SERVICES: TEMPERATURE MAPPING STUDY

Size: px
Start display at page:

Download "SERVICES: TEMPERATURE MAPPING STUDY"

Transcription

1 SERVICES: TEMPERATURE MAPPING STUDY Temperature mapping is the process used to confirm that the whole space within cold compartments operates uniformly and consistently within a specified temperature range. Defined areas throughout a cold compartment are individually recorded over a period of time using temperature monitoring data recorders. The results are then processed to give an accurate picture of the temperature profile of the whole compartment. Our temperature mapping service is a full solution offered to map a wide range of storage and transport environments. Regulatory guidelines demand that environments such as Warehouses, Cabinets, Cold Stores and Vehicles are all regularly mapped. The mapping service also documents justification of the position of where continuous monitoring probes should be positioned. Our temperature mapping consists of wired as well as wireless equipments from Dickson (USA), so cold storages of all sizes can be mapped simply, cost effectively and in real time. Using information from the temperature mapping exercise, we prepare protocols, analyze data, develop reports, and undertake ongoing routine temperature mapping. The end result is a complete and clearly documented temperature mapping report that will help you to enhance the existing storage and handling of your temperaturesensitive products, and by the same token will meet the overall objective of protecting and assuring product integrity and product efficacy.

2 TEMPERATURE MAPPING FOR WAREHOUSE The purpose of warehouse mapping studies is to analyze temperature and humidity distribution, to evaluate storage conditions and identify critical zones inside the warehouse. All warehouses should be temperature mapped to determine the temperature distribution under extremes of external temperature. Mapping should be repeated every two to three years and after any significant modification to the premises, stock layout, or heating system. A temperature mapping exercise for warehouse collects the following information: The impact of interventions (door openings / power failures, etc.) Identification of hot and cold spots Variation of temperature at a single point Temperature variation across the area Length of time of any temperature excursions

3 TEMPARATURE MAPPING FOR VEHICLE VALIDATION Validation refers to checking that a product, service, or system meets requirements and specifications and that it fulfills its intended purpose. It is necessary that vehicle validation is to be performed by a disinterested thirdparty. Temperature mapping for vehicles includes validating transit-sized delivery vehicles to full size trailers. A temperature mapping exercise for vehicles collects the following information: Empty & With load (product) data Cool down time verification Summer & Winter mapping data External ambient temperature Hot and cold spots identification Power failure tests Impact tests results (e.g Door open/ Door close study) Shipment Qualification tests

4 OUR CLIENTS

5 CASE STUDY: The client City Pharmacy has a diverse pharmaceutical product portfolio. Its focus is not only on pharmaceuticals, but also on medical equipment, instruments, servicing and maintenance. Operating from new, temperature-controlled and computerized warehouses and backed by 12 delivery vehicles, City Pharmacy s distribution network is second to none and covers all the towns and cities of the UAE. The requirement Temperature controlled warehouses: City pharmacy operate a number of chilled warehouse environments required to maintain between +2 C to +8 C. Dickson was asked to provide a temperature mapping solution for these ware houses. Temperature Vehicles: A number of newly acquired vehicles were required temperature performance qualification at City pharmacy. Dickson was approached to propose a solution, and after qualifying the requirements, provide a comprehensive protocol documenting a suggested approach. Results Temperature controlled warehouses: Dickson carried out an exercise of the store as part of the solution including full recommendations for the planned continuous monitoring system. Temperature vehicles: The mapping process of vehicles includes mapping in an empty state followed by mapping with load (product) and that consideration will be given to summer and winter projects as well as ongoing temperature monitoring practices. A power down impact test will also be included to simulate worse case scenarios during unforeseen cases.

Warehouse Mapping of GxP Storage Facilities: Why it s Not an Option. we prove it. A GxP Compliant Thermal Mapping Overview

Warehouse Mapping of GxP Storage Facilities: Why it s Not an Option. we prove it. A GxP Compliant Thermal Mapping Overview 1 A GxP Compliant Thermal Mapping Overview white paper Warehouse Mapping of GxP Storage Facilities: Why it s Not an Option we prove it. 2 Warehouse Mapping of GxP Storage Facilities: Why It s Not an Option

More information

DETAILED PROCEDURE AND GUIDELINES TEMPERATURE MAPPING STUDY & QUALIFICATION OF COLD ROOMS, WAREHOUSES, VANS, TRUCKS, REEFERS, REFRIGERATORS & BOXES

DETAILED PROCEDURE AND GUIDELINES TEMPERATURE MAPPING STUDY & QUALIFICATION OF COLD ROOMS, WAREHOUSES, VANS, TRUCKS, REEFERS, REFRIGERATORS & BOXES DETAILED PROCEDURE AND GUIDELINES ON TEMPERATURE MAPPING STUDY & QUALIFICATION OF COLD ROOMS, WAREHOUSES, VANS, TRUCKS, REEFERS, REFRIGERATORS & BOXES FOR PHARMACEUTICAL INDUSTRY Revision History: Revision

More information

Temperature Mapping Report

Temperature Mapping Report Document Status: Page: 1 of 13 Temperature Mapping Report Company Name & Site Warehouse Start Date: DD Month YYYY End Date: DD Month YYYY Document Status: Page: 2 of 13 Table of Contents 1 Approvals...

