Uncategorised

Technical Notes

Practical documentation that shows you how to effectively use our products in various applications.

Kaye GxP Dictionary

Our goal is to provide you with an overview of the most common cGxP abbreviations to help you navigate the technical language better and facilitate communication in your professional life. Naturally, the short explanations provided can only serve as brief references. For more detailed explanations, ample accessible professional literature is available. Whether you are a newcomer to this field or an experienced expert, we hope this little guide of abbreviations is helpful to anyone seeking transparency and clarity in a sometimes overwhelming technical language.

Download Technical note

Minimizing Risk when Using a Traceable Temperature Standard

Precision and reliability are of the utmost importance in the validation of thermal processes. These requirements demand time-consuming and complex procedures for the validation, calibration, and verification of the instruments used. In this context, the Kaye IRTD, a high-precision traceable temperature standard, plays a noteworthy role. Its application is crucial for the accuracy of Kaye’s validation systems, like the Kaye AVS and the Kaye ValProbe, and thus forms an integral part of these verification and calibration processes. However, the use of temperature standards also brings specific challenges and potential risks. This Technical Note shows how such risks can be minimized, and the validation and calibration processes can be optimized and have their risks reduced.

Download Technical note

Calibration of Embedded Sensors_thumbnail

The Calibration of Embedded Sensors

Embedded sensors have become widely adopted across industries — from food processing to pharmaceutical sterilization — due to their flexibility and ease of use. However, ensuring their metrological accuracy remains a critical challenge in thermal validation, especially in the absence of dedicated standards. This Technical Note explores common calibration strategies, outlines practical risk assessments, and provides guidance on optimizing accuracy using traceable tools such as the Kaye IRTD. Learn how to confidently manage embedded sensor calibration and strengthen compliance in regulated environments.

Download Technical note

Videos

AVS Remote Control

Using your AVS has never been easier! With AVS Remote Control, you have the ability to control your AVS remotely, allowing you to generate reports from the comfort of your desk or another location. Also, you can control multiple AVS units with a single tablet.

Common Reporting Tool

With Kaye’s Common Reporting Tool software, you can utilize any compatible Windows PC to give you the ability to generate reports from you AVS or ValProbe RT system. Using your qualification study files, you can document the results of your validation studies right on your PC.

CTR-25 Liquid Bath

The CTR-25 is the portable liquid bath that is designed to address portability, capacity, speed, and accuracy requirements that are not normally found in a portable liquid bath. With a temperature range from -25°C to 140°C, the CTR-25 has the ability to verify numerous loggers at one time, while still being compact enough to be easy for carrying and shipping.

HTR-420

With an operating temperature range of 30°C to 420°C, fast heating and cooling times, and the ability to calibrate up to 48 thermocouples at one time, the HTR-420 is an asset for any laboratory. The dry block is designed to accommodate not only thermocouples, but IRTDs, ValProbes, and RF ValProbes as well. It is also compatible with the Validator 2000, Validator AVS, ValProbe, and RF ValProbe software for automatic and manual calibrations.

HygroCal100 - Humidity Calibrator

The HygroCal100 provides a stable test chamber to quickly evaluate the performance of Kaye’s ValProbe RT Humidity Loggers or any relative humidity sensors across a wide range of 5 to 95% relative humidity. The intuitive design allows up to 8 probes or loggers under test to be easily sealed and immersed in the chamber.

IQ/OQ (Installation Qualification/Operational Qualification) Service

Kaye is proud to assist our customers with installation qualification/operational qualification protocols for numerous pieces of equipment. Customers can purchase the documentation and perform the IQ/OQ yourself. Or, you can save time, save money, and have peace of mind by allowing us to perform your IQ/OQ for you. Check out this video for more details on IQ/OQ services that we offer.

IRTD-400

Kaye’s IRTD is a high accuracy temperature standard probe that can be used as part of your validation system for calibrating sensors. With a temperature range of -196°C to 420°C, our IRTD enables you to use it in virtually all temperature validation applications.

Kaye Console Keyboard

Elevate your work and stay connected with the revolutionary Kaye Keyboard, designed to seamlessly integrate with the Kaye Tablet Console. Experience convenient features that transform the way you work on the go. Forego the necessity of an additional mouse and welcome superior portability. The Kaye Keyboard boasts an innovative touchpad that serves as a removable RF mouse. This clever design ensures that you always have a precise optical mouse at your fingertips, conveniently tucked away within the keyboard itself. Whether you're in the production area, in the laboratory, or at a meeting, you'll enjoy effortless handling and transportation, without compromising on functionality.

Kaye Feedthru

When you need to introduce thermocouples into your autoclave, Kaye’s Feedthru gives you the perfect solution to do so. Our feedthru gives you an easy way to introduce your thermocouples through your autoclave port, and then securely seal the port to preserve your temperature and pressure environments inside your autoclave.

