7/28/2019 Value Chain Fishery

1/2

Written by:

ptiblogadmin

Written on:

August 23, 2011

For pharmaceutical industry, cold chains assume significance due to the fact that many biologics and

pharmaceutical compounds can get damaged with excessive heat or freezing during shipment, resulting

in reduced efficacy. A cold chain, which is a temperature-controlled supply chain, is an uninterrupted

series of storage and distribution activities which maintain a given temperature range. Although, common

temperature range for a cold chain in pharmaceutical industries is 2 to 8 C., when it comes to specific

temperature tolerances the levels largely depend on the actual product being shipped.

The Good manufacturing practices (GMP) guidelines require that all processes that might impact the

safety, efficacy or quality of the drug substance (drug and biological products) must be validated, including

storage and distribution of the drug substance. Hence, this clearly suggests the growing importance and

need for a well-established cold chain distribution process for pharma products, which are nothing but an

extension of the GMP.

The way in which vaccines, parenterals, biologics and human cell & tissue products are shipped from one

place to another is called cold chain management. This process requires careful consideration, design,

validation, and supervision at all levels considering various factors such as the type of shipping containers

to be used, the distribution carriers to be contracted, what humidity control equipment is required (if any),

the types of environmental conditions expected at each location along the distribution chain, the length

and time of the distribution route etc.

Unless and until the pharma manufacturer does not specify, distributors are bound to deliver medications

to the hospital, clinic, or retail pharmacy maintaining the label temperature. Therefore, the packaging

needs to maintain product temperatures accommodate ambient temperature and weather changes. This

is especially important during the supply of vaccines by poor transport networks to distant clinics in hot

and humid climatic conditions.

In the last few years, driven by globalization of manufacturing practices, significant changes have

occurred leading to increase in the complexity and vulnerability in the supply chain. There is a lack of

clear guidance for shippers / distributors regarding regulatory expectations for ensuring that pharma

products are not damaged or compromised during transportation. Without clear guidelines, risk of freezing

during transportation increases and can affect the products leading to quality compromise and ultimately

loss of profits.

Hence, shippers today need to understand clearly the cold chain process as fully as possible to ensure

the delivery of safe high quality pharma products. Here is a snapshot of important factors to be

considered while selecting recording devices to test and validate the cold chain process:

High accuracy temperature sensing performance

Large memory to handle lengthy processes without missing readings

Ability to measure and record both interior container temperatures and exterior conditions along the

route

Ability to operate without requiring an external power source and to keep accurate track of time and

events across multiple time zones

Uneven performance to handle the knocks, bumps, and widely varying environmental conditions of the

shipping process

Click Here For Complete List of Pharmaceutical Machine

Cold Chain management, a significantpharma efficacy process

Connect with us on anyof our social profiles.

Most Popular Posts Random Posts

Register Login

Technical Blog dedicated to Pharmaceutical Industry

Home About Us Committee Categories Event Calendar

We invite Technocrats from Pharma Industry to share Articles here

CommentsAdd One

Pfizers star drug Lipitor no more

patented, generic versions to flood in

What is driving the change in PharmaPackaging Design?

Implementing Track & Trace in

Pharmaceutical Industry

Types of Washing Machines in

Pharmaceutical Industry

Pharma & Allied Sector Boom @

Vibrant Gujarat

Pharma PCDFranchise

franchisepharma.co.i

Indian Leading PharmaFranchise Co. Wide

Range of PCD Pharma

Products

PCD PharmaCompany

www.zavikdrugs.com

ISO Certified Pharma

Company Offers PCDPharma Franchise.

Enquire Now!

PCD PharmaCompany

www.rouzelpharma.i

Leading & Certified

Company In PCDPharma Franchise In

India. Contact!

December 5, 2011

March 21, 2011

October 12, 2012

October 10, 2011

October 3, 2011

Chain management, a significant pharma efficacy process | Pharma... http://blog.pharmatechnologyindex.com/2011/08/cold-chain-man

4/22/2013 1

7/28/2019 Value Chain Fishery

2/2

Previous post: A pharma machinery maker? Dont forget to mark your calendar for P-MEC India 2011

Next post: Ever wondered how that pill you keep popping is made? Heres a peak into a common

technique

Ampoule Washing

Machine

BioPharma

Bottle Washing

Machine

Cronic Disease

Drug Market

FDA

FDCA

Filling Machines

Healthcare Industry

Healthcare Packaging

Conference

IPPMA

Labeling Machines

Packaging Machines

Patients

PFS

Pharma Castle

Machines

Pharma industry

Pharma Labeling

Machines

Pharma Washing

Machine

Pharmaceutical

Sterilizers

Rubber Bung Washing

Machine

Tablets Manufacturing

Machines

Thermo Plastic

Track and Trace

Uncategorized

Vial Washing Machine

Categories

January 2013

December 2012

November 2012

October 2012

July 2012

May 2012

March 2012

January 2012

December 2011

November 2011

October 2011

September 2011

Archives

M T W T F S S

Jul Sep

1 2 3 4 5 6 7

8 9 10 11 12 13 14

15 16 17 18 19 20 21

22 23 24 25 26 27 28

29 30 31

August 2011

Blog Calendar

Who's Online

3 visitors online now2 guests, 1 bots, 0 members

Map of Visitors

About

Welcome to Pharmaceutical Technology Blog. Join, Share Knowledge & Comment !

Community of & for Pharmaceutical Technocrats.

Copyright 2013 www.PharmaTechnologyIndex.com. All Rights Reserved.

In category:

Tags:

Healthcare Industry, Uncategorized

biologic compounds , pharma manufacturer , pharma products , pharmaceutical compounds , Pharmaceutical

industry

Name *

Email *

Website

Leave a Comment

Your email address will not be published. Required fields are marked *

CAPTCHA Code *

You may use these HTML tags and attributes:

Chain management, a significant pharma efficacy process | Pharma... http://blog.pharmatechnologyindex.com/2011/08/cold-chain-man

4/22/2013 1