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    Academic Journals

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• Overcoming manufacturing and scale-up challenges

  Author:David J WilliamsFrom:Regenerative Medicine (Vol. 6, Issue 6s)

  Nov. 20111,673 words Article 1290LAuthor(s): David J Williams 1 Setting the scene July 2011 saw the publication of the results of the UK'âs national 'stock take'â of regenerative medicine [1] . This important report highlights that: "without...

• Make data integrity integral to CGMP training

  Author:Susan SchnieppFrom:Pharmaceutical Technology Europe (Vol. 28, Issue 6) Peer-Reviewed

  June 20161,034 words Article 1480LQ: I saw where the US Food and Drug Administration (FDA) released draft guidance on data integrity. In the guidance, the answer to question 16 says personnel should be trained in detecting data integrity issues as part...

• Building consensus for E&L testing standards: standardized testing protocols are crucial for acceptance of single-use systems

  Author:Rita PetersFrom:Pharmaceutical Technology Europe (Vol. 28, Issue 3) Peer-Reviewed

  Mar. 20161,464 words Article 1650LSingle-use systems (SUS) featuring plastic components and materials are widely used in bio/pharmaceutical development and clinical-trial material manufacturing, and are expected to become more common in commercial...

• Unconventional communication: cautionary tales from the files of "Control," as Senior Compliance officer: laboratory personnel share interesting tales as well as stories of unexpected tails

  From:Pharmaceutical Technology (Vol. 34, Issue 4) Peer-Reviewed

  Apr. 2010627 words Column Superstrained "Many years ago, we exported an over-the-counter liquid product in a plastic bottle to Japan," said our GMP Agent-In-Place. "We had sporadic complaints from our affiliate in Japan regarding bits of...

• A practical and pyrogen-free preparation of [sup]11C-L-methionine in a good manufacturing practice-compliant approach

  Authors:Kang-Po Li, Ming-Kuan Hu, Cheng-Yi Cheng, Li-Fan Hsu, Ta-Kai Chou, Chyng-Yann Shiue, et al.From:Journal of Medical Sciences (Vol. 37, Issue 1) Peer-Reviewed

  January-February 20172,273 words Report 1500LByline: Kang-Po. Li, Ming-Kuan. Hu, Cheng-Yi. Cheng, Li-Fan. Hsu, Ta-Kai. Chou, Chyng-Yann. Shiue, Daniel. Shen Aims: [sup]11C-L-methionine, an amino acid tracer used to delineate certain tumor tissues, has proven to...

• NEW RULES FOR EUROPEAN INVESTIGATIONAL MEDICINES

  Author:Peter O'DonnellFrom:Applied Clinical Trials (Vol. 26, Issue 9) Peer-Reviewed

  September-October 2017448 words Article 1460LGaps in the good manufacturing practice (GMP) controls on medicines for clinical trials are targeted in new rules from the European Union. A new regulation setting out GMP for investigational medicinal products...

• Data integrity challenges in manufacturing: designing systems using the principles of good documentation practice, including validated audit trails, is a key piece of a manufacturing data integrity programme

  Author:Jennifer MarkarianFrom:Pharmaceutical Technology Europe (Vol. 28, Issue 7) Peer-Reviewed

  July 20162,094 words Article 1410LData integrity, which refers to the completeness, consistency, and accuracy of data, is a key part of CGMP compliance for drugs, said United States Food and Drug Administration (FDA) in its April 2016 draft guidance...

• GMP-compatible and xeno-free cultivation of mesenchymal progenitors derived from human-induced pluripotent stem cells.

  Authors:Madison McGrath, Edmund Tam, Martina Sladkova, Athbah AlManaie, Matthew Zimmer, and Giuseppe Maria de PeppoFrom:Stem Cell Research & Therapy (Vol. 10, Issue 1) Peer-Reviewed

  Jan. 11, 20197,003 words Report 1510LBackground Human mesenchymal stem cells are a strong candidate for cell therapies owing to their regenerative potential, paracrine regulatory effects, and immunomodulatory activity. Yet, their scarcity, limited...

• Report from: Europe: Europe moves to place excipient GMP and GDP standards on the same level as active pharmaceutical ingredients

  Author:Sean MilmoFrom:Pharmaceutical Technology (Vol. 34, Issue 6) Peer-Reviewed

  June 2010729 words Article European Union leaders seem to have agreed to boost efforts across Europe to establish a strong excipient-certification system. As part of a directive on combating counterfeit medicines that is scheduled to be approved...

• Improved GMP compliant approach to manipulate lipoaspirates, to cryopreserve stromal vascular fraction, and to expand adipose stem cells in xeno-free media

  Authors:Francesco Agostini, Francesca Maria Rossi, Donatella Aldinucci, Monica Battiston, Elisabetta Lombardi, Stefania Zanolin, et al.From:Stem Cell Research & Therapy (Vol. 9, Issue 1) Peer-Reviewed

  May 11, 20189,979 words Report 1470LBackground The stromal vascular fraction (SVF) derived from adipose tissue contains adipose-derived stromal/stem cells (ASC) and can be used for regenerative applications. Thus, a validated protocol for SVF...

