Lesson #10: Global Regulations and Guidance Documents
This is the 10th Lesson in CoolPack’s series of Cold Chain Lessons.
CoolPack thanks David Ulrich, from Abbott Pharma Distribution QA for providing the original information in this Lesson.
Do you have an update to a regulation? Tell us about it so that we can maintain this Lesson up to date.
Regulatory Guidances by Countries and/or Regions:
- Argentina
- Australia
- Brazil
- Canada
- China
- Czech Republic
- Denmark
- Egypt
- Europe
- India
- Indonesia
- Ireland
- Japan
- Malaysia
- Pakistan
- Romania
- Russia (Belarus & Kazakhstan) & EEU (Eurasian Economic Union)
- Saudi Arabia
- Singapore
- Republic of South Africa
- Taiwan
- United Kingdom
- United States
Standard Based Guidances by Organization:
- AFF (Association Francaise du Froid)
- IATA (International Air Transport Association)
- IATA Chapter 17 – Time and Temperature Sensitive Label FAQ
- IPEC (The International Pharmaceutical Excipients Council – Europe)
- PDA (Parenteral Drug Association)
- USP (United States Pharmacopeial Convention)
- ISTA (International Safte Transit Association)
- WHO (World Health Organization)
| ARGENTINA | |
|---|---|
| Organization: | Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica |
| Country: | Argentina |
| Name: | MEDICAMENTOS – Ley 26.492 – Regulación de la cadena de frío de los medicamentos. |
| Doc.# / Rev#: | Ley 26.492 |
| Author/s: | NA |
| Date: | NA |
| Web Link: | Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica |
| Logo: |  |
| Attachments: | MEDICAMENTOS – Ley 26.492 – Regulación de la cadena de frío de los medicamentos. |
| Summary: |
NA
|
| Highlights: |
NA
|
| Revision History: | [7-1-15]Record Added |
| AUSTRALIA | |
|---|---|
| Organization: | Department of Health and Ageing – Therapeutic Goods Administration (Australian Government) |
| Country: | Australia |
| Name: | Code of Good Wholesaling Practice for Therapeutic Goods for Human Use |
| Doc.# / Rev#: | Draft Revision – June 2006 |
| Author/s: | NA |
| Date: | June 2006 |
| Web Link: | Department of Health and Ageing |
| Logo: |  |
| Attachments: | •Code of Good Wholesaling Practice for Therapeutic Goods for Human Use (Draft 2006)•Code of Good Wholesaling Practice for Therapeutic Goods for Human Use(November 1991) |
| Summary: |
•Standard GDP’s
•Wholesalers are responsible to ensure medicine is stored and distributed within the label requirements of the manufacturer and in accordance with this code. Includes the distribution of temperature sensitive medicines via the cold chain.
•Temperature sensitive therapeutic products (TSTPS)
•Transport
•Management of controlled goods, returned goods, product recalls, documentation.
|
| Highlights: |
•For TSTPS : temperature monitoring equipment and record
•Goods with a manufacturer-specified temperature range should not be stored in a temporary stock location that could expose them to temperatures outside the specified range.
•Goods requiring temperature maintenance in the range of + 2ºC to +8ºC should be labeled refrigerate – do not freeze. Goods requiring temperature maintenance in the range below 0ºC should be labeled keep frozen.
