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Capsules have become one of the main dosage forms of oral solid preparations other than tablets. Medicinal gelatin empty capsule is a special kind of medicinal excipient, which enters the digestive system of the human body together with the medicine and is finally absorbed by the human body. Therefore, the quality is directly related to the safety of the medicine. The quality of gelatin and the standardization of its production process are the main factors affecting the safety of empty capsules.

Any deviation from the predetermined production process, material balance limits, quality standards, inspection methods, operating procedures, etc. shall be recorded immediately on the relevant records of the post and filled in the Deviation Report Form by the personnel

The occurrence of deviation does not necessarily mean that the product will be scrapped or reworked; it is necessary to investigate the deviation, find out the reasons, determine whether the degree of deviation will affect the quality of the product, and then make a decision on the treatment of the product.

Capsules are commonly used in people's daily lives. The main capsular material of the empty capsule is gelatin. Because of its unique structure and dissociation of anion and cation on the molecular chain, medicinal gelatin has good solubility and water retention. However, not all medicines can be made into capsule preparations.

Deviation refers to any situation that deviates from the approved procedure (guidance document) or standard. Such as, the inspection results of raw materials or products exceed the standards, the storage of products is abnormal, equipment failures, the results of calibration exceed the standards, and environmental monitoring results exceed the standards, production process abnormalities, and other unexpected deviations from the results of drug-related regulations or approved standards and procedures.

When deviations occur or are predictable in the production process, there is the timely and accurate process standard to effectively control the impact of deviations and appropriate measures should be taken to prevent the recurrence of such deviations.

Although industrial gelatin and medicinal gelatin are not fundamentally different, industrial gelatin is definitely not used in the pharmaceutical industry. So how do we distinguish between these two gelatins?

Gelatin is a product obtained by partially hydrolyzing collagen obtained from the skin of an animal, connecting tissues and bone. Its main ingredient is protein. It has many excellent physical and chemical properties, such as adhesion, surface activity and the like. Depending on the application, gelatin can be divided into edible gelatin, medicinal gelatin, lighting gelatin and industrial gelatin.

Halal food refers to food that meets Islamic Halal food standards. Islamic eating habits come from the canon. According to the canon, halal foods do not contain contraindications such as dead objects, blood and pork. Therefore, for halal consumers, many of the ingredients in nutritional supplements limit their choice.

Nowadays, the process technology of soft capsule has been relatively mature, and there are various automatic solutions. The main process flow of soft capsules is: ingredients - sol - pelleting.