More information

Temperature Mapping Study of Walk-in incubator in a Pharma Industry

Temperature Mapping Study of Walk-in incubator in a Pharma Industry Research Article Temperature Mapping Study of Walk-in incubator in a Pharma Industry Harish Gowda G.S, Gangadharappa H.V*, Kiran H.C, Naveen Kumar V Department of Pharmaceutics (Pharmaceutical Quality

More information

GxP-Services for warehouse, logistics & transport

GxP-Services for warehouse, logistics & transport GxP-Services for warehouse, logistics & transport Testo Industrial Services Mehr assurance, better service. www.testotis.com GxP-Services for warehouse, logistics & transport GxP-Services for warehouse,

More information

Technical supplement to WHO Technical Report Series, No. 961, 2011

Technical supplement to WHO Technical Report Series, No. 961, 2011 Supplement 11 Qualification of refrigerated road vehicles Technical supplement to WHO Technical Report Series, No. 961, 2011 Annex 9: Model guidance for the storage and transport of time- and temperature-sensitive

More information

WAREHOUSE TEMPERATURE & HUMIDITY DISTRIBUTION VERIFICATION PROTOCOL - SUMMER SEASON 2017

WAREHOUSE TEMPERATURE & HUMIDITY DISTRIBUTION VERIFICATION PROTOCOL - SUMMER SEASON 2017 COMPANY NAME: SITE: LOCATION: XXXXXXXX WAREHOUSE- XXXXXXXX Name: Title: Company: Vacker Global Name: Title: Company: Vacker Global PROTOCOL PREPARED BY NAME SIGNATURE DATE PROTOCOL APPROVED BY dd- mm-yyyy

More information

RELIABLY CHILLED FROM A TO B IT ALL COMES DOWN TO THE RIGHT PACKAGING WHEN SHIPPING TEMPERATURE-SENSITIVE PRODUCTS. PERFECT PROTECTIVE PACKAGING

RELIABLY CHILLED FROM A TO B IT ALL COMES DOWN TO THE RIGHT PACKAGING WHEN SHIPPING TEMPERATURE-SENSITIVE PRODUCTS. PERFECT PROTECTIVE PACKAGING RELIABLY CHILLED FROM A TO B IT ALL COMES DOWN TO THE RIGHT PACKAGING WHEN SHIPPING TEMPERATURE-SENSITIVE PRODUCTS. Laboratories and hospitals have to transport items on a regular basis, whether it s blood

More information

Biologicals: cold chain and temperature control from product design to finished product

Biologicals: cold chain and temperature control from product design to finished product Biologicals: cold chain and temperature control from product design to finished product Symposium Biologicals, Bonn, Oct. 2008 Symposium der Fachgruppe Arzneimittelkontrolle/Pharmazeutische Analytik in

More information

Introduction to Temperature Mapping of Controlled Temperature Storage Areas Temperature Mapping 101. Presented by Grant South 7 February, 2018

Introduction to Temperature Mapping of Controlled Temperature Storage Areas Temperature Mapping 101. Presented by Grant South 7 February, 2018 Introduction to Temperature Mapping of Controlled Temperature Storage Areas Temperature Mapping 101 Presented by Grant South 7 February, 2018 Welcome Introduction to temperature mapping What and why GMP

More information

General European OMCL Network (GEON) QUALITY MANAGEMENT DOCUMENT

General European OMCL Network (GEON) QUALITY MANAGEMENT DOCUMENT General European OMCL Network (GEON) QUALITY MANAGEMENT DOCUMENT PA/PH/OMCL (16) 86 R2 MANAGEMENT OF ENVIRONMENTAL CONDITIONS Full document title and reference Document type Management of Environmental

More information

Overview sulla nuova guideline GDP

Overview sulla nuova guideline GDP AFTI 09 febbraio 2012 Overview sulla nuova guideline GDP Fabio Dotto Ispettorato Regionale Medicamenti Svizzera del Sud 1 113 GDP Guidelines GDP of Medicinal Products for Human Use Public consultation

More information

POL: 08:VP:003:03:NIBT PAGE : 1 of 7

POL: 08:VP:003:03:NIBT PAGE : 1 of 7 POL: 08:VP:003:03:NIBT PAGE : 1 of 7 Northern Ireland Blood Transfusion Service POLICY DOCUMENT Document Details Document Number: POL:08:VP:003:03:NIBT No. of Appendices: 2 Supersedes Number: 08:02:VP:003:NIBT

More information

Scientific Standards for Ambient Temperature Profile Development:

Scientific Standards for Ambient Temperature Profile Development: Scientific Standards for Ambient Temperature Profile Development: The creation of standard ambient temperature profiles for insulated package development and an analytical process for profile comparison

More information

<1079> Good Storage and Distribution Practices

<1079> Good Storage and Distribution Practices Good Storage and Distribution Practices Desmond Hunt, Ph.D. Principal Scientific Liaison September 7, 2017 Mexico City, Mexico Good Distribution Practice Activities Suppliers Procuring, holding,

More information

Manual 069 The validation of facilities and system

Manual 069 The validation of facilities and system 1. Purpose The purpose of this guideline is to provide requirements for the Validation of Facilities and Systems and to outline recommendations on how to achieve compliance. 2. Scope This guideline can

More information

ISOHOOD-2L2: Double-layer polyethylene bubble foil, coated with aluminum foil on both sides, PE-coating on aluminum foil

