Pharmaceutical packaging requirements can be a minefield

Do you work in the pharmaceutical industry on the ‘periphery’ of packaging, working for example in Marketing, Purchasing, Design or QA etc , and have always wanted to find out more about packaging, but without having to attend a lengthy 3 day training course? Or perhaps you are a Packaging Technologist working on toiletries or cosmetics and want to gain a better understanding pharma issues and opportunities?

If so, then this ONE DAY TRAINING COURSE could be for you!

It’s being held on 14th October 2010 in Nottingham, UK

Pharmaceutical packaging is a very specialised area with its own unique issues & problems. This one day course will provide delegates with a good basic grounding & appreciation of what is required for the packaging of pharmaceutical & healthcare products. Whether you know nothing, have a basic understanding or are familiar with the area, this course will provide you with useful knowledge and insights from experts who have each worked in the industry for over 25 years.

What will be covered:

1.Packaging component & material selection Key product requirements (Consumer, Barrier, Shelf Life & Regulatory – Child resistance, Tamper evidence, Dosing & Stability. Marketing expectations.

2. Key properties of various materials / systems Main barriers & benefits of various packaging materials, Key drivers for pack performance, Supply chain implications on the packs

3. Pack testing & evaluation Mandatory requirements for Consumer testing & Transit testing.

4. Packaging component specifications Key requirements for a specification, Control of the documents.

5. Artwork generation & control Establishing processes suitable to your business needs – Wording & Templates, Creation, Version control & authorisation.

6.Regulatory requirements Packaging data for the MA , Braille, barcodes, Child Resistance, Tamper Evidence, Readability & others – including emerging requirements (e.g. 2D data matrix barcodes). Key packaging data for the MA/Dossier (Specifications & data, Supplier details). Key requirements for Braille etc.

7. Transit packaging Considerations of risk, Establishing test programmes, Specific requirements for palletisation etc.

8. Trade /supply chain requirements Understanding the various markets & their particular requirements, Understanding trade requirements (e.g. Barcodes, Shelf Ready Trays etc).

A full set of documentation will be provided.

You can find out more and register for this event by clicking: More information on Packaging of Pharmaceuticals – a One Day Introductory Course 14th October 2010

Chris Penfold

The recommended 12 point font size for critical information is going to be challenging. (Annie Dallison)

To read the full article just follow the link to PMPNews

Denmark has introduced a temporary ban on bisphenol A (BPA) in all food contact materials for young children amid fears the chemical could inhibit brain development.

Thanks Beverage Daily for highlighting this ban, to see their full article just follow this link  – Beverage Daily

Packaging Top Ten Tips

In order to help you develop your packaging more productively, we have generated a series of  FREE short 1-2 minute videos detailing our Tip Ten Tips for getting it right. We will be posting 1 x video per day on this blog site over a 10 day period – so keep a look out for them – they could save you a £££$$$ fortune in the long run!

DAY 8 – Tip No8: I don’t need to tell you how important branding is on a pack, do I?. Get it wrong and you’ve got a ‘dead duck’ on your hands! But wording on packs performs many functions. There are many legal requirements & you must be able to substantiate any claim you make. Aesthetically the wording & graphics must work in harmony. Incorrect wording is the most common reason for product recalls, which can cost a producer many £000’s. Find out more on the video….

Have fun packaging. Cheers Chris

Today’s Video:

Packaging Tip No8 – Information & communication – by Chris Penfold – Design Cognition

Look out tomorrow for Tip No 9 – Cost minimisation…..

Packaging Top Ten Tips

In order to help you develop your packaging more productively, we have generated a series of  FREE short 1-2 minute videos detailing our Tip Ten Tips for getting it right. We will be posting 1 x video per day on this blog site over a 10 day period – so keep a look out for them – they could save you a £££$$$ fortune in the long run!

DAY 7 – Tip No7: In a previous video we looked at external damage to your packaging & how transit packaging can help, but what about protection from the product within? Is your product formulation particularly aggressive? Could it attack the packaging from the inside? Sound implausible? You might be surprised! Check out this video…..

Tip Top packaging! Cheers Chris

Today’s Video:

Packaging Tip No7 – Physical protection? – by Chris Penfold – Design Cognition

Look out on Monday for Tip No 8 – Information & communication…..

Blister Packaging

The following article is one that I’ve recently written for the Packaging Professional magazine, which details a fascinating 25 year transformation in the way we work and do business in the pharmaceutical packaging industry. Over that period the industry itself has undergone huge change and with recent economic pressures and the rise of generic competition is likely to continue unabated.

