In pharmaceutical supply chains, secondary packaging and labelling are often treated as low-risk activities. However, regulatory bodies across the world have increasingly highlighted them as critical control points—especially under Good Distribution Practice (GDP). Failing to audit these partners can result in mislabelling, packaging errors, traceability issues, or even product recalls.
At Quality and Vigilance (Q&V), we believe that every link in the pharmaceutical distribution chain, no matter how seemingly minor, must be held to high compliance standards. This includes your secondary packaging and labelling vendors.
What is Secondary Packaging?
Secondary packaging refers to the external wrapping or container that holds the primary drug packaging (like blister packs or vials). It includes:
- Cartons and boxes
- Inserts and leaflets
- Shrink-wrapping and tamper-evident seals
- Printed labelling
- Barcoding and serialisation elements
While secondary packaging does not come into direct contact with the medicinal product, its role in ensuring the correct product reaches the correct patient with accurate information cannot be overstated.
Why These Vendors Are a Hidden Compliance Risk
Many companies underestimate the risk associated with outsourced packaging and labelling. Here’s why this is dangerous:
1. Risk of Labelling Errors
Even minor typographical or batch number mistakes can lead to misuse, adverse drug events, or recalls.
2. Packaging Material Quality
Substandard cartons or leaflets may compromise product stability, traceability, or fail tamper checks.
3. Regulatory Documentation
GDP mandates full traceability of packaging components. Missing or poorly maintained batch records at these vendors may lead to compliance gaps during inspections.
4. Serialisation Failures
As global pharma supply chains move toward track-and-trace, even small packaging providers must integrate with serialisation and anti-counterfeiting systems.
How Q&V Supports GDP Compliance for Packaging Vendors
At Q&V, we apply a risk-based auditing model that helps sponsors and MAHs (Marketing Authorisation Holders) assess the performance and compliance status of their packaging and labelling suppliers.
1. Pre-Audit Risk Assessment
We assess the vendor’s role, product type, regulatory region, and past compliance history to determine audit priority.
2. Customised GDP Audit Checklists
Our audit tools cover GDP-specific requirements for secondary packaging, including:
- Material identification and segregation
- Labelling controls and version tracking
- Packaging process validations
- Security features and data integrity
- Traceability and reconciliation practices
3. On-Site or Remote Audits
Depending on the vendor’s risk rating and geographical location, Q&V can conduct:
- Full-scope on-site audits
- Efficient remote audits
- Desktop assessments supported by documentation reviews
4. Audit Reports and CAPA Follow-up
We deliver clear, actionable audit reports and support vendors in closing gaps through Corrective and Preventive Action Plans (CAPAs), employee training, and procedural upgrades.
Regulatory Expectations are Clear
Authorities such as the MHRA, EMA, and FDA now explicitly expect that all third-party vendors, including packaging and labelling partners, be audited and qualified—especially if they have a role in product identification or traceability.
Neglecting this area can lead to:
- GDP non-compliance findings
- Suspension of distribution rights
- Product recalls due to labelling or tampering errors
Work with Q&V to Strengthen Supply Chain Control
Secondary packaging may be the final step before your product reaches the patient. Don’t let it be the weakest link. Q&V helps companies ensure that their packaging and labelling partners meet the same GDP compliance standards expected throughout the pharmaceutical chain.
Let us support you in conducting thorough, risk-based audits that give you peace of mind—and ensure patient safety.