Pharmaceutical Quality by Design Using JMP: Solving Product Development and Manufacturing Problems

 

 

Solve your pharmaceutical product development and manufacturing problems using JMP®. Pharmaceutical Quality by Design Using JMP®: Solving Product Development and Manufacturing Problems provides broad-based techniques available in JMP to visualize data and run statistical analyses for areas common in healthcare product manufacturing. As international regulatory agencies push the concept of Quality by Design (QbD), there is a growing emphasis to optimize the processing of products. This book uses practical examples from the pharmaceutical and medical device industries

ISPE Good Practice Guide: Knowledge Management in the Pharmaceutical Industry

 

 

ICH Q10 outlines three objectives: achieve product realization, establish and maintain a state of control, and facilitate continual improvement. Embracing these objectives can be best achieved using the dual enablers, Knowledge Management (KM) and Quality Risk Management (QRM). The first reference to KM in the field of pharmaceutical quality was in ICH Q8 in 2005 as a tool used with QRM for a more systematic Quality by Design (QbD) approach to development throughout the product lifecycle. Three years later, ICH Q10 identified KM and QRM as the enablers of an effective Pharmaceutical Quality System (PQS).

Handbook of Pharmaceutical Granulation Technology (4th edition)

 

This fully revised edition of Handbook of Pharmaceutical Granulation Technology covers the rapid advances in the science of agglomeration,  process control, process modelling, scale-up, emerging particle engineering technologies, along with current regulatory changes presented by some of the prominent scientist and subject matter experts around the globe. Learn from more than 50 global subject matter experts who share their years of experience in areas ranging from drug delivery and pharmaceutical technology to advances in nanotechnology. Every pharmaceutical scientist should own a copy of this fourth edition resource.

ISPE Good Practice Guide: HVAC & Process Equipment Air Filters

 

The goal of the ISPE Good Practice Guide: HVAC and Process Equipment Air Filters is to to be a valuable reference on the selection, application, specification, testing, operation, and maintenance of filters in the pharmaceutical industry. This Guide is intended to be used as supplement to the ISPE Good Practice Guide: Heating, Ventilation, and Air Conditioning (HVAC), providing detailed

ISPE Baseline Guide Vol 2: Oral Solid Dosage Forms (Third Edition)

 

Technical content within this Baseline Guide covers pharmaceutical facilities for the manufacture of OSD forms, including tablets, capsules, and general powders. It may also be applied to pilot and clinical supply facilities and is intended to supplement Good Engineering Practice (GEP) with suggested approaches to Good Manufacturing Practice (GMP).

TRS 1033 - 55th report of the WHO Expert Committee on Specifications for Pharmaceutical Preparations

 

The Expert Committee on Specifications for Pharmaceutical Preparations works towards clear, independent and practical standards and guidelines for the quality assurance of medicines and provision of global regulatory tools. Standards are developed by the Expert Committee through worldwide consultation and an international consensus-building process. 

Dược điển Mỹ 43 (USP 43 NF38)

The USP–NF is a combination of two compendia, the United States Pharmacopeia (USP) and the National Formulary (NF). It contains standards for medicines, dosage forms, drug substances, excipients, biologics, compounded preparations, medical devices, dietary supplements, and other therapeutics

Drug stability and Chemical kinetics

 

This book comprehensively reviews drug stability and chemical kinetics: how external factors can influence the stability of drugs, and the reaction rates that trigger these effects. Explaining the important theoretical concepts of drug stability and chemical kinetics, and providing numerous examples in the form of illustrations, tables and calculations, the book helps readers gain a better understanding of the rates of reactions, order of

ISPE Good Practice Guide: Critical Utilities GMP Compliance

Because of their hidden nature, critical utility systems are vulnerable to non-compliance. With their potential to impact product quality or performance in a significant way, critical utilities consistently receive close scrutiny by regulatory inspectors. The goal of the ISPE Good Practice Guide: Critical Utilities GMP Compliance – How to Be Compliant and Ready to Prove It is to help pharmaceutical organizations achieve and maintain their critical utility systems in a state of control, and then be able to efficiently demonstrate their systems’ Good Manufacturing Practice (GMP) compliance to regulatory inspectors and auditors.

