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Raw Material Specification Compliance
Overview
Why Raw Material Specification Compliance Matters
Regulatory Approval
Adhering to regulations tailored to specific countries such as the FDA, EFSA, FSANZ, TGA, DRAP, SFDA, MFDS, MHLW, NHC
Product Safety
Ensuring that raw materials are free from contaminants, allergens, and other harmful substances.
Quality Assurance
Maintaining ingredient potency, purity, and composition consistency.
Market Access
Avoiding product recalls and import rejections due to non-compliance.
Major Regulations that affect the Raw Material Compliance Globally
Food Chemicals Codex (FCC):
- Applicable – USA
- Compliance Scope: Provides internationally recognized standards for the quality, identity, and purity of food ingredients regulatory requirements.
Commission Regulation (EU) No 231/2012
- Applicable – EU Member States
- Compliance Scope: Lays down specifications for food additives listed in Annexes II and III of Regulation (EC) No 1333/2008, detailing purity criteria and usage conditions.
JECFA Specifications
- Applicable: Globally
- Compliance Scope: Provides safety evaluations and establishes acceptable daily intakes (ADIs) for food additives regulatory approval, contaminants, naturally occurring toxicants, and residues of veterinary drugs in food.
Raw materials used in Food and Food supplements include
Key Regulatory Requirements
Pharma Wizard Expertise in Raw Material Specification Compliance
Pharma Wizard provides end-to-end support for manufacturers and suppliers to achieve Regulatory compliance for Food raw materials used in food and dietary supplements. Our services include:
Specification Development ā Creation of detailed raw material specifications aligned with pharmacopeial standards (USP, EP, JP, BP, ChP) and regulatory guidelines. Regulatory Compliance ā Verification of raw materials against international and local regulatory requirements. Supplier Qualification ā Assessment and approval of suppliers with full documentation support. Testing & Validation ā Analytical method verification (HPLC, GC, ICP-MS, Microbiological tests) to confirm compliance. Documentation & Audit Support ā Preparation of COA (Certificate of Analysis), stability data, and audit-ready documentation. Risk Management ā Identification of potential compliance risks and establishment of preventive controls