A raw material is any unprocessed or minimally processed substance used as an input for manufacturing. In industries such as pharmaceuticals, food, animal feed and nutritional supplements, raw materials include active ingredients, excipients, chemicals, and natural extracts that must meet strict quality and safety standards before being used in production.
Raw material testing is a critical step in quality control, ensuring that ingredients meet safety, purity, and regulatory requirements. By verifying the identity, composition, and quality of raw materials, businesses can prevent contamination, mislabeling, or product failures that may compromise safety or compliance.
Testing raw materials is particularly important when changing suppliers. Variations in sourcing, processing, or handling can introduce quality inconsistencies, impurities, or differences in composition that could affect the final product. Without proper testing, even small changes in raw materials can lead to regulatory non-compliance, safety concerns, or unexpected production issues.
Assurance in raw ingredients
AsureQuality provides raw material testing to ensure your ingredients meet required standards before they go into your products. Our testing helps verify whether a sample matches what your supplier claims or provides a report needed for export. Using an internal reference database of spectra, we compare test results against known standards and deliver a consistency rating from not consistent to consistent.
When switching to a new supplier whether local or importing from overseas, it is strongly recommended to conduct raw material testing. Even if a supplier meets regulatory requirements, variations in raw material sources, processing methods, or quality control practices can lead to differences in product performance. In some instances, the supplier may provide evidence which appears to meet the requirements, but it is important to be wary of the unfortunate possibility of fraudulent activity.
Testing helps confirm that the new supplier’s materials confirm that they are indeed what they say they are and ensure consistency with previous batches, ensuring continuity, safety, and compliance.
Importance of identity testing
If there is any uncertainty about a raw material’s identity, an identity test should be performed based on the relevant pharmacopeia monograph. This is particularly crucial when standard assay methods, such as titration, are generic or non-selective.
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Identity testing ensures that the raw material is what it claims to be.
- Purity (assay) testing confirms its quality and composition.
Regulatory guidelines emphasise treating identity and purity as distinct but complementary aspects of quality control. However, if the purity test uses a highly specific technique, such as chromatographic analysis, a separate identity test may not always be necessary. Additionally, impurity testing should be conducted when there is a risk of contamination or when regulatory limits apply.
GMP Compliance in raw material testing
GMP compliance for raw materials and chemical testing ensures quality, purity, and consistency before manufacturing begins. Testing identifies any impurities, contaminants, or inconsistencies that could affect product safety or regulatory compliance.
Why raw material testing matters
By following industry standards and cGMP requirements, raw material testing helps:
- Confirm ingredient identity and quality
- Prevent supply chain risks and contamination
- Ensure compliance with pharmacopeia guidelines and regulatory requirements
- Provide assurance for local and international markets
- Maintain product consistency when switching suppliers
Ensuring high-quality raw materials is a key part of maintaining trust, safety, and compliance in your products. Testing provides confidence in your ingredients, safeguards your supply chain and market reputation of your product as well as meeting both regulatory and industry standards.
AsureQuality works with customers to understand their supply chains, aiding them in qualifying suppliers based on technical capabilities, certifications, industry reputation, and sustainable practices. This process ensures that the raw materials used by our customers meet the highest standards of quality, safety, and compliance.
Background information
Pharmacopeia- guidelines and monographs
Pharmacopeia guidelines are official standards that define the quality, strength, and purity of medicines and their ingredients. Organisations such as the United States Pharmacopeia (USP), European Pharmacopoeia (Ph. Eur.), and British Pharmacopoeia (BP) set these standards to ensure consistency in pharmaceutical products worldwide.
Compliance with pharmacopeia monographs—detailed specifications for raw materials—helps manufacturers meet regulatory requirements and maintain product integrity. Pharmacopeia monographs set legally recognised standards that manufacturers must follow to ensure quality, safety, and consistency. They help regulatory bodies confirm that pharmaceutical ingredients and raw materials meet approved specifications before they are used in production.
A pharmacopeia monograph typically includes:
- Definition & description – identifies the substance, including its chemical name and structure.
- Identification tests – methods to verify that the material is what it claims to be.
- Purity & impurity limits – specifications for contaminants, degradation products, or residual solvents.
- Assay (Quantification) – a test to confirm the concentration or potency of the active ingredient.
- Storage & handling requirements – guidance on proper storage to maintain stability.
- Analytical methods – standardized testing methods such as chromatography, spectroscopy, or titration.
cGMP Requirements in New Zealand
Current Good Manufacturing Practices (cGMP) are regulations that ensure pharmaceuticals, dietary supplements, and other consumables are consistently produced and controlled according to quality standards. In New Zealand, cGMP compliance is overseen by:
- Medsafe, which regulates medicines and medical devices and follows PIC/S GMP guidelines (Pharmaceutical Inspection Co-operation Scheme).
- The Ministry for Primary Industries (MPI), which regulates food, dairy, and other consumable products, ensuring adherence to GMP standards in those sectors.
- International Standards, including compliance with FDA (U.S.) and EMA (Europe) regulations for companies exporting products overseas.
For more details on New Zealand’s cGMP regulations, visit: