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u Ônalytical test methods
u Ôutomated systems
u Cleaning procedures

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u Sterile products Ôll processes affecting the sterility, and
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u Non-sterile Low dose tablets and capsules: mixing and
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u Ôpproval page and table of contents
u 3ntroduction and objectives
u Facility and process description
u Personnel, planning and scheduling
u Responsibilities of validation team members
u Process control aspects
u Equipment, apparatus, processes and systems qualified,
validated ± and to be qualified or validated
u Ôcceptance criteria
u ’ocumentation, e.g.validation protocols and reports
u SOPs
u Training requirements and other elements«

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u Objectives of the validation and qualification study
u Site of the study
u Responsible personnel
u ’escription of the equipment
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