ISOHOOD-2L2: Double-layer polyethylene bubble foil, coated with aluminum foil on both sides, PE-coating on aluminum foil Page 1/7 THERMOCOVER ECO-SAFE ISOHOOD-2L2 Specification Thermocover for palletized gds, various dimensions, sewn Material ISOHOOD-2L2: Double-layer polyethylene bubble foil, coated with aluminum foil on

More information

THERMAL AND RELATIVE HUMIDITY MAPPING OF A SAMPLING ROOM

THERMAL AND RELATIVE HUMIDITY MAPPING OF A SAMPLING ROOM WORLD JOURNAL OF PHARMACY AND PHARMACEUTICAL SCIENCES Gangadharappa et al. SJIF Impact Factor 6.041 Volume 5, Issue 4, 1563-1572 Research Article ISSN 2278 4357 THERMAL AND RELATIVE HUMIDITY MAPPING OF

More information

Recommendations on the control and monitoring of storage and transportation temperatures of medicinal products

Recommendations on the control and monitoring of storage and transportation temperatures of medicinal products Recommendations on the control and monitoring of storage and transportation temperatures of medicinal products John Taylor, CChem, FRSC. 1. Introduction Medicinal products, and starting materials used

More information

Quality Assessment & GMP Similarities & Differences

Quality Assessment & GMP Similarities & Differences Quality Assessment & GMP Similarities & Differences EMEA, Monday 26 th October 2009 Cormac Dalton Inspector Irish Medicines Board Date 12-Oct-09 Slide 1 Content Overview of commonalities & differences

More information

IRISH MEDICINES BOARD

IRISH MEDICINES BOARD IRISH MEDICINES BOARD Earlsfort Centre, Earlsfort Terrace, Dublin 2. GUIDANCE NOTE ON CONTROL AND MONITORING OF STORAGE AND TRANSPORTATION TEMPERATURE CONDITIONS FOR MEDICINAL PRODUCTS This guidance note

More information

Corporate Capabilities Statement

Corporate Capabilities Statement Alliant IT, LLC is a diversified Information Technology company whose mission is to bring innovative solutions to the federal government and to become a partner in the process to make the agencies more

More information

About this guide 5 Section 1: Meeting VET sector requirements 7

About this guide 5 Section 1: Meeting VET sector requirements 7 Contents About this guide 5 Section 1: Meeting VET sector requirements 7 1.1 How Aspire s resources assist in meeting requirements 7 1.2 Resource quality assurance processes 16 Section 2: Unit of competency

More information

25 February 2010 Slide 1

25 February 2010 Slide 1 Cold chain Wholesale Distribution Information Day, 25/2/2010 Greg McGurk Executive Inspector 25 February 2010 Slide 1 Cold Chain Scope: Factors affecting transportation Small scale transportation Large

More information

MEDICINES CONTROL COUNCIL

MEDICINES CONTROL COUNCIL Licence to act as a Wholesaler or Distributor MEDICINES CONTROL COUNCIL GUIDELINES FOR LICENCE TO ACT AS A WHOLESALER or DISTRIBUTOR This guideline is intended to provide recommendations to applicants

More information

Good Distribution Practices Toolkit. Quality Management System 08 March 2016

Good Distribution Practices Toolkit. Quality Management System 08 March 2016 Good Distribution Practices Toolkit Quality Management System 08 March 2016 1 Quality Policy GDP, Legal, Environmental, H&S Processes & Systems Resources Risk Assessments 2 Quality Policy & Objectives

More information

Supplementary Training Modules on Good Manufacturing Practice. Validation. WHO Technical Report Series, No. 937, Annex 4.

Supplementary Training Modules on Good Manufacturing Practice. Validation. WHO Technical Report Series, No. 937, Annex 4. Supplementary Training Modules on Good Manufacturing Practice Validation WHO Technical Report Series, No. 937, 2006. Annex 4. Validation Slide 1 of 48 August 2006 Validation! Part 1. General overview on

More information

User Requirement Specification: User Requirement Specification

User Requirement Specification: User Requirement Specification Insert logo here Effective Date: : User Requirement Specification Document information, authorship and approvals Author signs to confirm technical content Prepared by: Job title: Signature: Date:

More information

How the AGV System Works

How the AGV System Works How the AGV System Works Although every automatic guided vehicle system is unique, typical operation is as follows. 1) Requests to move material can be initiated in one or more of the following ways: Manually

More information

Effective Quality Oversight of Pharmaceutical Contract Manufacturing Organizations (CMOs)

Effective Quality Oversight of Pharmaceutical Contract Manufacturing Organizations (CMOs) Effective Quality Oversight of Pharmaceutical Contract Manufacturing Organizations (CMOs) *** LIMITED TIME OFFER: FREE $100 AMAZON GIFT CARD! *** REGISTER TODAY! The globalization of the pharmaceutical

More information

DISTRIBUTION CONSTRUCTION SUPERVISOR

DISTRIBUTION CONSTRUCTION SUPERVISOR SANTA FE IRRIGATION DISTRICT DISTRIBUTION CONSTRUCTION SUPERVISOR DEFINITION To plan, organize, direct and supervise construction, repair and maintenance activities associated with the District s and Joint

More information

Internal Review Checklist (Manufacturing)

Internal Review Checklist (Manufacturing) Record Sheet 10 Internal Review Checklist (Manufacturing) This Internal Review is a tool to help you focus on areas that need attention and to ensure staff are following the Food Safety Plan. The questions

