Pharma-Guidelines-Nanodrug001 2021年 总页数 23页 发布单位 国家卫生健康委员会 适用范围 本指导原则所述纳米药物系指利用纳米制备技术将原料 药等制成的具有纳米尺度的颗粒,或以适当载体材料与原料 药结合形成的具有纳米尺度的颗粒等,及其最终制成的药物 制剂。纳米药物的最终产品或载体材料的外部尺寸、内部结 构...
Cleaning of equipment was first published in the Code of Feral Regulations (CFR) as 21CFR211.67 Equipment Cleaning and Maintenance in 1978. After that a lot of document guidelines are published on cleaning validation and nowadays cleaning validation is the main focus area of FDA GMP inspections. ...
1566April 8, 2025 Establish a proposed shelflife based on stability data with differenent temperature, Regulatory 09April 8, 2025 What is the difference (use ,structure, advantages - disadvantages)between Isolator and RABS in drug product mamufacturing?
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Build a Quality Culture in Pharmaceuticals Preparation of Master Formula Record (MFR) Requirements for Good Documentation Practice (GDP) ALCOA Principles of Data Integrity Why Cold Chain Logistics are Required in Pharmaceuticals? Regulatory Guidelines on Data Integrity ...
biological activity of a new pharmaceutical compound. The data collected during this stage are crucial for determining whether a compound is safe enough to proceed to human trials. It must adhere to the stringent guidelines set by the NMPA to ensure that all tests and results are reliable and ...
pharma Manual February 4, 2024 Uncategorized No Comments Introduction Sugar coating refers to the process of coating pharmaceutical tablets and pills with one or more layers of sugar for ease of swallowing, improved taste, and enhanced visual … [Continue Reading...] Peak Performance: How to...
Breaking ground with unprecedented continuous processing capabilities, Nebula is a multi-chamber decontamination tunnel which integrates seamlessly with IMA Life aseptic fill-finish lines. Responding to the latest Annex 1 guidelines, Nebula accomplishes 6-log decontamination using HC-VPHP while material cro...
The article focuses on the updated guidelines for medical meetings by the Pharmaceutical Research and Manufacturers of America. It notes that noneducational items, including mugs, ballpens, and note pads, are prohibited to serve as gifts and giveaways for attendees. According to Jennifer Palcher-...
E&L studies following most recent USP, ISO and ICH guidelines and PQRI recommendations SERVICE DETAILS Compendial Testing Conformity testing according to current USP, EP, and JP regulatory guidelines along with selected ISO, ASTM, and in-house methods ...