Pharmaceutical Contract Manufacturing - How to Audit and Select the Best CMO
Audit is an important event for those in manufacturing of drugs.
Traditionally Contract Manufacturing Organisations were chosen for reasons like cost efficiencies, to decrease the time-to-market or because the facility was not available in-house.
CMOs were thus involved in offering labor, equipment and specific technologies.
The economies of countries like India and China are growing to sizable proportions, due to the benefits of contract manufacturingthat these specific countries, and others like them, offer.
Contract manufacturingis gaining more and more importance these days, especially after the recession last year.
In addition to the traditional benefits, more recently, companies are outsourcing to CMOs so that they can be able to concentrate on marketing and business development.
Seen once as a strategy adopted mostly by European and US-based multi-national companies, Contract Manufacturing is increasingly being adopted by all level of companies, for its obvious benefits.
It has always been essential to ensure the quality and compliance of suppliers providing GMP related materials for manufacturing.
Companies look for GMP certified manufacturers who can offer quality, in the most efficient timeframes.
Also there is a need for quality testing, storage of APIs, drug products, excepients & packing materials.
In effect, both quality and commercial criteria dictate the choice of vendors.
In order to get maximum leverage of Contract Manufacturing, it is imperative to focus on critical business issues; How to decide if a contract manufacturer has desired qualifications, how to ensure that we can have best manufacturers, who can scrutinize this and what should this auditor/auditing team look for, etc.
With the level of contract manufacturing increasing, Audit of CMOs is now becoming critical for drug companies.
In view of this, the upcoming conference on audits, which is being organized by Prescription Pharma Support, has a session in agenda dedicated to discussing the audits and choice of CMOs.
The discussion is truly desired as audit is much beyond a regulatory inspection by FDA, EU or MHRA.
This is bound to benefit those in manufacturing and production, those that seek manufacturers for contract, validation and compliance teams, and technical operation teams and of course the senior management, who are faced with the arduous task of choosing the right vendor.
How to choose the correct vendor and ensure that the vendor complies with agreed specifications is a huge challenge.
Quality is the number one concern, but even established players in market may not be adequately skilled or prepared to assess quality standards in vendors accurately every time.
This calls for continuous training and upgradation in skills of the auditor and the auditing team.
The auditors should be induced to define specifications, like reference standards, impurity standards, bioburden, particle size, and so on.
One should know the product and material specifications, quality control, change specifications, packaging configuration, delivery conditions, sub-contracting, etc.
Above all, regulatory requirements, in terms of Material, Manufacturing, leading to overall quality should be met.
Technical details are not the only pre-requisite for Contract manufacturing arrangements; the commercial details are very often critical, and key to the success of the arrangement.
What is a good agreement - certainly one that meets requirements of both the parties to make a cohesive association.
Clearly, we need to be trained on how to make and sustain a good agreement.
Once an audit is done, is it viable enough to last for the whole tenure of the association/agreement? It would be ideal to have the audit repeated periodically.
If an auditor with needed expertise is not available in-house, one looks for external auditors.
How to choose an auditor in such cases and what should be the criteria of choosing one and making an agreement for the same.
It is hoped that the conference will help analyze and understand the process and criteria of choosing a CMO and how to be a good auditor.
Much beyond inspection and giving an opinion, audit of CMOs involves extending support to them to help them develop and design what is desired!
Traditionally Contract Manufacturing Organisations were chosen for reasons like cost efficiencies, to decrease the time-to-market or because the facility was not available in-house.
CMOs were thus involved in offering labor, equipment and specific technologies.
The economies of countries like India and China are growing to sizable proportions, due to the benefits of contract manufacturingthat these specific countries, and others like them, offer.
Contract manufacturingis gaining more and more importance these days, especially after the recession last year.
In addition to the traditional benefits, more recently, companies are outsourcing to CMOs so that they can be able to concentrate on marketing and business development.
Seen once as a strategy adopted mostly by European and US-based multi-national companies, Contract Manufacturing is increasingly being adopted by all level of companies, for its obvious benefits.
It has always been essential to ensure the quality and compliance of suppliers providing GMP related materials for manufacturing.
Companies look for GMP certified manufacturers who can offer quality, in the most efficient timeframes.
Also there is a need for quality testing, storage of APIs, drug products, excepients & packing materials.
In effect, both quality and commercial criteria dictate the choice of vendors.
In order to get maximum leverage of Contract Manufacturing, it is imperative to focus on critical business issues; How to decide if a contract manufacturer has desired qualifications, how to ensure that we can have best manufacturers, who can scrutinize this and what should this auditor/auditing team look for, etc.
With the level of contract manufacturing increasing, Audit of CMOs is now becoming critical for drug companies.
In view of this, the upcoming conference on audits, which is being organized by Prescription Pharma Support, has a session in agenda dedicated to discussing the audits and choice of CMOs.
The discussion is truly desired as audit is much beyond a regulatory inspection by FDA, EU or MHRA.
This is bound to benefit those in manufacturing and production, those that seek manufacturers for contract, validation and compliance teams, and technical operation teams and of course the senior management, who are faced with the arduous task of choosing the right vendor.
How to choose the correct vendor and ensure that the vendor complies with agreed specifications is a huge challenge.
Quality is the number one concern, but even established players in market may not be adequately skilled or prepared to assess quality standards in vendors accurately every time.
This calls for continuous training and upgradation in skills of the auditor and the auditing team.
The auditors should be induced to define specifications, like reference standards, impurity standards, bioburden, particle size, and so on.
One should know the product and material specifications, quality control, change specifications, packaging configuration, delivery conditions, sub-contracting, etc.
Above all, regulatory requirements, in terms of Material, Manufacturing, leading to overall quality should be met.
Technical details are not the only pre-requisite for Contract manufacturing arrangements; the commercial details are very often critical, and key to the success of the arrangement.
What is a good agreement - certainly one that meets requirements of both the parties to make a cohesive association.
Clearly, we need to be trained on how to make and sustain a good agreement.
Once an audit is done, is it viable enough to last for the whole tenure of the association/agreement? It would be ideal to have the audit repeated periodically.
If an auditor with needed expertise is not available in-house, one looks for external auditors.
How to choose an auditor in such cases and what should be the criteria of choosing one and making an agreement for the same.
It is hoped that the conference will help analyze and understand the process and criteria of choosing a CMO and how to be a good auditor.
Much beyond inspection and giving an opinion, audit of CMOs involves extending support to them to help them develop and design what is desired!
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