PHARMA VALIDATION

PHARMA VALIDATION

About the course:-

Pharma Validation is the process of establishing documentary evidence demonstrating that a procedure, process, or activity carried out in testing and then production maintains the desired level of compliance at all stages. 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.[1] The desired results are established in terms of specifications for outcome of the process. Qualification of systems and equipment is therefore a part of the process of validation. Validation is a requirement of food, drug and pharmaceutical regulating agencies such as the US FDA and their good manufacturing practices guidelines. Since a wide variety of procedures, processes, and activities need to be validated, the field of validation is divided into a number of subsections

Objective of the course:-

THIS PROGRAMME HELPS TO UNDERSTAND THE BASIC CONCEPT OFVALIDATION, THEIR TYPES AND USAGE IN PHARMA INDUSTRY.

Course Syllabus

Topic : 1 INTRODUCTION

• Validation plays a Key Role in Pharmaceutical, Clinical Trial, Medical Device , Food, Biological industries. Validation helps one establish and demonstrate that a particular activity is maintainig a desired level of compliance.
• Process Validation is a term used in the medical device industry to indicate that a process has been subject to such scrutiny that the result of the process (a product, a service or other outcome) can be practically guaranteed. This is vitally important if the predetermined requirements of product can only be assured by destructive testing.
• Using a series of formal presentations, combined with various practical exercises and case studies, the workshop is designed to be interactive, and so promote understanding of validation.

Topic : 2 DIFFERENT TYPES OF VALIDATION

Process Validations

Process validation is the analysis of data gathered throughout the design and manufacturing of a product in order to confirm that the process can reliably output products of a determined standard. 

Analytical Validation

Analytical method validation is the process used to confirm that the analytical procedure employed for a specific test is suitable for its intended use. Results from method validation can be used to judge the quality, reliability, and consistency of analytical results; it is an integral part of any good 

Equipment Validation

The Equipment Validation Process or IQ, OQ, PQ, ensures that your instrument operates properly and is appropriate for its intended use 

Validation Master Plan

A Validation Master Plan also referred to as "VMP", outlines the principles involved in the qualification of a facility, defining the areas and systems to be validated, and provides a written program for achieving and maintaining a qualified facility

Cleaning Validation

Cleaning Validation is the methodology used to assure that a cleaning process removes residues of the active pharmaceutical ingredients of the product manufactured in a piece of equipment, the cleaning aids utilized in the cleaning process and the microbial attributes.

IQ/OQ/PQ, CommissioningActivites

Will be covered as part of equipment validation

Computer System Validation

Computer system validation (sometimes called computer validation or CSV) is the process of documenting that a computer system meets a set of defined system requirements.

Topic : 3 CONCLUSION

• Pharmaceutical Validations Courses are designed for individuals who need basic, but a thorough understanding of all the validation in the pharmaceutical industry.
• It will help to understand the fundamentals and concepts of Pharmaceutical Validation.
• Overview and understanding of Pharmaceutical validation, how to organize and carry out the same & the Key areas to Look forward to the whole process.

Our industry experts have developed the modules in such a way that it gives the participants in-depth knowledge of the above-mentioned points in Validation