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Revised 503B Guidance for Outsourcing Compounders

According to the Federal Register Notice that announced the guidance revision (here), the FDA notes that “This revised draft guidance reflects the FDA’s intent to recognize the differences between outsourcing facilities and conventional drug manufacturers and to tailor CGMP requirements to the nature of the specific compounding operations conducted by outsourcing facilities while maintaining the …

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Customizing Industrial-Quality Workbenches for Your Needs

Workbenches are used in many industries including those engaged in manufacturing, assembly, packaging, and shipping. Industrial-quality workbenches are also found in laboratories, educational institutions, research centers, and healthcare facilities. Whether they are subjected to light, medium, or heavy use, these furnishings may become more functional when certain accessories are added. Some accessories are designed for …

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Basic Cleanroom Protocol

Most basic protocol programs for cleanrooms are based on the Institute of Environmental Science and Technology (IEST) recommended practices for contamination control and the ISO 14644 series of international standards for cleanrooms and associated controlled environments. The focus of any protocol program is to protect the integrity of the cleanroom and the products and processes …

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Cleaning Program under the Revised Propositions

The proposed revisions to USP <795>, USP <797>, as well as proposed USP <800>, all include sections devoted to cleaning and surface sampling. Proposed/Revised USP <795> defines cleaning as: The process of removing soil (eg, organic and inorganic material) from objects and surfaces, normally accomplished by manually or mechanically using water with detergents or enzymatic …

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Preventing Contamination In Compounding Facilities

Compounding pharmacies come in many different shapes and sizes. They can consist of a pharmacist creating a drug under a doctor’s prescription or they can be pharmacy-type facilities that compound drugs and sell them like a manufacturer. Sporadic and serious infection outbreaks have been linked to compounding pharmacies outside of the hospital setting.1 These problems date …

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Personnel Aseptic Practices Training

Personnel Aseptic Practices Training The primary purpose of cleanroom gowning is to protect the products and the processing environment from human contamination.Cleanroom gowning greatly reduces the microorganisms released by personnel.All personnel should be properly gowning qualified before entering the cleanroom, and the qualification should be performed by a trained analyst. The degree of gowning should …

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Prinston Pharmaceutical Inc. issues Voluntary Nationwide Recall of Irbesartan Tablets

Prinston Pharmaceutical Inc. issues Voluntary Nationwide Recall of Irbesartan and Irbesartan HCTZ Tablets Due to detection of a Trace Amount of Unexpected Impurity, N- nitrosodiethylamine (NDEA) in the Products Prinston Pharmaceutical Inc., dba Solco Healthcare LLC., has initiated a voluntary recall of one (1) lot of Irbesartan and seven (7) lots of Irbesartan HCTZ Tablets …

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How should we Keep Cleanrooms Clean

Controlling microbial ingress into the cleanroom is a critical concern for the entire cleaning and disinfection process. Components, personnel, carts, tanks, tools, cleaning supplies, and instruments that are transferred into the clean area should be clean and free of contamination. Gross contamination is easier to prevent than to correct. Cleaning is the first step of …

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