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.
Pharmaceutical packaging must perform consistently
Manufactured under GMP-aligned conditions ALPLApharma supplies primary solutions for: OTC, medical device, and diagnostic applications across human and veterinary healthcare offering:
Efficient qualification and audit readiness
Audit-ready documentation, QA support, and full traceability support structured qualification and inspection procedures. Production sites are regularly audited by certification bodies, pharmaceutical customers, and platforms such as Qualifyze.
Audit reports are available to reduce duplicate audits and support supplier qualification. DMF and inspection support are provided where required.
Selected Qualifyze site assessments include:
- Ansbach (Germany): Gold standard rating
- Markdorf (Germany): Silver standard rating
Reproducible batch quality through inspection
Validated manufacturing processes and defined inspection procedures ensure reproducible results across batches. Materials are verified and released prior to use. Production takes place under GMP-aligned conditions, including cleanroom environments where required.
Quality is continuously monitored throughout production using in-process control (IPC) checkpoints, automated and visual inspection, and defined batch release procedures, ensuring full traceability.
Test planning is adapted during serial production based on product and process performance.
Reliable performance and change control
Validated processes and structured change management ensure consistent product performance for standard products and custom-made solutions.
Changes are assessed, documented, and verified before implementation. Environmental monitoring, line clearance, and defined batch release procedures ensure qualified production conditions. Deviations are managed through defined processes, ensuring risks are identified, controlled, and continuously monitored, supporting consistent performance and supply continuity.
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
For sensitive applications, production takes place in controlled 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
If you are qualifying a supplier, preparing for an audit or managing lifecycle changes, our team can support you with the required quality framework.
