as of 2019 - 03 - 18

7.C Organisation, planning and implementation

7.C Organisation, planning and implementation
Here you will find answers to the following questions:

Who is responsible for process validation?

What are the responsibilities of the validation coordinator, QP and validation team?

What are the different types of validation?

What is a hybrid approach?

Under what specific conditions may a concurrent validation be carried out?

What requirements have to be met before a traditional (prospective) validation can be carried out?

How is the scope of a validation defined?

What are critical parameters and how are they identified?

During which validation phases should risk analyses be carried out?

During which part of the product life cycle is the traditional validation carried out?

Can validation batches be sold and are they suitable for human use?

What must be observed during a product transfer with regard to validation?

When is revalidation necessary?

How is an ongoing process verification carried out?

What needs to be observed during continuous process verification (CPV)?

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