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The PIC (Pharmaceutical Inspection Convention) was founded in October 1970 by the European Free Trade Association (EFTA), under the title of the Convention for the Mutual Recognition of Inspections in Respect of the Manufacture of Pharmaceutical Products.
Aseptic processing was derived from Olin Ball's heat-cool-fill (HCF) machine that was developed in 1927. [5] While HCF was successful in improving the sensory quality of the processed chocolate milk as compared to canned product, the use of the equipment was hindered by its cost, maintenance, and inflexibility to process various container sizes, rendering the machine a failure.
Validation involves collecting documentary evidence of all aspects of compliance. [20] Hazard analysis and critical control points is a methodology which has been proven useful. [21] Quality assurance extends beyond the packaging operations through distribution and cold chain management; Good distribution practice is often a regulatory requirement.
For example, sterile equipment and fluids are used during invasive medical and nursing procedures. [11] The largest manifestation of such aseptic techniques is in hospital operating theaters, where the aim is to keep patients free from hospital micro-organisms. [12] Packaged, sterilized surgical instruments
Aseptic sampling is the process of aseptically withdrawing materials used in biopharmaceutical processes for analysis so as not contaminate or alter the sample or the source of the sample. [1] Aseptic samples are drawn throughout the entire biopharmaceutical process ( cell culture /fermentation, buffer & media prep, purification , final fill ...
A VMP is the foundation for the validation program and should include process validation, facility and utility qualification and validation, equipment qualification, cleaning and computer validation. It is a key document in the GMP ( Good manufacturing practice ) regulated pharmaceutical industry as it drives a structured approach to validation ...
Process validation involves a series of activities taking place over the lifecycle of the product and process.". [4] A properly designed system will provide a high degree of assurance that every step, process, and change has been properly evaluated before its implementation. Testing a sample of a final product is not considered sufficient ...
Continued process verification (CPV) is the collection and analysis of end-to-end production components and processes data to ensure product outputs are within predetermined quality limits. In 2011 the Food and Drug Administration published a report [ 1 ] outlining best practices regarding business process validation in the pharmaceutical ...