More information

Effective Quality Oversight of Pharmaceutical Contract Manufacturing Organizations (COM) COURSE DESCRIPTION

Effective Quality Oversight of Pharmaceutical Contract Manufacturing Organizations (COM) COURSE DESCRIPTION Effective Quality Oversight of Pharmaceutical Contract Manufacturing Organizations (COM) COURSE DESCRIPTION The globalization of the pharmaceutical supply chain has led increased use of Contract Manufacturing

More information

DuPont Tyvek Air Cargo Covers. Cold Chain Protection for Temperature Sensitive Cargo

DuPont Tyvek Air Cargo Covers. Cold Chain Protection for Temperature Sensitive Cargo DuPont Tyvek Air Cargo Covers Cold Chain Protection for Temperature Sensitive Cargo What is Tyvek? 100% HDPE Exceptionally Strong & Lightweight Highly Reflective High Puncture and Tear resistance Permeable

More information

Technical supplement to WHO Technical Report Series, No. 961, 2011

Technical supplement to WHO Technical Report Series, No. 961, 2011 Supplement 6 Temperature and humidity monitoring systems for fixed storage areas Technical supplement to WHO Technical Report Series, No. 961, 2011 Annex 9: Model guidance for the storage and transport

More information

WHITE PAPER. HVLS Industrial Fans Evaluation Guide: 7 Defining Application Design Factors That Will Add Up to a Smart Investment

WHITE PAPER. HVLS Industrial Fans Evaluation Guide: 7 Defining Application Design Factors That Will Add Up to a Smart Investment WHITE PAPER 7 Defining Application Design Factors That Will Add Up to a Smart Investment 2 Contents Introduction 3 Factor #1: 4 Establish your goals early to ensure the right results later. Determine what

More information

Facility Management Solutions

Facility Management Solutions Facility Management Solutions ` NEWSLETTER Oct. 2013 >> Complete Maintenance Solutions for Remote Site IN THIS ISSUE: IN THIS ISSUE: COVER STORY: Preventive Maintenance Program DID YOU KNOW: 3 Phases in

More information

The benchmark in cold chain. 30+ years experience in cold chain

The benchmark in cold chain. 30+ years experience in cold chain The benchmark in cold chain 30+ years experience in cold chain Why Temperature Controlled Transportation? A drug that has been temperature abused is every bit as dangerous as one that is not authentic

More information

Cold Chain. Sonya Nicholl Senior Policy Analyst. Immunisation Unit Health Protection NSW

Cold Chain. Sonya Nicholl Senior Policy Analyst. Immunisation Unit Health Protection NSW Cold Chain Sonya Nicholl Senior Policy Analyst Immunisation Unit Health Protection NSW Primary Health Network Conference Dubbo/Orange 3 rd & 4 th May 2017 What is the cold chain? The cold chain is the

More information

Pallet Thermal Model (PTM) Validation

Pallet Thermal Model (PTM) Validation Pallet Thermal Model (PTM) Validation ASME 2017 V&V Symposium Eugen Nisipeanu, PhD Carlos Corrales, MS May, 2017 Disclaimer The information shared in this meeting is not for redistribution or reuse and

More information

WHO GUIDELINE Stability testing of active pharmaceutical ingredients and finished pharmaceutical products

WHO GUIDELINE Stability testing of active pharmaceutical ingredients and finished pharmaceutical products WHO GUIDELINE Stability testing of active pharmaceutical ingredients and finished pharmaceutical products 1. Introduction 1.1 Objectives of these guidelines 1.2 Scope of these guidelines 1.3 General principles

More information

INTELSIUS BIOCAIR TEMPERATURE MAPPING

INTELSIUS BIOCAIR TEMPERATURE MAPPING INTELSIUS BIOCAIR TEMPERATURE MAPPING BACKGROUND Biocair is an international logistics company that provides a specialist courier service for clinical trials, research and development and dangerous goods.

More information

About this guide 5 Section 1: Meeting VET sector requirements 7

About this guide 5 Section 1: Meeting VET sector requirements 7 Contents About this guide 5 Section 1: Meeting VET sector requirements 7 1.1 How Aspire s resources assist in meeting requirements 7 1.2 Resource quality assurance processes 16 Section 2: Unit of competency

More information

Pharmaceutical Good Manufacturing Practice. Contents are subject to change. For the latest updates visit

Pharmaceutical Good Manufacturing Practice. Contents are subject to change. For the latest updates visit Pharmaceutical Good Manufacturing Practice Page 1 of 6 Why Attend A robust quality system that meets the requirements of pharmaceutical regulators is an essential element of every good pharmaceutical manufacturing

More information

Advanced 3D and 4D Temperature Mapping Capabilities

Advanced 3D and 4D Temperature Mapping Capabilities Advanced 3D and 4D Temperature Mapping Capabilities Background Temperature recording is used in a wide variety of US FDA regulated firms from food canneries to medical device manufacturers to drug manufacturers

More information

A PROCESS VALIDATION GUIDE FOR COLD CHAIN LOGISTICS: ENSURING COMPLIANCE GLOBALLY

A PROCESS VALIDATION GUIDE FOR COLD CHAIN LOGISTICS: ENSURING COMPLIANCE GLOBALLY A PROCESS VALIDATION GUIDE FOR COLD CHAIN LOGISTICS: ENSURING COMPLIANCE GLOBALLY Presented by: Gary Hutchinson, President, Modality Solutions 8 th BSMA Conference Preparing the Biotech Supply Chain for