Kaye IRTD Display

The Kaye IRTD Display is a standalone interface with a touchscreen. This advanced display unit seamlessly connects with up to two Kaye IRTD Reference Standard probes, offering real-time temperature data in a user-friendly format. Equipped with a 4.3" touch screen, the Kaye IRTD Display provides clear and intuitive readings for both IRTDs, allowing users to monitor temperature with ease. The display also showcases the temperature difference (Delta) between the two connected IRTDs, enabling quick and accurate analysis. Supporting both types of IRTD Connector cables, this versatile unit ensures compatibility with your preferred setup.

Kaye Thermocouple Sensors

The right sensor which perfectly fits to the application and temperature range is part of your validation system. Kaye offers a broad selection of different sensor types suitable for your application needs. Learn about several options offered by Kaye for your thermocouple needs.

LabWatch IoT - New Features

Over the last year, numerous improvements have been made to LabWatch IoT, Kaye’s cloud-based environmental and facility monitoring system. In this video, we are going to take a look at some of the major feature updates that have been put into place recently.

LabWatch® IoT

LabWatch® IoT is a cloud-based facility and environmental monitoring system that gives you a complete solution for critical environments where precision measuring is needed. With the system being cloud based, you get access to your current status, past data, and alarms from anywhere around the globe.

Liquid Nitrogen Comparator

Kaye’s easy to use, simply designed comparator that gives you the perfect option of validations at the boiling point of liquid nitrogen, -196°C. Working in tandem with another comparator, the Liquid Nitrogen Comparator allows you to complete your cryo validations.

LTR-150 Multi-Purpose Calibrator

The LTR-150 is the most advanced, multi-purpose temperature calibrator. This device can function as dry block, liquid bath, or surface temperature calibrator, with an operating temperature range of -30°C to 150°C. The LTR-150 has combability with Validator AVS, Validator 2000, ValProbe and RF ValProbe.

LTR-90 Ultra Cool Dry Block Calibrator

The Kaye LTR-90 is an ultra-cool dry well calibrator designed for portability and ease of operation. The dry well calibrator operates from -90°C to +140°C and delivers fast response, high stability, and automated sensor calibration for ultra-low temperature applications.

Rental Options From Kaye

Whether you need more equipment because of higher demands on your organization, something unexpected happens, or you are looking to minimize downtime, Kaye has rental options that can help you in all situations. Nearly all of Kaye’s validation equipment can be rented and the rental program offers a simple, quick, and affordable solution for any unexpected measurement needs within your validation equipment.

Service & Service Agreements Offered By Kaye

At Kaye, our offerings don't end at the point of sale. We have numerous service options to help our customers keep their equipment in proper working and calibrated order. We also offer several service agreements to help make the process even easier for our customers.

Service Solutions Offered By Kaye

At Kaye, we offer complete product support for the life of your equipment. As the manufacturer we maintain laboratory accreditation and provide both “in-house” and “on-site” service options using our modern high precision calibration facilities and high-end lab equipment.

Summer Warehouse Mapping

When the calendar turns toward summer, it means that weather changes are soon to follow. Summer means higher temperatures and higher humidity levels. When those levels go up outside of your warehouse, it can make the temperature and humidity levels climb inside your warehouse as well. That is where Kaye’s environmental monitoring systems come in to help you!

Upgrade From ValProbe to ValProbe RT

If you haven’t updated from Kaye’s ValProbe system to our ValProbe RT system, now is the time to do it! In this video, we are going to look at the numerous benefits of upgrading to our real-time system.

Using ValProbe RT Loggers & Console

Using Kaye’s ValProbe RT system is easy to do. In this video we show you how simple it is to run an accurate qualification using the Kaye ValProbe RT system with the Validation Console.

Validation Console Key Features

See some of the features on the Kaye Validation Console, which comes with our Validator AVS and can also be purchased with our ValProbe RT wireless data logger system. See real-time data from anywhere in your facility, set up your asset management concept, and use the two built-in cameras with ease to store specific information for all your assets.

Validator AVS

Kaye’s Validator AVS combines accurate sensor measurements with all requirements for calibration and traceability to national standards, while generating compliant reports and managing the validated assets and validation equipment.

ValProbe Battery & O-Ring Replacement

When you ValProbe logger needs to have the battery replaced, it is simple and easy to do, and this video will show you how. Replacement batteries, O-rings, everything that you need for your replacement is available directly from Kaye.

ValProbe RT 1.2

Learn about the major features that are part of ValProbe RT’s newest update, version 1.2. This software update brings in numerous key features and improves usability for everyone. From active directory support, improved programming and read speeds, a new battery estimator, and so much more, this update is definitely something you will want to check out!

ValProbe RT 1.3

Kaye'nin sektör lideri kablosuz doğrulama sistemi ValProbe RT, 1.3 sürümünde çalışmaya hazır. Bu güncellemenin en önemli özelliklerinden biri, bir çalışmada 50 adede kadar ValProbe RT Kaydedicinin desteklenmesidir. Çok talep edilen bir öğe olan ValProbe RT 1.3, ACTIVE DIRECTORY* ile Kullanıcı Yönetimini desteklemektedir. ValProbe RT 1.3, kalifikasyon çalışmalarını bir sıcaklık koşuluyla da başlatma desteği ve RT Veri Kaydedicinizin bağıl nem sensörünü veya CO2 sensörünü sahada değiştirme esnekliği sunar.

