Author: Site Editor Publish Time: 11-11-2025 Origin: Site
Pharmaceutical packaging is not merely a protective shell for drugs; it is a crucial element in ensuring drug quality, safety, and efficacy.
With increasingly stringent global pharmaceutical regulations and greater market internationalization, packaging materials and designs must not only comply with GMP (Good Manufacturing Practices) but also meet the trends of sustainable and intelligent development.
1. Moisture and Oxidation Protection: Pharmaceuticals are highly susceptible to damage from moisture and oxygen, therefore packaging materials must possess high barrier properties (such as aluminum foil, composite films, PVDC coatings, etc.) to ensure stable efficacy.
2. Sealing and Airtightness: The packaging seal must be completely airtight to prevent the entry of air, microorganisms, odors, or dust. **Solid dosage forms (tablets, capsules) and liquid dosage forms (syrups, injections)** require different levels of sealing technology.
3. Light Protection: Many drugs are sensitive to light and easily decompose or deteriorate; therefore, packaging must have a light-proof or opaque design, such as using dark glass bottles, aluminum foil bags, or plastic bottles with light-blocking layers.
4. Material Safety and Compatibility: Packaging materials must not chemically react with the drug, adsorb, or leach substances. Commonly used materials such as HDPE, glass, aluminum-plastic composite films, and pharmaceutical-grade PVC must pass pharmaceutical packaging material compatibility testing.
5. Traceability and Anti-counterfeiting: Drug packaging should have a unique code (QR code/barcode), batch number tracking, and anti-counterfeiting labels to prevent the circulation of counterfeit drugs and ensure traceability during recalls.
6. Ease of Opening and Safety: Packaging must be both airtight and easy for patients to use (especially the elderly). Children's medications must have child-resistant packaging to prevent accidental ingestion.
7. Compliance with Regulatory Standards: All drug packaging must comply with local drug regulatory regulations, such as: China's "Regulations for the Registration and Management of Pharmaceutical Packaging Materials," the US FDA 21 CFR Part 211, and the EU EMA Packaging Standards. Ensure material certification, cleanliness of production, and label compliance.
8. Clear Labeling and Complete Information: Labels must clearly indicate the drug name, ingredients, batch number, expiration date, dosage, storage conditions, and manufacturer information, and must comply with local language and regulatory requirements.
9. Stability and Storage/Transportation Conditions: Packaging must remain stable throughout the entire lifecycle of the pharmaceutical product (production, transportation, storage, and sales), preventing damage, leakage, deformation, or adverse effects from temperature and humidity.
10. Environmental Protection and Sustainability: While ensuring drug safety, the gradual adoption of recyclable, biodegradable, or green materials (such as bio-based plastics and paper-plastic composite structures) aligns with global pharmaceutical industry environmental trends.
1. Material Classification
Primary Packaging: Materials that come into direct contact with the drug, such as bottles, blister packs, bags, and ampoules.
Secondary Packaging: Outer boxes, labels, and instructions for use.
2. Validation and Testing Requirements
Compatibility Test
Extractables/Leachables Test
Seal Integrity Test
Light & Stability Test
3. Material Selection Principles
Safety (Non-toxic, Free of heavy metals)
Functionality (Moisture-proof, Oxygen-proof)
Process Compatibility (Heat-sealing, Filling)
Environmental Compatibility (Storage and Transportation Stability)
I. Controlling from the Source: Selecting Compliant and Qualified Suppliers
✅ Verifying Supplier Qualifications
Confirm whether they possess a Pharmaceutical Packaging Material Production License (required by China's NMPA) or ISO 15378 certification (GMP for Primary Packaging Materials).
Check whether they are registered with the FDA, EMA, or DMF (especially important for exported pharmaceuticals).
Check whether they have an independent quality management system (ISO9001 / ISO13485).
✅ Supplier Audit
On-site inspection of the factory's cleanroom level (at least Class 100,000 or higher).
Review production records, quality inspection reports, and raw material batch traceability forms.
Request retained samples for testing and COA (Certificate of Acceptance).
✅ 1. Appearance Inspection
The surface should be smooth, free of pinholes, black spots, and delamination; the sealing edges should be neat, free of bubbles or delamination.
