[Book] Practical Compliance with the Latest GMP and Related ICH Guidelines (No. 2263)

[Available for preview] How to implement changing regulations in your own factory? A practical guide for response.

Book Title: Practical Compliance with the Latest GMP and Related ICH Guidelines －－－－－－－－－－－－－－－－－－－－－ ★ Thorough and comprehensive explanation of key points of the revised GMP, including data integrity, risk management, PQS, and supply chain management! ★ Requirements and countermeasures for related guidelines such as ICH Q3C, Q3D, M7 (Impurities GL), and Q13 (Continuous Manufacturing GL)! －－－－－－－－－－－－－－－－－－－－－ ■ Breakdown of GMP requirements in response to changing regulations and ongoing transformations in digital technology! 【1】 Requirements for building a Quality System (PQS) and specific countermeasures 【2】 GMP documentation and its creation and management 【3】 Quality assurance and audits in line with PQS 【4】 Response to Data Integrity (DI) 【5】 Prevention of cross-contamination 【6】 Impurity regulations and required management strategies 【7】 Promotion of digital transformation (DX) in pharmaceutical factories and response to GMP and DI 【8】 Management strategies for continuous manufacturing, GMP compliance, and implementation examples

• others

The "Mechanical Stitching Method" by Nichinichisui Road Machinery Co., Ltd. is a new technique that allows for the repair of metal cracks without the application of heat. By using special bolts and reinforcement plates, cracks are physically removed, and repairs are made without causing any thermal impact on the base material. Repairs can be carried out even in environments where open flames cannot be used. Since no heat is applied, the disassembly of equipment is kept to a minimum. ◎ For more details, please contact us. ◎ If a detailed technical explanation is needed, please contact us.

The "Mechanical Stitching Method" by Nichinichisui Road Machinery Co., Ltd. is a new technique that allows for the repair of metal cracks without the application of heat. By using special bolts and reinforcement plates, cracks are physically removed, and repairs are made without any thermal impact on the base material. Repairs can be conducted in environments where open flames cannot be used. Since no heat is applied, the disassembly of equipment is minimized. ◎ For more details, please contact us. ◎ If a detailed technical explanation is required, please contact us.

When measuring the flow rate of liquids or gases that are unsuitable for plastic due to high pressure or high temperature, our robust "glass tube variable area flow meter (rotameter)" allows for more accurate flow measurements. It offers a wider flow range and is suitable for various liquids and gases! 【Features】 ■ Glass tube variable area flow meter ・ Flow measurement technology with high durability, economy, and excellent operability ・ Capable of a wider flow range, suitable for various liquids and gases ■ Metal tube variable area flow meter ・ Durability and accuracy that withstands high pressure and harsh temperature environments 【Product Lineup】 ■ Glass tube variable area flow meter ・ Sho-Rate models 1350, 1355, 1358 ・ GT1600 series ■ Metal tube variable area flow meter ・ MT3750 series ・ MT3809 series ▼ For more details, visit https://www.brooksinstrument.com/ja-jp/products/variable-area-flow-meters

The "Mechanical Stitching Method" by Nichinichisui Road Machinery Co., Ltd. is a new technique that allows for the repair of metal cracks without the application of heat. By using special bolts and reinforcement plates, cracks are physically removed, and repairs are made without affecting the base material with heat. Repairs can be carried out in environments where open flames cannot be used. Since no heat is applied, the disassembly of equipment is minimized. ◎ For more details, please contact us. ◎ If a detailed technical explanation is needed, please contact us.

The "Mechanical Stitching Method" by Nichinichisui Road Machinery Co., Ltd. is a new technique that allows for the repair of metal cracks without the application of heat. By using special bolts and reinforcement plates, cracks are physically removed, and repairs are made without causing any thermal impact on the base material. Repairs can be carried out even in environments where open flames cannot be used. Since no heat is applied, the disassembly of equipment is minimized. ◎ For more details, please contact us. ◎ If a detailed technical explanation is needed, please contact us.