ValProbe RT 5-Channel Bendable Logger

The real-time Kaye ValProbe RT data loggers, obtainable in one and two sensor versions, are now also available with five sensors in conjunction with bendable probes. The advanced electronics of the loggers in combination with the PT-1000 Sensors achieves an accuracy of up to 0.10°C and at the same time enable an extended battery life. This Logger supports up to 100,000 samples per measurement channel – so a total of up to half a million datapoints per device.

ValProbe RT Humidity/Temperature Logger

Real-time data for both humidity and temperature is achievable with the ValProbe RT Humidity & Temperature Logger. With sensor technology that gives you the highest level of accuracy, you have the ability to program sample rates starting at 1 seconding for humidity range of 15% to 95% and temperature range of 0°C to 70°C.

ValProbe RT System

ValProbe RT is Kaye’s wireless real-time validation and monitoring system designed specifically for the thermal validation and regulatory needs of the pharmaceutical and biotech industries. With numerous logger options, there are many options to achieve what you need.

Bilgi Kütüphanesi

Ürünlerimiz ve hizmetlerimiz hakkında kapsamlı bilgi ve kaynaklar için merkeziniz olan Kaye Bilgi Kütüphanesine hoş geldiniz. Bilgi Kütüphanemiz, projelerinizi ve kararlarınızı destekleyebilecek çok çeşitli materyallere erişmenizi sağlar. Burada videolar, broşürler, teknik belgeler, standartlar ve kılavuzlar bulabilirsiniz.

Videos

Kapsamlı video koleksiyonumuzu keşfedin. Burada ürün sunumları, öğreticiler, eğitim videoları ve çok daha fazlasını bulacaksınız. Videolarımız, ürünlerimizin kullanımı ve faydaları hakkında size daha derin bilgiler vermek için tasarlanmıştır.

Brochures

Broşürlerimiz size ürün gruplarımız ve hizmetlerimiz hakkında ayrıntılı bilgi sunar. Amphenol'ün yenilikçi çözümleri hakkında bilgi edinmek ve bunları günlük işlerinize uygulamak için en yeni broşürleri indirin.

Whitepaper

In-depth scientific and technical articles to help you better understand the fundamental technologies and innovations in the industry.

Technical Notes

Practical documentation that shows you how to effectively use our products in various applications.

Norms & Guidelines

Standartlar ve kılavuzlar bölümümüz, ürünlerimiz ve çözümlerimizle çalışmak için gerekli olan önemli standartları ve en iyi uygulamaları içerir. En son gereksinimler ve tavsiyelerle güncel kalın.

GxP Dictonary

Bu koleksiyon, temel kısaltmalar için bir referans kılavuzu görevi görerek teknik terimlerin anlaşılmasını kolaylaştırır. Hem yeni başlayanlar hem de uzmanlar için tasarlanmıştır ve karmaşık terminolojide netlik sağlar.

Bilgi sahibi olmak ve size sunduğumuz sayısız kaynaktan faydalanmak için Bilgi Kütüphanemizi düzenli olarak ziyaret edin. Herhangi bir sorunuz veya öneriniz varsa, lütfen bizimle iletişime geçmekten çekinmeyin.

Norms & Guidelines

Note: When you click on any of the links, you will leave the Kaye website and thus, our jurisdiction/responsibility. All listed guidelines/standards/ organizations do not claim to be exhaustive. We regularly update this page to stay as current as possible with the constantly changing standards and regulations.

