GAMP RDI Good Practice Guide: Data Integrity by Design

 

Data Integrity by Design is the concept that data integrity must be incorporated from the initial planning of a business process through to the implementation, operation, and retirement of computerized systems supporting that business process. It promotes the application of critical thinking to identify how data flows through the business process and to proactively assess and mitigate risks across both the system and data lifecycles. It emphasizes data integrity as foundational to protecting patient safety and product quality.

GAMP Guide: Records & Data Integrity

 

The Guide is intended to be a complete and comprehensive single point of reference covering the requirements, expectations, and principles of pharmaceutical data integrity. Topics covered include regulatory focus areas, the data governance framework, the data life cycle, culture and human factors, and the application of Quality Risk Management (QRM) to data integrity. As such, it is of great interest to anyone with a responsibility for ensuring data integrity.

SUPAC-IR Questions and Answers

 

Các hướng dẫn BS EN ISO 13408 & 11138

 

 

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).

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. 

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.

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.

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

So sánh độ hòa tan của viên bao tan trong ruột

Điều kiện thử so sánh độ hòa tan của viên bao tan trong ruột được một số cơ quản lý quy định như sau: 

Hướng dẫn của ISPE: Thẩm định vệ sinh (Cleaning Validation)

This ISPE Guide: Cleaning Validation Lifecycle - Applications, Methods, and Controls provides a hands-on approach to support the life science industry in the development and establishment of compliant cleaning programs that meet or exceed regulatory expectations. Topics covered include:

Pharmaceutical Process Validation (Thẩm định quy trình sản xuất thuốc)

 1. Hướng dẫn của IVT (Institue of Validation Technology)

  a. Process design special edition (Stage 1)

  b. Process performance qualification special edition (Stage 2)

Bộ tài liệu hướng dẫn của ISPE (International Society for Pharmaceutical Engineering)

Các tài liệu hướng dẫn của ISPE được viết bởi các chuyên gia trong lĩnh vực sản xuất dược phẩm, sẽ cung cấp cho bạn những thông tin thực tế cần thiết để giúp công ty của mình xây dựng dựa trên các phương pháp tốt nhất để đáp ứng và vượt mức các tiêu chuẩn quy định bởi các cơ quan quản lý.