Handbook of Analytical Quality by Design

 

Phần mềm Design Expert 12

 

ISPE Baseline® Guide: Risk-Based Manufacture of Pharmaceutical Products (first edition - 2011, second edition - 2017)

 

ISPE Baseline® Guide: Risk-Based Manufacture of Pharmaceutical Products (Risk-Mapp) second edition cung cấp phương pháp tiếp cận dựa trên khoa học và quản lý rủi ro, được xây dựng trên nguyên tắc của ICH Q9 về quản lý rủi ro chất lượng, trong quản lý nguy cơ nhiễm chéo trong nhà máy sản xuất dược phẩm. Quy trình quản lý rủi ro nên được sử dụng để xác định và tài liệu hóa các rủi ro phù hợp và có thể chấp nhận, để duy trì chất lượng sản phẩm, sự toàn cho nhân viên vận hành và đáp ứng yêu cầu của các cơ quan quản lý.

Thiết kế thí nghiệm trong phát triển sản phẩm thuốc (Design of Experiments for Pharmaceutical Product Development)

                 

This book volume provides complete and updated information on the applications of Design of Experiments (DoE) and related multivariate techniques at various stages of pharmaceutical product development. It discusses the applications of experimental designs that shall include oral, topical, transdermal, injectables preparations, and beyond for nanopharmaceutical product development, leading to dedicated case studies on various pharmaceutical experiments through illustrations, art-works, tables and figures. 

Phát triển sản phẩm theo hướng "Chất lượng theo thiết kế - QbD"

       

Chất lượng theo thiết kế (Quality by Design - QbD) là một phương pháp tiếp cận có hệ thống trong quá trình phát triển sản phẩm, bắt đầu với các mục tiêu được xác định trước, chú trọng đến sự hiểu biết về sản phẩm, quy trình và kiểm soát quy trình dựa trên cơ sở khoa học và quản lý rủi ro chất lượng.

Chuyển giao công nghệ trong sản xuất dược phẩm (Technology Transfer)

1. ISPE Good Practice Guide: Technology Transfer 3rd Edition (2018)

This Guide is intended to be used as a generic guide to technology transfer between two parties for any applicable transfers in the product lifecycle. This Guide provides information and tools for its practical application, under three main topics:

Tiêu chuẩn ASTM cho Kiểm tra chất lượng (Quality Control Standards)

 ASTM E456-13a(2017)e2: Standard Terminology Relating to Quality and Statistics

ASTM E2554-13: Standard Practice for Estimating and Monitoring the Uncertainty of Test Results of a Test Method Using Control Chart Techniques

Hướng dẫn của ISPE - Hệ thống CAPA (ISPE APQ guide - Corrective Action and Preventive Action System)

 

What is the current state of your organization’s Corrective Action and Preventive Action (CAPA) System? Is it robust, consistent, and efficient? The ISPE APQ Guide: Corrective Action and Preventive Action (CAPA) System provides a quality management framework for assessing and advancing CAPA system maturity level by evaluating:

Tiêu chuẩn ASQ/ANSI Z1.4 & Z1.9 - 2003 (R2018)

 

ANSI/ASQ Z1.4-2003 (R2018): Sampling Procedures and Tables for Inspection by Attributes is an acceptance sampling system to be used with switching rules on a continuing stream of lots for Acceptance Quality

Bộ tiêu chuẩn ASTM cho ngành Dược

 

ASTM E2500-20: Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment

ASTM E2810-19: Standard Practice for Demonstrating Capability to Comply with the Test for Uniformity of Dosage Units

Dược điển Anh 2020 (British Pharmacopoeia 2020)

 

Dược điển Anh (tiếng Anh là British Pharmacopoeia , được viết tắt là BP) là một tài liệu tham khảo quan trọng trong rất nhiều lĩnh vực của ngành dược cho các dược sĩ. BP cung cấp bộ sưu tập toàn diện duy nhất các tiêu chuẩn chính thức có hiệu lực đối với các thành phần thuốc và các dược phẩm của

Dược điển châu Âu 10.0 (European Pharmacopoeia)

 

Dược điển Châu Âu (tiếng Anh là European Pharmacopoeia, gọi tắt là Ph. Eur.) là một dược điển chính của khu vực, cung cấp các tiêu chuẩn chất lượng chung trong toàn ngành dược phẩm ở Châu Âu để kiểm soát chất lượng thuốc và các chất được sử dụng để sản xuất chúng. Ph. Eur. được áp dụng tại 38 quốc gia châu Âu và được sử dụng tại hơn 100 quốc gia trên toàn thế giới.