Guidelines & Standards

Download as PDF

Standard/ Guideline	Name
Comprehensive guide to steam sterilization and sterility assurance in healthcare facilities	AAMI ST79
Sterilization of health care productsRadiation sterilization—Product adoption and alternative sampling plans for verification dose experiments and sterilization dose audits	AAMI TIR35:2016/(R)2021
Sterilization of health care products - Radiation - Guidance on sterilization of human tissue-based products	AAMI TIR37: 2013
Sterilization of health care products-Radiation	AAMI TIR40:2018
Guidelines on the Calibration of Temperature and/or Humidity Controlled Enclosures	AFNOR NF X 15-140
Dry heat (heated air) sterilizers	ANSI/AAMI ST50:2004/(R)2018
Table-top steam sterilizers	ANSI/AAMI ST55:2016/(R)2023
Comprehensive guide to steam sterilization and sterility assurance in health care facilities	ANSI/AAMI ST79
Hospital steam sterilizers	ANSI/AAMI ST8:2013/(R)2018
Sterilization of health care products - Radiation	ANSI/AAMI/ISO 11137-03: 2017
Sterilization of health care products—Biological indicators—Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes	ANSI/AAMI/ISO 11138-5:2017/(R)2024
Sterilization of health care products—Radiation—Substantiation of selected sterilization dose: Method VDmaxSD	ANSI/AAMI/ISO 13004:2022
Sterilization of health care products — General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices	ANSI/AAMI/ISO 14937:2009/(R)2013
Sterilization of health care products -Ethylene oxide - Requirements for development, validation and routine control of a sterilization process for medical devices	ANSI/AAMI/ISO 11135:2014
Sterilization of health care products - Moist Heat	ANSI/AAMI/ISO TIR17665-2:2009/(R)2016
Sterilization of health care products - Chemical indicators	CAN/CSA-ISO 11140-3
Sterilization of health care products - Vocabulary of terms used in sterilization and related equipment and process standards	CSA ISO 11139
Sterilization of health care products - Microbiological methods	CSA ISO 11737-1
Sterilization of health care products - Dry heat - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 20857:2010, IDT)	CSA ISO 20857
Sterilization of health care products - Moist heat	CSA Z17665-1
Electrical laboratory devices - Heating ovens and incubators	DIN 12880
Requirements for the validation of cleaning and disinfection processes	DIN 58341
Sterilization of health care products - Radiation - Confirmation of selected sterilization dose: Method	DIN CEN ISO/TS 13004
Biotechnology - Performance criteria for steam sterilizers and autoclaves	DIN EN 12347
Temperature recorders for the transport, storage and distribution of temperature	DIN EN 12830
Sterilization - Steam sterilizers - Large sterilizers	DIN EN 13060
Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing	DIN EN 14180
Controlled environment storage cabinet for processed thermolabile endoscopes	DIN EN 16442
Sterilizers for medical purposes - Low temperature vapourized hydrogen peroxide sterilizers - Requirements and testing	DIN EN 17180
Sterilization - Steam sterilizers - Large sterilizers	DIN EN 285
Sterilization of medical devices - Validation and routine control of ethylene oxide sterilization	DIN EN 550
Sterilization of medical devices - Validation and routine control of sterilization by moist heat	DIN EN 554 (replaced by DIN ISO 17665)
Sterilization of medical devices	DIN EN 556
Environmental testing	DIN EN 60068
Non-biological systems for use in sterilizers - Part 5: Specification for indicator systems and process challenge devices for use in performance testing for small sterilizers	DIN EN 867-5
General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices	DIN EN ISO 14937
Sterilization of health-care products - Ethylene oxide; Requirements for the development, validation and routine control of a sterilization process for medical devices	DIN EN ISO 11135
Sterilization of health care products - Biological indicators	DIN EN ISO 11138
Sterilization of health care products - Chemical indicators	DIN EN ISO 11140
Sterilization of health care products - Chemical indicators - Guidance for selection, use and interpretation of results	DIN EN ISO 15882
Washer-disinfector; Performance requirements and test method criteria for demonstrating cleaning efficacy.	DIN EN ISO 15883
Sterilization of health care products - Biological and chemical indicators - Test equipment	DIN EN ISO 18472
Specifies requirements for the development, validation and routine control of a dry heat sterilization process for medical devices	DIN EN ISO 20857
