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| home > white papers > Convergence in the Pharmaceutical Market - PCI Pharma Services |
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 WHITE PAPERS |
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PCI Pharma Services
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Convergence in the Pharmaceutical Market
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Convergence is currently playing a large part in the growth of the pharmaceutical market. The need for convergence is due to many factors including the declining economy and high competition within the sector. There are many convergences within this sector to date; these include the convergence of food based products with medical and health products and the convergence of prescription drugs to over the counter (OTC) products. Although convergence is helping the pharmaceutical industry expand and develop, it also poses some challenges; these include the regulatory outlook and counterfeiting.
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News and Press Releases |
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Merck Announces Collaboration with Agilent Technologies to Fill Industry Gap in Process Analytical Technologies for Downstream Processing
Darmstadt, Germany, June 14, 2022: Merck, a leading science and
technology company, today announced that it has entered a collaboration
with Agilent Technologies to advance Process Analytical Technologies
(PAT). PAT, which is strongly encouraged by global regulatory
authorities, is a key enabler for real-time release and Bioprocessing
4.0.
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White Papers |
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Extractables and Leachables Testing: A Risk Based Approach
RSSL
Pharmaceutical products are in contact with many external components during both manufacture and usage and small amounts of chemicals may leach from these components with a potential health risk to the patient. Extractables and leachables (E&L) studies therefore play an important role in verifying the safety of a drug product over its lifetime.
Regulatory organisations such as the US Food and Drug Administration (FDA) and the European Medicines Agency (EMEA) are taking an increased interest in the interactions of various drug delivery devices, pharmaceutical product containers and medical devices with drug product and/or patient and this field is therefore growing in importance.
Regulatory guidelines indicate that an extractables profile should be determined for all materials that contact the drug product. Once established, this profile can be used to determine whether any of these extractables are present as leachables within the product. If a leachable is detected, amounts can be determined using validated analytical methods, after which a biological risk can be established based on the exposure.
This white paper will provide an overview of the processes used to determine extractables and leachables from plastics.
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