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  • 1
    Article
    Article
    2013
    ISSN: 1753-7967 
    Language: English
    In: Pharmaceutical technology Europe, 2013-12-01, Vol.25 (12), p.32
    Description: Akers (Akers Kennedy and Associates): QbD is not really a new requirement in my experience. I believe in sterile manufacturing, we've done QbD before it was formally termed QbD. I believe much of what we now do as QbD was once part of our design qualification activities. The design parameters for sterile production facilities in terms of cleanrooms and sanitary designs have been well defined for years.
    Subject(s): Officials and employees ; Baseman, Hal ; Akers, James E ; Pharmaceutical industry ; Weikmann, Wolfgang ; Analytical chemistry ; Drugs ; Product quality ; Process controls ; Sterilization
    ISSN: 1753-7967
    Source: Business Source Ultimate
    Source: Alma/SFX Local Collection
    Source: © ProQuest LLC All rights reserved〈img src="https://exlibris-pub.s3.amazonaws.com/PQ_Logo.jpg" style="vertical-align:middle;margin-left:7px"〉
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  • 2
    Article
    Article
    2019
    ISSN: 1753-7967 
    Language: English
    In: Pharmaceutical technology Europe, 2019-11-01, Vol.31 (11), p.43-44
    Description: In the spirit of International Council for Harmonization (ICH) Q8(R2) Pharmaceutical Development (1): the results of a thorough evaluation of the quality target product profile (QTPP) of the product and the associated critical quality attributes (CQAs) define the scope of the transfer. Zimmermann (Vetter): The inception of any process transfer is the process qualification campaign, which is based on [the US Food and Drug Administration's] FDA's approach of first (process design), second (process qualification), and third (continuous process verification). Zimmermann (Vetter): It is the nature of the business that to a certain extent, the introduction of new products and processes will interrupt running operations. [...]the goal is to always keep interruptions to a minimum.
    Subject(s): Technology transfer ; Quality ; Manufacturing ; Pharmaceuticals
    ISSN: 1753-7967
    Source: Business Source Ultimate
    Source: Alma/SFX Local Collection
    Source: © ProQuest LLC All rights reserved〈img src="https://exlibris-pub.s3.amazonaws.com/PQ_Logo.jpg" style="vertical-align:middle;margin-left:7px"〉
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  • 3
    Article
    Article
    2019
    ISSN: 1753-7967 
    Language: English
    In: Pharmaceutical technology Europe, 2019-11-01, Vol.31 (11), p.12-15
    Description: Pharmaceutical companies are responsible for ensuring the standards of all drug components, Including excipients, APIs, and packaging materials, says Susan J. Schniepp, executive vice-president of post-approval pharma and distinguished fellow at Regulatory Compliance Associates, and It is the QC unit's responsibility to Investigate why any of these components fails to meet those standards. According to Ginsbury, the message in the GMP regulations is unclear and possibly misleading. According to Oates, the QC unit includes both quality assurance and quality control functions and should be involved in the approval of the drug product, testing results, production records, procedures, and all materials that might affect the final drug product whether that product is produced in house or "manufactured, processed, packed, or held under contract by another company," says Oates. Europe Directive 2001/83/EC (9) states, "Member States shall take all appropriate measures to ensure that the qualified person referred to in Article 48, without prejudice to his relationship with the holder of the manufacturing authorization, is responsible, in the context of the procedures referred to in Article 52, for securing: (a) in the case of medicinal products manufactured within the Member States concerned, that each batch of medicinal products has been manufactured and checked in compliance with the laws in force in that Member State and in accordance with the requirements of the marketing authorization..."
    Subject(s): Executives ; Compliance ; Good Manufacturing Practice ; Quality control ; Federal regulation ; Manufacturing ; FDA approval ; Pharmaceutical industry ; Standards ; Failure ; CFR ; Defects
    ISSN: 1753-7967
    Source: Business Source Ultimate
    Source: Alma/SFX Local Collection
    Source: © ProQuest LLC All rights reserved〈img src="https://exlibris-pub.s3.amazonaws.com/PQ_Logo.jpg" style="vertical-align:middle;margin-left:7px"〉
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  • 4
    Article
    Article
    2019
    ISSN: 1753-7967 
    Language: English
    In: Pharmaceutical technology Europe, 2019-10-01, Vol.31 (10), p.58-60
    Description: Pharmaceutical Technology Europe spoke with Bhroma Patel, head of product stability, and Baldev Jogi, lead scientist, both at Lonza; and Will Hatcher, senior manager, QC, and Rekha Patel, director, biologics analytical solutions, both at Catalent, about what steps companies need to take when setting up a current good manufacturing practice (CGMP)-compliant stability testing programme for biologics. A stability programme should be described in the protocol to support the shelf life and storage condition and include: * Objective/scope of the study (e.g., the stability study results may form part of submissions to the regulatory authorities to support the use of the product in toxicological studies and clinical trials). * Storage conditions (e.g., intended, accelerated, and stress storage conditions) * Sampling plan (e.g., samples to be tested at 0, 3, 6, 9, 12, 18, 24, and 36 months) * Stability indicating parameters for testing of product characteristics, identity, potency, purity, and safety, which have been developed and validated * Stability test methods (e.g., capillary electrophorsis sodium dodecyl sulfate [CE SDS], image capillary isoelectric focusing [icIEF], gel permeation chromatography [GPC], ELISA), which have been qualified for usage * Acceptance criteria (e.g., limits for the test results) * Reference standard to compare the sample against * Approval process (e.g., approved by quality assurance [QA]) * Stability chambers are serviced, inspected, calibrated, and qualified regularly * Out-of-specification and out-of-trend SOPs QA regulated * Evaluation of the acquired data to provide a shelf life * Trained operators, which includes GMP training and data integrity training annual. [...]a strong track record of quality compliance and experience working with regulatory bodies in different jurisdictions is also paramount. [...]the site's regulatory history should be reviewed to confirm that the site has received approval from all relevant regulatory agencies.
    Subject(s): Studies ; Biological products ; Compliance ; Laboratories ; Good Manufacturing Practice ; Clinical trials ; FDA approval ; Outsourcing ; Cost control
    ISSN: 1753-7967
    Source: Business Source Ultimate
    Source: Alma/SFX Local Collection
    Source: © ProQuest LLC All rights reserved〈img src="https://exlibris-pub.s3.amazonaws.com/PQ_Logo.jpg" style="vertical-align:middle;margin-left:7px"〉
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  • 5
    Language: English
    In: Pharmaceutical technology Europe, 2019-10-01, Vol.31 (10), p.58
    Subject(s): Government regulation of business ; Best practices
    ISSN: 1753-7967
    Source: Business Source Ultimate
    Source: Alma/SFX Local Collection
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  • 6
    Article
    Article
    2019
    ISSN: 1753-7967 
    Language: English
    In: Pharmaceutical technology Europe, 2019-09-01, Vol.31 (9), p.48-49
    Description: According to SBL, the ATF perfusion system allows for a 10-fold improvement in cell culture densities while retaining cell viabilities of over 98% at the seed stage. SSB offers its cell bank manufacturing in a package along with cell bank characterization services, making the company a single-source provider from vial thaw to released cell banks. With the acquisition, the company can now provide holistic solutions to customers, including regulatory coverage for its products-lSO 13485, ISO 9001, CLIA, CAP, good laboratory practice, and FDA compliance- for the manufacturing of cGMP oligonucleotides used in analytespecific reagent and in-vitro diagnostic products for the clinical industry.
    Subject(s): Bank acquisitions & mergers ; Biological products ; Laboratories ; Good Manufacturing Practice ; ISO standards ; Genomics ; Quality control ; Manufacturing
    ISSN: 1753-7967
    Source: Business Source Ultimate
    Source: Alma/SFX Local Collection
    Source: © ProQuest LLC All rights reserved〈img src="https://exlibris-pub.s3.amazonaws.com/PQ_Logo.jpg" style="vertical-align:middle;margin-left:7px"〉
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  • 7
    Language: English
    In: Pharmaceutical technology Europe, 2019-09-01, Vol.31 (9), p.48
    Subject(s): Contract manufacturing ; International marketing ; Outsourcing
    ISSN: 1753-7967
    Source: Business Source Ultimate
    Source: Alma/SFX Local Collection
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  • 8
    Article
    Article
    2019
    ISSN: 1753-7967 
    Language: English
    In: Pharmaceutical technology Europe, 2019-07-01, Vol.31 (7), p.8-9
    Description: The US Food and Drug Administration (FDA) expects the agency will receive more than 200 investigational new drug applications for cell and gene therapies by 2020, with the agency predicting that it will be approving 10-20 cell- and gene-therapy products each year by 2025 (1). Because gene therapies use the patient's own body to manufacture the active ingredient, the treatment is specific to that patient. According to Clark, outsourcing the manufacture of gene therapies requires relatively low volumes to fulfil demand, making it an attractive option. According to Clark, the company has multiple initiatives in the works to shorten timelines and increase efficiency (5).
    Subject(s): Leadership ; Customers ; Gottlieb, Scott ; Clinical trials ; Manufacturing ; Outsourcing ; FDA approval ; Gene therapy ; Vectors (Biology)
    ISSN: 1753-7967
    Source: Business Source Ultimate
    Source: Alma/SFX Local Collection
    Source: © ProQuest LLC All rights reserved〈img src="https://exlibris-pub.s3.amazonaws.com/PQ_Logo.jpg" style="vertical-align:middle;margin-left:7px"〉
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  • 9
    Language: English
    In: Pharmaceutical technology Europe, 2019-07-01, Vol.31 (7), p.8
    Subject(s): Scientific equipment and supplies industry ; Outsourcing ; Gene therapy ; Investments ; Statistics ; Genes
    ISSN: 1753-7967
    Source: Business Source Ultimate
    Source: Alma/SFX Local Collection
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  • 10
    Article
    Article
    2019
    ISSN: 1753-7967 
    Language: English
    In: Pharmaceutical technology Europe, 2019-04-01, Vol.31 (4), p.41-41
    Subject(s): Technology transfer ; Product development ; Market positioning
    ISSN: 1753-7967
    Source: Business Source Ultimate
    Source: Alma/SFX Local Collection
    Source: © ProQuest LLC All rights reserved〈img src="https://exlibris-pub.s3.amazonaws.com/PQ_Logo.jpg" style="vertical-align:middle;margin-left:7px"〉
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