Stephen McIndoe’s Blog

In this blog series I’m looking at the, often very necessary, issues of product packaging complexity and how these can be addressed via appropriate product portfolio, optimising the packaging facility design and examining key attributes of product packaging. In part three I offered my...

Optimising Your Packaging Facilities: Part 4

In this blog series I’m looking at the, often very necessary, issues of product packaging complexity and how these can be addressed via appropriate product portfolio, optimising the packaging facility design and examining key attributes of product packaging. In part three I offered my...

Is the commercialisation strategy for the product and therapy and the subsequent value of complexity understood? Different products will have different requirements for the complexity of the packaging componentry and SKU portfolio. This can be driven from many factors, including but not limited to:...

Packaging Complexity Management Tip 1: Understand the product/therapy strategy and value of complexity

Is the commercialisation strategy for the product and therapy and the subsequent value of complexity understood? Different products will have different requirements for the complexity of the packaging componentry and SKU portfolio. This can be driven from many factors, including but not limited to:...

Pharmaceutical product serialisation legislation is being developed and approved across the World to ensure patient safety and prevent fraud. Achieving this across the supply chain is a major and very costly undertaking. Failure to comply with these legislative requirements will mean that pharmaceutical companies...

Managing Serialisation 1 – The situation in 2012

Pharmaceutical product serialisation legislation is being developed and approved across the World to ensure patient safety and prevent fraud. Achieving this across the supply chain is a major and very costly undertaking. Failure to comply with these legislative requirements will mean that pharmaceutical companies...

My latest column has just been posted with Pharma IQ. To read it, please click here http://www.pharma-iq.com/business-development/columns/making-it-happen-change-management-issues-in-artwo/ If you have any thoughts or comments on this blog please contact me at  Andrew.Love@be4ward.com

May Column with Pharma IQ

My latest column has just been posted with Pharma IQ. To read it, please click here http://www.pharma-iq.com/business-development/columns/making-it-happen-change-management-issues-in-artwo/ If you have any thoughts or comments on this blog please contact me at  Andrew.Love@be4ward.com

Proofreading is a critical quality control step in the process of ensuring that the artwork that appears on finished product is correct. Mistakes in this artwork can, and have, put patient safety at risk. Therefore, we would recommend that any tools that are relied...

Causes of Proof Reading Errors 15 – Electronic tools not identifying errors due to a lack of validation

Proofreading is a critical quality control step in the process of ensuring that the artwork that appears on finished product is correct. Mistakes in this artwork can, and have, put patient safety at risk. Therefore, we would recommend that any tools that are relied...

ndrew Love, VP Capability Development, Be4ward Ltd, will be presenting and hosting a workshop at IQPC’s  3rd Annual Pharmaceutical Packaging and Labelling conference which is taking place in Basel, Switzerland on the 27th-28th June 2013.   Andrew will be presenting on ‘Top Tips for...

Be4ward presenting and hosting workshop at IQPC 3rd Annual Pharmaceutical Packaging and Labelling conference

ndrew Love, VP Capability Development, Be4ward Ltd, will be presenting and hosting a workshop at IQPC’s  3rd Annual Pharmaceutical Packaging and Labelling conference which is taking place in Basel, Switzerland on the 27th-28th June 2013.   Andrew will be presenting on ‘Top Tips for...

Modern electronic proofreading tools provide an excellent way of minimising the risk of artwork errors going undetected. Table 14.1 lists the typical types of tools used during proofreading activity.   Table 14.1 Typical Proofreading Tools Tool Type Typical Uses in Proofreading Text Comparison Comparing...

Causes of Proof Reading Errors 14 – Relying on electronic proofreading tools to do everything

Modern electronic proofreading tools provide an excellent way of minimising the risk of artwork errors going undetected. Table 14.1 lists the typical types of tools used during proofreading activity.   Table 14.1 Typical Proofreading Tools Tool Type Typical Uses in Proofreading Text Comparison Comparing...

In this series of articles I am going to discuss the topic of packaging complexity and outline a series of tips on approaches you can take to manage.   So to start with, what is packaging complexity?  Many pharmaceutical companies have broad product portfolios...

Dealing with Packaging Complexity

In this series of articles I am going to discuss the topic of packaging complexity and outline a series of tips on approaches you can take to manage.   So to start with, what is packaging complexity?  Many pharmaceutical companies have broad product portfolios...

One very simple reason for inadequate proofreading being performed is that the appropriate tools are not available.   At it’s simplest level, we have come across situations where there was no way for the proof reader to print out documents at full size and...

Causes of Proof Reading Errors 13 – Not proofreading all elements because of a lack of tools

One very simple reason for inadequate proofreading being performed is that the appropriate tools are not available.   At it’s simplest level, we have come across situations where there was no way for the proof reader to print out documents at full size and...

