PharmOut’s Approach to cGMP Compliance and Design

cGMP Compliance and Success by Design

Our philosophy is to ensure cGMP compliance by keeping it simple: write concise quality systems and validation protocols that tell your team what to do to ensure that your instructions are followed correctly.

We call this concept ‘success by design’. We believe that the more convoluted and complex the systems you create, the less likely the users will able be to follow it, so compliance lies on designing simple systems that are easy to follow across the board.

Our architectural and engineering teams adopt this same philosophy in plant design and layouts, seeking out Lean operations and reducing construction costs in the process.

When our compliance consultants are asked to set up Quality Management Systems we drive to having “shorter” protocols, SOPs and other GMP documents. Sticking to the crucial points is essential.

Our validation consultants also in this ‘success by design’ mindset and are experts at writing thorough but uncomplicated validation protocols.

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Watch the video below to hear PharmOut’s Managing Director, Trevor, describe PharmOut’s approach to GMP compliance and Design.

Interview