Quality & Compliance

Quality Built Into Every Component We Manufacture

Pharmaceutical packaging components must perform without exception. Our ISO 9001 certified quality management system, GMP-compliant manufacturing, and deep regulatory expertise ensure that every label, foil, and custom component we produce meets the standards your products demand.

From incoming material inspection through batch release documentation, quality is not a final check — it is embedded in every step of our process.

Certifications

Our Quality Credentials

Independently certified and continuously maintained — our quality credentials provide the assurance your QA team requires.

ISO 9001 Certified

Our quality management system is certified to ISO 9001, providing a structured framework for consistent process control, continual improvement, and customer satisfaction across all manufacturing operations.

GMP-Compliant Manufacturing

All production operations are conducted in accordance with Good Manufacturing Practice principles — covering personnel, premises, equipment, documentation, production, quality control, and distribution.

FDA Registered Facility

Our facility is registered with the U.S. Food and Drug Administration, enabling supply of packaging components to FDA-regulated drug products and compliance with 21 CFR labeling requirements.

Full Material Traceability

Every raw material and finished component is tracked through our quality management system from incoming inspection through batch release — providing complete traceability for every production lot.

Quality Control Process

From Incoming Inspection to Batch Release

A five-stage quality control process that ensures every component leaving our facility meets specification — with full documentation at every step.

01

Incoming Material Inspection

All substrates, adhesives, inks, and foils are inspected and tested against approved specifications before entering production.

02

In-Process Quality Control

Inline inspection systems monitor print registration, colour density, barcode readability, and dimensional accuracy throughout every production run.

03

Barcode & Serialization Verification

Every serialized label is 100% verified against ISO/IEC 15415 and 15416 standards. Non-conforming labels are automatically rejected and quarantined.

04

Finished Goods Inspection

Final inspection covers print quality, die-cut accuracy, adhesion testing, and label count verification before batch release.

05

Batch Release & Documentation

Every batch ships with a Certificate of Analysis, material traceability records, and full quality documentation to support your QA release process.

Regulatory Standards

Standards We Design and Manufacture To

A comprehensive reference of the regulatory frameworks and technical standards that govern our products and processes.

StandardTitleScope at PharmaPackPro
ISO 9001Quality Management SystemsAll manufacturing operations
ISO 11607Packaging for Terminally Sterilized Medical DevicesSterile barrier systems and packaging materials
ISO 11040Prefilled SyringesSyringe label design and application
ISO 15223Symbols for Medical DevicesLabel symbology and graphical elements
ISO 17351Braille on Packaging for Medicinal ProductsBraille embossing specification and verification
EU FMDFalsified Medicines Directive (2011/62/EU)Serialization, unique identifiers, tamper-evident features
FDA 21 CFR 801Labeling — General RequirementsU.S. drug product labeling compliance
FDA 21 CFR Part 11Electronic Records and SignaturesVariable data printing and serialization systems
ICH Q1BPhotostability Testing of New Drug SubstancesLight-protective substrate qualification
USP <661>Plastic Packaging Systems and Their MaterialsSubstrate material compliance
USP <1>Injections and Implanted Drug ProductsVial and syringe label performance
EP 3.2.1Glass Containers for Pharmaceutical UseLabel adhesion on glass primary containers
DSCSADrug Supply Chain Security ActU.S. serialization and traceability requirements
PharmaPackPro quality management documentation
Quality Management System

A QMS Designed for Pharmaceutical Supply

Our quality management system goes beyond ISO 9001 certification. It is specifically structured to meet the expectations of pharmaceutical QA teams — with the documentation, traceability, and change control processes that regulated supply chains require.

Documented change control procedures
Supplier qualification and audit programme
Non-conformance and CAPA management
Customer complaint handling and root cause analysis
Internal audit schedule and management review
Calibration and equipment qualification records
Retention samples held for every production batch
Full electronic batch records available on request
Quality Documentation

Need Our Quality Documentation?

We can provide ISO certificates, facility registration details, material compliance data, and supplier questionnaire responses to support your vendor qualification process. Contact our quality team to request a documentation pack.