DRAP GDP Guidelines 2023 - Detailed Summary
1. Quality Management
- Distributors must establish a comprehensive quality system covering roles, responsibilities, risk management, SOPs,
and document control.
- All operations should be regularly reviewed by management with documentation of changes and continuous
improvements.
- Any outsourced activities (transport, storage) must comply with GDP. Risk-based audits must be conducted.
- CAPA (Corrective and Preventive Actions) should be taken for all deviations.
- Change control system must assess and manage any changes in premises, equipment, or processes.
2. Personnel
- Competent and trained staff are essential. Responsibilities must be clearly documented.
- A Responsible Person (RP) ensures the implementation of the quality system, manages SOPs, recalls, complaints,
returns, and staff training.
- Staff must be trained initially and regularly, including identification of falsified medicines.
- Personal hygiene procedures, protective clothing, and codes of ethics must be in place.
3. Premises and Equipment
- Facilities must be secure, clean, temperature-controlled, and pest-free.
- Products should be physically or electronically segregated based on their status (e.g., quarantined, returned, expired).
- Temperature mapping should be done before use and after major changes.
- Equipment like refrigerators and alarms must be regularly calibrated and maintained.
- Computer systems must be validated; data should be backed up and secured.
4. Documentation
- All operations must be documented including SOPs, records of training, procurement, dispatch, returns, etc.
- Records must be legible, signed, and preserved for at least 3 years.
- Changes in documents must be tracked; obsolete versions must not be used.
- Documents should be accessible and regularly reviewed to remain compliant with GDP.
5. Operations
DRAP GDP Guidelines 2023 - Detailed Summary
- Verify suppliers (DML, GMP certificate) and customers (DSL or institutional authorization).
- New products must be classified and assessed for regulatory and storage requirements.
- Upon receiving, inspect the shipment for correctness and damage.
- Follow FEFO (First Expiry First Out) principles for inventory management.
- Maintain a pest control program and ensure clean storage.
- Dispatch procedures must be documented with all details (product, batch, expiry, etc.).
- Cold chain management must comply with DRAP's specific guidelines.
- Disposal of expired or recalled drugs must follow DRAP and environmental laws.
6. Complaints, Returns, Falsified Drugs & Recalls
- Complaint records must differentiate between quality and distribution issues.
- Returned products must be assessed and can only re-enter stock with RP's approval.
- Falsified products must be reported to DRAP and the MAH.
- Recall procedures must be pre-approved, documented, and coordinated with DRAP.
- Maintain recall logs and evaluate effectiveness after completion.
7. Outsourced Activities
- Contracts between the principal and contractor must define roles and ensure compliance.
- Contractors must not sublet work without permission and must provide all distribution-related information.
8. Self-Inspection
- Regular internal audits must be carried out on all GDP processes.
- Reports must document findings, root causes, and corrective actions.
9. Transportation
- Distributors must maintain product quality during transport using risk-based planning.
- Vehicles must be clean, secure, and appropriate for drug distribution.
- Cold chain and controlled substances require special validated transport.
- All transportation conditions (e.g., temperature logs) must be documented.
