制药生产流程英文表达有哪些?

The pharmaceutical production process involves a series of complex steps that ensure the quality and efficacy of medications. Here are some key terms and expressions used in English to describe the various stages of pharmaceutical production:

  1. Raw Material Procurement: This is the initial stage where raw materials are sourced. Common expressions include:

    • Sourcing raw materials
    • Procuring active pharmaceutical ingredients (APIs)
    • Supply chain management
    • Raw material quality control
  2. Preparation of Raw Materials: Before the actual manufacturing process begins, raw materials need to be prepared. Relevant terms include:

    • Raw material characterization
    • Sample preparation
    • Solvent selection
    • Drying and grinding
    • Homogenization
  3. Formulation Development: This stage involves creating the final product's composition. Key expressions are:

    • Formulation design
    • Dosage form selection
    • Excipient selection
    • Stability testing
    • Quality by design (QbD)
  4. Manufacturing Process: The actual production of the medication. Common terms include:

    • Manufacturing process development
    • Process validation
    • Continuous manufacturing
    • Batch production
    • Scale-up
  5. Mixing and Granulation: These steps involve combining ingredients and creating granules. Relevant expressions are:

    • Mixing
    • Blending
    • Granulation
    • Dry blending
    • Wet granulation
  6. Tableting and Capsule Filling: For solid dosage forms, these steps are crucial. Terms include:

    • Tablet compression
    • Capsule filling
    • Coating
    • Tablet hardness testing
    • Friability testing
  7. In-process Controls: Ensuring quality at various stages of production. Expressions include:

    • In-process testing
    • Process analytical technology (PAT)
    • Real-time release
    • Quality assurance (QA)
    • Quality control (QC)
  8. Chilling and Drying: For certain products, chilling and drying are essential steps. Terms include:

    • Chilling
    • Drying
    • Lyophilization (freeze-drying)
    • Vacuum drying
    • Spray drying
  9. Packaging: The final step before the product is ready for distribution. Key expressions are:

    • Packaging design
    • Primary packaging
    • Secondary packaging
    • Child-resistant packaging
    • Packaging material selection
  10. Quality Assurance and Control: Ensuring the product meets all regulatory standards. Terms include:

    • Quality assurance (QA)
    • Quality control (QC)
    • Good Manufacturing Practices (GMP)
    • Current Good Manufacturing Practices (cGMP)
    • Regulatory compliance
  11. Release Testing: Before the product is released for distribution, it must pass several tests. Expressions include:

    • Release testing
    • Stability testing
    • Microbial testing
    • Chemical testing
    • Physical testing
  12. Distribution and Logistics: The final stage involves getting the product to the end-user. Terms include:

    • Distribution channels
    • Logistics management
    • Inventory control
    • Cold chain logistics
    • Supply chain optimization

Each of these stages is critical to the overall pharmaceutical production process, and the use of specific terminology helps to ensure clear communication and adherence to quality standards. From raw material procurement to final product distribution, the pharmaceutical industry relies on a well-defined and regulated production process to deliver safe and effective medications to patients worldwide.

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