Good Distribution Practice
Temperature control, FEFO, traceability and party qualification are managed together for medicinal-product storage and distribution.
About Omega Depot
Quality Assurance
The quality system behind Omega Depot services: GDP-governed storage and distribution, pharmaceutical track and trace, deviation/CAPA and change control,…
92active procedures
70quality lists
507forms and records
166audit records
GDP systemCold chainİTS processesISO 9001TİTCK inspections
PLT.01
Our quality policy
Our primary goal is to be an organisation that supports sustainable growth, creates value and gives competent professionals pride in their contribution.
We commit to improving process efficiency through data management and digital tools, and to meeting customer expectations with quality products and services.
We work to improve process, product and service quality continually by evaluating risks and opportunities.
Quality management system
The control structure behind every operation
Pharmaceutical Track and Trace
In-scope medicine movements are linked to İTS records through receipt, dispatch, return and destruction.
Quality risk management
Process risks, controls, monitoring actions and owners are identified and documented.
Document control
Policies, procedures, lists and forms are governed through controlled-copy, version and effective-date rules.
Training and competence
Role-specific GDP, quality, cold-chain and occupational-safety training is planned and recorded.
Continual improvement
Internal audit, deviation, CAPA and management-review outputs are used to improve the quality system.
Depot operation
Controlled product flow from receipt to dispatch
- 01
Receipt
Supplier, document, packaging and temperature-record checks
- 02
Quality check
Visual inspection, İTS and conformity assessment
- 03
Quarantine
Physical and system segregation pending disposition
- 04
Storage
FEFO, location, temperature and stock-status control
- 05
Dispatch
Vehicle, packaging, logger and delivery records
Controlled products
Additional security and accountability
- Locked and controlled storage
- Role-based physical access
- Complete movement records
- Responsible-manager oversight
- Tracking of statutory notifications
CAPA · DÖF
From deviation to effectiveness check
- Deviation detectionTemperature, packaging, document or process deviations are recorded.
- Root-cause analysisRoot and contributing causes are investigated with an appropriate method.
- Corrective actionAction is taken to remove the current nonconformity.
- Preventive actionSystem improvements are planned to reduce recurrence risk.
- Effectiveness checkResults are monitored and the closure decision is documented.
Controlled documentation
Pharmaceutical warehouse procedure map
Temperature monitoring
Records, alarms, calibration and deviation
Continuous monitoring
Sensor data from storage areas is recorded automatically.
Alarm management
Defined limit events initiate the escalation workflow.
Calibration
Measuring devices are calibrated to schedule; overdue devices are withheld from use.
Deviation management
Product impact is assessed and CAPA is opened when required.
Assurance
Internal and external audit cycle
Internal audit
Planned audits cover storage, temperature, dispatch, controlled products and record management.
External audit
Authority, customer and supplier audit outputs are tracked under control.
Management review
Quality-system performance, risks and improvement actions are evaluated by senior management.
Content is based on Omega’s quality-system compilation derived from PLT.01, PRD.31, PRD.55–74 and related quality lists. Contact the Quality Unit for current controlled copies.
Qualification package
Vendor qualification readiness
These materials may be supplied during qualification after confidentiality, validity and sharing authority are checked.
Exact scope and controlled copies are confirmed against the requester, product and audit agenda.- 01Current licence and certificate index
- 02Quality manual/procedure map
- 03Training and role-competence approach
- 04Deviation, CAPA and change workflow
- 05Supplier qualification and audit approach
Quality system
The controls and records behind every process
Quality-system governance
The starting point is product and study scope. Client-facing output: Qualification response package.
Training and role competence
The starting point is audit or qualification agenda. Client-facing output: Approved document index.
Deviation, CAPA and change control
The starting point is expected document list. Client-facing output: Action and ownership list.
Supplier and record management
The starting point is target assessment date. Client-facing output: Meeting/close-out record.
Procurement brief
Quality Assurance
Quality assessment goes beyond certificate logos: it examines how procedures, training, deviations, CAPA and change are governed.
Included in scope
- Quality-system governance
- Training and role competence
- Deviation, CAPA and change control
- Supplier and record management
Outside scope
- Unsupported certification claims
- Quality disposition on the customer’s behalf
- Public release of confidential audit records
Inputs we need
- Product and study scope
- Audit or qualification agenda
- Expected document list
- Target assessment date
Records delivered
- Qualification response package
- Approved document index
- Action and ownership list
- Meeting/close-out record
Risks affecting timing
- Expired evidence
- Misread certification scope
- Unclear action ownership
Operating model
From uncertainty to a traceable outcome
Every project follows the same control logic, adapted to product and protocol requirements.
- 01
Validate inputs
Product and study scope
- 02
Lock the scope
Audit or qualification agenda
- 03
Execute with control
Action and ownership list
- 04
Close with records
Meeting/close-out record
Service-specific FAQ
What to know before scoping
Expired evidence
Evidence is validated during scoping and shared only when publication is authorised.
Misread certification scope
Evidence is validated during scoping and shared only when publication is authorised.
Unclear action ownership
Evidence is validated during scoping and shared only when publication is authorised.
Inside the facility
Real infrastructure, real operations
Omega Depot
Plan your next shipment with confidence
Share the product, route and timeline; our team will map a workable operational flow.