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Infant Formula Milk Powder Formula Development and Process Validation

According to the Administrative Measures on Infant Formula Milk Powder and its supporting documents, applicants shall possess proper R&D, production, and testing capabilities appropriate for their products. In addition, they are required to submit comprehensive scientific reports on formula development and process validation when seeking for infant formula milk powder registration, including the quality and safety standards of raw materials and excipients, product formula, report on the rationale for formula development, production process description, documentation proving the R&D, production, and testing capabilities. The reports should elaborate on several key aspects, including compliance standards for food ingredients and food additives, product formula composition, dosage table, nutritional facts, product formula characteristics and research objectives, sufficient evidence demonstrating the scientific and safety aspects of the formula, control measures for potential harmful substances such as pollutants, microorganisms, and mycotoxins, commercial production process validation report (sample uniformity, process stability, and compliance analysis of nutritional components), description of significant differences in formula, proof of R&D, production and testing capabilities, among others.


Therefore, gathering valid research data and scientific justifications throughout the R&D process is crucial for securing regulatory approval and ensuring a successful product launch in the market.

With a decade of expertise in infant formula milk powder application, CIRS Group has established long-term partnerships with several renowned research institutions with extensive R&D experience. Our team is well-equipped to offer tailored formula design, process research, and data collection services based on clients’ needs and product registration requirements. This ensures scientifically sound support for future product registration applications and commercial production.

Product R&D Service

1. Product formula research

  • Conduct scientific literature research based on clients’ needs;
  • Identify product formula characteristics and research objectives;
  • Select raw materials that meet the standards and requirements;
  • Determine product formula composition and nutritional facts;
  • Identify the suitable population;
  • Determine product packaging materials; and
  • Determine product technical standards and requirements

2. Product process research

  • Offer recommendations for laboratory-scale trial production and product process validation;
  • Assist in determining the process route and parameters for the commercial production line;
  • Advise on carrying out three batches of commercial-scale trial production and process validation; and
  • Provide guidance for conducting full-item inspections of three batches of commercial-scale trial production samples

3. Provide guidance for conducting stability tests in accordance with requirements for infant formula milk powder stability tests, including accelerated tests and long-term tests, etc.

4. Assist in preparing documentation and conducting self-inspection before the on-site inspection in accordance with the key points and principles for on-site inspection of infant formula milk powder registration; and

5. Other customized R&D services.

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