My latest column has just been posted with Pharma IQ. To read it, please click here http://www.pharma-iq.com/logistics/articles/packaging-labelling-technology/   If you have any thoughts or comments on this blog please contact me at  Andrew.Love@be4ward.com  

April Column with Pharma IQ

My latest column has just been posted with Pharma IQ. To read it, please click here http://www.pharma-iq.com/logistics/articles/packaging-labelling-technology/   If you have any thoughts or comments on this blog please contact me at  Andrew.Love@be4ward.com  

As anyone involved in Quality will tell you that not providing adequate quality time to perform tasks is a sure way to introduce errors and non-compliance. Proofreading is no exception to this rule and seems to suffer particularly badly due to the nature of...

Causes of Proof Reading Errors 12 – Not ensuring that people have quality time to do their work

As anyone involved in Quality will tell you that not providing adequate quality time to perform tasks is a sure way to introduce errors and non-compliance. Proofreading is no exception to this rule and seems to suffer particularly badly due to the nature of...

Proofreading requires concentration on often large documents for extended periods of time. A small desk and laptop in a busy, noisy open plan office is hardly conducive to performing this task well. In all cases we would recommend that the office environment in which...

Causes of Proof Reading Errors 11 – Not ensuring people have the right environment to work in

Proofreading requires concentration on often large documents for extended periods of time. A small desk and laptop in a busy, noisy open plan office is hardly conducive to performing this task well. In all cases we would recommend that the office environment in which...

In my first four articles in this series on change and programme management of artwork improvement projects, I talked about: some of the issues that need to be considered when setting up an artwork capability improvement programme some of the change management aspects to...

Programme Management considerations

In my first four articles in this series on change and programme management of artwork improvement projects, I talked about: some of the issues that need to be considered when setting up an artwork capability improvement programme some of the change management aspects to...

In my first three articles in this series on change and programme management of artwork improvement projects, I talked about some of the issues that need to be considered when setting up an artwork capability improvement programme, some of the change management aspects to...

Key roles for artwork improvement projects

In my first three articles in this series on change and programme management of artwork improvement projects, I talked about some of the issues that need to be considered when setting up an artwork capability improvement programme, some of the change management aspects to...

Artworks often exist in a number of different forms, each one having subtle differences. Take for example the situation where a single artwork is used to create one or more print ready files for one or more printing machines. In this case the artwork,...

Causes of Proof Reading Errors 8 – Not proofreading all instances of an artwork

Artworks often exist in a number of different forms, each one having subtle differences. Take for example the situation where a single artwork is used to create one or more print ready files for one or more printing machines. In this case the artwork,...

In my first two articles in this series on change and programme management of artwork improvement projects, I talked about some of the issues that need to be considered when setting up an artwork capability improvement programme and some of the change management aspects...

Project considerations for artwork improvement programmes

In my first two articles in this series on change and programme management of artwork improvement projects, I talked about some of the issues that need to be considered when setting up an artwork capability improvement programme and some of the change management aspects...

In my first article on this subject, ‘Change Management issues in artwork improvement programmes’, I talked about some of the issues that need to be considered when setting up an artwork capability improvement programme.  The cross-functional and cross-geographic nature of the process adds complexity...

Design of effective change management programmes for artwork improvement

In my first article on this subject, ‘Change Management issues in artwork improvement programmes’, I talked about some of the issues that need to be considered when setting up an artwork capability improvement programme.  The cross-functional and cross-geographic nature of the process adds complexity...

The act of proofreading inevitably means verifying information from source documents or systems with the information contained in the finished document. Many artwork errors have occurred because individuals have used the wrong source data or documents. The first example of this would be the...

Causes of Proof Reading Errors 7 – Not ensuring source data and documents are correct

The act of proofreading inevitably means verifying information from source documents or systems with the information contained in the finished document. Many artwork errors have occurred because individuals have used the wrong source data or documents. The first example of this would be the...

The human brain is excellent at filling in gaps in information and correcting mistakes in information so that it can see meaning very quickly. As an example, try to read the following: Cna yuo raed tihs? 55 plepoe out of 100 can. i cdnuolt...

Causes of Proof Reading Errors 6 – Not using techniques that “disable” the human mind’s ability to auto-correct

The human brain is excellent at filling in gaps in information and correcting mistakes in information so that it can see meaning very quickly. As an example, try to read the following: Cna yuo raed tihs? 55 plepoe out of 100 can. i cdnuolt...

Last week I attended and spoke at the Fleming Europe 3rd Annual Pharma Packaging and Labelling Conference in Berlin.  There were a number of excellent presentations from a range of speakers. Present 1 - The implementation of anti-counterfeiting features in Pharma Packaging material.  Pilar...

