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Supply and distribution records in pharmacy

Last updated See all updates
Topics: Record keeping

Recommendations on the retention of pharmacy records relating to the movement of medicines between locations.

This article forms part of a series
  1. Retaining and storing pharmacy records in England
    1. Additional services records in community pharmacy
    2. Clinical governance and patient safety records in pharmacy
    3. Clinical trial records in hospital pharmacy
    4. Controlled Drugs (CD) records in pharmacy
    5. Prescription and dispensing records in community pharmacy
    6. Prescription and dispensing records in hospital pharmacy
    7. Stock management, waste and recall records in pharmacy
    8. Supply and distribution records in pharmacy
    9. Technical service records in hospital pharmacy

Contents

  1. Using our advice
  2. Specific records
    1. ATMP traceability
    2. Distribution and transfer
    3. Homecare medicine distribution
    4. Procurement and receipt
    5. Traceability and recall
  4. Update history

Using our advice

Pharmacy teams create supply and distribution records to demonstrate that medicines have been procured, stored, transported and supplied safely throughout the supply chain.

These records support traceability, product recalls, audit, regulatory inspections and investigations into medicine quality defects.

Retention requirements for these records are primarily derived from Guidelines on Good Manufacturing Practice (GMP), Guidelines on Good Distribution Practice of medicinal products for human use (GDP), with additional requirements applying to certain products such as advanced therapy medicinal products (ATMPs).

Where multiple retention periods apply, organisations should normally retain records for the longest applicable period. See Retaining and storing pharmacy records in England (SPS page) for factors that may justify longer retention.

Specific records

Record description

Records such as chain of custody, donor and recipient traceability, storage, distribution, and disposal.

Minimum retention time

  • retain traceability records for at least 30 years after the expiry date of the product

Supporting source

The Guidelines on Good Manufacturing Practice for Advanced Therapy Medicinal Products advises manufacturers on traceability record retention.

Record description

Records such as inter-site transfer, delivery manifests, goods dispatch, and proof of delivery.

Minimum retention time

  • retain records for at least 5 years

Supporting source

The GMP advises on distribution record retention.

Record description

Records such as delivery confirmations, tracking and failed delivery.

Minimum retention time

  • retain records for at least 5 years

Supporting source

The GMP advises on distribution record retention.

Record description

Records such as purchase orders, good received receipts, and delivery notes.

Minimum retention time

  • retain records for at least 5 years

Supporting source

The GMP advises on distribution record retention.

Record description

Records such as batch traceability, product tracking, recall actions, and recall communications.

Minimum retention time

  • retain records for at least 5 years

Supporting source

The GMP advises on traceability and distribution record retention.

Update history

  1. Republished
  2. Full review and republish
  1. Link updated for the Records Management Code of Practice (RMCoP).
  1. Published