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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...

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....

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...

Oral solid preparations of drugs are widely used clinically, and the attention paid to their quality and safety is lower than that of other dosage forms. The safety of oral solid preparations cannot be ignored. The 2010 version of drug GMP puts forward the concept of quality risk...

In order to meet the requirements of aseptic and easy cleaning, the application of magnetic stirring devices in the biopharmaceutical industry is becoming more and more extensive. This article starts with the classification, main internal structure and working principle of magnetic...

Part 1 Pharmacovigilance Activities And Gelatin For Capsules   Pharmacovigilance activities refer to the monitoring, identification, evaluation and control of adverse drug reactions and other adverse reactions related to medication. Gelatin for bovine bone capsules is a product...

In the field of biopharmaceuticals, how to ensure that the instruments and equipment not only meet the compliance requirements, but also realize the rapid mixing of powder and liquid solvents without agglomeration – this is an important issue in the product preparation and mixing...

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...

Under the healthy development trend of the market economy, it has brought great development opportunities for innovation and reform in various fields. As an industry that wins by quality and participates in market competition, pharmaceutical companies need to pay more attention to...

Pharmaceutical water is widely used in the pharmaceutical production process and the preparation of pharmaceutical preparations, and is also used as a solvent, flushing agent, etc. The quality of pharmaceutical water directly affects the quality of medicines and is closely related...