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Extemporaneous Compounding

RX Note

Introduction In 2018, the Ministry of Health Malaysia published the Good Compounding Practice as a guidance for compounding practices. NOTE: When compounding a preparation using the contents of an ampoule , care should be taken to withdraw the solution using a filter needle to avoid incorporating glass particles into the compound.

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Cleanroom

RX Note

Compounding Sterile Preparations, 2018 Guide to the Development of Sterile Pharmaceutical Preparation Facilities, 2010 NOTE: Best refer PIC/S for the updated info. Contamination Pressurization Temperature and humidity Personnel Access It is typically used in industries such as pharmaceuticals, biotechnology, electronics and aerospace.

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Preventing fungal contamination in pharmaceuticals

European Pharmaceutical Review

In a review on fungal-contaminated compounded pharmaceuticals and medical devices, researchers have described how the contamination of these products can be due to breaches in sterile compounding procedures. Ahmed et al.

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Extemporaneous Preparation with Unknown Stability

RX Note

Today, stability information can be obtained from manufacturer’s labelling information (such as in the package insert), the USP compounding monographs, or peer-reviewed articles and references , such as articles in American Journal of Health-System Pharmacy, the International Journal of Pharmaceutical Compounding.

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The role of outsourcing in antibody drug manufacture

European Pharmaceutical Review

stated that when conventional small-molecule compounds were the norm within the industry, closed innovation was standard practise and pharmaceutical companies did R&D in-house. Until 2010, contract manufacturing arrangements were for contract manufacturing (drug-manufacturing/supply) of antibody drugs. Yoshiura et al.

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Ethnopharmacology: traditional medicine and modern drug discovery

Pharmaceutical Technology

For example, a widely referenced study from 2012 reported that up to 50% of approved drugs between 1981 and 2010 were directly or indirectly from natural products, while according to the WHO, 11% of drugs considered basic or essential originated from flowering plants.

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Establishing quality assurance in personalised preparations

European Pharmaceutical Review

A paper published in Pharmaceutics has proposed how a personalised preparation quality assurance programme can achieve this when these products are developed in compounding laboratories. It requests that compounding laboratories adhering to the programme send samples of it. PACMI selects a drug on a quarterly basis.