V- Model Validation Concept in Pharmaceuticals

V- model means Verification and Validation model. It is a widely accepted reference model for computer system validation and was introduced by International Society of Pharmaceutical Engineers (ISPE) in 1994 in the first edition of their Good Automated Manufacturing Practices guideline, (gAMP).

It is called the V-model because of it’s characteristic “V” shape. The left arm of the “V” represents the planning / specification phases such as User Requirements Specification, Functional Specification, Detailed Design, and the right arm of the “V” represents the execution-validation phases such as Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) and both the arms converge at the Build and Unit Testing phases at the V-Point.

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The V-model provides a logical sequence that helps to organize the complex activities of defining a project scope, executing it, and qualifying it.

The V model provides an excellent basis for design control and tracking design changes through the proceeding of the project.

CODEX ALIMETARIUS - International “Food Law” or “Food Code”

CODEX  ALIMETARIUS  International “Food Law” or “Food Code”

The Codex Alimentarius is a collection of internationally recognized standards, codes of practice, guidelines, and other recommendations relating to foods, food production, and food safety. The Codex international food standards ensures product safety internationally and  facilitate global trade.

 

Codex commission is responsible for publishing Codex Alimentarius. The Codex Commission was established in 1963.It is Subsidiary of Food and Agriculture Organization (FAO), United Nations (UN)and World Health Organization (WHO).

Isolators in Pharmaceutical Industry

Isolators in Pharmaceutical Industry

In Pharmaceutical industry isolation technology is either used to protect the product from the operator (ex: aseptic processes), or protect the operator from the product (ex: potent product handling).

Isolator is a leak tight enclosure which acts as a physical barrier and provides a workspace, which is separated from the surrounding environment. 

It usually consists of a shell, viewing window, glove/sleeve assemblies, supply and exhaust filters, light (s), gauge (s), Input and Output openings (equipment door airlocks, Rapid Transfer Ports (RTPs), etc.), and various other penetrations. There are two types of isolators:

1. Closed Isolators – Isolators operated as closed systems do not exchange unfiltered air or contaminants with adjacent environments. Their ability to operate without personnel access to the critical zone makes isolators capable of levels of separation between the internal and external environment unattainable with other technologies. Because the effectiveness of this separation, closed isolators are ideally suited for application in the preparation of sterile and/or toxic material. Aseptic and Containment isolators are two types of closed isolators.

2. Open Isolators – Open isolators differ from closed isolators in that they are designed to allow for the continuous or semi-continuous egress of materials during operation, while maintaining a level of protection over the internal environment. Open isolators are decontaminated while closed, and then opened during manufacturing. Open isolators typically are used for the aseptic filling of finished pharmaceuticals. 

The intent of isolators is to create an airtight barrier or enclosure around a piece of equipment or process which provides an absolute separation between the operator and product. The operator can perform tasks through half-suits or glove ports. Isolators provide a specific environment inside the isolator using HEPA filters. The environment can be positive pressure or negative, can have humidity control and oxygen control.