More information

Vaccine Storage and Handling INTERIM GUIDANCE

Vaccine Storage and Handling INTERIM GUIDANCE Vaccine Storage and Handling INTERIM GUIDANCE Introduction In response to recent scientific studies i on equipment used for vaccine storage and a better understanding of best practices for vaccine storage

More information

Vaccine Storage and Handling Protocol, 2014

Vaccine Storage and Handling Protocol, 2014 Vaccine Storage and Handling Protocol, 2014 Preamble The Ontario Public Health Standards (OPHS) are published by the Minister of Health and Long- Term Care under the authority of the Health Protection

More information

AUDIT UNDP SOUTH SUDAN GRANTS FROM THE GLOBAL FUND TO FIGHT AIDS, TUBERCULOSIS AND MALARIA. Report No.1400 Issue Date: 6 February 2015

AUDIT UNDP SOUTH SUDAN GRANTS FROM THE GLOBAL FUND TO FIGHT AIDS, TUBERCULOSIS AND MALARIA. Report No.1400 Issue Date: 6 February 2015 UNITED NATIONS DEVELOPMENT PROGRAMME AUDIT OF UNDP SOUTH SUDAN GRANTS FROM THE GLOBAL FUND TO FIGHT AIDS, TUBERCULOSIS AND MALARIA Report No.1400 Issue Date: 6 February 2015 Table of Contents Executive

More information

DHL Solutions & Innovations. Amir Mousavi September 2010, Bonn

DHL Solutions & Innovations. Amir Mousavi September 2010, Bonn DHL Solutions & Innovations Temperature monitoring of non- actively cooled pharmaceutical transportation A i M i Amir Mousavi September 2010, Bonn Agenda Introduction Scope Methodology Results Summary

More information

Quality Risk Management (QRM) of active pharmaceutical ingredients during transportation by using FMEA tools and methodology

Quality Risk Management (QRM) of active pharmaceutical ingredients during transportation by using FMEA tools and methodology PharmaTutor PRINT ISSN: 294-6679 E-ISSN: 247-788 2 Quality Risk Management (QRM) of active pharmaceutical ingredients during transportation by using FMEA tools and methodology Upendra Kumar Singh*, Sammer

More information

Re: Proposed revisions to USP General Chapter <1079> Good Storage and Distribution Practices For Drug Products

Re: Proposed revisions to USP General Chapter <1079> Good Storage and Distribution Practices For Drug Products 30 September 2011 Scientific Liaison (PS05) Packaging and Storage Expert Committee US Pharmacopeia 12601 Twinbrook Pkwy Rockville MD 20852-1790 Re: Proposed revisions to USP General Chapter Good

More information

Document 2007 Rev 0 December 2005 Page 1 of 8

Document 2007 Rev 0 December 2005 Page 1 of 8 Document 2007 Rev 0 December 2005 Page 1 of 8 1. Scope... 2 2. Definitions... 2 a. LabTest...2 b. Factory Location/ Manufacturer's Premises...2 c. Manufacturer...2 d. Subcontractor...2 e. f. Out-Worker...2

More information

How to Map a Warehouse. Mapping & Monitoring for Controlled Environments

How to Map a Warehouse. Mapping & Monitoring for Controlled Environments How to Map a Warehouse Mapping & Monitoring for Controlled Environments Webinar Presenters & Humidity Experts Bruce McDuffee Steve Chenal Agenda & Takeaways Agenda Regulations & Guidance Overview Step

More information

Remote Monitoring. Validated Remote Monitoring Platform

Remote Monitoring. Validated Remote Monitoring Platform Validated Remote Monitoring Platform The challenge to your cold chain Companies that produce, transport or store temperature-sensitive products face many challenges and risks related to the storage and

More information

Developing ISTA Cold Chain Environmental Standards

Developing ISTA Cold Chain Environmental Standards FRIDAY morning session Developing ISTA Cold Chain Environmental Standards Industry approved testing profiles have not been developed for the Cold Chain transportation environment. This presentation will

More information

AQUALAB 4TE, 4TEV, 4TE DUO, 4TEV DUO BENCHTOP WATER ACTIVITY

AQUALAB 4TE, 4TEV, 4TE DUO, 4TEV DUO BENCHTOP WATER ACTIVITY AQUALAB 4TE, 4TEV, 4TE DUO, 4TEV DUO BENCHTOP WATER ACTIVITY Installation Qualification + Operational Qualification Protocols and Instructions TABLE OF CONTENTS 1. Introduction.. 3 2. Installation Qualification

More information

Monitoring climate in the storage of pharmaceutical goods with testo Saveris.

