Evaluation of the Overall Effectiveness of Selected Current Tamper Resistant Packages
Author: Lisa A. Hewartson
Publisher:
Published: 1989
Total Pages: 350
ISBN-13:
DOWNLOAD EBOOKRead and Download eBook Full
Author: Lisa A. Hewartson
Publisher:
Published: 1989
Total Pages: 350
ISBN-13:
DOWNLOAD EBOOKAuthor: Frank A. Paine
Publisher: Springer Science & Business Media
Published: 2012-12-06
Total Pages: 221
ISBN-13: 1461521254
DOWNLOAD EBOOKAs was the case with Charles Ross's Packaging of Pharmaceuticals published by the UK Institute of Packaging in 1975 it is assumed that the reader of this book already has a broad understanding of the basics of packaging. If not the Packaging Users Handbook and the Handbook of Food Packaging are recommended. The packaging needs of pharmaceuticals are different in degree only from those of other perishable products such as processed foods. Because the required action of a medication can be nullified by any deterioration in its active principles the protection required from its packaging is at least an order of magnitude greater than that needed by foods for example. Functional efficiency is therefore of prime importance. Conversely the need for the packaging to 'sell' the medication is much less, hence the graphics required need only provide the right 'image' for the product when presented for use in hospital or surgery. Even when on sale at the pharmacy the 'appeal' required is that of providing hygiene and confidence more than anything else. Thus, the textual requirements are paramount including traceability (batch numbers, date-coding etc) in case of recall; while striking appearance to attract customer attention is in lower key. And with the increase in malicious tampering nowadays recall is more frequent.
Author: Julia Corinna Breisinger
Publisher:
Published: 2010
Total Pages: 280
ISBN-13:
DOWNLOAD EBOOKAuthor: Ronald A. Iwaszkiewicz
Publisher:
Published: 1991
Total Pages: 516
ISBN-13:
DOWNLOAD EBOOKAuthor: United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health and the Environment
Publisher:
Published: 1983
Total Pages: 1212
ISBN-13:
DOWNLOAD EBOOKAuthor: United States. Congress. Senate. Committee on Banking, Housing, and Urban Affairs
Publisher:
Published: 2004
Total Pages: 1132
ISBN-13:
DOWNLOAD EBOOKAuthor: José Rodríguez-Pérez
Publisher: Quality Press
Published: 2014-08-15
Total Pages: 246
ISBN-13: 0873898699
DOWNLOAD EBOOKThis guidance book is meant as a resource to manufacturers of pharmaceuticals, providing up-to-date information concerning required and recommended quality system practices. It should be used as a companion to the regulations/standards themselves and texts on the specific processes and activities contained within the QMS. This book includes chapters on US current Good Manufacturing Practice (GMP); international GMP; global GMP guides and harmonization; detailed analysis of the requirements and guidances; missing subparts; what inspectors are looking for; and the price of noncompliance. It also includes an appendix with two tabulated comparisons: the first compares US, European-PIC/S, Canadian, and WHO cGMPs, while the second compares US cGMPs with effective quality system elements. The companion CD contains cGMP regulations for sterile products produced by aseptic processing; it also includes updated data of statistical enforcement by the FDA, both domestically and abroad; a detailed glossary; and dozens of FDA guidance documents as well as international regulations (EU and Canada) and harmonization documents (WHO, PIC/S, and ICH). A very comprehensive checklist for a cGMP audit that is based on risk management criteria is also included. Finally, a comprehensive GMP exam is also included.
Author: D. A. Dean
Publisher: CRC Press
Published: 2005-07-12
Total Pages: 459
ISBN-13: 0203301811
DOWNLOAD EBOOKPharmaceutical packaging requires a greater knowledge of materials and a greater intensity of testing than most other packed products, not to mention a sound knowledge of pharmaceutical products and an understanding of regulatory requirements. Structured to meet the needs of the global market, this volume provides an assessment of a wide range of issues. It covers the entire supply chain from conversion of raw materials into packaging materials and then assembled into product packs. Integrating information from many drug delivery systems, the author discusses testing and evaluation and emphasizes traceability and the need to for additional safeguards.
Author: National Library of Medicine (U.S.)
Publisher:
Published:
Total Pages: 1964
ISBN-13:
DOWNLOAD EBOOKFirst multi-year cumulation covers six years: 1965-70.