And To These: 1. Raw Material Selection: • Have We

The text discusses various aspects related to starting materials and active ingredients in the pharmaceutical industry. It touches upon the expectations of EU competent authorities regarding starting materials, documentation and quality agreements, and the clarification provided by the EMA's reflection paper on API starting materials. It also mentions the need for appropriate quality requirements, specifications, and justification for starting materials. The guidance mentions that a GMP certificate is not always required for manufacturing and testing sites of starting materials.

Here are the references to the specific guidelines from the EMA for the questions you've provided:

  1. Raw Material Selection:

    • The criteria for raw material selection and challenges with chosen materials can be referenced in the EMA's reflection paper titled "Reflection paper on API (Active Pharmaceutical Ingredient) starting materials" and "Guideline on setting specifications for related impurities in antibiotics."
  2. Supplier Qualification:

    • Guidelines for supplier qualification and assessment for reliability and compliance with regulatory standards can be found in EMA's "Good Manufacturing Practice for Active Pharmaceutical Ingredients" and "Guidelines for GMP IL chapter 7".
  3. Supply Chain Resilience:

    • The resilience of the current supply chain for critical raw materials can be evaluated based on EMA's "Guideline on Good Distribution Practice of Medicinal Products for Human Use" and "Guidance for Industry: Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients."
  4. Quality Control of Raw Materials:

    • The establishment of quality control measures for incoming raw materials and instances of raw material variability impacting the manufacturing process or product quality is detailed in the EMA's "Guidance on GMP for Active Pharmaceutical Ingredients" and "Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use."

These guidelines provide specific regulatory expectations and insights for various aspects related to raw material selection, supplier qualification, supply chain resilience, and quality control.

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