✅ 2. Performance Testing The following key performance indicators must be passed:
Test Items | Function | Acceptance Standard |
Moisture Barrier Performance (WVTR) | Moisture Resistance | ≤0.5 g/m²·24h (room temperature) |
Oxygen Barrier Performance (OTR) | Oxidation Resistance | ≤0.5 cm³/m²·24h |
Tensile Strength | Bursting Resistance | ≥25 MPa |
Sealing Strength | Leakage Resistance | ≥30 N/15mm |
Microbiological Limits | Sterility | No detectable mold/bacteria |
Heavy Metal Migration | Safety | Complies with pharmacopoeia limits |
✅ 3. Compatibility and Migration Testing
Pharmaceuticals and packaging materials must undergo compatibility and extractables/leachables testing to prevent plasticizers, solvents, or ink components from seeping into the pharmaceuticals.
Common Problems with Inferior Pharmaceutical Packaging Materials
*Unpleasant Odor in Plastic Bags (Materials Contain Recycled Materials or Low-Quality Resin);
*Poor Sealing or Bursting at the Sealing Edges (Unstable Heat-Sealing Temperature);
*Layer Delamination or Bubbling (Poor Quality Composite Adhesive);** **Uneven Coloring or Fading (Ink Not Fully Cured);
*Surface Fogging or Yellowing (Aging or Moisture Ingress).
If any of the above problems are found, the package should be rejected immediately and the supplier corrective action procedure should be initiated.
1. Every batch of packaging materials entering the factory must undergo IQC testing by the quality inspection department;
2. The random sampling rate should not be less than 5%;
3. Verify the batch number, raw material source, and test report;
4. Maintain accurate sample records to ensure traceability;
5. Report any abnormalities to the QA department immediately.
Procurement and Supply Chain Control
✅ Technical Agreement Signing
Sign detailed technical agreements with suppliers, clearly defining:
1. Packaging material structure (e.g., PET/AL/PE, OPA/AL/CPP, etc.);
2. Physical performance parameter range;
3. Testing methods and acceptance standards;
4. Mechanism for handling violations or non-compliance.
✅ Multi-source supply strategy
Avoid complete reliance on a single supplier. Establish a primary + backup supply chain to avoid being forced to use substandard products due to raw material shortages or price monopolies.
1. For exported pharmaceutical packaging, conduct a comparison with the regulations of the destination country in advance (e.g., Arabic labeling is required in the Middle East, CE marking is required in the EU).
2. Conduct regular (annual) re-audits and on-site assessments of packaging material suppliers.
3. Establish an internal "pharmaceutical packaging material blacklist system," permanently removing suppliers whose products fail to meet quality standards.
4. Promote sustainable material alternatives, such as bio-based plastics and medical-grade PE bottles, to enhance brand credibility.
1. Easy-Open Design
Unit Dose Packaging
Droplet, Metering Cap, and Straw Auxiliary Functions
2. Readability and Clarity
Clear, high-contrast label fonts; Multilingual labeling (e.g., Chinese-English bilingual or Arabic for Middle Eastern markets); Key information such as "Expiration Date" and "Batch Number" should be prominently displayed.
3. Misidentification Prevention and Differentiated Design
Different dosage forms should use different color codes; Similar drug packaging should be clearly distinguishable to prevent confusion.
Sustainable and Environmentally Friendly Materials
Bio-based Plastics (PLA, PBS, etc.)
Recyclable PET/PE Bottles
Reduced Plastic and Lightweight Design
Smart Packaging Technology
Temperature/Humidity Monitoring Labels
NFC/RFID Anti-counterfeiting Identification
Electronic Tracking Systems
Digital Management
Digital Traceability Platform (Full-Process Visualization)
Batch Cloud Archiving and Recall Tracking System
Region | Main Standards | Content |
China | *Regulations for the Registration and Management of Pharmaceutical Packaging Materials* | Packaging materials must pass registration and conformity verification |
US | FDA 21 CFR Part 211 | GMP requirements for production and packaging |
EU | EMA Guidelines | Packaging material safety and labeling requirements |
International | ISO 15378:2017 | GMP standards for primary packaging materials for pharmaceuticals |
1. Choose the Right Manufacturer (Complete Qualifications)
2. Material Verification (Qualified Testing)
3. Rigorous Inspection (Batch-by-Batch Sampling)
4. Process Review (Sealing/Lamination Quality)
5. Regulatory Compliance (International Certification)
Pharmaceutical packaging is the "first line of defense" in the pharmaceutical safety system,
it runs through the entire process of research and development, production, storage, transportation, sales, and use.
1. Safe and Reliable
2. Sustainable Development
3. Smart and Efficient
Continuously improving packaging systems is not only a reflection of a company's competitiveness but also the best commitment to patient safety and social responsibility.