Sterilizers for medical purposes - Small steam sterilizers	DIN EN ISO 13060
Calibration of Climatic Chambers	DKD-R 5-7
Manufacture of Sterile Medicinal Products	EU GMP Annex 01
Manufacture of Biological Medicinal Products for Human Use	EU GMP Annex 02
Manufacture of Radiopharmaceuticals	EU GMP Annex 03
Computerised Systems	EU GMP Annex 11
Qualification and Validation	EU GMP Annex 15
Pharmaceutical Quality System	EU GMP Chapter 1
Premises and Equipment	EU GMP Chapter 3
Production	EU GMP Chapter 5
Quality Control	EU GMP Chapter 6
Current Good Manufacturing Practice in Manufacturing Processing, packing, or Holding of Drugs	FDA 21 CFR part 210
Current Good Manufacturing Practice for Finished Pharmaceuticals	FDA 21 CFR part 211
Regulations on electronic records and electronic signatures	FDA 21 CFR part11
FDA Guide to Inspections of Lyophilization of Parenteral	FDA Inspection Guide
FDA Guide to Inspections of Sterile Drug Substance Manufacturers	FDA Inspection Guide
FDA Guide to Inspections of Pharmaceutical Quality Control Labs	FDA Inspection Guide
FDA Guide to Inspections of Foreign Medical Device Manufacturers	FDA Inspection Guide
FDA Guide to Inspections of Foreign Pharmaceutical Manufacturers	FDA Inspection Guide
FDA Inspection Technical Guide Water for Pharmaceutical Use	FDA Inspection Guide
FDA Instection Technical Guide Expiration Dating and Stability Testing for Human Drug Products	FDA Inspection Guide
Validation and periodic testing of the various sterilization processes used in hospitals, laboratories and other healthcare facilities	HTM 2010
Stability testing of active pharmaceutical ingredients and finished pharmaceutical products	ICH Guideline - Annex10
Targeted Revisions of the ICH Stability Guideline Series	ICH Guideline - Q1/Q5C EWG
Pharmaceutical Quality System	ICH Guideline - Q10
Stability testing of Biotechnological / Biological products	ICH Guideline - Q1A
Stability testing of New Drug Substances and Products	ICH Guideline - Q5C
Quality Risk Management	ICH Guideline - Q9
Stability Testing of new drug substances and products	ICH Q1A (R2)
Environmental testing	IEC 60068
Thermocouples	IEC 60584-1
Industrial Platinum Resistance Thermometers	IEC 60751
ILAC Guidelines for Measurement Uncertainty in Testing	ILAC G17
Measurement management systems — Requirements for measurement processes and measuring equipmen	ISO 10012
Sterilization of health care products; requirements for validation and routine control; industrial moist heat sterilization	ISO 11134
Sterilization of health care products - Radiation	ISO 11137
Sterilization of health care products - General requirements for characterization of a sterilizing agent and for the development, validation and routine control of a sterilization process	ISO 14937
Sterilization of health care products - Moist heat	ISO 17665
Testing and calibration laboratories	ISO/IEC 17025
Sterilization of health care products — Low temperature vaporized hydrogen peroxide — Requirements for the development, validation and routine control of a sterilization process for medical devices	ISO/WD 22441
Controlled Temperature Chamber Mapping and Monitoring	ISPE Good Practice Guide
Validation of Moist Heat Sterilization Processes Cycle Design, Development, Qualification and Ongoing Control	PDA Technical Report No. 01
Validation of Dry Heat Processes Used for Depyrogenation and Sterilization	PDA Technical Report No. 03
Design Concepts For the Validation of a Water for Injection System	PDA Technical Report No. 04
Parametric Release of Pharmaceuticals and Medical Device Products Terminally Sterilized by Moist Heat	PDA Technical Report No. 30
Design and Validation of Isolator Systems for the Manufacturing and Testing of Health Care Products	PDA Technical Report No. 34
Moist Heat Sterilizer Systems: Design, Commissioning, Operation, Qualification	PDA Technical Report No. 48
Implementation of Quality Risk Management For Pharmaceutical and Biotechnology Manufacturing Operations	PDA Technical Report No. 54
Process Validation: A Lifecycle Approach Annex 1: Oral Solid Dosage/Semisolid/ Dosage Forms	PDA Technical Report No. 60
Data Integrity Management System for Pharmaceutical Laboratorie	PDA Technical Report No. 80
Guide to Good Manufacturing Practice for Medicinal Products	PIC/S (PE 009-17)
Chapters on Good Storage and Distribution Practices	USP (1079) Series
Monitoring Devices—Time, Temperature, and Humidity	USP〈1118〉
WHO Guidelines on quality and risk management	WHO Guidelines