|
| Revision History: | [3-20-11]Record Added |
| Organization: | Department of Health and Ageing – Therapeutic Goods Administration (Australian Government) |
| Country: | Australia |
| Name: | Australian code of good wholesaling practice for medicines in Schedules 2, 3, 4 & 8 |
| Doc.# / Rev#: | Effective April 1, 2011 |
| Author/s: | NA |
| Date: | October 2010 (Effective April 1, 2011) |
| Web Link: | Department of Health and Ageing |
| Logo: | |
| Attachments: | Australian code of good wholesaling practice for medicines in Schedules 2, 3, 4 & 8 (Effective April 1, 2011) |
| Summary: |
•This Code is applicable to wholesalers who, for the purposes of this Code, are defined as persons or organisations, including manufacturers, wholesalers, manufacturer’s agents, importers and distributors who store and/or supply by wholesale substances and preparations (referred to in this document as “medicines”) included in Schedules 2, 3, 4 and 8 of the Standard for the Uniform Scheduling of Drugs and Poisons or other applicable State or Territory poisons legislation. The term “wholesaler” also includes providers of third party logistics and distribution. The code applies to substances in Schedules 2, 3, 4 and 8 from raw materials to finished goods.
•Wholesaling forms part of the supply chain for medicines in Schedules 2, 3, 4 and 8. Wholesalers are responsible for the effective, efficient and safe handling, storage and distribution of those medicines.
•This Code of Practice is concerned with ensuring that quality is maintained during wholesaling and it sets out appropriate standards to be applied. In short, medicines in Schedules 2, 3, 4 and 8 need to be stored and distributed in accordance with the label requirements of the sponsor, State and Territory legislation and this Code.
•Although it is a Code of Practice and not legislation, compliance with it may be made mandatory in States and Territories. Compliance with the Code is considered to be attained if alternative practices to those set out in this document that achieve an equivalent or better outcome are adopted. However, if an alternative practice is adopted, the wholesaler should be prepared to demonstrate that the alternative practice achieves an outcome that is equivalent to, or better than, the provisions of the Code.
•This Code does not negate, detract from or supersede other Codes or common or statute law requirements such as the obligations of contractors, Occupational Health and Safety, Customs and Excise, Poisons (including narcotics), Dangerous Goods, or the many legal requirements surrounding building construction. This Code does not, in any way, diminish the obligations of wholesalers to comply with these and other legal requirements.
|
| Highlights: | NA |
| Revision History: | [3-20-11]Record Added |
| BRAZIL | |
|---|---|
| Organization: | “Agência Nacional de Vigilância Sanitária” (HealthControl Agency) (ANVISA) |
| Country: | Brazil |
| Name: | Resolution –RDC No. 234 |
| Doc.# / Rev#: | RDC No. 234 |
| Author/s: | NA |
| Date: | August 2005 |
| Web Link: | ANVISA |
| Logo: |  |
| Attachments: | Resolution –RDC No. 234 |
| Summary: |
•“Agência Nacional de Vigilância Sanitária” (HealthControl Agency) (ANVISA) adopted resolutions to regulate quality control activities for imports of biological products.
•Importing company must be registered
•Records of temperature during transport chain and storage and a Quality Assurance Unit must be provided to the importing company.
•Importing company must, upon clearance of the lots, present the “Custody and Liability Commitment” for the product clearance until they deliver to the General Management of Ports, Airports and Borders the imported lot Clearance Certificate issued by the importing company quality assurance division, as well as a copy of the temperature records with all information
|
| Highlights: | NA |
| Revision History: | [3-20-11]Record Added |
| Organization: | “Agência Nacional de Vigilância Sanitária” (HealthControl Agency) (ANVISA) |
| Country: | Brazil |
| Name: | Public consultation meets standards of Good Manufacturing Practices |
| Doc.# / Rev#: | Consulta Pública n° 2, de 7 de janeiro de 2013 D.O.U de 08/01/2013 |
| Author/s: | Jaime Cesar De Moura Oliveira |
| Date: | January 7, 2013 |
| Web Link: | ANVISA |
| Logo: | |
| Attachments: | Public consultation meets standards of Good Manufacturing Practices |
| Summary: |
The National Health Surveillance Agency (Anvisa) published on Tuesday (8/1), a public consultation that brings together in a single draft resolution, the rules for the granting of certificates of Good Manufacturing Practices for drugs, products health, cosmetics, perfumes, toiletries, cleaning products and pharmaceutical ingredients. The text also includes the requirements for certifications of Good Practices in Distribution and Storage of medicines, health products and pharmaceutical ingredients.The Best Practices are the technical requirements for establishments that produce, store and distribute medicines, health products, cosmetics, perfumes, toiletries, cleaning products and pharmaceutical ingredients. The aim is to ensure the quality, safety and efficacy of these products, which offer no risk to consumer health.
