Validating cleaning procedures in biopharmaceutical manufacturing facilities

The lack of new molecules and the challenges in registering new products, due to increasingly stringent requirements from preclinical and clinical through to registration phases, are driving many pharmaceutical companies to revamp old products in their portfolio.The Food and Drug Administration (FDA) is issuing a final rule amending the regulations on premarket approval of medical devices to include requirements relating to the submission of information on pediatric subpopulations that suffer from the disease or condition that a device is intended to treat, diagnose, or cure.: Sergey 07 2016 Chinese Heparin Manufacturer again involved in Falsification and GMP Non-Compliance : Sergey 07 2016 16: : Sergey 10 2016 2015 MA 93 : News 04 2016 FDA 2015 : News 04 2016 2015 : Sergey 04 2016 : News 04 2016 SHAYNE COX GAD, PH. Arnold, The University of Georgia, Athens, Georgia, Biotechnology - Derived Drug Product Development C. ( 1994 ), Chitosan as a novel nasal delivery system for peptide drugs , Pharm. 5.11.7.10 Daytrana Daytrana is a newly approved methylphenidate transdermal system. The epithelial layer of the vaginal mucosa presents itself as the main permeability barrier for drug absorption. Control and exploitation of these effects can lead to new and useful changes to the thermal, magnetic, electrical, optical and mechanical, and biological and physicochemical properties of materials. Alany, The University of Auckland, Auckland, New Zealand, Ocular Drug Delivery; Microemulsions as Drug Delivery Systems Monique Alric, Universit e d Auvergne, Clermont - Ferrand, France, Recombinant Saccharomyces Cerevisiae as New Drug Delivery System to Gut: In Vitro Validation and Oral Formulation Sacide Alsoy Altinkaya, Izmir Institute of Technology, Urla - Izmir, Turkey, Controlled Release of Drugs from Tablet Coatings Maria Helena Amaral, University of Porto, Porto, Portugal, Vaginal Drug Delivery Anil Kumar Anal, Living Cell Technologies (Global) Limited, Auckland, New Zealand, Controlled - Release Dosage Forms Gavin Andrews, Queen s University Belfast, Belfast, Northern Ireland, Effects of Grinding in Pharmaceutical Tablet Production Sophia G. Emsam is a matrix - type patch that has three layers and is available in three size. In general, systemic drug absorption requires three steps: drug release from the delivery system, drug dissolution in the vaginal fl uid, and permeation of the vaginal mucosa. Properties that can be exploited to provide novel and unique properties to materials include surface and quantum effects, for example, van der Waals forces; electrostatic interaction; ionic, covalent and hydrogen bonding; and quantum confi nement. Gad Consulting Services Cary, North Carolina CONTRIBUTORS Susanna Abrahms e n - Alami, Astra Zeneca R & D Lund, Lund, Sweden, Oral Extended - Release Formulations James Agalloco, Agalloco & Associates, Belle Mead, New Jersey, Sterile Product Manufacturing Fakhrul Ahsan, Texas Tech University, Amarillo, Texas, Nasal Delivery of Peptide and Nonpeptide Drugs James Akers, Akers Kennedy & Associates, Kansas City, Missouri, Sterile Product Manufacturing Raid G. Selegiline is an irreversible monoamine oxidase inhibitor and has a molecular weight of 187.30. - estradiol (Figure 3 ), arecoline, arecaidine, and vasopressin, than colonic or small intestinal mucosa, or at least as permeable as when compared to human buccal mucosa [46, 47] . ( 2002 ), Macrophages and HIV infection: Therapeutical approaches toward this strategic virus reservoir , Antivir. Ability to control or manipulate at the atomic scale Nanotechnology is therefore essentially about understanding and manipulating materials at the atomic, molecular, and macromolecular level in a way that imparts properties to the material that would otherwise not exist either as individual atoms or as bulk processed macroscopic systems. Scott Asbill, Samford University, Birmingham, Alabama, Transdermal Drug Delivery Maria Fernanda Bahia, University of Porto, Porto, Portugal, Vaginal Drug Delivery Bernard Bataille, University of Montpelier 1, Montpellier, France, Tablet Design Gerald W. It is a 9 - h adhesive matrix patch and comes in four sizes: a 12.5 - cm 2 patch that has a delivery rate of 1.1 mg/h, an 18.75 - cm 2 patch that has a delivery rate of 1.6 mg/h, a 25 - cm 2 patch that delivers 2.2 mg/h, and a 37.5 - cm 2 patch that delivers 3.3 mg/h. As the epithelium is hormonally dependent, its permeability also changes, usually decreasing with higher estrogen levels because of the induced membrane thickening. 7.3.1.1 Top - Down and Bottom - Up Approaches to Nanotechnology There are generally two approaches to nanotechnology, the top - down and bottom - up approaches.

Experienced Instructors: Subject matter experts and top leaders in the pharmaceutical industry who have years of experience in their field of study.This article provides a brief description of a stepwise approach for the manufacturing process transfer of a legacy product, using a combination of techniques (e.g., risk analysis tools and a logical approach) wherever possible.Regulatory framework of legacy product Legacy products are believed to be experiencing some kind of “new life” in the pharmaceutical market.A mix of feature articles and current new stories that are critical to staying up-to-date on the industry, delivered to your inbox.Choose from an assortment of different topics and frequencies. Harmonization of USP with ICH Q3D Guideline for Elemental Impurities The United States Pharmacopeia (USP) has published in the Pharmacopeial Forum, (PF 42(2) [Mar.-Apr.2016]) a proposed revision to the USP General Chapter , Elemental Impurities – Limits.In the latter case, historical knowledge is often not transferable for various reasons—for example, know-how is worker-related; there is no or little documentation on pharmaceutical development; and the process has been built-up with reference to old equipment, techniques, and materials, without taking into account the behaviour of the product itself.Such a situation forces the acquiring company and the receiving manufacturing site to use various approaches to perform manufacturing transfer in the shortest possible time and in the most accurate way.Chakravarthi, University of Nebraska Medical Center, College of Pharmacy, Omaha, Nebraska, Biodegradable Nanoparticles D. Chowdhury, University of Oxford, Oxford, United Kingdom, Pharmaceutical Nanosystems: Manufacture, Characterization, and Safety Barbara R. ( 2003 ), Nasal drug delivery Possibilities, problems and solutions , J. These permeation enhancers are compounds which partition into the stratum corneum and promote the passage of topically applied compounds across the skin layers by using three possible mechanisms of action (Table 5 ). ( 2005 ), Nicotine exposure and decontamination on tobacco harvesters hands , Ann. Also, receptor - mediated transport mechanisms can be involved in the absorption of some substances. 7.3.2 TAXONOMY OF NANOMEDICINE TECHNOLOGIES A useful starting point would be to gauge the breadth of technologies falling under the classifi cation of nanomedicine. Novel composite core - shell nanoparticles as busulfan carriers , J. The United States Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have issued guidelines on process validation (1, 2).

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