Preventing Crosscontamination In Pharmaceutical Production Essay

1951 words - 8 pages

This assignment will be exploring the areas in production how it is regulated and controlled. It is exploring the rules governing the pharmaceutical production. It gives the guidelines for example to how monitor, prevent and control cross contamination within the pharmaceutical plants. Production operation, validation, starting material from the purchasing stage till manufacturing, packaging materials and operation. Also the quality of the finishing product, rejecting of raw material or end product and returned materials. Due to the word limitation of this assignment exploring each are of the above will be brief.
1-Prevention of cross contamination
Cross contamination in pharmaceutical production should be prevented at all the stages of production. It is defined as:
“The process by which foreign chemical, microbial, or physical
substances are unintentionally transferred from one
substance or object to medicines with harmful effects that
might affect the purity and quality of the pharmaceutical
Cross contamination can occur either by introduction of micro-organisms to the product or by other pharmaceutical products in the mixed plant manufacturing.
Studies showed that main contamination within pharmaceutical production occurs by people, air, equipment, water and or raw materials. [1]
Severity of the cross contamination of medicinal products depends on the route of its administration. Contamination of parenteral products carries more risk to the patient can lead to severe implications varies between severe illness or even death. [2]
Cross contamination should be avoided by strict measures and guidelines summarised as follows:
• According to the Good manufacturing practice guidelines (GMP).
Personnel working in the production area should be wearing protective clothing, regular alcohol hand washing, regular swabbing and adequate training. They have to follow the standard operating procedures (SOP) before entering the production area. [3]
• Examining of the raw material for any signs of contamination and good Laboratory practice (GLP) should be followed for testing the materials.
• Equipment cleaning procedures and cleaning validation should be followed, continuous and regular testing of the equipment for any potential contamination.[4]
• If two types of the products are produced current GMP suggested that there should be separation of time followed by appropriate cleaning.[1]
Detailed cleaning procedure should be available detailing methods of cleaning, type of cleaning products, sampling and testing plan .Residual cleaning limits should be practical achievable and verifiable. [5]
• Air in the production area should be filtered to prevent contamination. Type of filter, replacing filter and validation of air filtering system should be in the SOP. Regular sampling and testing of air should also be maintained.
• Water used widely in the manufacturing processing and in cleaning. Regular...

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