HOW SAP CAN HELP IN CREATING VALIDATION ENVIRONMENT FOR PHARMA COMPANIES

INTRODUCTION

The pharmaceutical business is in charge of all the improvement, generation and supply of pharmaceutical items.

These items are required to save lives, avert infection and aides in keeping up personal satisfaction.

Preparations must be safe and successful for patients as well as the overall population. Preparation ought to be such that there is no danger to life or symptom included. It must protect buyers.

For this, we require administrative bodies who can control the preparation procedure of these items.

REGULATION BODIES

There are International presumed organizations who goes about as Regulated bodies for Pharmaceuticals industry:-

Food & Drug Administration (FDA) –Relevant for US Market mainly

European Medicines Evaluation Agency (EMEA) –For European Region

Drug Controller General of India –For India

Following are the Regulation involved: GCP (Good Clinical Practices) GLP (Good Laboratory Practices) GDP (Good Distribution Practices)

VALIDATION IN PHARMA COMPANIESValidation is a procedure of establishing reports which ensures that if we follow a particular process consistently to produce a product we will be able to meet predetermined specifications and attributes.Following are the validations in Pharm Companies:Process Validation: This includes acceptance of creating Process, Plant & Machines, and Manufacturing Techniques and so forth.

Cleaning Validation: This includes acceptance of Labs, Production, Packaging (Proof of clean), Equipment, Machinery, Instruments, Cleaning Techniques and so forth.

Strategy Validation: This includes approval of Laboratory systems (R&d… ), Quality Verification techniques, Analytical Equipment and so forth.

Machine System Validation: This includes approval of Computer Related Systems (wherever), Computer Systems & Operating systems, Design, Installation, Performance and so forth.

V MODEL FOR SYSTEM VALIDATIONCompanies like ArchitectSAP Solutions which are specialized in providing SAP ECC Support Services follows below model for establishing necessary SAP environment for pharma companies:-

V MODEL User Requirement Specifications (URS) : This step characterizes what client needs

from the framework and verifies that necessity is met

Functional Specifications: This step characterizes or makes an archive in client justifiable arrangement focused around URS. This is produced by functional expert or merchant or administration supplier.

Design Qualification DQ: This step gives a report which states that the machine framework prerequisites have been obviously characterized and is sanctioned as URS. It likewise gives report that states all extra framework particulars are produced, investigated and approved.

Installation Qualification IQ: In this step record is given which gives the insurance that all equipment establishment viewpoints are considered as per fitting codes and sanction outline. Additionally programming establishment is likewise considered.

Operation Qualification OQ: In this step record is given which gives the insurance that introduced framework functions as tagged.

Performance Qualification PQ: In this step report is given which gives the assurance that whole framework executes as expected under all operating ranges.

For More Information, Please visit:-http://www.architectsap.com/blog/sap-ecc/sap-validation-environment-for-pharma-companies/Or Follow us on:- G+ , Facebook or twitter

V MODEL User Requirement Specifications (URS) : This step characterizes what client needs

from the framework and verifies that necessity is met

Functional Specifications: This step characterizes or makes an archive in client justifiable arrangement focused around URS. This is produced by functional expert or merchant or administration supplier.

Design Qualification DQ: This step gives a report which states that the machine framework prerequisites have been obviously characterized and is sanctioned as URS. It likewise gives report that states all extra framework particulars are produced, investigated and approved.

Installation Qualification IQ: In this step record is given which gives the insurance that all equipment establishment viewpoints are considered as per fitting codes and sanction outline. Additionally programming establishment is likewise considered.

Operation Qualification OQ: In this step record is given which gives the insurance that introduced framework functions as tagged.

Performance Qualification PQ: In this step report is given which gives the assurance that whole framework executes as expected under all operating ranges.

For More Information, Please visit:-http://www.architectsap.com/blog/sap-ecc/sap-validation-environment-for-pharma-companies/Or Follow us on:- G+ , Facebook or twitter