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1. HOW SAP CAN HELP IN CREATING
VALIDATION ENVIRONMENT FOR
PHARMA COMPANIES

2. 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.

3. 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)

4. VALIDATION IN PHARMA COMPANIES
Validation 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.

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

6. 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/
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