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Contamination control is one of the core contents of drug production quality management. Based on the basic requirements of drug production quality management, this paper summarizes the key points of sterile drug contamination control strategies; , equipment and components, facility environment, materials, process, detection and prevention, etc. to refine and explain the typical and easily […]

01 According to the requirements of the EU decision tree, if it cannot be sterilized at 121°C for 15 minutes, the residual probability method with F0≥8 can be selected. Excuse me, if the product can be sterilized at 121°C for 12 minutes, can you not choose 121°C for 10 minutes? Similarly, if it can reach

1 After Lyophilization And Layering, The Lower Layer Shrank   Phenomenon: After freeze-drying and layering, the lower layer shrinks. Or the entire product shrinks. Some of the product freezes well, some shrink into very few almost empty bottles Possible cause analysis and solution: Not pre-frozen, sublimation is too fast, it may be that the local

Objective: To provide a reference for the detection of seal integrity in injection consistency evaluation.   Methods: Based on literature research and combined with practical work experience, the relevant research on the existing injection packaging seal integrity detection technology was systematically summarized.   RESULTS AND CONCLUSION: At present, our country is still in the initial

Oral solid dosage forms are still the most commonly used drug dosage form in the world pharmaceutical industry. Oral solid dosage forms will continue to grow in the near future. This article points out that the major challenge currently affecting drug development in the world is overcoming bioavailability issues. The advantages of accelerated drug development

Part 1 Introduction   Sterile drugs can be divided into terminally sterilized products and non-terminal sterilized products according to different production processes. The latter needs to be produced using aseptic production processes because the semi-finished products cannot use any form of terminal sterilization process to remove microorganisms.   The routine non-terminal sterilized small-capacity injection subpackage

Changes in drug production sites may be related to changes in drug prescriptions, suppliers of raw and excipient materials, production processes, process parameters and batches, and other registration management matters, which is the most complicated of all change situations. This article discusses the technical risk considerations for the production site change of oral solid preparations

A generic drug is a drug that is consistent with the original drug (reference drug, RLD) in terms of dosage form, strength, route of administration, quality, curative effect, and use. Generics play a key role in the health care system, accounting for more than 50% of all prescriptions. Generic drugs are approved on the basis

The research and development of polymorphic forms of drugs has always been a research hotspot in the field of biopharmaceuticals. Different crystal states of drugs will have an important impact on drug solubility, dissolution rate, bioavailability and other aspects. It is also a key link in the quality and safety control of drug production. It

Oral solid preparation production plant layout has two-dimensional layout and three-dimensional layout, and there are various material conveying methods. Through case analysis, the application of gravity flow material conveying and automatic three-dimensional warehouse in three-dimensional plant layout is explained, and the three-dimensional layout and material conveying methods are summarized. Advantage.   Part 1 Overview