Fleming Europe 3rd Annual Pharma Packaging and Labelling Conference, 19-20 March, Berlin

Last week I attended and spoke at the Fleming Europe 3rd Annual Pharma Packaging and Labelling Conference in Berlin.  There were a number of excellent presentations from a range of speakers. Present 1 - The implementation of anti-counterfeiting features in Pharma Packaging material.  Pilar...

Packaging artwork often contains multiple instances of the same information. For example, the product name and strength will often appear on multiple faces of a carton, or will be stated many times within a leaflet. Many recalls have occurred because one or more instances...

Causes of Proof Reading Errors 5 – Not Checking Multiple Instances of the Same Information

Packaging artwork often contains multiple instances of the same information. For example, the product name and strength will often appear on multiple faces of a carton, or will be stated many times within a leaflet. Many recalls have occurred because one or more instances...

The nature of the artwork process means that there are many occasions where only a small part of the artwork needs to be updated to affect the desired change. This may be because the overall change in question is only minor, or it may...

Causes of Proof Reading Errors 4 – Not checking for inadvertent Changes

The nature of the artwork process means that there are many occasions where only a small part of the artwork needs to be updated to affect the desired change. This may be because the overall change in question is only minor, or it may...

In the previous article on this topic, I discussed some key considerations in using the Commercial artwork process as a base-on for the Clinical Trials artwork process. In doing this, it is essential to understand the differences required as there isn’t a ‘one size...

Managing Clinical Trial Artwork 3: Some Pitfalls to Avoid

In the previous article on this topic, I discussed some key considerations in using the Commercial artwork process as a base-on for the Clinical Trials artwork process. In doing this, it is essential to understand the differences required as there isn’t a ‘one size...

In the previous article on this topic, I discussed some key considerations in the development of an artwork process to support clinical trials . The clinical trials artwork process needs to deliver accurate and repeatable artwork in a fast changing and dynamic environment. The...

Managing clinical trials artwork 2: opportunities to leverage the commercial artwork process

In the previous article on this topic, I discussed some key considerations in the development of an artwork process to support clinical trials . The clinical trials artwork process needs to deliver accurate and repeatable artwork in a fast changing and dynamic environment. The...

As pressure to deliver new products intensifies in an increasingly complex regulatory environment, clinical trials are a vital endeavour for the pharmaceutical company. If things go well, it will mean approval of the drug and potential revenue for the company. However slight errors have...

Managing Clinical Trials Artwork 1: Some Key Considerations to Support Effective Trials

As pressure to deliver new products intensifies in an increasingly complex regulatory environment, clinical trials are a vital endeavour for the pharmaceutical company. If things go well, it will mean approval of the drug and potential revenue for the company. However slight errors have...

To gain support for improvement in any area of business, it is critical that the appropriate group of senior stakeholders understand the area sufficiently well to be able to take appropriate and timely decisions. In a previous article How big a risk is your...

Are your senior management equipped to make effective decisions about your packaging labelling and artwork capability?

To gain support for improvement in any area of business, it is critical that the appropriate group of senior stakeholders understand the area sufficiently well to be able to take appropriate and timely decisions. In a previous article How big a risk is your...

Many thanks to Alan Reynolds and the team at CAPDM for inviting me to speak to them about global trends in product coding and serialization. I had the pleasure of presenting to about seventy of the CAPDM members a couple of weeks ago in...

Serialization with the Canadian Association for Pharmaceutical Distribution Management

Many thanks to Alan Reynolds and the team at CAPDM for inviting me to speak to them about global trends in product coding and serialization. I had the pleasure of presenting to about seventy of the CAPDM members a couple of weeks ago in...

Errors in packaging labelling and artwork presents a significant compliance and reputation risk to pharmaceutical and medical device companies, a topic which I have explored in a previous blog article . Here I will discuss how to assess your end-to-end capabilities in this area,...

How big a risk is your packaging labelling and artwork capability?

Errors in packaging labelling and artwork presents a significant compliance and reputation risk to pharmaceutical and medical device companies, a topic which I have explored in a previous blog article . Here I will discuss how to assess your end-to-end capabilities in this area,...

Many thanks to Anna Fraenkel and the team at IQPC for organising this year’s Packaging and Labelling Summit in Basel, it was a great event that was well attended. I have pulled out a few my highlights of the event below. Book launch and...

IQPC Packaging and Labelling Summit 2012

Many thanks to Anna Fraenkel and the team at IQPC for organising this year’s Packaging and Labelling Summit in Basel, it was a great event that was well attended. I have pulled out a few my highlights of the event below. Book launch and...

Technology is a necessary and useful part of any packaging labelling and artwork capability, indeed it is practically impossible to operate an artwork capability today without some elements of technology. Technology helps address many issues which can lead to improvements in compliance, performance and...

