Gap Analysis

CoolPac offers an out-sourced auditing service for pharmaceutical / medical device companies.

The number of audits has grown past the company’s capability to manage & companies have down sized operations leaving little resources for routine audits.

Some companies may not have the internal skill, experience or niche knowledge to audit adequately and the trend towards outsourcing this specialised activity is growing.

Cold Chain audits require a blend of many disciplines, including:

·         Regulation requirements

·         Quality Management Systems

·         Validation and qualification of equipment & facilities

·         Design and validation of cold chain mechanisms

·         Logistic options

·         Distribution practices (local and international)

The growth in out-sourcing has seen some 3rd party providers extend from their traditional business and offer additional services, often adding value to existing activities.  Examples of this include: transportation providers offering on-site storage, order processing, labelling, & packing of product.  This allows Pharma/medical companies to focus on their core business and stay lean.
Audit Scope

Service Level Agreements (SLA) are common to many industries, often containing punitive legal clauses and financial costs.  Many Pharma/medical companies include a “quality agreement” as an appendix or a separate contract.  The Quality Agreement (sometimes called GMP Agreement) details additional requirements that must be implemented by the 3rd party provider.   Over or under specification of requirements often leads to costly contract re-negotiations or assumed deliverables unfulfilled; either outcome can poison relationships.

Central to any company’s operation is the Quality Management System (QMS).  Although not compulsory for all operations (depending on the scope of activities conducted by the 3rd party provider TGA regulations could demand one) it is often a customer requirement.  A general QMS will provide the frame-work needed to satisfy many customer requirements.  See CoolPac’s QMS brochure.


Facilities and equipment should be reviewed to determine their adequacy for operations.  Are they too old; are they adequately maintained; are they under specification for the job?  Some facilities and equipment will require formal qualification and validation.  Incorrect identification and detail of quantification / validation can be costly if over executed (un-necessary cost) or under executed (non-conformances, re-validation and constant involvement of management).

Pack-out Design and validation for maintaining the cold chain must be performed to a “Pharmaceutical” standard.  Regulatory requirements differ from country to country and many multinational companies have their own in-house standards which 3rd party providers must comply too.  Locally sourced solutions (e.g. packaging) that 3rd party providers purchase must be appraised and validated.

Routine monitoring of despatches are often a customer requirement where the 3rd party provider must analyse data, identify excursions, and escalate issues for resolution. These are ongoing  tasks which must be reviewed for adequacy and commitment periodically.


To talk to us about your Third Party Cold Chain Auditing, please call us on the numbers listed below or email This e-mail address is being protected from spambots. You need JavaScript enabled to view it .