Organizations

Main Pharma Trade Associations

Download as PDF

By Region	Name
Global Trade Associations	IFPMA (International Federation of Pharmaceutical Manufacturers and Associations)
Central America	Fedefarma (Federation of Central American Pharmaceutical Laboratories)
Europe	Medtech Europe (Medical Devices Association)
Europe	EFPIA (European Federation of Pharmaceutical Industries and Associations)
Gulf	PhRMAG (Pharmaceutical Research and Manufacturers Association Gulf)
Middle East and Africa	PhRMA MEA (Pharmaceutical Research & Manufacturers of America Middle East & Africa)

By Country	Name
Algeria	UNOP (National Association of Pharmaceutical Corporations)
Argentina	CAEMe (Argentine Chamber of Medical Specialties)
Australia	Medicines Australia (Pharmaceutical Industry Association)
Austria	PHARMIG (Pharmaceutical Industry Association)
Austria	FOPI (Pharmaceutical Industry Association of researching pharma companies in Austria)
Austria	OVIH (Austrian Association of Vaccine Manufacturers)
Belarus	BAIPM (Belarus Association of International Pharmaceutical Manufacturers)
Belgium	pharma.be (Belgian Pharmaceutical Trade Association)
Belgium	Essenscia (Federation of Chemistry & Life Science Industry)
Brazil	Interfarma (Association of Pharmaceutical Research-based Industry)
Canada	IMC (Innovative Medicines Canada)
Chile	CIF (Chamber of Pharmaceutical Industry)
China	RDPAC (R&D-based Pharmaceutical Association Committee)
Colombia	AFIDRO (Association of Pharmaceutical R&D companies)
Czech Republic	AIFP (Association of the Innovative Pharmaceutical Industry)
Denmark	LIF (The Danish Association of the Pharmaceutical Industry)
Dominican Republic	ARAPF (National Association of Pharmaceutical Companies)
Ecuador	IFI (Pharmaceutical R&D Industry Association)
Egypt	Pharmaceutical Cosmetics & Appliances Chamber
Finland	PIF (Pharmaceutical Industry Finland)
France	LEEM (French Pharmaceutical Industry Association)
Germany	BAH (Federation of Pharmaceutical Manufacturers)
Germany	Vfa (Trade Association for Research-based Pharmaceutical Companies)
Greece	SFEE (Hellenic Association of Pharmaceutical Companies)
Hong Kong	HKAPI (Hong Kong Association of the Pharmaceutical Industry)
Ireland	IPHA (Irish Pharmaceutical Healthcare Association)
India	OPPI (Organisation of Pharmaceutical Producers of India)
Indonesia	IPMG (International Pharmaceutical Manufacturers Group)
Israel	The Association of Research-based Pharmaceutical Companies
Italy	Farmindustria (Association of Pharmaceutical Companies)
Japan	JPMA (Japan Pharmaceutical Manufacturers' Association)
Japan	Japanese Association of Vaccine Industries
Kazakhstan	AIPM (Association of International Pharmaceutical Manufacturers)
Kenya	KAPI (Kenya Association of Pharmaceutical Industry)
Korea	KRPIA (Korea Research-based Pharmaceutical Industry Association)
Korea	KOBIA (Korea Biomedicine Industry Association)
Korea	KPTA (Korea Pharmaceutical Traders Association)
Luxembourg	APL (Pharmaceutical Association of Luxembourg)
Malaysia	PhAMA (Pharmaceutical Association of Malaysia)
Mexico	AMIIF (Mexican Association of Pharmaceutical Research Industries)
Morocco	LEMM (Les Entreprises du Médicament Marocaines - Research-based Pharmaceutical Association)
Netherlands	Association for Innovative Medicines
Netherlands	HollandBio
New Zealand	Medicines New Zealand
Nigeria	NIROPHARM (Association of Representatives of Overseas Pharmaceutical Manufacturers)
Nigeria	PMG - MAN (Pharmaceutical Manufacturers Group of the Manufacturers Association of Nigeria)
Norway	LMI (The Pharmaceutical Industry Association)
Pakistan	Pharma Bureau
Peru	ALAFARPE (National Association of Pharmaceutical Laboratories)
Philippines	PHAP (Pharmaceutical and Healthcare Association of the Philippines)
Poland	INFARMA (Employers’ Union of Innovative Pharmaceutical Companies)
Portugal	APIFARMA (Portuguese Association of Pharmaceutical Industry)
Russia	AIPM (Association of International Pharmaceutical Manufacturers)
Saudi Arabia	RPCC (Research-based Pharmaceutical Companies Group)
Singapore	SAPI (Singapore Association of Pharmaceutical Industries)
South Africa	IPASA (Innovative Pharmaceutical Association SA)
Spain	Farmaindustria (R&D Pharmaceutical Association)
Sri Lanka	Sri Lanka Chamber of Pharmaceutical Industry
Sweden	LIF (The Research-based Pharmaceutical Industry Association)
Switzerland	Scienceindustries
Switzerland	Interpharma (Pharmaceutical Industry Association)
Taiwan	IRPMA (International Research-based Pharmaceutical Manufacturers' Association)
Taiwan	CAPA (Chinese Association for Pharmaceutical Agents)
Thailand	PreMA (The Pharmaceutical Research and Manufacturers' Association)
Tunisia	SEPHIRE (Association of Innovative Pharmaceutical Research Companies)
Turkey	AIFD (Association of Research-based Pharmaceutical companies)
UK	ABPI (Association of the British Pharmaceutical Industry)
UK	BIA (BioIndustry Association)
Ukraine	APRaD (Association of Pharmaceutical Research and Development)
Uruguay	CEFA (Chamber of Pharmaceutical and Related Specialties)
USA	PhRMA (Pharmaceutical Research and Manufacturers of America)
USA	BIO (Biotechnology Industry Organisation)
Venezuela	CAVEME (Venezuelan Chamber of Medicines)
Vietnam	Pharma Group (The Pharmaceutical Sector Committee of EuroCham)

