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GMP Procedures (SOPs)

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  • Creation of Standard Operating Procedures

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    Creation of Standard Operating Procedures

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  • Document Change Control

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    Document Change Control

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  • Creation of Forms

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    Creation of Forms

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  • Personnel Qualifications

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    Personnel Qualifications

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    Audits and Reports

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    GMP Protocols and Reports

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  • Creation of Logs and Logbooks

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    Creation of Logs and Logbooks

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  • Customer Complaint Processing

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    Customer Complaint Processing

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  • Regulatory Inspections

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    Regulatory Inspections

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  • Technical Change Control

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    Technical Change Control

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    Batch Record Review

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  • Quality Assurance Disposition Process

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    Quality Assurance Disposition Process

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  • Management Reporting and Quality Review

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    Management Reporting and Quality Review

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  • Corrective and Preventative Actions (CAPA)

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    Corrective and Preventative Actions (CAPA)

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  • Creation of Item Specifications

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    Creation of Item Specifications

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  • Creation of List Documents

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    Creation of List Documents

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  • Creation of Installation Qualification Protocols

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    Creation of Installation Qualification Protocols

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  • Creation of Operational Qualification Protocols

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    Creation of Operational Qualification Protocols

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  • Creation of Performance Qualification Protocols

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    Creation of Performance Qualification Protocols

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  • Laboratory Notebook Issuance

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    Laboratory Notebook Issuance

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  • Deviation Reporting System

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    Deviation Reporting System

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  • Corporate QA Audits

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    Corporate QA Audits

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  • Third Party Change Control Oversight

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    Third Party Change Control Oversight

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  • Risk Analysis

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    Risk Analysis

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