Standards · Quality Assurance
Quality assurance.
Quality assurance at ExoBioCorp is the framework that selects manufacturing partners, controls documentation, and authorizes per-lot release. The framework is applied uniformly across the Altogex, CytoCord, ExCyte, and Nexa Biologix product lines.
Supplier qualification
Every manufacturing partner in the ExoBioCorp supply chain undergoes initial qualification before any product flows through. Qualification reviews include:
- Establishment registration documentation under applicable frameworks (21 CFR Part 1271 Subpart B where the manufacturer ships HCT/Ps)
- Quality system documentation (ISO 9001:2015 or equivalent)
- Laboratory accreditation (ISO/IEC 17025:2017 where the manufacturer performs in-scope testing)
- Biobanking accreditation (ISO 20387 where applicable)
- GLP framework adherence for relevant product categories
- Donor-source documentation and 21 CFR Part 1271 Subpart C compliance
- Sample lot inspection and characterization data review
Document control
Per-lot documentation is captured at receipt and stored in a versioned, lot-traceable archive accessible to the customer through the verified-account portal. Documentation includes:
- Certificate of Analysis (manufacturer-issued)
- Donor eligibility documentation (where applicable)
- Cold-chain temperature log for the manufacturer-to-distributor leg
- Cold-chain temperature log for the distributor-to-customer leg
- Customs and import documentation for international lots
- Per-order RUO acknowledgment
Lot-release procedure
Each lot is reviewed before release to a customer order. Lot review verifies:
- Certificate of Analysis is complete and meets product specification
- Donor eligibility documentation is present where applicable
- Sterility, mycoplasma, and endotoxin results are within specification
- Identity / characterization results are within specification
- Cold-chain documentation shows no excursions
- Storage history at ExoBioCorp shows no temperature excursions
Lots failing any of the above are placed on hold and not released to customers.
Customer complaints and adverse-event reporting
Customer complaints relating to product quality are logged, investigated with the manufacturing partner, and resolved with corrective action where applicable. Where a complaint indicates a product-quality issue affecting other lots or customers, ExoBioCorp will issue a customer notification consistent with our quality system commitments.
Continuous improvement
Supplier performance, lot-release exception rates, customer complaint trends, and cold-chain exception rates are reviewed periodically and feed back into supplier qualification renewal and procedural updates.