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The preparation of APIs is the initial stage of drug research and development, the basis of drug research and development, mainly to provide detailed information for quality research, to provide preparation processes in line with industrial production, and to provide qualified APIs...

1. Tablet Preparation With Powder Compression     Tablets are a tablet-like solid formulation that is pressed after mixing the drug with suitable excipients, suitable for industrial production and easy to carry, and is one of the most important and widely used dosage forms...

Stages Of Development Of Generic Drugs   Oral Solid Preparations, Tablets   1. Chemical Properties, Production And Control In The Development Of Oral Solid Preparations   Through the analysis of the components within the packaging material of the control drug, the basic...

Clean Room Clean Area Hygienic Cleaning Practice:    Area cleanliness and hygiene requirements    Clean shop hygienic cleaning operating procedures    Disinfectants are formulated using SOP    Luminaire cleaning SOP    Wall cleaning SOP    Floor cleaning...

This paper summarizes and draws up the decision tree for the in vitro consistency evaluation of oral solid generic drugs in combination with the relevant technical requirements such as “Requirements for Application Materials for Consistency Evaluation of the Quality and Efficacy...

Pharmaceutical water must meet quality standards – it participates in the entire pharmaceutical production process, including preparation, cleaning and disinfection. Therefore, pharmaceutical water is an important part of the pharmaceutical production process. It is necessary...

In recent years, the FDA (U.S. Food and Drug Administration) has found an increasing number of cGMP violations in terms of data integrity in its cGMP (current Good Manufacturing Practices) inspections. cGMP violations related to data integrity have led to a number of regulatory actions...

The 2010 edition of GMP (Good Manufacturing Practice for Pharmaceuticals) puts forward the following two requirements for the interior decoration of the clean room – the inner surface of the clean area (wall, ground, ceiling) should be smooth and smooth, without cracks, with...

More and more people are getting better and better treatment through drugs and medical devices – 50 drugs were approved in the US market alone in 2021, continuing the positive growth trend of recent years. However, compared with the achievements and commercial potential of pharmaceutical...

In view of the imperative application of QbD in China’s drug R&D, Dr. Wang Xingwang told R&D supervisors with a number of specific R&D examples: some QbD elements can be appropriately added at different stages of R&D, such as R&D objectives (QTPP), CQA, CMA,...