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According to EU GMP Guideline Chapter 1 “Pharmaceutical Quality System” the holder of a Manufacturing Authorisation must manufacture medicinal products so as … (2 correct answers)

Norm DIN EN ISO 13845  … (2 correct answers)

Which of these statements are true? ( 3 correct answers)

Which of these statements are false? (3 correct answers) Guidance for Industry Process Validation: General Principles and Practices (FDA, 2011)

If 5 process steps (departments) all have a service level of 90 %, what is the overall service level of the process … (1 correct answer)

The Certification by a Qualified Person and Batch Release is described in detail with EU GMP Guideline … (1 correct answer)

Reasons for outsourcing are: (3 correct answers)

The Risk evaluation of a situation … (1 correct answer)

Operational Priorities can be categorized by: (1 correct answer)

The principles behind a Bud Box include all of the following except: