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Good Quality Practice (GQP) in Pharmaceutical Manufacturing: A Handbook

Pharmaceutical manufacturing can be viewed as a supply chain which spans from the production and purchase of the starting and packaging materials through the manufacture of dosage forms until the safe reception of the finished product by the patient. The entire chain comprises of several processes: auditing, materials purchase (procurement), production, storage, distribution, quality control, and quality assurance. The quality standard for pharmaceutical production is ‘current good manufacturing practice (CGMP)’‘, which is applied within the frame of a pharmaceutical quality system (PQS). This implementation, however, requires a scientific approach and has to take into account several elements such as risk assessment, life cycle, patient protection, among other factors. Hence, pharmaceutical manufacturing is a complex subject in terms of regulation, given the technical and managerial requirements. This comprehensive handbook describes CGMP for new professionals who want to understand and apply the elements which build up pharmaceutical quality assurance. The book gives details about basic quality control requirements (such as risk management, quality hazards and management systems, documentation, clean environments, personnel training) and gives guidelines on regulatory aspects. This is an ideal handbook for undergraduates studying pharmaceutical or industrial manufacturing and supply chains as well for entrepreneurs and quality control professionals seeking to learn about CGMP standards and implementing quality assurance systems in the pharmaceutical sector. Close

WHO Good manufacturing practices for pharmaceutical products: main principles
. In: WHO Expert Committee on Specifications for Pharmaceutical Preparations.
Forty-eighth report (WHO Technical Report Series, No. 986). WHO, Geneva ...

Good Pharmaceutical Manufacturing Practice

Rationale and Compliance

With over twenty different official regulatory statements worldwide on Good Manufacturing Practice (GMP) for pharmaceutical, drug, or medicinal products, two stand out as being the most influential and most frequently referenced. Bridging the gap between U.S. regulations and European Good Manufacturing Practice guidelines, Good Pharmaceutical Manufacturing Practice: Rationale and Compliance gleans the most important substance from the U.S. Current Good Manufacturing Practice, parts 210 and 211 (US cGMPs, 2002) and the European Guide to Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use (EU GMP guide, 2002). The author uses his 40+ years of experience in technical management, production, quality assurance, and distribution within the pharmaceutical industry, offering a hands-on guide to better understand and implement optimal pharmaceutical practices. This book also compares the principle requirements of GMP, and explores the reasoning behind these requirements and ways to comply with them. Relevant topics include personnel, documentation, premises and equipment, production, quality control, self-inspection, recalls, and more. This is an essential guidebook for those who wish to expand their pharmaceutical business in any international capacity.

This is an essential guidebook for those who wish to expand their pharmaceutical business in any international capacity.

Dietary Supplement Good Manufacturing Practices

Preparing for Compliance

Dietary Supplement GMP is a one-stop "how-to" road map to the final dietary supplement GMP regulations recently issued by the FDA covering the manufacture, packaging, and holding of dietary supplement products. The recent regulations, outlining broad goals, intentionally avoid specifics to allow for future technological advances—leaving implementation to the discretion of each firm. Given this latitude and flexibility, this new resource is an essential source of workable and practical suggestions on ways the industry can best meet the goals. Based on broad experience with GMP compliance techniques worked out over the years in the food, drug, and medical device industries, it is a must-have guide for all DS companies, especially the many smaller firms for whom this is new territory. Dietary Supplement GMP provides: a practical guide in easy to understand language to help navigate through the requirements for systems covering process and quality control suggestions and practical recommendations on "how-to" achieve full compliance explanation of the FDA’s role regarding inspection, enforcement, recall/seizure of products and prosecution Dietary Supplement Good Manufacturing Practices (GMP) covers: Personnel Plants and Grounds Equipment and Utensils Sanitation of Buildings and Equipment Quality Assurance and Laboratory Operations The Quality Control Unit Production and Process Controls

PART 111—CURRENT GOOD MANUFACTURING PRACTICE IN
MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR
DIETARY SUPPLEMENTS Subpart A—General Provisions § 111.1 Who is
subject to this part ...

Good manufacturing practices for pharmaceuticals

a plan for total quality control

Good Manufacturing Practices for Pharmaceuticals

A Plan for Total Quality Control from Manufacturer to Consumer: Fifth Edition,

Highlighting key issues and differences among GMPs of Europe, Canada, and the WHO, this reference examines US law and governmental policy affecting domestic and multinational pharmaceutical manufacturing. The book recommend pragmatic ways to interpret and comply with FDA CGMP regulation and related criteria. They focus on geographical redistribution of manufacturing facilities, accommodation of a diversity of regulatory and statutory governance, adaptation to disparate human resources, and new growth areas of manufacture and distribution of homeopathic remedies and dietary supplements, in addition to the greater quality control required of pharmacists and other authorized dispensers.

The book recommend pragmatic ways to interpret and comply with FDA CGMP regulation and related criteria.

Good Manufacturing Practices for Pharmaceuticals, Sixth Edition

With global harmonization of regulatory requirements and quality standards and national and global business consolidations ongoing at a fast pace, pharmaceutical manufacturers, suppliers, contractors, and distributors are impacted by continual change. Offering a wide assortment of policy and guidance document references and interpretations, this Sixth Edition is significantly expanded to reflect the increase of information and changing practices in CGMP regulation and pharmaceutical manufacturing and control practices worldwide. An essential companion for every pharmaceutical professional, this guide is updated and expanded by a team of industry experts, each member with extensive experience in industry or academic settings.

An essential companion for every pharmaceutical professional, this guide is updated and expanded by a team of industry experts, each member with extensive experience in industry or academic settings.

The Wisdom of the Body

Describes the relation of the autonomic system to the self-regulation of psysiological processes. Bibliogs

Describes the relation of the autonomic system to the self-regulation of psysiological processes. Bibliogs

Metodologi Penelitian Kebidanan

Panduan Penulisan Protokol dan Laporan Hasil Penelitian

Buku Metodologi Penelitian Kebidanan terdiri atas 2 bagian yaitu Bagian I tentang Topik-topik yang Mendasari Penelitian dan Bagian II tentang Panduan Penulisan Protokol dan Laporan Hasil Penelitian. Bagian I berisi 10 bab yaitu Ilmu Pengetahuan dan Metodologi Penelitian, Perkembangan Kebidanan dan Kebutuhan Penelitian, Metode Penelitian Kualitatif dan Kuantitatif Kebidanan, Benang Merah dalam Protokol dan Laporan Hasil Penelitian, Jenis-jenis Desain Penelitian, Populasi dan Sampel, Pengumpulan Data, Pengolahan dan Analisa Data, Penilaian Hasil Penelitian, dan Inferensi Penyebab Masalah. Bagian II berisi panduan penulisan protocol dan laporan hasil penelitian untuk D-3 Kebidanan, Skripsi untuk D-4 Kebidanan atau S-1 Kesmas dengan Peminatan Kebidanan dan Karya Ilmiah Magister untuk S-2 Kesmas Peminatan Kespro atau S-2 Kebidanan.

D. Bab pendahuluan Bab ini terdiri atas seksi-seksi Latar Belakang, Tujuan Penelitian, Langkah-langkah & Desain Penelitian dan Sigifikansi Penelitian. Dalam Latar Belakang, situasi masalah yang ada dalam judul, didefinisikan dan ...