Monitoring climate in the storage of pharmaceutical goods with testo Saveris. Testo Solution Application example Monitoring climate in the storage of pharmaceutical goods with testo Saveris. Pharmaceutical goods whether APIs or end products must be stored at defined and constant

More information

GUIDE TO GOOD MANUFACTURING PRACTICE FOR MEDICINAL PRODUCTS

GUIDE TO GOOD MANUFACTURING PRACTICE FOR MEDICINAL PRODUCTS PHARMACEUTICAL INSPECTION CONVENTION PHARMACEUTICAL INSPECTION CO-OPERATION SCHEME GUIDE TO GOOD MANUFACTURING PRACTICE FOR MEDICINAL PRODUCTS PH 1/97 (Rev. 3), 15 January 2002 ANNEX 15 QUALIFICATION AND

More information

Transport route profiling qualification

Transport route profiling qualification WHO Vaccine Transport route profiling qualification Technical supplement to WHO Technical Report Series, No. 961, 2011 Annex 9: Model guidance for the storage and transport of time and temperature sensitive

More information

Installation Qualification/Operational Qualification Protocols and Instructions

Installation Qualification/Operational Qualification Protocols and Instructions Installation Qualification/Operational Qualification Protocols and Instructions AquaLab PRE Decagon Devices, Inc July 20, 2016 4:05 PM 1 Table of Contents Section 1 Section 2 Section 2.1 Section 2.2 Section

More information

The Infitrak Validated Remote Monitoring Platform

The Infitrak Validated Remote Monitoring Platform The Infitrak Validated Remote Monitoring Platform THE INFITRAK REMOTE MONITORING SOLUTION WAS DESIGNED TO MONITOR ENVIRONMENTAL CONDITIONS 24 HOURS A DAY, 365 DAYS A YEAR. PROTECT THE QUALITY OF YOUR TEMPERATURE-SENSITIVE

More information

Assessing competencies at higher AQF levels

Assessing competencies at higher AQF levels Assessing competencies at higher AQF levels The assessment of competencies in higher qualifications (Certificate IV, Diploma, Advanced Diploma and Graduate Certificates) presents special challenges for

More information

Total Engineering Solution

Total Engineering Solution Total Engineering Solution Hyundai Elevator is a total moving solution provider that offers comprehensive engineering solutions for optimal supply. These range from providing consultations, designs as

More information

<1079> GOOD STORAGE AND SHIPPING PRACTICES-General Chapters

<1079> GOOD STORAGE AND SHIPPING PRACTICES-General Chapters US. Pharmacopoeia USP29 GOOD STORAGE AND SHIPPING PRACTICES-General Chapters 1079 GOOD STORAGE AND SHIPPING PRACTICES This general information chapter is intended to provide general guidance concerning

More information

Managing the Challenges of Controlled Room Temperature Requirements in Cold Chain Pharmaceutical Distribution

Managing the Challenges of Controlled Room Temperature Requirements in Cold Chain Pharmaceutical Distribution Managing the Challenges of Controlled Room Temperature Requirements in Cold Chain Pharmaceutical Distribution The Challenge of Controlled Room Temperature Shipments Controlled room temperature (CRT) cold

More information

CASE STUDY: PACKAGING QUALIFICATION WITH INTEGRATED COLD CHAIN LOGISTICS DESIGN

CASE STUDY: PACKAGING QUALIFICATION WITH INTEGRATED COLD CHAIN LOGISTICS DESIGN WITH INTEGRATED COLD CHAIN LOGISTICS DESIGN BACKGROUND A biopharmaceutical manufacturer contacted LifeConEx to help them with the launch of their new chemotherapy product. The medicine was scheduled to

More information

1 Management Responsibility 1 Management Responsibility 1.1 General 1.1 General

1 Management Responsibility 1 Management Responsibility 1.1 General 1.1 General 1 Management Responsibility 1 Management Responsibility 1.1 General 1.1 General The organization s management with executive The commitment and involvement of the responsibility shall define, document

More information

Innovative. to the pharmaceutical, biotechnology and advanced technology. and equipment. Our learning management

Innovative. to the pharmaceutical, biotechnology and advanced technology. and equipment. Our learning management Innovative S o l u t i o n s Pharma-Tech Process and Facilities Services is an industry leader in providing innovative technical consulting and staff-augmentation services to the pharmaceutical, biotechnology

More information

On behalf of Pharmacy Department Name: Position:

On behalf of Pharmacy Department Name: Position: SOP reference SOP Title Version Number Version 1 Date of issue/ implementation Written by Temperature monitoring in clinic rooms where medicines are stored. May 2015 Orla Macdonald Name: Position: Date:

More information

Food Defense Supplier Guidelines

Food Defense Supplier Guidelines Food Defense Supplier Guidelines Revised: May 2015 Table of Contents Introduction 3 1. Program administration 3 a. Plan management 3 b. Roles and responsibilities 3 c. Reporting procedures 3 d. Self-assessments

More information

Reducing Risk and Costs in the Global Supply Chain

Reducing Risk and Costs in the Global Supply Chain Reducing Risk and Costs in the Global Supply Chain Global Quality & Compliance Services for the Life Sciences Industry sensitech.com @sensitech Protecting the Life Sciences Supply Chain Can Be Costly Maintaining

More information

Delivery of materials (usually finished product from a distribution center) to a first paying customer external to Site

Delivery of materials (usually finished product from a distribution center) to a first paying customer external to Site Title: Cold Chain Management of Biopharmaceutical Materials Guidance Number: 122 Prepared by: Date: Supersedes: Checked by: Date: Date Issued: Approved by: Date: Review Date: Introduction The risk of compromising

More information

What Forges High Reliability

What Forges High Reliability What Forges High Reliability ----Endurance Tests of Huawei Inverters PV system is normally installed outdoor,exposed to hash environment, like extreme high or low temperature, high humidity, strong wind,

More information

Temperature Monitoring (Clinical Trials)

Temperature Monitoring (Clinical Trials) York Foundation Trust R&D Unit Standard Operating Procedure Pharm/S48 Temperature Monitoring (Clinical Trials) IT IS THE RESPONSIBILITY OF ALL USERS OF THIS SOP TO ENSURE THAT THE CORRECT VERSION IS BEING

More information

Supplement 7 Qualification of temperature-controlled storage areas. Technical supplement to WHO Technical Report Series, No.