Excellent Packaging Artwork Capabilities 10 – Technology

Technology is a necessary and useful part of any packaging labelling and artwork capability, indeed it is practically impossible to operate an artwork capability today without some elements of technology. Technology helps address many issues which can lead to improvements in compliance, performance and...

It is highly likely that one or more parts of your organisation are already working on this issue, perhaps in a coordinated way, perhaps not. Initially, we would recommend continuing this work until the appropriate course of action has been decided. We would recommend...

Managing Serialisation 9 – Where to start

It is highly likely that one or more parts of your organisation are already working on this issue, perhaps in a coordinated way, perhaps not. Initially, we would recommend continuing this work until the appropriate course of action has been decided. We would recommend...

Given the cross-functional and cross-organisational nature of the artwork capability, establishing the right inclusive leadership and governance is key to the long-term success of the capability. All stakeholder groups involved in the delivery of the artwork capability need to contribute effectively or the whole...

Excellent Packaging Artwork Capabilities 9 – Leadership and Governance

Given the cross-functional and cross-organisational nature of the artwork capability, establishing the right inclusive leadership and governance is key to the long-term success of the capability. All stakeholder groups involved in the delivery of the artwork capability need to contribute effectively or the whole...

Companies are faced with several specific issues when managing serialisation related legislation, these include: Identifying and interpreting the emerging and evolving legislation. Serialisation legislation, particularly in its early iterations, tends to be somewhat vague, incomplete and sometimes contradictory. Interpreting the legislation and predicting it’s...

Managing Serialisation 8 – What Needs to Be Done

Companies are faced with several specific issues when managing serialisation related legislation, these include: Identifying and interpreting the emerging and evolving legislation. Serialisation legislation, particularly in its early iterations, tends to be somewhat vague, incomplete and sometimes contradictory. Interpreting the legislation and predicting it’s...

Serialisation legislation will require new capabilities to be implemented across many different functions of a typical company. The more obvious impacts include: Packaging operations, where serialisation will have to be applied to product packaging at one or more levels. In the more complex serialisation...

Managing Serialisation 7 – Impacts of Serialisation

Serialisation legislation will require new capabilities to be implemented across many different functions of a typical company. The more obvious impacts include: Packaging operations, where serialisation will have to be applied to product packaging at one or more levels. In the more complex serialisation...

As we have discussed in earlier articles, creating correct artwork is an activity that requires many groups to act together in an orchestrated way to deliver a successful result, on time. The way of ensuring that these people act together in a co-ordinated way...

Excellent Packaging Artwork Capabilities 5 – The core artwork process

As we have discussed in earlier articles, creating correct artwork is an activity that requires many groups to act together in an orchestrated way to deliver a successful result, on time. The way of ensuring that these people act together in a co-ordinated way...

Whilst the primary objective of many organisations will be to meet the requirements of the emerging serialisation legislation, serialisation presents other opportunities. I have listed a few below, but please feel free to add others if you have them. Improved Compliance and Persistence Linking...

Managing Serialisation 6 – Opportunities beyond legislative compliance

Whilst the primary objective of many organisations will be to meet the requirements of the emerging serialisation legislation, serialisation presents other opportunities. I have listed a few below, but please feel free to add others if you have them. Improved Compliance and Persistence Linking...

In the last article we talked about arguably the most complex of serialisation models, Track & Trace. In this article we will discuss some other aspects and the important topic of standards. Reverse and Abnormal Process Flows It should be noted that reverse product...

Managing Serialisation 5 – The Basics and Standards

In the last article we talked about arguably the most complex of serialisation models, Track & Trace. In this article we will discuss some other aspects and the important topic of standards. Reverse and Abnormal Process Flows It should be noted that reverse product...

In the last article we talked about publishing serialisation information and the simplest of serialisation models, Authentication. In this article we will discuss arguably the most complex serialisation model, Track and Trace. Track & Trace Track and trace legislative models attempt to further improve...

Managing Serialisation 4 – The Basics and Track & Trace

In the last article we talked about publishing serialisation information and the simplest of serialisation models, Authentication. In this article we will discuss arguably the most complex serialisation model, Track and Trace. Track & Trace Track and trace legislative models attempt to further improve...

The development of packaging labelling and artwork involves many different groups across the company and, more often than not, external service providers and supply-chain partners. As we have already discussed, the creation of artwork requires many elements of information to be drawn together in...

Excellent Packaging Artwork Capabilities 4 – Service Culture

The development of packaging labelling and artwork involves many different groups across the company and, more often than not, external service providers and supply-chain partners. As we have already discussed, the creation of artwork requires many elements of information to be drawn together in...

