Packaging Materials

• Innovator Companies
• Generic Companies
• Biologics Companies
• Biosimilars Companies
• CRO (Clinical Research Organization)
• CDMO (Contract Development and Manufacturing Organization)
• CMO (Contract Manufacturing Organization)
• Raw Material & Intermediates
• API (Active Pharmaceutical Ingredients)
• Pharma Research & Development (R&D)
• Excipients
• Formulation (Drug/Biologics)
• Packaging Materials
• Medical Devices
• Analytical Labs
• OTC (Over the Counter)
• Cosmetics
• Nutraceutical
• Food/Dietary Supplement
• Veterinary

Pharmaceutical Packaging Materials

Packaging materials refer to the components used to protect, contain, and deliver drug products while ensuring their safety, stability, and integrity throughout the product’s lifecycle. Packaging materials must comply with Good Manufacturing Practices (GMP), pharmacopeial standards, and regulatory guidelines set by agencies like the FDA, EMA, MHRA, and WHO to prevent contamination, degradation, and counterfeiting.

1. Primary Packaging Materials
   • Directly in contact with the drug product, affecting its stability and safety.
   • Examples: Blister packs, glass vials, ampoules, syringes, IV bags, plastic bottles, and closures.
   • Must comply with ICH Q3D (Elemental Impurities), USP <661> (Plastic Packaging), USP <660> (Glass Containers), and extractable/leachable studies to ensure material compatibility.

2. Secondary Packaging Materials
   • Used for external protection, labeling, and information display.
   • Examples: Cartons, paperboard boxes, leaflets, and inserts.
   • Must comply with GDP (Good Distribution Practices) and serialization requirements to prevent tampering and counterfeiting.

3. Tertiary Packaging Materials
   • Designed for bulk transport and storage to maintain cold chain integrity (for biologics, vaccines, and temperature-sensitive drugs).
   • Examples: Pallets, crates, and shipping containers with temperature control.
   • Must comply with GDP guidelines, ICH Q5C (Biologics Stability), and WHO Annex 9 (Packaging & Transport of Pharmaceuticals).

• Packaging materials undergo rigorous testing such as stability testing (ICH Q1A), extractable/leachable studies, and moisture barrier assessments.
• Serialization & track-and-trace systems ensure compliance with global regulations for anti-counterfeiting measures.

Proper selection and regulatory compliance of packaging materials are critical to ensuring drug quality, safety, and regulatory approval in the global market.

Masuu provides comprehensive regulatory consulting, supplier audits, and quality assurance to ensure that your packaging materials meet global regulatory standards. Proper packaging is essential to protect drug products, maintain stability, prevent contamination, and comply with international regulations. Our expert services help pharmaceutical companies navigate complex packaging requirements while ensuring product integrity and compliance.

1. Regulatory Consulting & Compliance Support
   • We assist in ensuring that your packaging materials meet FDA, EMA, MHRA, WHO, and ICH regulatory requirements.
   • Our experts provide guidance on compliance with Good Manufacturing Practices (GMP), Good Distribution Practices (GDP), and serialization laws such as the EU Falsified Medicines Directive (FMD) and U.S. Drug Supply Chain Security Act (DSCSA).
   • We support regulatory documentation, including stability studies, extractables & leachables testing, and packaging component compatibility assessments.

2. Supplier Audits & Qualification
   • We conduct supplier audits to evaluate the quality and regulatory compliance of packaging manufacturers.
   • Our audits ensure that suppliers follow pharmacopeial standards (USP <661>, USP <660>, Ph. Eur., JP) and meet international safety standards.

3. Quality Assurance & Risk Management
   • We provide quality risk assessments for primary, secondary, and tertiary packaging materials to prevent issues related to contamination, degradation, and counterfeit risks.
   • Our team supports stability testing (ICH Q1A), extractable/leachable analysis, and container closure integrity testing to ensure that packaging materials do not compromise drug safety.

With Masuu’s expertise, your packaging materials will meet all regulatory requirements, ensuring the safety, quality, and compliance of your pharmaceutical products in global markets.