Supplement 7 Qualification of temperature-controlled storage areas. Technical supplement to WHO Technical Report Series, No. Supplement 7 Qualification of temperature-controlled storage areas Technical supplement to WHO Technical Report Series, No. 961, 2011 Annex 9: Model guidance for the storage and transport of time- and

More information

PERFORMANCE QUALIFICATION PROTOCOL HVAC SYSTEM

PERFORMANCE QUALIFICATION PROTOCOL HVAC SYSTEM Page 1 of 24 PERFORMANCE QUALIFICATION PROTOCOL FOR HVAC SYSTEM Signing of this Performance Qualification Protocol indicates agreement with the Validation Master Plan approach of the equipment. Further

More information

P O L A R E X P R E S S C O L D C H A I N L O G I S T I C S TURKEY S LARGEST COLD CHAIN LOGISTICS SERVICE PROVIDER

P O L A R E X P R E S S C O L D C H A I N L O G I S T I C S TURKEY S LARGEST COLD CHAIN LOGISTICS SERVICE PROVIDER P O L A R E X P R E S S C O L D C H A I N L O G I S T I C S 1 INDEX SECTION 1 ABOUT THE GROUP SECTION 2 ABOUT POLAR EXPRESS SECTION 3 KNOW-HOW THE REASON OF OUR BEING ABOUT NETLOG LOGISTICS GROUP NETLOG

More information

Cold-Chain & Logistical Challenges of Cell Therapeutics in Clinical Trials

Cold-Chain & Logistical Challenges of Cell Therapeutics in Clinical Trials Cold-Chain & Logistical Challenges of Cell Therapeutics in Clinical Trials Dan O Donnell Associate Director, Cell Therapy Logistics Fisher BioServices Part of Thermo Fisher Scientific Logistics of Biologics

More information

Dr. Abdulrahman Mohammad Al Jassmi Chief Executive Officer Dubai Hospital Dubai Health Authority

Dr. Abdulrahman Mohammad Al Jassmi Chief Executive Officer Dubai Hospital Dubai Health Authority CHALLENGES AND OPPORTUNITIES IN COLD CHAIN: HEALTH CARE RELATED DRIVERS Dr. Abdulrahman Mohammad Al Jassmi Chief Executive Officer Dubai Hospital Dubai Health Authority AGENDA Integrating stakeholders

More information

Taking a Leap Toward Global Supply Chain Efficiency - Part II

Taking a Leap Toward Global Supply Chain Efficiency - Part II Taking a Leap Toward Global Supply Chain Efficiency - Part II 2 Supply Chain Brochure - Part II INTRODUCTION Pharmaceutical manufacturers face a number of challenges in the production and delivery of medicinal

More information

Audit Validation Programs Like a Champ (When your time is limited!!) Cathelene Compton 12 October 2017

Audit Validation Programs Like a Champ (When your time is limited!!) Cathelene Compton 12 October 2017 Audit Validation Programs Like a Champ (When your time is limited!!) Cathelene Compton 12 October 2017 FDA 483 Observations 2 FDA 483 Observations 3 FDA 483 Observations 4 Auditing Validation How to cover

More information

IA-G OCTOBER This guide does not purport to be an interpretation of law and/or regulations and is for guidance purposes only.

IA-G OCTOBER This guide does not purport to be an interpretation of law and/or regulations and is for guidance purposes only. IRISH MEDICINES BOARD GUIDE TO CONTROL AND MONITORING OF STORAGE AND TRANSPORTATION TEMPERATURE CONDITIONS FOR MEDICINAL PRODUCTS AND ACTIVE SUBSTANCES IA-G0011-1 05 OCTOBER 2011 This guide does not purport

More information

Shipper Validation Ambient Test Temperature Profile

Shipper Validation Ambient Test Temperature Profile Shipper Validation Ambient Test Temperature Profile Summer and Winter Profiles (Australia Wide) Table of Contents 1 About this document... 2 1.1 Purpose... 2 1.2 Review... 2 1.3 Approval... 2 1.4 Document

More information

Using the Internet of Things to Understand Climate Exposure for Ambient Commodities (Temperature Monitoring)

Using the Internet of Things to Understand Climate Exposure for Ambient Commodities (Temperature Monitoring) Using the Internet of Things to Understand Climate Exposure for Ambient Commodities (Temperature Monitoring) USAID GLOBAL HEALTH SUPPLY CHAIN PROGRAM Procurement and Supply Management What do we know about

More information

Dr. Sheelpriya walde Professor Gurunanak college of pharmacy, Nagpur

Dr. Sheelpriya walde Professor Gurunanak college of pharmacy, Nagpur Dr. Sheelpriya walde Professor Gurunanak college of pharmacy, Nagpur GMP ( Adopted in 1975 ) In India Good manufacturing practices are the practices required in order to conform to guidelines recommended

