- Legal and Official Requirements for Containers ensure that container is made from approved materials, maintain product stability, and prevent contamination.
- Legal and Official Requirements for Containers include mandatory labeling, tamper-evident features, and compliance with pharmacopeial and regulatory standards.
- Pharmaceutical packaging must meet strict regulations to ensure safety, efficacy, and protection:
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Pharmacopeial Standards:
- USP/NF (U.S.) and EP (EU): Define material specifications, leachables/extractables tests, and labeling requirements.
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Regulatory Agency Guidelines:
- Agencies like FDA (U.S.), EMA (EU), and MHRA (UK) require data on container-closure integrity, stability testing, and packaging suitability.
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Good Manufacturing Practice (GMP):
- Ensures packaging materials are high-quality, properly stored, and free from contamination.
- Requires process validation, in-process controls, and batch traceability.
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Tamper-Evident and Child-Resistant Closures:
- Mandatory for OTC and prescription drugs in many regions to prevent tampering and child access.
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Labeling Requirements:
- Must include product name, batch number, expiration date, usage instructions, and storage conditions.
- Barcodes or 2D codes are often required for tracking and tracing.
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