Local Authorities

Download as PDF

Country	Authorities	Website
Argentina	National Administration of Drugs, Foods and Medical Devices	www.argentina.gob.ar/anmat
Armenia	Scientific Center of Drug and Medical Technologies Expertise (SCDMTE)	www.pharm.am
Australia	Therapeutic Goods Administration (TGA)	www.tga.gov.au
Austria	Australian Pesticides and Veterinary Medicines Authority (APVMA)	apvma.gov.au
Austria	Austrian Agency for Health and Food Safety	www.ages.at
Austria	Austrian Federal Office for Safety in Health Care	www.basg.gv.at
Azerbaijan	Azerbaijan Ministry of Health, Analytical Expertise Center	www.sehiyye.gov.az/
Belarus	Center for Examinations and Tests in Health Service	www.rceth.by
Belgium	Federal Agency for Medicines and Health Products (FAMHP)	www.afmps.be
Brazil	Brazilian Health Regulatory Agency	www.gov.br/anvisa
Bulgaria	Bulgarian Drug Agency	www.bda.bg
Bulgaria	Bulgarian Food Safety Agency, Veterinary medicinal products	www.bfsa.egov.bg
Canada	Health Canada (HC) / Santé Canada (SC)	www.canada.ca/health-canada
Croatia	Agency for Medicinal Products and Medical Devices of Croatia	www.halmed.hr
Croatia	Ministry of Agriculture, Veterinary and food safety directorate	www.veterinarstvo.hr
Cuba	Center for State Control of Drugs, Equipment and Medical Devices	www.cecmed.cu
Cyprus	Ministry of Health, Pharmaceutical Services	www.moh.gov.cy
Czech Republic	State Institute for Drug Control	www.sukl.cz
Czech Republic	Institute for State Control of Veterinary Biologicals and Medicaments	www.uskvbl.cz
Denmark	Danish Medicines Agency	laegemiddelstyrelsen.dk
Egypt	Egyptian Drug Authority (EDA)	norcb.gov.eg
Estonia	State Agency of Medicines	ravimiamet.ee
Finland	Finnish Medicines Agency (fimea)	www.fimea.fi
France	French National Agency for Medicines and Health Products Safety	ansm.sante.fr
France	The French Agency for Veterinary Medicinal Products / French Agency for Food, Environmental and Occupational Health & Safety	www.anses.fr
Germany	Federal Institute for Drugs and Medical Devices	www.bfarm.de
Germany	Federal Institute for Vaccines and Biomedicines	www.pei.de
Germany	Federal Office of Consumer Protection and Food Safety	www.bvl.bund.de
Greece	National Organization for Medicines	www.eof.gr
Hungary	National Institute of Pharmacy and Nutrition	ogyei.gov.hu
Hungary	National Food Chain Safety Office, Directorate of Veterinary Medicinal Products	www.nebih.gov.hu
Iceland	Icelandic Medicines Agency (IMA)	www.ima.is
India	Central Drugs Standard Control Organization (CDSCO)	cdsco.gov.in
Indonesia	National Agency of Drug and Food Control (NA-DFC)	www.pom.go.id
Iran	Iran’s Food and Drug Administration (IFDA)	www.fda.gov.ir
Ireland	Health Products Regulatory Authority (HPRA)	www.hpra.ie
Ireland	Department of Agriculture, Food and the Marine	www.agriculture.gov.ie
Israel	Ministry of Health - Pharmaceutical Division	www.health.gov.il
Italy	Italian Medicines Agency	www.aifa.gov.it
Italy	National Institute of Health	www.iss.it
Italy	Ministry of Health, Directorate-General for animal health and veterinary medicinal products	www.salute.gov.it
Japan	Pharmaceuticals and Medical Devices Agency (PMDA)	www.pmda.go.jp
Kazakhstan	National Center for Expertise of Medicines and Medical Devices	www.ndda.kz
Latvia	State Agency of Medicines of Latvia	www.zva.gov.lv
Latvia	Food and Veterinary Service	www.pvd.gov.lv
Liechtenstein	Office of Health/Dpt. of Pharmaceuticals	www.llv.li
Lithuania	State Medicines Control Agency	www.vvkt.lt
Lithuania	State Food and Veterinary Service;	vmvt.lt
Lithuania	National Food and Veterinary Risk Assessment Institute	nmvrvi.lrv.lt
Luxembourg	Ministry of Health	www.santesecu.public.lu/fr.html
Malaysia	National Pharmaceutical Regulatory Agency (NPRA)	npra.gov.my
Malta	Malta Medicines Authority (MMA)	www.medicinesauthority.gov.mt
Malta	Veterinary Regulation Directorate	agrifish.gov.mt
Mexico	Federal Commission for the Protection against Sanitary Risk	www.gob.mx/cofepris
Netherlands	Medicines Evaluation Board (MEB)	www.cbg-meb.nl
New Zealand	New Zealand Medicines and Medical Devices Safety Authority (Medsafe)	www.medsafe.govt.nz
Norway	Norwegian Medicines Agency (NOMA)	legemiddelverket.no
People’s Republic of China	National Medical Products Administration (NMPA)	www.nmpa.gov.cn
Philippines	Food and Drug Administration Philippines	www.fda.gov.ph
Poland	Chief Pharmaceutical Inspectorate	www.gif.gov.pl
Poland	Office for Registration of Medicinal Products, Medical Devices and Biocidal Products	urpl.gov.pl/pl
Portugal	INFARMED – National Authority of Medicines and Health Products, IP	www.infarmed.pt
Portugal	Food and Veterinary Directorate General	www.dgav.pt
Romania	National Agency of Medicines and Medical Devices	www.anm.ro
Romania	Institute for Control of biological products and veterinary medicines	www.icbmv.ro
Russia	Ministry of Health of Russian Federation	minzdrav.gov.ru
Russia	Federal Service for Surveillance in Healthcare	roszdravnadzor.gov.ru
Saudi Arabia	Saudi Food and Drug Authority (SFDA)	www.sfda.gov.sa
Serbia	Medicines and Medical Devices Agency of Serbia (ALIMS)	www.alims.gov.rs
Singapore	Health Sciences Authority (HSA)	www.hsa.gov.sg
Slovakia	State Institute for Drug Control (SIDC)	www.sukl.sk
Slovakia	Institute for State Control of Veterinary Biologicals and Medicaments	www.uskvbl.sk
Slovenia	Agency for Medicinal Products and Medical Devices of the Republic of Slovenia	www.jazmp.si
South Africa	South African Health Products Regulatory Authority (SAHPRA)	www.sahpra.org.za
South Korea	Ministry of Food and Drug Safety (MFDS)	www.mfds.go.kr
Spain	Spanish Agency of Medicines and Medical Devices	www.aemps.gob.es
Sweden	Medical Products Agency	www.lakemedelsverket.se
Switzerland	Swissmedic	www.swissmedic.ch
Tajikistan	Ministry of Health and Social Protection of the Population of the Republic of Tajikistan	moh.tj
Thailand	Food and Drug Administration (Thai FDA)	www.fda.moph.go.th
Turkey	Turkish Medicines and Medical Devices Agency (TMMDA)	www.titck.gov.tr
Ukraine	State Service of Ukraine on Medicines and Drugs Control (SMDC)	www.dls.gov.ua
United Kingdom	Medicines and Healthcare products Regulatory Agency (MHRA)	https://www.gov.uk
United Kingdom	Veterinary Medicines Directorate (VMD)	www.gov.uk
United States	U.S. Food and Drug Administration (FDA)	www.fda.gov