|
| Highlights: | NA |
| Revision History: | [7-1-15]Record Added |
| CANADA | |
|---|---|
| Organization: | Health Canada |
| Country: | Canada |
| Name: | Health Canada- 0069 Guidelines for: Temp control of Drug Products during Storage and Transportation |
| Doc.# / Rev#: | 0069 |
| Author/s: | NA |
| Date: | Issued January 2011 – Effective April 2011 |
| Web Link: | Health Canada |
| Logo: |  |
| Attachments: | 0069 |
| Summary: |
Standard GDP’s:
•Warehouse and storage (temperature monitored)
•Transport of products (refrigerated vehicles/transportation containers should be mapped and monitored—if they are the primary means of environmental control).
•“Drug products must be transported in a manner that ensures the products will be maintained within an acceptable temperature range as defined in the approved labeling and supported by stability data. Temperature excursions outside of their respective labeled storage conditions, for brief periods, may be acceptable provided stability data and scientific/technical justification exist demonstrating that product quality is not affected.”
|
| Highlights: |
•Canadian GMP regulation (0069) was recently revised with the addition of section 4.1 to the requirements for return policy.
•The revised documentation state: “Documentation is available to support the rationale to place returned goods into inventory for further resale. Wholesalers should obtain guidance from importers/distributors to make an informed decision pertaining to the restock of the product.”
|
| Revision History: | [3-20-11]Record Added |
| CHINA | |
|---|---|
| Organization: | China Food and Drug Administration (Chinese Government) |
| Country: | China |
| Name: | Good Supply Practice for Pharmaceutical Products |
| Doc.# / Rev#: | Order of the Ministry of Health of the People’s Republic of China No. 90, January 22, 2013 |
| Author/s: | NA |
| Date: | January 22, 2013 |
| Web Link: | China Food and Drug Administration |
| Logo: |  |
| Attachments: | Good Supply Practice for Pharmaceutical Products |
| Summary: |
•Not Available
|
| Highlights: | •Potential requirement for up to 9 temperature probes to be used during thermal qualification |
| Revision History: | [4-10-15]Record Added |
| CZECH REPUBLIC | |
|---|---|
| Organization: | State Institute for Drug Control |
| Country: | Czech Republic |
| Name: | Czech GDP Guidelines |
| Doc.# / Rev#: | DIS-15 V.1 |
| Author/s: | NA |
| Date: | 2009 |
| Web Link: | DIS-15 V.1 |
| Logo: | NA |
| Attachments: | NA |
| Summary: | Standard GDP to ensure, control and document temperature during storage and transport of medicinal products. |
| Highlights: |
•Temperature map using measuring devices- required for storage.
•Temperature during transport must be monitored with a measuring devices.
•Measuring devices must be equipped with an alarm and calibrated (time between 2 subsequent calibrations should not be longer than 24 months).
•Measuring device error should also be determined during calibration.
•The used thermometers should not have a greater error than ± 0.5 °C for the monitoring of storage temperature for thermolabile medicinal products.
•Used thermometers should not indicate greater error than ± 1.0°C for the monitoring of the temperature conditions other than those in the freezing and cooling appliances.
•Thermolabile medicinal products are transported in cooling vehicles or in cooled transport containers, they are stored in order to avoid freezing (with the exception of medicinal products, which should be transported under freezing temperatures).
|
| Revision History: | [3-14-11]Record Added |
| Organization: | State Institute for Drug Control |
| Country: | Czech Republic |
| Name: | Guidelines for Correct Distribution Practice of Human Medicinal Products |
| Doc.# / Rev#: | DIS-11 |
| Author/s: | NA |
| Date: | 2009 |
| Web Link: | DIS-11 |
| Logo: | NA |
| Attachments: | NA |
| Summary: |
•Distributors must observe the rules and guidelines of good distribution practice published by the European Commission
•Standard GDP’s for Storage, Transportation and distribution.
