Quality packaging solutions for pharmaceutical and regulated applications
Pharmaceutical primary packaging solutions manufactured under GMP-aligned conditions, with full batch traceability and cleanroom production where required.
Ensuring Patient Safety and Regulatory Compliance
Manufactured under GMP-aligned conditions ALPLApharma supplies primary packaging solutions for: pharma, OTC, medical device, and diagnostic applications across human and veterinary healthcare offering:
What proves our quality?
1. Performance in qualification and audits
Supplier qualification is often time-intensive and audit-driven. Our production sites operate with audit-ready systems and transparent documentation. Regular audits by certification bodies, pharmaceutical customers and independent platforms provide a consistent, verified view of performance. Our selected sites have achieved external ratings of Qualifyze, such as Gold (Ansbach Germany) and Silver (Markdorf Germany), with audit reports available to support qualification.
DMF and inspection support are provided where required. Existing documentation, QA support and pre-assessed sites help:
✔ Reduce duplicate audits
✔ Enables teams to move faster from evaluation to approval.
2. Reproducible batch quality through inspection
Quality performance is ultimately measured by consistency in outputs. Validated manufacturing processes, defined inspection procedures and controlled material release ensure that each batch meets the same requirements. Quality is validated initially, but also continuously demonstrated in production through:
✔ Systematic automated inspection
✔ Test planning
✔ Defined batch release procedures
✔ Consistent in-process control (IPC) checkpoints
3. Traceability at every step
All relevant production and quality data is documented and traceable at batch level. From material verification to final inspection, each step is recorded and accessible, for all our standardised products and custom-made solutions. Ensuring :
✔ Full visibility for audits, investigations and regulatory requirements
✔ Quality performance can be demonstrated with evidence
4. Controlled change across the lifecycle
Maintaining consistent performance over time requires structured control of change. All process adjustments, material changes and product adaptations are formally assessed, documented and verified before implementation. Deviations are managed through defined quality systems, with risks identified, tracked and controlled throughout. This ensures that:
✔ performance remains stable after changes
✔ risks are identified early
✔ corrective actions are clearly documented
5. Continuous monitoring and improvement
Quality performance is continuously monitored during production. Inspection strategies and test plans are adapted based on process performance, enabling early detection of deviations and ongoing optimisation. Environmental conditions, process stability and inspection results are part of this continuous review. This ensures that:
✔ Quality systems evolve with product requirements
✔ Maintaining control and compliance
Certified for pharmaceutical compliance
Internationally recognized certifications confirm compliance with pharmaceutical, medical device, cleanroom, and environmental standards across relevant production sites. They support customer qualification, audit preparation, and regulatory requirements for regulated applications.
Cleanroom Production
For sensitive applications, production takes place in cleanroom environments aligned with ISO and EU GMP requirements enabling controlled manufacturing capabilities.
Production follows defined cleanliness control strategies, including validated processes, environmental monitoring, and defined material and personnel flows. These measures minimize contamination risk and ensure reproducible product quality under controlled conditions.
* depending on product requirements
Discuss your quality requirements
Whether you are preparing for an audit, in need of quality documentation or managing lifecycle changes, our team can support you.