In the last article we talked about the consequences of errors. In this article we will talk about some of the ways these errors occur, prior to discussing how to avoid them. Causes of artwork errors We have divided the many causes of artwork...

Excellent Packaging Artwork Capabilities 3 – The Causes of Errors

In the last article we talked about the consequences of errors. In this article we will talk about some of the ways these errors occur, prior to discussing how to avoid them. Causes of artwork errors We have divided the many causes of artwork...

In the last article we talked about unique identification and getting the unique identification onto the product or shipping unit. In this article we will discuss publishing the related serialisation information and one of the common serialisation models, Authentication. Product Information Notification Typically, once...

Managing Serialisation 3 – The Basics and Authentication

In the last article we talked about unique identification and getting the unique identification onto the product or shipping unit. In this article we will discuss publishing the related serialisation information and one of the common serialisation models, Authentication. Product Information Notification Typically, once...

In this article we will discuss the types of packaging labelling and artwork errors (which we refer to as “artwork errors”) that occur and their significant and far reaching impacts. This will provide context for later articles discussing the capabilities that need to be...

Excellent Packaging Artwork Capabilities 2 – Consequences of errors

In this article we will discuss the types of packaging labelling and artwork errors (which we refer to as “artwork errors”) that occur and their significant and far reaching impacts. This will provide context for later articles discussing the capabilities that need to be...

We will break serialisation legislative requirements down into four elements to help explain them: ● Unique Identification ● Product Information Notification ● Authentication ● Track & Trace In this article we will discuss the first of these, unique identification. Unique Identification All serialisation legislation...

Managing Serialisation 2 – The Basics and Unique Identification

We will break serialisation legislative requirements down into four elements to help explain them: ● Unique Identification ● Product Information Notification ● Authentication ● Track & Trace In this article we will discuss the first of these, unique identification. Unique Identification All serialisation legislation...

Pharmaceutical product serialisation legislation is being developed and approved across the World to ensure patient safety and prevent fraud. Achieving this across the supply chain is a major and very costly undertaking. Failure to comply with these legislative requirements will mean that pharmaceutical companies...

Managing Serialisation 1 – The situation in 2012

Pharmaceutical product serialisation legislation is being developed and approved across the World to ensure patient safety and prevent fraud. Achieving this across the supply chain is a major and very costly undertaking. Failure to comply with these legislative requirements will mean that pharmaceutical companies...

Packaging artwork is an often forgotten back room process in most pharmaceutical companies, but the changing business environment has brought issues from this capability to the fore. Pharmaceutical and other healthcare companies are facing one of the most difficult periods in their history. Current...

Excellent Packaging Artwork Capabilities 1 – Why packaging artwork capabilities matter

Packaging artwork is an often forgotten back room process in most pharmaceutical companies, but the changing business environment has brought issues from this capability to the fore. Pharmaceutical and other healthcare companies are facing one of the most difficult periods in their history. Current...

Hi everyone, we have just written a short paper that explains serialisation legislation, it’s impacts on an organisation and how to go about managing it. We will also do a series of articles on the topic as well.

Do you need to know more about serialisation legislation and how to manage it?

Hi everyone, we have just written a short paper that explains serialisation legislation, it’s impacts on an organisation and how to go about managing it. We will also do a series of articles on the topic as well.

Contact us and we will send you a copy while free stocks last! Our new book Developing and Sustaining Excellent Packaging Labelling and Artwork Capabilities will be launched mid-year, but we will soon have a limited number of free copies available. Delivering right first...

New book: Developing and Sustaining Excellent Packaging Labelling and Artwork Capabilities

Contact us and we will send you a copy while free stocks last! Our new book Developing and Sustaining Excellent Packaging Labelling and Artwork Capabilities will be launched mid-year, but we will soon have a limited number of free copies available. Delivering right first...

All processes need governance to ensure they operate effectively within and across companies. Due to the potential significant impact of errors created by the artwork process on patients and the company, it would seem appropriate for the governance of the process to be at...

Artwork Auditor Tip 20 – Is there adequate cross functional / organisation governance in place?

All processes need governance to ensure they operate effectively within and across companies. Due to the potential significant impact of errors created by the artwork process on patients and the company, it would seem appropriate for the governance of the process to be at...

It is important to address any issues across the different pharma packing design departments in a company to ensure that there is a continuous improvement process in place by analyzing different aspects.

Artwork Auditor Tip 19 – Is there an issue management and continuous improvement process in place?

It is important to address any issues across the different pharma packing design departments in a company to ensure that there is a continuous improvement process in place by analyzing different aspects.

Many of the tasks involved in the end-to-end artwork process require a great deal of focus and attention to detail on the part of the individuals performing them. Some tasks also require specific tools to be able to them correctly. Consideration should be given...

