CPhI Report Indicates a Need for Greater Third Party Certification to Ensure GMP Vigilance

AsiaNet 53817

AMSTERDAM, July 26, /PRN=KYODO JBN/ --

- QbD and PAT only being used by a third of the industry currently

- CPhI Pharma Insights: formulation and ingredients report

Report highlights:

Particle size reduction a major challenge for 60% industry during formulation

Bioavailability still a major formulation obstacle- with two thirds listing it

as their most urgent challenge

India and China thriving as leading API source

However quality is still seen as the top issue with APIs and ingredients for

half of the industry

Over half of respondents outsource clinical work to CROs

There is still a reluctance to use CMOs and CDMOs when developing new chemical

entities

Academic partnerships are on the rise with nearly 40% working with them

CPhI Worldwide [ http://www.cphi.com/ ] and CPhI Pharma Evolution, part of UBM

Live's Pharmaceutical Portfolio, announce the conclusions of its first monthly

report into the current status of the formulation and ingredients market-

conducted amongst high level executives and experts from across the industry

over the last month.

     (Logo: http://photos.prnewswire.com/prnh/20130723/629764-a )

The report echoes concerns the regulatory bodies (FDA, EMA) have raised in

regards to the necessity of third party auditors to ensure the safety and

quality of API and ingredients facilities. Nearly 95% of the respondents agreed

that supplier's certification was an important factor, yet despite this only

less than a quarter were actively working with third party auditors to vet

suppliers- suggesting a greater vigilance is needed to a problem that the

industry is still avoiding.

Of those working with third parties, nearly 31% of respondents said they are

working with USP's Verified Ingredients Program; with 18% using EXCIPACT; and

10% using either IPEC or APIC.

The lack of action on the part of industry is due to poor communication both

internally and with suppliers according to Girish Malhotra, CPhI expert

industry panel member. "People who are visiting supplier sites must be familiar

with manufacturing and analytical practices and both suppliers and buyers must

agree on what certifications are needed. No shortcuts!"

Fellow panel members echoed these thoughts with Emil Ciurczak, commenting

"there are inconsistencies because we work in silos", whilst Brian Carlin

reiterated these sentiments adding "the combination of concerns over quality,

supply and a lack of understanding suggest the need to move to more

pharmaceutically aligned suppliers".

In fact, half of the respondents felt quality was a top issue, with 41% adding

that supply was a major issue with API and ingredients. However, problems with

quality may not be entirely down to a lack of certification of ingredients

according to Carlin, "If inconsistency of quality is due to unknown excipient

attributes, beyond the certification of analysis, part of the problem may be

inadequate feedback to suppliers".

Outsourcing is widely recognised as a major trend across the industry, yet

despite this only just over a third of the industry is currently partnering

with CMOs and CDMOs, which perhaps reflects a reluctance to outsource new

chemical entity development for fear of potential IP infringement. However,

over half the respondents are already working with CROs during clinical trials

and nearly 40% are currently working with academic groups during development.

The leading formulation issues, according to the survey respondents, are a

result of new drug targets becoming more complex and suffering from solubility

issues and poor release profiles. Over two thirds of the pharmaceutical sector

suggested 'bioavailability' and 'stability' were pressing challenges for the

industry today, with 'dissolution' and 'release' profile also being sources of

major concerns for over half the industry.

Solid dosage forms of tablets and capsules still represent 70% of the market

with particle size reduction (60%) and tableting and compression (20%) seen as

the most difficult to control operations. One solution to this problem could be

an increased use of cross-functional teams, with 21% actively hiring and 35%

planning to hire more material scientists.

"Material science is a good addition to the diverse range of expertise required

for good QbD" notes Carlin. Already we are seeing PAT and QbD are being used

more in formulation projects with 35% saying they are using both and a further

36% planning to use them in the near future.  

Yet despite these encouraging signs Ciurczak is critical of the industries

hesitance "so 65% of the respondents are waiting to see if QbD really works…

when the concepts have already been proven to work in every other industry in

the world, from cake mixers to cars". However, Carlin has a more optimistic

outlook, especially since the FDAs Office of Generic Drugs is encouraging the

adoption of QbD. "The ANDA checklist in being updated to include elements of

QbD and as such ANDAs will not be accepted for filing without these elements".

The report concludes that overall the pharmaceutical API and ingredients market

is becoming more global and competitive and as regulations change the overall

business environment and drug manufacturers will have to adopt. "Companies in

the EU and the US have to work with their suppliers to emphasize the value of

quality. Quality can no longer be taken for granted and a signed paper is no

guarantee" added Malhotra.

As to the source of most APIs and ingredients unsurprisingly over 45% answered

India followed by 25% for China and 19% for Europe as the top supplier. More

interestingly however, 62% of respondents said they have focused their solid

dose efforts onto extended release and orally disintegrating forms.  

Chris Kilbee - Group Director, CPhI & Pharma - commenting on the success of

CPhI's first monthly insight report: "This report has highlighted some really

striking findings that both suppliers and pharma need to take account of,

particularly in relation to quality and inspections, as it is impossible in a

globalised environment to inspect every pharmaceutical ingredients plant on the

planet- so independent certification is a must. Beyond this, it is clear that

in terms of formulation for NCEs bioavailability and stability remain difficult

to achieve with the proliferation of more complex drug compounds. And in fact,

it is likely that as certification improves, pharma will increasingly look to

outsource the development process and it is from this increased competition

that solutions to formulation issues will be found. In the future, this will

enable drug targets that were previously unworkable and reformulations of

existing compounds to make it through the development cycle and on to

commercial supply".

For a copy of the full report please visit:

http://www.pharmaevolution.com/lg_redirect.asp?piddl_lgid_docid=560465&piddl_lg_pcode=featuredrightcolumn

Where the Global Pharma Community Meets

CPhI drives growth and innovation at every step of the global pharmaceutical

supply chain from drug discovery to finished dosage. Through exhibitions,

conferences and online communities, CPhI brings together more than 100,000

pharmaceutical professionals each year to network, identify business

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and analysis at PharmaEvolution.com. For more information visit:

http://www.cphi.com

About CPhI Pharma Evolution

CPhI Pharma Evolution (http://www.pharmaevolution.com) launched in February

2013 as a global online community where professionals from across the

pharmaceutical manufacturing sector can talk with their peers and share

best-practices and regulatory updates across the pharmaceutical ingredient and

contract manufacturing space. Pharma Evolution is the new go-to community for

industry professionals to exchange thoughts and network on key areas including:

formulation, APIs, excipients, drug delivery, R&D, manufacturing and quality,

packaging and anti-counterfeiting, regulatory compliance, and outsourcing and

supply chain management. Pharma Evolution was created as an extension of CPhI's

global events business as a forum and resource for pharmaceutical executives to

employ 365 days a year. Pharma Evolution is published by CPhI and UBM DeusM

(http://www.deusm.com), the marketing services division of UBM specializing in

building and operating highly engaged communities of qualified users within

specialist B2B markets, using a strategy of best-practices focused on content

and technology.

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Source: UBM Live