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Introduction of Cleaning validation

Introduction

        The primary benefit usually attributed to a cleaning validation  is ensuring compliance with federal regulation. However, a more important benefit from conducting cleaning validation work is the identification and correction of potential problem, previously unsuspected, which could compression the safety, efficacy, or quality of subsequent batches of the drug product produced with the equipment.

    Several serious problem can be prevented through the use of the reasonable cleaning validation program. All are related to adulteration, therapeutic safety and efficacy, or overall quality of the product over its shelf life.

Cross contamination with active ingredients:  Contamination of one batch of product with significant level of residual active ingredients from a previous batch cannot be tolerated. 

Contamination with unintended material or components: Excipients used in drug products are generally recognized as safe or have been shown to be safe for human consumption, the routine use, maintenance and cleaning of equipment provide the potential for contamination with such items as equipment parts and lubricants, chemical cleaning agents and peace of cleaning tools. Contamination from such item can cause problem ranging from poor pharmaceutical elegance, to exceeding acceptable level of particulate matter in parenteral products, to inadvertent inclusion of toxic compounds in the product.  

Microbiological contamination: Maintenance, cleaning and storage conditions may provide adventitious microorganism with the opportunity to proliferate within process equipment. This could pose obvious problem for sterile product manufacture. It can also be a serious problem for the manufacture of nonsterile dosage forms, particularly unpreserved product which support microbial growth.

The major objective of cleaning validation program should be to provide an adequate level of assurance that the problem described above will not occur during routine manufacturing operation. Cleaning validation can provide fairly high level of assurance of product safety, purity, and efficacy. 

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