strate flexibility in packaging operations?
Telling a client that they can have a packaging slot for a launch
product next month just does not happen in Almac Pharma Services. Flexibility is key, particularly when a new product launch
is involved. In our UK operations we have acted as site of
launch for the EU market for more than ten orphan drug products in the last three years. A fully integrated and experienced
project team consisting of Almac and client personnel follow a
well worn launch approach that Almac have refined over many
years. Objectives are defined within this plan with built in flexibility to address the challenges that sometimes arise.
manufacture and packaging experience in the EU we are well
versed in client audits. As we grow the business, specifically
within Almac Pharma Services, we are often seeing two client
audits per week across our various service lines. Similarly, as
we are named in more NDA’s, ANDA’s and MAA’s we see more
oversight from the regulatory agencies, whether they be FDA,
MHRA, ANVISA, JP authorities etc. We welcome these visits as
it illustrates our ongoing growth and success.
key, particularly when a
How important is the input and expertise of packaging
equipment vendors to the success of your operation?
Developing a close relationship with your packaging equipment supplier is always advantageous to ensure you are fully
aware of the capabilities/limitations of the technology. Should
technical issues with the packaging equipment arise a solid
partnership with your supplier will also help minimize downtime through expedited response times.
Have you seen an increase in FDA inspections/audits? Do your
customers inspect your facility now more than in the past?
Our new US commercial packaging operation in PA was recently
inspected by the FDA with no 483s. However allowing for this
milestone, our clients still have an internal audit requirement
to visit and “sign off” the site. With 40 years of commercial
Where do you see the biggest growth in contract packaging in
the next five years or so? Will there be more growth in Rx or
That’s a good question and one we thought long and hard about
before opening our US commercial packaging operation. Personally, I believe big pharma will continue to outsource more contract packaging in an effort to reduce internal labor and overhead
costs – this will particularly be true in the OTC space.
Additionally, I believe, and hope, that pharma focuses more
heavily on quality and flexibility within that contracted packaging environment so we avoid the negative headlines of recalls,
For innovative Rx products Almac Pharma Services has seen
more and more smaller companies do business with us on
packaging/3PL of niche and orphan drug products, where all
requirements are fully outsourced. This fits perfectly with the
“one stop shop” model operated by Almac Pharma Services for
this particular type of product. ■
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