks, industrial designs, utility models, service marks, trade names, geographical indications and the repression of unfair competition. paris convention , protection, industrial property

Alphabetical list of intellectual property offices

Alphabetical list of intellectual property offices. Afghanistan central business registry and intellectual property ministry of commerce and industry Alphabetical , list of intellectual , property offices 

Schedule of drugs

Categorisation of drugs according to schedules. Drugs, substances, and certain chemicals used to make drugs are classified into five (5) distinct categories or schedules depending upon the drug’s acceptable medical use and the drug’s abuse or dependency potential. The abuse rate is a determinate factor in the scheduling of the drug ; for example, schedule i drugs have a high potential for abuse and the potential to create severe psychological and/or physical dependence. Drugs categorization.

Who market

Prequalification of active pharmaceutical ingredients (apis) is an independent procedure that identifies apis that are of good quality and manufactured in compliance with who good manufacturing practices (gmp) Who site

Guidelines for prescribing opioids for chronic pain

Improving practice through recommendations. in order to prevent misuse, abuse, or overdose from opioids for chronic pain treatment, cdc (centers for disease control and prevention) improved clinical practice guidelines. these recommendations ensure patients have access to safer and more effective chronic treatment. Opioid therapy , chronic pain , extended release opioids

The fda’s social-media guidelines for the pharmaceutical industry-2014

The u.s. food and drug administration suggested few recommendations on role of social media in pharmaceutical industry. nowadays, social media offering a flexible way to health care providers for collaborating with consumers in different domains who involved in healthcare like accountable care, personalized medicine, shared decision making, to emerging trends in diagnoses, treatments and models of care management Fda , social media , healthcare, pharma industry

Pharmaceutical and Healthcare PowerPoint Presentations

World’s largest infographic presentation portal for healthcare and pharmaceutical industry need functionality, performance, relevant advertising

ICHAPPS Journals

The recording, reproducing, or broadcasting of moving visual images. a recording of moving visual images made digitally or on videotape Pharmaceutical jobs, Healthcare jobs, Doctors, Disease and treatment, Drug metabolism, Pharmaceutical Guidelines, Validations, Protocols, Stability studies, Publications, journals , Research articles, Resumes, Job consultancies , Manufacturers, Suppliers, Exporters, Importers, Products, Trade Leads