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Founded in 1998 in Dublin, Ireland, Skillpad's team of industry-experienced Subject Matter Experts and Consultants believes Pharma, Biopharma, and Life Science Industry manufacturing companies can achieve production excellence with improved performance, productivity & compliance, as well as reduced losses & down-time, if they have KNOWLEDGE CONSISTENCY in all critical areas of manufacturing operations.

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    SOPs in API Manufacturing

    A comprehensive overview of Standard Operating Procedures (SOPs) and their critical role in ensuring compliance with Good Manufacturing Practice (GMP) regulations. It explores the purpose of SOPs, the risks of verbal instructions, the importance of version control, and the essential rules for using SOPs correctly. Participants will also learn about the structure of GMP-compliant SOPs and the impact of following standardized procedures on product quality, regulatory compliance, and manufacturing efficiency.

    Whether for onboarding or annual refresher training, this Module is seamlessly deployable on any LMS and can be tailored to your company’s exact needs.

      Duration: 30 Mins
    Grade: Core Library

    SKU: BGI-1100-SPL02-EN Categories: , Tag:

    Description

    Learning Objectives:

    • Describe the purpose of Standard Operating Procedures (SOPs)
    • Explain why SOPs are essential in API manufacturing
    • Explain the purpose of SOP version control
    • List the information typically contained in a GMP-compliant SOP
    • List the rules that must be followed when using SOPs

    Learner Benefits:

    • Understand the Importance of SOPs in API Manufacturing: Learn why SOPs are essential in ensuring consistency, compliance, and quality in API production processes.
    • Reduce Risk and Ensure Regulatory Compliance: Discover how properly documented procedures help prevent errors, reduce contamination risks, and ensure compliance with GMP regulations.
    • Recognize the Dangers of Verbal Instructions: Understand why verbal instructions are not permitted under GMP regulations and how written procedures safeguard against miscommunication and process deviations.
    • Master the Components of a GMP-Compliant SOP: Gain insight into the key elements of an SOP, including instructions, approval details, version numbers, and regulatory requirements.
    • Ensure the Correct Use of SOPs in Daily Operations: Learn the essential rules for SOP usage, including ensuring you are always using the most up-to-date approved version and following all instructions precisely.
    • Maintain Manufacturing Efficiency and Product Quality: Explore how SOPs contribute to minimizing rework, reducing costs, and improving overall operational efficiency in API manufacturing.
    • Strengthen Your Role in GMP Compliance: Develop the knowledge and skills to work confidently with SOPs, ensuring both personal accountability and regulatory adherence in your daily tasks.
    Module Features:

        Animations
       Voice Over
        Knowledge Checks
        Assessments
       SCORM/AICC compatible
        Full Screen

    Keywords

    • Standard Operating Procedures
    • SOP Compliance
    • GMP Documentation
    • API Manufacturing
    • SOP Version Control
    • GMP Best Practices
    • Regulatory Compliance
    • Quality Assurance
    • Manufacturing Consistency
    • Process Standardization
    • cGMP
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