Back in the 1980’s, before the days of email and the internet, working in packaging could sometimes be a lonely business, especially in an area like pharmaceuticals where regulatory requirements, standards and process were constantly being updated as authorities, such as the US Food and Drug Administration (FDA) and the UK Medicines Control Agency (MCA), evolved  increasing powers and rules. A situation where ‘fit for purpose’ packaging could be a matter of life and death.

Pharma companies are strictly regulated and need to work to tight and common standards and most companies were running similar, machinery, quality systems and packaging materials. So learnings from one company could greatly help another and save having to ‘reinvent the wheel’. It was also important for the industry to provide a collective view to positively influence proposed legislation and regulations, with a common and pragmatic ‘voice’.

So back in 1984, the ‘seed’ of an idea for a group was ‘sown’ by Alan Haskins of Roussel Laboratories and Roy Gray of ICI Pharmaceuticals, after Roy’s boss had visited the USA and seen a successful American group working in the same sector. This was a defining moment and the group would not have happened without their collective vision and proactive approach. The first Pharmaceutical Common Interest Group (PCIG) meeting took place on 16^th October 1984 at Sysonby Lodge, which was the head office of The Institute of Packaging (IOP) at the time). The meeting was chaired by Alan Haskins, with Roy Gray as Secretary and an attendance of 18 people from 15 pharmaceutical companies from across the industry. There were 37 questions raised & discussed at that meeting on a range of topics, including: a New British Standard for aluminium flexible tubes, label adhesives, Tamper Evidence and EAN bar codes – themes that would arise again and again over the years.

It was agreed that there would be three meetings per year and venues would rotate across the various company sites, but over the years most were actually hosted by the IOP.

One of the original members, Mike Shorten, who worked for Boots Pharmaceuticals at the time and is now retired, recalls:

“The PCIG soon became my most important network. Forty pharmaceutical practitioners across all sectors of the industry provided a powerful resource that could offer practical experience about most issues and without any consultants’ fees! A great strength of the group was the willingness of its members to talk openly about issues and share best practice and then to collectively influence new regulations and standards”

How the CIG has changed over the years

I have myself have been a member of the group for over 18 years (since 1991) and over that time can recall a great deal of camaraderie, focused help for each other and pragmatism having helped us all deal with issues as diverse as use of high barrier blister materials, bar coding issues and leeching of preservative through polyethylene bottles.

As issues became apparent, some common themes evolved and a number of dedicated ‘sub groups’ were set up to focus on specific topics. Four of these were Working Groups for Digital Artwork & Reprographics (DAR), Validation, Child Resistance and Quality Standards. The DAR subgroup was set up at a time when ‘desktop publishing’ was a buzz word being used as artwork generation moved from ‘old fashioned’ layout board, to a digitised computerised system.  At the time there was no common standard. There was a range of hardware (PC & Mac based), a number of operating systems, and various artwork creative software packages on each platform. The ease by which artwork could be generated and manipulated raised its own issues in terms of artwork version control and (in the early days) data going ‘missing’ sometimes between approval and print – which had the potential to cause a catastrophic result. So the group played a critical role in sharing ‘best practice’ and setting appropriate standards.

The Validation subgroup was formed in 1992, the founding Chairman being Mike Harwood of The Wellcome Foundation, Dartford. A subsequent Chairman (1993-98) John Cooper (of Pfizer at the time) recalls “The original intent was to develop a set of guidelines for validating pharmaceutical packaging equipment and then issue to IOP members, but as the guideline developed and the information was shared informally with machine manufacturers it became obvious that it would be of a wider benefit to publish a ‘book’. As I was a member both of the PCIG and Institute of Quality Assurance Pharma Quality Group (IQA PQG), I suggested that this was published jointly as a monograph in the series which was already established by the PQG. The monograph was published in 1998 and launched at a joint meeting of PCIG and PQG at the Royal Pharmaceutical Society in Lambeth with over 200 people in attendance, including the MCA Head of Inspection and Enforcement, Gordon Munro!” That was another defining moment in the ‘life’ of the PCIG and evidence of the esteem with which the group was held within the pharmaceutical industry. The third edition of that monograph is presently due for print.

