Quality and control

Quality is the foundation of everything we do at Nexgen Pharma Pack. Our commitment is to deliver sterile, reliable and fully compliant primary packaging solutions through rigorous controls, certified processes and a culture of continuous improvement.

1. Total Quality Management

We apply a comprehensive and integrated quality system aligned with GMP, ISO standards and global regulatory requirements. Each phase — from raw material selection to final inspection — follows validated and documented procedures.

2. Advanced Inspection Technologies

Our production lines are equipped with state-of-the-art control systems, including:

  • automated optical inspection (AOI),

  • dimensional and metrological verification,

  • integrity and sealing tests,

  • in-line and end-of-line sterility checks.

These technologies ensure maximum accuracy and zero-compromise quality.

3. Full Traceability

Every component is tracked throughout the entire production cycle. Serial numbers, batch records, cleanroom data and process parameters are digitally recorded to ensure complete transparency and rapid retrieval.

4. Controlled Cleanroom Environment

Production takes place in certified sterile environments with continuous monitoring of:

  • particulate levels

  • microbial contamination

  • temperature and humidity

  • process integrity and operator compliance

This guarantees the highest level of product safety for pharmaceutical and biotech applications.

5. Supplier Qualification & Material Verification

All suppliers undergo rigorous qualification processes. Incoming materials are tested for purity, dimensional consistency, mechanical performance and regulatory compliance before entering production.

6. Continuous Improvement & Training

Quality is a shared responsibility. Our teams receive ongoing technical training, and our processes are constantly reviewed to optimize performance, reduce risks and prevent deviations.

7. Documented Compliance

We provide complete documentation, including:

  • Certificates of Analysis (CoA)

  • Certificates of Conformity (CoC)

  • validation reports

  • IQ/OQ/PQ data

  • risk assessments and CAPA records

This ensures full regulatory support for all partners worldwide.

Nexgen Pharma Pack PLC

Headquarters 124-128 City Road 
EC1V2NX London 
Industrial address Highwork Road Swindon 
SN34TZ United Kingdom
Share capital 1,300.000.00

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