Quality & patient safety

Quality is the system that connects every decision.

Our approach brings partner qualification, documentation, product oversight, safety reporting, storage, distribution, and continuous improvement into one accountable framework.

Quality framework

Controls designed around the medicine lifecycle.

Requirements are scaled to the product, activity, market, and risk. The goal is consistent: protect patients and preserve product integrity.

Quality governance

Defined responsibilities, documented procedures, controlled records, issue escalation, and periodic review.

Partner qualification

Risk-based due diligence covering capability, authorisation, documentation, history, and intended role.

Distribution integrity

Storage, transport, monitoring, traceability, complaints, and deviation management.

Safety surveillance

Collection, documentation, assessment, and appropriate onward reporting of safety information.

Change control

Structured evaluation of changes that may affect product quality, information, supply, or patients.

Continuous improvement

Use complaints, deviations, audits, safety data, and partner feedback to improve controls.

Pharmaceutical bottles on an automated production line

Supply-chain integrity

Traceability from approved source to intended recipient.

Responsible supply depends on knowing who handled the product, under what conditions, against which specification, and with what documentation.

  • Source and counterparty verification
  • Batch, expiry, packaging, and label checks
  • Temperature and handling requirement review
  • Controlled complaint and recall communication

Pharmacovigilance

Every safety report matters.

A suspected adverse event does not need to be proven before it is reported. Useful initial information includes the patient, the reporter, the suspected product, and what happened. Our team may follow up for details needed to assess and process the report.

For urgent medical concerns, contact a healthcare professional or local emergency service first. Reporting to Bastian does not replace immediate medical care.

What you can report

  • Suspected side effects or unexpected symptoms
  • Medication errors, overdose, misuse, or exposure
  • Pregnancy or breastfeeding exposure
  • Lack of expected effect where clinically significant
  • Product appearance, packaging, device, or storage concerns

Responsible sourcing

Quality expectations extend to how we choose partners.

Authorisation

Appropriate legal and professional standing for the proposed activity.

Capability

People, systems, facilities, and controls suited to the product and role.

Transparency

Accurate information, responsive communication, and clear records.

Improvement

Willingness to investigate issues and strengthen performance.

Quality contact

Raise a product-quality or safety concern.

Provide the product name, batch or pack details if available, what happened, when it occurred, and the best way to contact you.