The Significance Of Cleaning Validation Protocol In The Pharmaceutical Industry

Page 1

The Significance Of Cleaning Validation Protocol In The Pharmaceutical Industry Due to the sensitive conditions under which medications are made, avoiding residual crosscontamination in the pharmaceutical industry is extremely important to public safety. To ensure that all products are manufactured under the highest of standards of quality and safety, an authorized process must be constantly in place which is precisely why cleaning validation protocol is a must. This validation technique, which is documented in writing to make sure all tools, machinery and surfaces are free of contamination, is extremely important to the general public, the industry and to the businesses that dispense pharmaceutical products. Recall Prevention The cleaning protocol increases public safety by eliminating cross-contamination that could result in a product recall. In the drug market, if a medication is prepared on a work surface that holds trace elements of a different formula, the medication can seriously harm individuals if they were to make contact with the product. Pharmaceutical personnel are given a step by step guideline for cleaning tools, machinery and surfaces that is documented to ensure everything is sanitized correctly. Once this type of protocol is in place, product recalls due to contamination are reduced or eliminated and instances of lawsuits that result from people using contaminated products are less likely too. Product Quality Remains High Cleaning protocol in the pharmaceutical industry guarantees consistent quality plus increases consumer confidence. When cleaning protocols are implemented on a daily basis, contamination is much less likely to happen. When active ingredients are called for, the cleaning protocols is especially important because these materials can react in unpredictable and unexpected ways if they should come into contact with any type of residue left from other prepared medicines. Because countless medicines are prepared in large batches, if an active ingredient should become inert or its chemistry changed because of residual contamination, the entire batch might have to be destroyed or thrown away. When a large amount of waste is experienced, the company loses money and they will most likely see a drop in their production rating. If there is an effective protocol in place for all cleaning procedures, the quality and production quantity is able to remain high. Updated Protocols Reveal Potential Problems Cleaning validation protocol procedures, when implemented successfully can even expose new problems should they occur in the future. For instance, protocols pertaining to the cleaning process can be updated when starting production of a new product that is not sufficient enough. Issues that would be addressed during an update could include things like how new cleaning procedures will improve the outcome of the medication and how the new protocols can be put in place.

IQSValidation.com

Page 1


Turn static files into dynamic content formats.

Create a flipbook
Issuu converts static files into: digital portfolios, online yearbooks, online catalogs, digital photo albums and more. Sign up and create your flipbook.
The Significance Of Cleaning Validation Protocol In The Pharmaceutical Industry by smithg21272@gabbug.com - Issuu