It was not uncommon in the early days for PCIG meeting attendance to be around 35-40 people, with standing room only. Questions would be collated by the Secretary and shared at each meeting. It would sometimes take 3 or 4 hours to go through them all, one-by-one. As the years have gone by and we have moved in to a digital age, email has enabled members to converse more easily and questions can be asked and answered sometimes within minutes. So the focus and frequency of face-to-face meetings changed to providing more of an opportunity for discussing in more depth, processes, procedures, technology and impending legislation, and to keep in touch with old colleagues and friends. Together with the myriad of mergers among the pharma companies, this has meant attendances have dropped.

Where we are going with it in future
The PCIG (now called the Pharmaceutical Packaging Forum – PPF) is still active, with a core of ‘stalwart’ members and a new voluntary Secretary, David Pethick, former Director of Packaging Development at GSK. David is upbeat about future for the group and says “the pharma landscape, increasing demands and changing regulations on packaging present as much, if not more of, a challenge as when the PCIG was first established. I see both a need and role for a vibrant PCIG to help the pharma packaging professional meet those challenges, whether that be from simply providing networking among its members, to wider influencing, technical leadership, training needs or whatever”.

Pharma packaging legislation/regulation has changed enormously, and the Society recently received an enquiry about training courses on this. Feedback from PCIG members showed a high level of similar interest. Whether or not such a course could be developed is still a work in progress, but both David (for PPF) and Ian Morris, Training Manager at IOM3, would be interested in readers’ feedback.

Ultimately, the future and utility of PCIG, as over its past history, is reliant on the members who actively value and contribute to it.

Chris Penfold

If you work in Pharma and are interested in knowing more or in joining the PPF group, you can contact David Pethick (the Secretary) at dppk@btinternet .

On my own part (Chris), as well as continuing to be an active member of the PPF and a consultant, I am also the External Relations Officer of the East Midlands Packaging Society, for which you can find more information at: East Midlands Packaging Society.

You can find more help and advice on various aspects of pharmaceutical packaging at our sister site: The Pharma Gateway

We are routinely coming across pharma companies (small & large) who just don’t keep up with or monitor changes in packaging legislation, that will have a major impact on their businesses.

A good example is Braille legislation which is now MANDATORY for ALL pharma packs sold in Europe and has to be in place (i.e. on packs on the market) within the next 7 MONTHS.

As a consequence of non-compliance, an estimated 20% of pharma companies could have their products de-listed and taken off the market. So why do companies ignore it?

The following link will take you to a very interesting and comprehensive article on the European Pharmaceutical Manufacturer (EPM) magazine website: Braille labelling on medicines packaging

This article will give you some good tips on how to ensure that you comply and a summary of it has been printed in the latest version of the EPM printed magazine. Chris Penfold

The newspaper continues, “Authorities estimate that up to a third of the contraceptives used in some parts of China are counterfeits, despite improvements in state food and drug oversight. None of the counterfeits are properly sterilized, and others are of such inferior quality that they could rupture during use.”

The article details how authorities are attempting to track down what they estimate are more than one million condoms distributed throughout China, and notes how the knock-off condoms were uncovered in discount stores in New York, Texas and Virginia in 2008.

Thanks to @TheBodyGlobal for bringing our attention to this article via Twitter. More articles like this can be read at: www.thebody.com

 It’s not an appealing topic, but it has grabbed recent headlines.

The Tylenol national recall—ongoing at the time of this article’s publication—is a reminder that wood pallets can be the source of packaging/product contamination. Such a capability is reason for brand owners to have in place a Pallet Purity Program (PPP).

Written by Sterling Anthony, CPP.  Published in Packworld.com 20th January 2010 to read the full article to follow this link http://bit.ly/5uLMHF

Medical, food & water supplies packaged to survive a harsh environment

Although of no consolation to those that have perished over the past week, luckily the logistical situation is improving now that US ships have arrived and helicopters are finally getting to the places they are needed with those essential supplies. It is at times like this that we are reminded of the true worth of packaging,  in an environment where there are no fridges to keep things cool and packaging has to perform an even more essential role than normal in a very hostile environment. The packaging contains, avoiding spillage. It protects against crushing, vermin & pilfering. It preserves, providing protection for the products within and extended shelf life. It enables ease of transport, whether by plane, truck or onwards by hand and lastly it informs, providing vital information on contents, storage, dosage and application.

In summary, it provides a lifeline where, without it, medical supplies would arrive dirty and non-sterile, food would ’spoil’ within hours and water would become contaminated, leading to dysentery and further distress and trauma. So, packaging, where on earth would we be without it? Chris Penfold