Good Distribution Practices (GDP) and Good Storage Practices (GSP)

Comprehensive vocabulary flashcards covering Good Distribution Practices (Annex 5) and Good Storage Practices (Annex 9) for pharmaceuticals and medical devices.

Scope of Distribution and Storage Guidelines

The principle that guidelines apply across all steps of distribution and storage in the supply chain for both drugs and medical devices.

Good Distribution Practices (GDP / Annex 5)

Guidelines established to maintain drug quality, safety, and identity throughout all stages of the distribution process (such as procurement, purchasing, storage, transport, import/export, and repackaging) and to prevent substandard or falsified medicines from entering the market.

Good Storage Practices (GSP / Annex 9)

Standards intended to ensure that the quality of pharmaceutical products is maintained through adequate and highly controlled storage conditions.

Personnel Hygiene and Sanitation

The requirement for staff to receive documented training on GDP/GSP, health, hygiene, and pest control.

Storage Area Access Control

Safety and security measures implemented to prevent unauthorized persons from entering pharmaceutical storage areas.

Storage Status Labelling

Mandatory identification markers applied to designated materials and holding zones, specifically labeling items as "Quarantine, Rejected, and Recalled".

Storage Capacity and Layout Requirements

The requirement that storage areas have sufficient capacity to provide orderly storage for various categories of materials or pharmaceutical products.

Storage Area Environmental Maintenance

The operational requirement that warehouse facilities remain clean, dry, and maintained within acceptable temperature limits.

Spacing Requirements in Storage Areas

The rule that pharmaceutical products must be stored off the floor and off the wall with adequate spacing to allow for proper cleaning and inspection.

Normal Storage Conditions

Environmental parameters kept in compliance with product labels, defined as temperatures of $15-25^\top$ to $25^\top$ (or up to $30^\top$) and a relative humidity below $60\,\%$.

Container Labelling Standards

The standard stating that all containers must be clearly and indelibly labeled without unauthorized abbreviations, internal codes, or handwritten shorthand, showing product name (generic and brand), batch/lot number, expiry or retest date, specified storage conditions, and pharmacopoeia references (e.g., USP, BP, JP).

Receipt Rule 1 (Verification)

The incoming material procedure where every delivery is cross-checked against the relevant purchase order and physically verified by label description, batch number, material type, and quantity.

Receipt Rule 2 (Inspection & Quarantine)

The incoming material protocol requiring careful inspection of each container for contamination, tampering, and damage, with suspect containers or whole deliveries placed in quarantine for further investigation.

FEFO (First Expiry, First Out)

The primary pharmaceutical stock rotation standard dictating that products with the earliest expiration dates are dispatched or distributed first, regardless of when they arrived at the warehouse.

FIFO (First In, First Out)

The operational backup stock rotation method where the oldest stock in the warehouse, determined by the date of receipt, is dispatched first.

Control of Obsolete and Outdated Products

GSP guidelines requiring immediate physical segregation of obsolete, outdated, and expired materials from active, sellable inventory into a designated Quarantine Area or Rejected Area.

Visual Controls for Segregated Inventory

Distinct, highly visible color markers used on storage areas, bins, pallets, or cartons, typically utilizing RED for "Rejected/Expired" and YELLOW for "Hold/Quarantine".

Returned Goods Protocol

The procedure requiring returned and recalled goods to be handled under approved processes, recorded, quarantined, and only returned to saleable stock upon approval by a nominated, responsible person after a satisfactory quality re-evaluation.

Mandatory Shipping Documents

Documentation required under GDP to ensure complete batch traceability, consisting of a Delivery Receipt (DR) and Sales Invoice stating dispatch date, customer contact and delivery details, product description, batch/lot number, expiry date, quantity dispatched, and required storage conditions.

Cold Chain Management

A critical aspect of pharmaceutical logistics focused on preserving temperature control for sensitive biologics, vaccines, and injectables, typically maintained at $2^\top$ to $8^\top$ or below $25^\top$.