Pharmaceutical packaging must meet strict regulations to ensure safety, efficacy, and protection:
1) Pharmacopoeial Standards
USP/NF (U.S.) and EP (EU): Define material specifications, leachables/extractables tests, and labeling requirements.
2) Regulatory Agency Guidelines
Agencies like FDA (U.S.), EMA (EU), and MHRA (UK) require data on container-closure integrity, stability testing, and packaging suitability.
3) 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.
4) Tamper-Evident and Child-Resistant Closures
Mandatory for OTC and prescription drugs in many regions to prevent tampering and child access.
5) 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.