In the pharmaceutical industry, it is very important that in addition to final testing and compliance of products, it is also assured that the process will consistently produce the expected results. The desired results are established in terms of hvac system in pharmaceutical industry pdf for outcome of the process.
Qualification of systems and equipment is therefore a part of the process of validation. Ted Byers and Bud Loftus, in the mid 1970s in order to improve the quality of pharmaceuticals. The use of validation spread to other areas of industry after several large-scale problems highlighted the potential risks in the design of products. Here, the software for a large radiotherapy device was poorly designed and tested. In use, several interconnected problems led to several devices giving doses of radiation several thousands of times higher than intended, which resulted in the death of three patients and several more being permanently injured.
In 2005 an individual wrote a standard by which the transportation process could be validated for cold chain products. 39, thus establishing the industry standard for cold chain validation. This was critical for the industry due to the sensitivity of drug substances, biologics and vaccines to various temperature conditions. The FDA has also been very focused on this final area of distribution and the potential for a drug substances quality to be impacted by extreme temperature exposure. FDA, or any other food and drugs regulatory agency around the globe not only ask for a product that meets its specification but also require a process, procedures, intermediate stages of inspections, and testing adopted during manufacturing are designed such that when they are adopted they produce consistently similar, reproducible, desired results which meet the quality standard of product being manufactured and Complies the Regulatory and Security Aspects. Such procedures are developed through the process of validation.
This is to maintain and assure a higher degree of quality of food and drug products. Process validation involves a series of activities taking place over the lifecycle of the product and process. 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 evidence that every product within a batch meets the required specification. Even though it is not mandatory, it is the document that outlines the principles involved in the qualification of a facility, defines the areas and systems to be validated and provides a written program for achieving and maintaining a qualified facility with validated processes.