The pharmaceutical industry is responsible for all the development, production and supply of pharmaceutical products. These products are needed to save lives, prevent disease and helps in maintaining quality of life. Preparations must be safe and effective for patients and the general public. Preparation should be such that there is no risk to life or side effect involved.  It must protect consumer. For this, we need regulatory bodies who can control the preparation process of these products.

There are International reputed agencies who acts 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:

GxP: The term GxP means GMP (Good Manufacturing Practices) ,where ‘x’  includes

  • GCP (Good Clinical Practices)
  • GLP (Good Laboratory Practices)
  • GDP (Good Distribution Practices)

What is Validation?
Validation is a process of establishing documents that provides guarantee that if we follow a particular process consistently to produce a product we will be able to meet predetermined specifications and attributes.

Validations in Pharmaceutical Company

  1. Process Validation: This involves validation of Manufacturing Process, Plant & Machines, and Manufacturing Techniques etc.
  2. Cleaning Validation: This involves validation of Labs, Production, Packaging (Proof of clean), Equipments, Machinery, Instruments, Cleaning Techniques etc.
  3. Method Validation: This involves validation of Laboratory methods (R&D…), Quality Verification methods, Analytical Equipment etc.
  4. Computer System Validation: This involves validation of Computer Related Systems (any place), Computer Systems & Operating procedures, Design, Installation, Performance etc.

V Model Concept for System Validation
Below is universally accepted model popularly known as V model for validation

V model System Validation

V Model Concept for System Validation

  • User Requirement Specifications (URS) : This step defines what user wants from the system and makes sure that requirement is met
  • Functional Specifications: This step defines or creates a document in user understandable format based on URS. This is developed by functional analyst or vendor or service provider.
  • Design Qualification DQ: This step provides a document which states that the computer system requirements have been clearly defined and is approved in the form of URS. It also provides document that states all additional system specifications are developed, reviewed and approved.
  • Installation Qualification IQ: In this step document is provided which gives the guarantee that all hardware installation aspects are considered according to appropriate codes and approved design. Also software installation is also considered.
  • Operation Qualification OQ: In this step document is provided which gives the guarantee that installed system works as specified.
  • Performance Qualification PQ: In this step document is provided which gives the guarantee that entire system performs as expected under all operating ranges.

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By Sreedhar Babu. (on behalf of SAP Consulting Team)

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