Definations and brife explanations for pharmacy studants

In pharmaceutical manufacturing industry Validation is very important part of Quality assurance and in Good manufacturing Practice activities or guidelines .FDA gives special emphasis on validation , also it is one of the prime requirement of all regulatory authorities world wide. It is of great importance in Pharmaceutical manufacturing as well as medical devices manufacturing industry.
Validation is a process of collection of documentary evidence , it is a process of demonstration that any of the procedure, process, method, or activity is being adapted is capable of producing consistant and satisfactory result in terms of measurements or in terms of product quality.


To demonstrate this it is required that the systems it slef and equipment are properly designed and qualified. To demonstrate that a pharmaceutical product manufactured with any process in any pharmaceutical company it is required to validate many procedures, processes, methods activities associated with pharmaceutical manufacturing including machinery , skills and testing procedures , methods.
Validation In pharmaceutical is classified as follows
1.Cleaning Validation
2.Process Validation
3.Analytical Method Validation
4.Computer System Validation

And qualifying systems ,equipments are required to qualify for following Qualifications:
1.Design qualification (DQ)
2.Component qualification (CQ)
3.Installation qualification (IQ)
4.Operational qualification (OQ)
5.Process qualification (PQ)

Design Qualification (DQ)- It consists process of gathering documentary evidence of a particular instruments or machine’s fundamental operational and functional specification of an instrument , and its inherent program , or equipment and details about and its detailed design and its qualifications , why this instrument and is supplier chosen.

Installation Qualification (IQ) - It consists process of gathering documentary evidence and process of Demonstration that the process or equipment being installed complies with all of its qualifications of successful installation in a particular aria , so as to comply with intended requiremts of process , with respect to its specifications, is it installed correctly, are all necessary accessories and components installed correctly and its documentation required for continued utilization are installed properly.

Operational Qualification (OQ) - It consists process of gathering documentary evidence and of Demonstration of all aspects of a equipment , process are functioning properly and accurately so as to yield intended ,mesurments, results quality of a pharmaceutical being manufactured.

Performance Qualification (PQ) - It consists process of gathering documentary evidence and process of Demonstration of all aspects of a equipment , process are functioning properly and accurately so as to produce intended ,mesurments, results , intended quality of a pharmaceutical manufactured over a period of time. in a consistent manner



Validation Master Plan
It is a document which identifies and provides complete steps, guide or map or guidelines for caring out a particular validation procedure.
Where ever there is requirement of any validation , Validation procedure is first asiged a Validation Master Plan.

The Validation Process
It is a process of monitoring ,testing,and evaluation of all steps and process involved in a pharmaceutical manufacturing
.
Computer system Validation:
It requires that the software or programs which are utilized by pharmaceutical companies in manufacturing of pharmaceuticals should work without any error, it provides or leads to an accurate measures or activity .Example Dispensing of Raw Material using computarised system. Process control using a computarised system
In 21 CFR Part 11 this topic is covered in very detail and you can read it over here
Here screen shot prints are gathered to validate and document that the procedure adapted is leads to correct measures or activity

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