Pharmaceutical labeling process

Our seven-step labeling/packaging process for prescription and over-the-counter pharmaceutical applications ensures fidelity on every order.

MedLit Solutions, A Resource Label Group Company. Pharmaceutical labeling and packaging.
Pharmaceutic Litho & Label Company, A Resource Label Group Company. Pharmaceutical labeling and packaging.
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our Process

Seven steps to ethical Rx and consumer healthcare product labels

From initial design to final quality controls, our experts will guide your pharmaceutical label orders all the way to consumers in a market where dependability can be truly vital.

Folded medical inserts.

We’re making the essential seem effortless

Every detail of our process is designed to deliver the components essential to your operations and remove stress from DSCSA compliance and other regulatory requirements.

Digital, flexographic and offset technology

Digital, flexographic and offset technology

Complete process documentation

Complete process documentation

ISO 13485 standards

ISO 13485 standards
(Gintzler International, NY)

Our PRocess

Our seven-step process to pharmaceutical labeling

1. Needs analysis

We begin by identifying the optimal drug packaging based on the unique demands of the product, branding and applicable regulations.

2. Concept evaluation

Once we’ve determined the best solution, we prove it by conducting a feasibility study, initial testing and material review in compliance with ISO, FDA, REACH and other regulations. We also consider further security, product performance and innovative applications improvements.

3. Pre-production planning

Next, we establish timelines to ensure we meet every milestone. This planning includes reviewing samples and prototypes, establishing initial production methodology, performing quality-control testing and linking critical requirements within the ERP system.

4. Proofing

Creating proofs is the last stage of label and packaging accuracy review. This could include ink drawdowns, 3D modeling and/or production press proofing.

5. Pre-production approval

Before the rollout, we validate the product and application. Samples can be provided for client testing at this time.

6. Customized production

Products are then manufactured in accordance with ISO 13485 standards, including:

  • Regulatory compliance assistance and component verification testing (e.g., trace element analysis, performance and composition certification, etc.)
  • Security controls best suited for the needs of the individual customer
  • Line clearances, area segregation and individual product cages throughout the converting process
  • Complete inline text verification when necessary
  • Backside consecutive numbering for label count reconciliation upon request
  • Finish rolls with leaders and trailers as required, and perfect roll tension to ensure smooth operation on application equipment
  • Sealed and securely wrapped pallets of finished goods to support FDA/GS1 initiatives
  • Complete chain of custody within a secure production facility

7. Documentation

Document controls offer complete product traceability in line with current good manufacturing practices (cGMPs). This process includes full raw material and shipment chain of custody, first piece validation by internal PCM, a certificate of compliance supplied with each shipment, final QC inspection and approval, and a product record finalized within the ERP system.

Who we are

National Reach. Local Touch.®

When you work with the Resource Label Group family, you’re gaining an efficient edge over the competition. With locations throughout the U.S. and Canada, we provide the services, solutions and reach you expect from a national company, with the dedication and touch of a local partner.