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Handbook of Pharmaceutical Manufacturing Formulations - by Sarfaraz K. Niazi

Posted On February 25, 2017 at 3:55 pm by / Comments Off on Handbook of Pharmaceutical Manufacturing Formulations - by Sarfaraz K. Niazi

By Sarfaraz K. Niazi

content material: v. 1. Compressed good items --
v. 2. Uncompressed stable items --
v. three. Liquid items --
v. four. Semisolids items --
v. five. over the counter items --
v. 6. Sterile products.

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Extra resources for Handbook of Pharmaceutical Manufacturing Formulations - Sterile Products (Volume 6 of 6)

Sample text

Where procedures lack specificity, there would be insufficient justification for exclusion of units removed during an intervention from incubation. , for production and media fills) should clearly document conformance with this procedure. In no case should more units be removed during a media fill intervention than would be cleared during a production run. The ability of a media fill run to detect potential contamination from a given simulated activity should not be compromised by a large-scale line clearance, which can result in removal of a positive unit caused by an unrelated event or intervention.

Monitoring should be accomplished by obtaining surface samples of each aseptic processing operator’s gloves on at least a daily basis or in association with each batch. 7 The quality control unit should establish a more comprehensive monitoring program for operators involved in operations that are especially labor intensive, that is, those requiring repeated or complex aseptic manipulations. Asepsis is fundamental to an aseptic processing operation. An ongoing goal for manufacturing personnel in the aseptic processing room is to maintain contamination-free gloves throughout operations.

B. Inspection of Container/Closure System A container–closure system that permits penetration of air, or microorganisms, is unsuitable for a sterile product. Any damaged or defective units should be detected and removed during inspection of the final sealed product. Safeguards should be implemented to strictly preclude shipment of product that may lack container–closure integrity and lead to nonsterility. Equipment suitability problems or incoming container or closure deficiencies have caused loss of container–closure system integrity.

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