• Zone in on: regulation: FDA and EMA seek candidates for GMP pilot

  Author:Angie DrakulichFrom:Pharmaceutical Technology (Vol. 34, Issue 9) Peer-Reviewed

  Sept. 2010224 words Brief article 1460LThe US Food and Drug Administration and European Medicines Agency (EMA) are looking for drug-manufacturing companies to participate in their joint good manufacturing practice (GMP) inspection pilot program. A new EMA...

• Selecting the right cleanroom solutions

  Author:Mark DalzielFrom:Pharmaceutical Technology Europe (Vol. 22, Issue 12) Peer-Reviewed

  Dec. 2010564 words Article 1430LContamination in all its forms should be identified and reduced whenever and wherever possible. The best managed cleanrooms/critical environments start at the entrance to the building and implement a holistic...

• Everybody's got problem: too much or too little control can actually lead to the same result

  From:Pharmaceutical Technology (Vol. 34, Issue 6) Peer-Reviewed

  June 2010747 words Article In search of nightgowns "We were undergoing our biennial GMP inspection and the FDA inspector wanted to observe second-shift aseptic-filling operations," recalled our GMP Agent-In-Place. "I arranged access for the...

• Grouping Products and Equipment for a Worst-Case Cleaning Validation Study:Cleaning validation requires a significant effort to design a strategic and effective program that is defendable with regulatory agencies. Of primary concern is what to validate. A robust selection of which product(s) and equipment to validate for cleaning is the cornerstone of a successful cleaning validation program. A strategy for selection of products and equipment for cleaning validation is presented.

  Author:Richard J. ForsythFrom:Pharmaceutical Technology (Vol. 45, Issue 8) Peer-Reviewed

  Aug. 20214,016 words Article 1290LA robust cleaning validation program is a crucial component in a good manufacturing practice (GMP)-compliant manufacturing facility. The quality systems supporting a GMP manufacturing facility are mutually dependent, and...

• GMPs Guide COVID-19 Vaccine Manufacturing: Recent industry guidance aims to anchor rapid COVID-19 vaccine development in good manufacturing practice protocols.

  Author:Feliza MirasolFrom:Pharmaceutical Technology (Vol. 44, Issue 11) Peer-Reviewed

  Nov. 20201,304 words Article 1750LMajor bio/pharmaceutical companies and contract service providers leading the charge to bring COVID-19 vaccines to market are familiar with established good manufacturing practices (GMPs). To support manufacturers in the...

• Implementing quality risk management: representatives to PIC/S provide an example of methodology for implementing ICH Q9

  Authors:Lionel Viornery and Philippe LegoffFrom:Pharmaceutical Technology (Vol. 33, Issue 12) Peer-Reviewed

  Dec. 2009799 words Article 1440LThe International Conference on Harmonization guideline on quality risk management, ICH Q9, addresses active substances and medicinal products, and was adopted by the European Union and Pharmaceutical Inspection...

• Process analytical technology and process control in solid-dosage manufacturing: industry is moving toward closed-loop control of continuous processing

  Author:Jennifer MarkarianFrom:Pharmaceutical Technology Europe (Vol. 25, Issue 4) Peer-Reviewed

  Apr. 20132,419 words Article 1510LSince the US Food and Drug Administration (FDA) issued its report, Pharmaceutical Current Good Manufacturing Practices (CGMPs) for the 21st Century--A Risk-Based Approach (1) and its guidance on process analytical...

• Collaboration on GMP Inspections Has Been Successful but Challenges Exist: EMA, the leading driver behind GMP inspection collaboration schemes, will be cutting back its involvement because of the need to concentrate on its relocation to Amsterdam

  Author:Sean MilmoFrom:Pharmaceutical Technology Europe (Vol. 30, Issue 7) Peer-Reviewed

  July 20181,617 words Report 1500LThe drive by the European Union, the United States, and other leading developed regions and countries to harmonize standards of good manufacturing practice (GMP) inspections to avoid duplications and gain other...

• Getting, and staying, ahead of global quality demands: more life-sciences companies are starting to manage global suppliers holistically

  Author:Mike JovanisFrom:Pharmaceutical Technology (Vol. 41, Issue 2) Peer-Reviewed

  Feb. 20171,831 words Report 1490LAs life-sciences companies expand the number of providers they work with around the world, it has become more difficult to maintain a high level of supply-chain integrity and supplier quality. Properly inspecting and...

• A risk approach to stainless steel equipment maintenance: laboratory tests can determine critical cleaning parameters for passivation treatments used to prevent rouge on GMP stainless-steel equipment

  Authors:Elizabeth Rivera, Paul Lopolito, and Dijana HadziselimovicFrom:Pharmaceutical Technology (Vol. 41, Issue 2) Peer-Reviewed

  Feb. 20172,862 words Report 1510LStainless steel is usually the preferred substrate for good manufacturing practice (GMP) applications, and it constitutes the majority of GMP product-contact surface areas. The austenitic stainless-steel series (e.g.,...