Compliance is not a checkpoint — it's the workflow
Every material that moves through Adapharma is qualified, tested and documented against the same regulatory bar our clients are audited on. Here is exactly how that process works.
No supplier enters the network unaudited
Every manufacturing partner is evaluated against facility GMP status, quality management systems, regulatory dossier availability and historical batch performance before being approved to supply. Approval is re-confirmed on a fixed audit cycle, not granted permanently.
| Step 1 | Facility & GMP status review |
|---|---|
| Step 2 | Regulatory dossier verification |
| Step 3 | Independent sample testing |
| Step 4 | Trial batch traceability audit |
| Step 5 | Network approval & listing |
| Ongoing | Scheduled re-audit & surveillance |
Every shipment can be traced to its source batch
Traceability isn't a report we generate on request — it's structured into how each order is documented from the moment a batch is produced.
Batch-Level Traceability
Every batch is tracked from manufacturing site to receiving dock, with a documented chain of custody.
Complete Documentation Sets
COA, MSDS/SDS, and applicable regulatory files are compiled before an order ships, not requested after.
Continuous Surveillance
Approved suppliers remain subject to periodic re-audit, batch monitoring and documentation renewal.
The paperwork your regulatory team actually needs
Certificate of Analysis
Batch-specific testing results issued with every shipment, matched to compendial or client specifications.
Safety Data Sheet
GHS-aligned safety documentation, formatted for the destination market's regulatory requirements.
Drug Master File
Available for applicable APIs, supporting client regulatory submissions where required.
Certificate of Suitability
Verified CEP status for European market materials, confirmed at point of sourcing.
GMP and ISO are the floor, not the ceiling
Adapharma requires current Good Manufacturing Practice certification and relevant ISO quality management certification from every manufacturing partner as a baseline — then layers our own audit and testing requirements on top.
GMP
Good Manufacturing Practice, verified at facility level
ISO 9001
Quality management system certification
ISO 13485
Applicable for medical device-linked equipment suppliers
ICH Q7
GMP guideline for API manufacturing, applied in supplier review
From audit to delivery
Supplier Audit & Approval
Facility, dossier and quality system review before network entry.
Order Qualification
Specification confirmation and documentation planning per order.
Batch Testing Verification
COA cross-checked against agreed specification prior to release.
Traceable Logistics
Chain-of-custody documentation maintained through transit and customs.
Delivery & Documentation Handover
Full documentation package delivered alongside physical shipment.