International GDP Guidelines and Regulations 2014

COUNTRIES / AREA WORLDWIDE

AUSTRALIA – Therapeutic Goods Administration (TGA).

Australian Code of Good Wholesaling practice for therapeutic goods for human use.

WORLD HEALTH ORGANIZATION (WHO)

1. WHO TRS No. 957, Annex 5 (2010). Good Distribution Practices for Pharmaceutical Products.
2. WHO TRS No. 961, Annex 9 (2011). Model Requirements for the storage and transport of time and temperature sensitive pharmaceutical products

ARGENTINA – National Administration of Drugs, Food and Medical Devices (ANMAT).

Ley 26.492, Regulación de la cadena de frio de los Medicamentos, 2009

IATA – IATA Perishable Cargo Regulations (PCR).

Chapter 17: “Air Transport Logistics for Time and Temperature Sensitive Healthcare Products”

BRAZIL – The National Health Surveillance Agency (ANVISA).

Public Consultation on GMP and GDP certification requirements. (15/01/13 until 15/03/13)

ISTA – International Safe Transit Association.

Standard 20: Design and Qualification of Insulated Shipping Containers.

CANADA – Health Canada

(GUI-0069). Guideline for Temperature Control of Drug Products during Storage and Transportation

UNITED STATES PHARMACOPEIA (USP).

1. USP General Chapter <1079> Good Storage and Shipping Practices.

2. USP General Chapter <1083> Good Distribution Practices—Supply Chain Integrity.

CHINA – Chinese Ministry of Health (MOH).

Revised Good Supply Practice (GSP) Standards for Pharmaceutical Products.

IPEC – International Pharmaceutical Excipients Council (IPEC).

The IPEC—Europe Good Distribution Practices Audit Guideline for PHARAMCEUTICAL EXCIPIENTS 2011

DENMARK – Danish Health and Medicines Agency.

Executive Order No. 823 (IDRAC 148449): Distribution of Medicinal Products.

ICH – International Conference on Harmonization.

Quality Guidelines Q1A (R2) Stability Testing of New Drug Substances and Products.

EU – European Commission.

Guidelines of 5 November 2013 on Good Distribution Practice of Medicinal Products for Human Use (2013/C 343/01)

PDA – Parental Drug Association (PDA)

  1. PDA Technical Report Technical Report No. 52 (Aug 2011), Guidance for Good Distribution Practices (GDPs) for the Pharmaceutical Supply Chain.
  2. PDA Technical Report Technical Report No. 39, Guidance for T emperature Controlled Medicinal Products: Maintaining the T emperature Sensitive Medicinal Products through the Transportation Environment.
  3. PDA Technical Report Technical Report No. 46, Last Mile: Guidance for Good Distribution Practices for Pharmaceutical Products to the End User.

INDIA – Central Drugs Standard Control Organisation (CDSCO)

Guidelines On Good Distribution Practices for Biological Products.

DRAFT Guidance on Good Distribution Practices for Pharmaceutical Products

IRELAND – Irish Medicines Board (IMB).

Guide to Control and Monitoring of Storage and Transportation Temperature Conditions for Medical Products and Active Substance.

SINGAPORE – Health Sciences Authority (HAS)

DRAFT Guidance notes on Good Distribution Practices

UNITED KINGDOM – Medicines and Healthcare products Regulatory Agency (MHRA).

Guidance in the Transportation of Medicinal, ambient and refrigerated.

Guidance: Medicines distribution in the maritime sector.

USA – FDA Food and Drug Administration.

Code of Federal Regulations, 49 CFR, Food Drug & Cosmetic Act, Chapter V, Sect. 501, Sub-chapter A,

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