Artwork Auditor Tip 18 – Do individuals have an appropriate working environment?

Many of the tasks involved in the end-to-end artwork process require a great deal of focus and attention to detail on the part of the individuals performing them. Some tasks also require specific tools to be able to them correctly. Consideration should be given...

A significant cause of error in artwork processes is a lack of adequate planning and resource level management. To be successful, many individuals from many different locations, functions and often companies need to play their part in the artwork process at the right time....

Artwork Auditor Tip 17 – Is work planning and adequate resource level management in place?

A significant cause of error in artwork processes is a lack of adequate planning and resource level management. To be successful, many individuals from many different locations, functions and often companies need to play their part in the artwork process at the right time....

As we discussed in Tip 11, documents are likely to exist in a number of different formats and different individuals may need to deal with these different formats in different ways, e.g. images on screen, printouts. It is essential that everyone viewing a document,...

Artwork Auditor Tip 16 – Do all IT tools used during review and approval ensure the correct image is displayed?

As we discussed in Tip 11, documents are likely to exist in a number of different formats and different individuals may need to deal with these different formats in different ways, e.g. images on screen, printouts. It is essential that everyone viewing a document,...

Many Information Technology (IT) tools are often used to support a typical end-to-end artwork process. Examples would include: Artwork creation desktop Electronic proof reading tools Document management and electronic signature systems Workflow tools Barcode creation Verification tools As with any IT tools used to...

Artwork Auditor Tip 15 – Are critical Information Technology tools managed under a Quality Management System?

Many Information Technology (IT) tools are often used to support a typical end-to-end artwork process. Examples would include: Artwork creation desktop Electronic proof reading tools Document management and electronic signature systems Workflow tools Barcode creation Verification tools As with any IT tools used to...

Service providers such as external artwork studios and printers are often used by a company to make up their full artwork capability.  Where 3rd parties are used to carry out patient and product safety related activity in the end-to-end process, a company needs to...

Artwork Auditor Tip 14 – Are service providers formally managed under a Quality Management System and Subject to Routine Audits?

Service providers such as external artwork studios and printers are often used by a company to make up their full artwork capability.  Where 3rd parties are used to carry out patient and product safety related activity in the end-to-end process, a company needs to...

Many of the tasks that need to be performed in the end-to-end artwork process rely heavily on the skill and competence of the operators. Particular examples of this would be artwork operators, proof readers and other document reviewers. Some operators are regularly involved in...

Artwork Auditor Tip 13 – Is ongoing education, training and competency assessment in place?

Many of the tasks that need to be performed in the end-to-end artwork process rely heavily on the skill and competence of the operators. Particular examples of this would be artwork operators, proof readers and other document reviewers. Some operators are regularly involved in...

We discussed the issue of ensuring that the evolution of a document is identified robustly in Tip 10. Having uniquely identified different versions of a document, the next thing to ensure is that everyone in the process is using the right version of a...

Artwork Auditor Tip 12 – Is everyone using the correct version of a document?

We discussed the issue of ensuring that the evolution of a document is identified robustly in Tip 10. Having uniquely identified different versions of a document, the next thing to ensure is that everyone in the process is using the right version of a...

We live in a world where we constantly deal with documents in different interchangeable formats. Rarely are the documents we deal with today created on paper, normally they are created electronically and shared using a number of different electronic and paper formats. Artwork and...

Artwork Auditor Tip 11 – Are there methods in place to ensure different forms of each document are the same?

We live in a world where we constantly deal with documents in different interchangeable formats. Rarely are the documents we deal with today created on paper, normally they are created electronically and shared using a number of different electronic and paper formats. Artwork and...

As with all document management activities, it is essential that everyone is clear which iteration of a document needs to be used at any particular time in the process. Many errors have occurred in artwork management processes because this has not been clear. For...

Artwork Auditor Tip 10 – Is there effective document version management in place?

As with all document management activities, it is essential that everyone is clear which iteration of a document needs to be used at any particular time in the process. Many errors have occurred in artwork management processes because this has not been clear. For...

An adequate audit trail should be maintained to ensure that it can be demonstrated that the process was carried out completely and correctly. It can also be beneficial to record additional information in the audit trail to assist with continuous improvement activities. For example,...

Artwork Auditor Tip 9 – Is an audit trail created and held for an appropriate period of time?

An adequate audit trail should be maintained to ensure that it can be demonstrated that the process was carried out completely and correctly. It can also be beneficial to record additional information in the audit trail to assist with continuous improvement activities. For example,...

In January 2013 securPharma are planning to start a medicines serialisation pilot designed to demonstrate the requirements of EU Directive 2011/62/EU in the German market. securPharma is a German organisation involving the whole German pharmaceutical supply chain in improving supply chain security. The pilot...