Name	Website
AALAS (American Association for Laboratory Animal Science)	https://www.aalas.org
AAMI (Association for Advancedment of Medical Instrumentation)	https://www.aami.org
AAMI (Association for the Advancement of Medical Instrumentation)	https://www.aami.org
AFAR (Association francaise des affaires rékemntaires)	https://www.afar.asso.fr
CEN (European Commitee for Standardization)	https://www.cencenelec.eu
DIN (German Institute for Standardization)	https://www.din.de
EDQM (European Directorate for the Quality of Medicines & HealthCare)	https://www.edqm.eu
EMA (European Medicines Agency)	https://www.ema.europa.eu
EuropaBio (European Association for Bioindustries)	https://www.europabio.org
GCCA (Global Cold Chain Alliance)	https://www.gcca.org
HMA (European Heads of Medicines Agencies)	https://www.hma.eu
ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use)	https://www.ich.org
ISO (International Organization for Standardization)	https://www.iso.org
ISPE (International Society for Pharmaceutical Engineering)	https://ispe.org
ispe (International Society for Pharmacoepidemilogy)	https://www.pharmacoepi.org
NCSL (National Conference of Standards Laboratories)	https://www.ncsl.org
NIST (National Institute of Standards and Technology)	https://www.nist.gov
OECD (Organisation for Economic Co-operation and Development: Good Laboratory Practice (GLP))	https://www.oecd.org
PDA (Parenteral Drug Association)	https://www.pda.org
PIC/S (Pharmaceutical Inspection Co-operation Scheme)	https://picscheme.org
PTB (Physikalisch-Technische Bundesanstalt)	https://www.ptb.de
SIARV (Società Italiana Attività Regolatorie, Accesso, FarmacoVigilanza )	https://www.siarv.it
TOPRA (Professionals in Regulatory Affairs)	https://www.topra.org
WHO (World Health Organization)	https://www.who.int
DAkkS (German Accreditation Body)	https://www.dakks.de

Termal Doğrulama ve Ortam İzlemede Bir İlk !

Termal Doğrulama ve Ortam İzlemede Bir İlk !

Ofislerimiz

Bizimle iletişime geçin !

Son Çıkan Ürünler

Common Reporting Tool 1.7

Kaye ValProbe RM

Kaye ValProbe RT için Veritabanı Desteği

Kaye Sırt Çantası, Taşıma ve Nakliye Çantaları

Kaye Validator AVS Yazılımı 2.1

News

Uncategorised

Technical Notes

Kaye GxP Dictionary

Minimizing Risk when Using a Traceable Temperature Standard

The Calibration of Embedded Sensors

Videos

AVS Remote Control

Common Reporting Tool

CTR-25 Liquid Bath

HTR-420

HygroCal100 - Humidity Calibrator

IQ/OQ (Installation Qualification/Operational Qualification) Service

IRTD-400

Kaye Console Keyboard

Kaye Feedthru

Kaye IRTD Display

Kaye Thermocouple Sensors

LabWatch IoT - New Features

LabWatch® IoT

Liquid Nitrogen Comparator

LTR-150 Multi-Purpose Calibrator

LTR-90 Ultra Cool Dry Block Calibrator

Rental Options From Kaye

Service & Service Agreements Offered By Kaye

Service Solutions Offered By Kaye

Summer Warehouse Mapping

Upgrade From ValProbe to ValProbe RT

Using ValProbe RT Loggers & Console

Validation Console Key Features

Validator AVS

ValProbe Battery & O-Ring Replacement

ValProbe RT 1.2

ValProbe RT 1.3

ValProbe RT 5-Channel Bendable Logger

ValProbe RT Humidity/Temperature Logger

ValProbe RT System

Norms & Guidelines

Guidelines & Standards

Organizations

Main Pharma Trade Associations

Local Authorities

stay up-to-date

with Kaye Products

KAYE GENEL MÜDÜRLÜK

KAYE AMERİKA

QUICK CONTACT

KAYE HABER BÜLTENİ

Termal Doğrulama ve
Ortam İzlemede Bir İlk !