Introduction
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.
Discussion
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
products.”[1]
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 g...
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...urate documentation of the material condition (seal on packages, labelling) should be done.
Sampling of material should then be done and sample taken to the lab for testing of purity, clearance from contamination.
Moving the sample to the storage area where appropriate storage conditions required should be met.
Sampling materials then labelled with the name of the material, batch number where these material will be used, test results and expiry date. In some cases some starting up materials will not be tested for by the manufacturer for hazard reasons, the supplier then should supply a quality certificate with each batch. [5]
Starting materials will be weighed and appropriately dispensed by a designated person.
Works Cited
DMSJ;19(2) 17-19
www.pewhealth.org
Chapter2,3,4, of the Eudralex
Apps.who.int/medicinedocs
who technical report seriesno 902,2002
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