German serialisation pilot due to begin in January 2013

In January 2013 securPharma are planning to start a medicines serialisation pilot designed to demonstrate the requirements of EU Directive 2011/62/EU in the German market. securPharma is a German organisation involving the whole German pharmaceutical supply chain in improving supply chain security. The pilot...

It is important that checks are carried out to verify that changes to an artwork have been performed correctly and that no unintentional changes have been made by mistake. For this latter reason, we would recommend carrying out full checks at all verification steps,...

Artwork Auditor Tip 8 – Are there adequate quality checks performed at every document revision?

It is important that checks are carried out to verify that changes to an artwork have been performed correctly and that no unintentional changes have been made by mistake. For this latter reason, we would recommend carrying out full checks at all verification steps,...

In our opinion, ensuring that the roles and responsibilities are clear for the artwork process is important for a number of reasons. Firstly, it is critical that, where an individual needs to carry out tasks in the process, they are clear which specific tasks...

Artwork Auditor Tip 7 – Are roles and responsibilities clearly defined, especially at key control points?

In our opinion, ensuring that the roles and responsibilities are clear for the artwork process is important for a number of reasons. Firstly, it is critical that, where an individual needs to carry out tasks in the process, they are clear which specific tasks...

In a Public Notice dated 22nd December 2012, the Indian Ministry of Commerce and Industry announced deferred dates for the requirements to serialise, track and trace Secondary and Primary level export product packaging. The revised dates are as follows and represent a delay of...

India delay Primary and Secondary export packaging serialisation requirements

In a Public Notice dated 22nd December 2012, the Indian Ministry of Commerce and Industry announced deferred dates for the requirements to serialise, track and trace Secondary and Primary level export product packaging. The revised dates are as follows and represent a delay of...

In a press release from ANVISA dated 8th December 2011, the results of the Brazil Government Integrated Task Force review of the serialisation legislation (Law No. 11.903/2009) were announced. An intention to implement full tracking of serialised product through the supply chain is still...

Brazil’s ANVISA update their serialisation track and trace requirements

In a press release from ANVISA dated 8th December 2011, the results of the Brazil Government Integrated Task Force review of the serialisation legislation (Law No. 11.903/2009) were announced. An intention to implement full tracking of serialised product through the supply chain is still...

Having established the status, scope and critical controls of the artwork management process in the relevant Quality Management Systems, the next area to look at is the definition of the process activities themselves. Given the detailed nature of the artwork process and the fact...

Artwork Auditor Tip 6 – Is the overall process defined in a way which ensures complete and consistent working?

Having established the status, scope and critical controls of the artwork management process in the relevant Quality Management Systems, the next area to look at is the definition of the process activities themselves. Given the detailed nature of the artwork process and the fact...

We have encountered a number of occasions where errors occurred because the artwork that is initially developed and approved by the relevant stakeholders is not complete. Subsequent additions to the artwork, say to add product barcodes, create errors which are then not caught in...

Artwork Auditor Tip 5 – Is a complete version of the artwork created and approved?

We have encountered a number of occasions where errors occurred because the artwork that is initially developed and approved by the relevant stakeholders is not complete. Subsequent additions to the artwork, say to add product barcodes, create errors which are then not caught in...

We have observed many artwork errors occurring because the artwork process has continued despite the fact that a previous stage of the process has not been fully completed. A typical artwork change management process will divide the development of new or changed artwork, and...

Artwork Auditor Tip 4 – Are critical control points adequately defined?

We have observed many artwork errors occurring because the artwork process has continued despite the fact that a previous stage of the process has not been fully completed. A typical artwork change management process will divide the development of new or changed artwork, and...

One of the most basic causes of artwork error is not carrying out every change that is necessary as a result of a change trigger. For example, if a local regulator introduces a new packaging regulation requirement, one of the first questions that needs...

Artwork Auditor Tip 3 – Does a trigger for change result in all relevant artworks being changed?

One of the most basic causes of artwork error is not carrying out every change that is necessary as a result of a change trigger. For example, if a local regulator introduces a new packaging regulation requirement, one of the first questions that needs...

Once the existence of a Quality Management System (QMS) is established, the next thing to verify is that all artwork changes are managed within this framework. We have come across several situations where there was a good artwork capability in place, but unfortunately, it...

Artwork Auditor Tip 2 – Does the scope of the artwork management capability cover all labelling and artwork creation?

Once the existence of a Quality Management System (QMS) is established, the next thing to verify is that all artwork changes are managed within this framework. We have come across several situations where there was a good artwork capability in place, but unfortunately, it...

The packaging labeling and artwork management process in the healthcare industry creates an output which, if incorrect, can have serious implication on patient safety. Therefore, I would suggest that the artwork process must be managed under one or more formal Quality Management Systems (QMS)....