More information

Quality Management. Efficient Quality Management in a Regulated Environment

Quality Management. Efficient Quality Management in a Regulated Environment Efficient Quality Management in a Regulated Environment Ensuring compliance with quality management and regulatory standards such as ISO or GMP, requires an understanding of parameters influencing the

More information

Supplier Oversight PQRI. September Steven Lynn, MS, CMQ/OE Vice President Global Quality Compliance Mylan

Supplier Oversight PQRI. September Steven Lynn, MS, CMQ/OE Vice President Global Quality Compliance Mylan Supplier Oversight September 2014 PQRI Steven Lynn, MS, CMQ/OE Vice President Global Quality Compliance Mylan Agenda Mylan Background Setting the Stage with a Scenario Current State Thinking Supplier Qualification

More information

Real-time Shipment Management

Real-time Shipment Management ORIGIN: Luxembourg Airport (LUX) + 18.45 C Temperature Controlled Area - 14.55 C Ambient on Tarmac DESTINATION: Huntsville/AL Airport (HSV) + 19.82 C Temperature Controlled Area + 5.93 C Ambient on Tarmac

More information

Cold Chain Committee Guidance for shippers, transport service providers and subcontractors

Cold Chain Committee Guidance for shippers, transport service providers and subcontractors Guidance for shippers, transport service providers and subcontractors involved in the distribution of pharmaceutical products registered for storage between 2 and 8 Celsius Guidance for Shippers 1 of 7

More information

About this guide 5 Section 1: Meeting VET sector requirements 7

About this guide 5 Section 1: Meeting VET sector requirements 7 Contents About this guide 5 Section 1: Meeting VET sector 7 1.1 How Aspire s resources assist in meeting 7 1.2 Resource quality assurance processes 16 Section 2: Unit of competency information 17 2.1 Unit

More information

SYNERTECH CORPORATE PROFILE [ ENTER ]

SYNERTECH CORPORATE PROFILE [ ENTER ] SYNERTECH CORPORATE PROFILE [ ENTER ] About us About us Synertech specialises in the turnkey design, development, installation, support and maintenance of benefit-driven business systems and computerised

More information

SOLAR ASSISTED HVAC HVAC

SOLAR ASSISTED HVAC HVAC HVAC Team Members Shaun Worthmann, Real Time Energy (Pty) Ltd; Professor Ognyan Dintchev, Tshwane University of Technology; Professor Ian Joseph Lazarus, Durban University of Technology ABSTRACT Toyota

More information

Warehouse Monitoring & Mapping

Warehouse Monitoring & Mapping Warehouse Monitoring & Mapping A Step by Step Guide for Good Manufacturing Practices RFRHTemp2000A Wireless Humidity and Temperature Data Logger www.madgetech.com/ rfrhtemp2000a.html Simplifying How the

More information

Applying a Knowledge-Based Approach to Pharmaceutical Supply Chain Temperature Control Management

Applying a Knowledge-Based Approach to Pharmaceutical Supply Chain Temperature Control Management May 1-3, 2012 Javits Center New York, NY Applying a Knowledge-Based Approach to Pharmaceutical Supply Chain Control Management Arminda O. Montero Program Manager, Distribution QA Global Pharmaceutical

More information

Edexcel Level 4 Certificate for Financial Advisers (QCF)

Edexcel Level 4 Certificate for Financial Advisers (QCF) Edexcel Level 4 Certificate for Financial Advisers (QCF) Specification Edexcel NVQ/competence-based qualifications For first registration January 2011 Issue 2 Edexcel, a Pearson company, is the UK s largest

More information

ISPE NORDIC COP CLEAN UTILITIES SEPTEMBER TUUSULA FINLAND. Timo Kuosmanen STERIS Finn-Aqua

ISPE NORDIC COP CLEAN UTILITIES SEPTEMBER TUUSULA FINLAND. Timo Kuosmanen STERIS Finn-Aqua ISPE NORDIC COP CLEAN UTILITIES SEPTEMBER 7 2016 TUUSULA FINLAND Timo Kuosmanen STERIS Finn-Aqua Timo_Kuosmanen@steris.com AUDIT TRAIL IN CRITICAL UTILITIES MONITORING CURRENT TRENDS CONTENTS BACKGROUND

More information

Guidelines Guidelines for the assessment of knowledge and competence

Guidelines Guidelines for the assessment of knowledge and competence Guidelines Guidelines for the assessment of knowledge and competence 22/03/2016 ESMA/2015/1886 EN Table of Contents I. Scope... 3 II. References, abbreviations and definitions... 3 III. Purposes... 5

More information

PIL Product/Process Information Letter

PIL Product/Process Information Letter STMicroelectronics IPD - ASD & IPAD Division 1 BU Rectifiers (1) IPD: Industrial & Power Discretes - ASD: Application Specific Device IPAD : Integrated Passive and Active Devices PIL Product/Process Information

More information

REPORT ON THE BENEFITS OF ICE- BASED THERMAL STORAGE FOR DISTRICT COOLING IN THE UAE MARKETS

REPORT ON THE BENEFITS OF ICE- BASED THERMAL STORAGE FOR DISTRICT COOLING IN THE UAE MARKETS REPORT ON THE BENEFITS OF ICE- BASED THERMAL STORAGE FOR DISTRICT COOLING IN THE UAE MARKETS Prepared by: Brady Consulting Services, Inc. SUMMARY ADVANTAGES OF THERMAL STORAGE WITH 1.1ºC WATER SUPPLY 1)

More information