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Level of Details In the USA, GMP’s principles have been covered in part 210 and part 211 of the code of federal regulations. Because these regulations are hard to amend or add, FDA has released different documents of GMP regulations and operation guidance for pharmaceuticals, such as Guidance fo...Read more »
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GMP (Good Manufacturing Practice) is a guideline aimed to control and supervise the medicine manufacture activities worldwide. It is also a necessary permission for pharmaceutical manufacturers to enter the field of international trade. GMP include: facility, people, site, hygiene, validation, do...Read more »
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China has always been a huge emerging market of pharmaceutical industry, recently showing the possibility of dominance in the world. Among which, pharmaceutical equipment keeps growing and follows closely to pharmaceutical manufacturers. In this case, what will happen in its future? 1. Auto...Read more »
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1. Choose proper excipients After adding some hydrated magnesium silicate into herbal medicine granules, the angle of repose has clearly decreased, fluidity has increased and fill weight variation has narrowed. In the other case, Avicel PH302 as a diluent also narrows the fill weight variation of...Read more »
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Three possible causes need to be located: capsule shell, content characteristics and equipment. Capsule shell It is essential to ensure the quality of your empty capsule supply. Any fragile or deformed capsule shell would bring catastrophic effects. Test the capsule shell chemically and physicall...Read more »
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In the process of pharmaceutical capsule closing, filled capsule defects appear to be the most troublesome problem. Splits, telescoped capsules, folds and cap tucks occur during capsule closing, causing a possibility of product leaking. When defective capsules are almost inevitable, discarding or...Read more »
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Empty capsules are made from gelatin, which is derived from animal protein (pork skin, animal bones & skin and fish bones) and plant polysaccharides or their derivatives (HPMC, starch, pullulan and others). These empty capsules are made in two halves: a lower-diameter “body” that ...Read more »