How to fill acid products ?
Choose the proper bottle filling and capping machine for chemical industry products. First, strong acid or alkaline liquid filling materials […]
Popular Science about API Machinery and Equipment
In the entire pharmaceutical production chain, active pharmaceutical ingredients (APIs) are the “core soul” of drugs—the active ingredients in the […]
What is a computer system validation CSV in GMP?
Computer System Validation (CSV) in GMP is a documented, risk based, lifecycle process that proves a computerized system is fit for […]
Standard Operating Procedure (SOP) for Active Pharmaceutical Ingredient (API) Manufacturing Proces 【 Part -2 】
5.2 Process Flow Diagram (English) Starting Materials (QC Verified) → Charging/Feed Preparation → Chemical Synthesis (Controlled Temp/Pressure/Time) → Quenching (Quenching […]
Standard Operating Procedure (SOP) for Active Pharmaceutical Ingredient (API) Manufacturing Proces 【 Part -1 】
1. Purpose This Standard Operating Procedure (SOP) defines the detailed manufacturing process of Active Pharmaceutical Ingredient (API) by chemical synthesis, […]
White Paper on 21 CFR Part 11 Compliance for Pharmaceutical Liquid Filling and Capping Machines
FOREWORD: 21 CFR Part 11 is a core regulation issued by the U.S. FDA for regulated industries, including pharmaceuticals, medical […]
EU GMP Annex 1 Requirements for Sterile Filling Machine | Complete Guide 【 Part – 3 】
Frequently Asked Questions (FAQ) Q-1: Does EU GMP Annex 1 require the use of isolators? A: Not necessarily. Annex 1 recognizes […]
EU GMP Annex 1 Requirements for Sterile Filling Machine | Complete Guide 【 Part – 2 】
Recommended Features of an Annex 1-Compliant Sterile Filling Machine： When selecting sterile filling equipment, pharmaceutical manufacturers should look for features […]
EU GMP Annex 1 Requirements for Sterile Filling Machine | Complete Guide 【 Part – 1 】
EU GMP Annex 1 Requirements for Sterile Filling Machine: A Complete Guide for Pharmaceutical Manufacturers The release of the revised […]
What’s Documentation and Qualification of Pharma Bottle Liquid Filling and Packing Machines ?
The qualification documentation can be adapted to the specific needs of the client offering an individual approach. DESIGN PROTOCOLS — […]