Artwork Auditor Tip 1 – Is the end-to-end artwork capability managed under a formal Quality Management System?

The packaging labeling and artwork management process in the healthcare industry creates an output which, if incorrect, can have serious implication on patient safety. Therefore, I would suggest that the artwork process must be managed under one or more formal Quality Management Systems (QMS)....

Today, large Pharmaceutical and other Healthcare companies are arguably in the midst of the toughest challenges that they have ever faced. These challenges include: Blockbuster drug patents are expiring at an alarming rate and product development pipelines are not ready to fill the ensuing...

Are Healthcare packaging labelling and artwork management capabilities key to meeting today’s business challenges?

Today, large Pharmaceutical and other Healthcare companies are arguably in the midst of the toughest challenges that they have ever faced. These challenges include: Blockbuster drug patents are expiring at an alarming rate and product development pipelines are not ready to fill the ensuing...

Top 20 things to consider when auditing pharmaceutical labelling and artwork content creation capabilities.

Top 20 Artwork Auditor Tips

Top 20 things to consider when auditing pharmaceutical labelling and artwork content creation capabilities.

GS1 is instrumental in driving global standards for product identification, serialisation and other supply chain efficiency standards.

GS1

GS1 is instrumental in driving global standards for product identification, serialisation and other supply chain efficiency standards.

The USA Food and Drug Administration’s Guidance, Compliance, & Regulatory Information website.

FDA

The USA Food and Drug Administration’s Guidance, Compliance, & Regulatory Information website.

A great site covering many aspects of Pharma supply chain and brand security.

SecuringPharma

A great site covering many aspects of Pharma supply chain and brand security.

Information sources suggest that Turkey is about to delay it’s Phase II Serialisation requirements to January 2012. The Phase II requirements introduce case serialisation, aggregation and track & trace.

Turkey Serialisation Phase II Delay

Information sources suggest that Turkey is about to delay it’s Phase II Serialisation requirements to January 2012. The Phase II requirements introduce case serialisation, aggregation and track & trace.

Brazil sets January 2012 as the deadline for serialisation of all medical products circulating in country, using government supplied labels.

Brazil January 2012 Serialisation Deadline

Brazil sets January 2012 as the deadline for serialisation of all medical products circulating in country, using government supplied labels.

The FDA has defined how prescription pharmaceutical drugs will be serialized by defining it’s document Standards for Securing the Drug Supply Chain - Standardized Numerical Identification for Prescription Drug Packages.

FDA Announces Drug Serialization Identification Method

The FDA has defined how prescription pharmaceutical drugs will be serialized by defining it’s document Standards for Securing the Drug Supply Chain - Standardized Numerical Identification for Prescription Drug Packages.

Welcome to WordPress. This is your first post. Edit or delete it, then start blogging!

Hello world!

Welcome to WordPress. This is your first post. Edit or delete it, then start blogging!

Be4ward provides specialist consulting services to the Pharmaceutical and other highly regulated industries.   We deliver value to our clients thorough a combination of deep subject matter expertise and excellent consulting skills.   Whilst we have a thorough understanding of the supply base in...

What We Do

Be4ward provides specialist consulting services to the Pharmaceutical and other highly regulated industries.   We deliver value to our clients thorough a combination of deep subject matter expertise and excellent consulting skills.   Whilst we have a thorough understanding of the supply base in...

• Product coding, serialization and anti-counterfeiting   capabilities • Packaging and artwork design capabilities • Post merger legal or acquisition brand integration • Secondary packaging and distribution supply chain   design • Product complexity management, late customization   and postponement • Pharmaceutical product launch and portfolio   management

Our Areas of Focus

• Product coding, serialization and anti-counterfeiting   capabilities • Packaging and artwork design capabilities • Post merger legal or acquisition brand integration • Secondary packaging and distribution supply chain   design • Product complexity management, late customization   and postponement • Pharmaceutical product launch and portfolio   management

Be4ward provides specialist consulting assistance to clients across the globe. We are happy to work at your location(s), remotely or in a combination of the two.

Global Coverage

Be4ward provides specialist consulting assistance to clients across the globe. We are happy to work at your location(s), remotely or in a combination of the two.

Understand how to efficiently and effectively integrate legal entities and manage their subsequent impacts on product registrations and packaging design.

Legal Entity Integration Management

Understand how to efficiently and effectively integrate legal entities and manage their subsequent impacts on product registrations and packaging design.

In November 2009, the Argentinian Government released a draft Bill which, if passed, will require product serialisation similar to Brazil.

Argentina Issues Draft Serialisation Legislation

In November 2009, the Argentinian Government released a draft Bill which, if passed, will require product serialisation similar to Brazil.