•Medicinal products should be commonly stored separated from other marketable goods
•Temperature is monitored and regularly recorded
•Control should ensure that all parts of particular storage areas keep the temperature within the established temperature range
•System of stock circulation introduced (i.e. “first in – first out”).
•Products should be delivered only to other authorised distributors
|
| Highlights: | This guideline is a translation of the European commission- EU Guidelines on Good Distribution Practice of medicinal products of Human use. |
| Revision History: | [3-14-11]Record Added |
| DENMARK | |
|---|---|
| Organization: | Danish Health and Medicines Authority |
| Country: | Denmark |
| Name: | GMP – executive order no. 1358 of 18 December 2012 on manufacture and import of medicinal products and intermediary products |
| Doc.# / Rev#: | order no. 1358 |
| Author/s: | NA |
| Date: | December 18, 2012 |
| Web Link: | Danish Health and Medicines Authority |
| Logo: |  |
| Attachments: | GMP – executive order no. 1358 of 18 December 2012 on manufacture and import of medicinal products and intermediary products |
| Summary: |
NA
|
| Highlights: |
NA
|
| Revision History: | [07-01-15]Record Added |
| Organization: | Danish Health and Medicines Authority |
| Country: | Denmark |
| Name: | GDP – Danish executive order no. 1359 of 18 December 2012 on distribution of medicinal products |
| Doc.# / Rev#: | order no. 1359 |
| Author/s: | NA |
| Date: | December 18, 2012 |
| Web Link: | Danish Health and Medicines Authority |
| Logo: | |
| Attachments: | GDP – Danish executive order no. 1359 of 18 December 2012 on distribution of medicinal products |
| Summary: |
NA
|
| Highlights: |
NA
|
| Revision History: | [07-01-15]Record Added |
| EGYPT | |
|---|---|
| Organization: | Egypt MOH |
| Country: | Egypt |
| Name: | Minister Decree for Wholesalers |
| Doc.# / Rev#: | NA |
| Author/s: | •Dr. Madiha Ahmed •Dr. Abd El-Rahman Maged |
| Date: | January 2009 |
| Web Link: | Egypt MOH |
| Logo: | NA |
| Attachments: | Decree for Wholesalers and Distribution Companies |
| Summary: |
•Rules issued by the MOH and Population (resolution No. 25/2009)
•Standard GDP’s:
-Temperature monitoring during cold storage
-Temperature mapping of warehouses
|
| Highlights: |
•Insulated containers may be used for small volumes
•Refrigerated transport for larger volumes
•Temperature must be monitored and recorded
|
| Revision History: | [3-14-11]Record Added |
| EUROPE | |
|---|---|
| Organization: | European Commission Health and Consumers Directorate-General (European Government) |
| Country: | European Union |
| Name: | European (EU) Guidelines on the Good Distribution Practice of Medicinal Products for Human Use, (first published on March 8th 2013 as 2013/C 68/01 and updated on November 5th 2013 as 2013/C 343/01) |
| Doc.# / Rev#: | 2013/C 343/01 |
| Author/s: | NA |
| Date: | March 19, 2015Previous Revision: November 5th 2013 |
| Web Link: | European Commission Health and Consumers Directorate |
| Logo: |  |
| Attachments: | |
| Summary: | •Not Available |
| Highlights: | •Not Available |
| Revision History: | [4-10-15]Record Added[7-1-15]Added Attachment for March 19, 2015 revision |
| Organization: | European Commission Health and Consumers Directorate-General (European Government) |
| Country: | European Union |
| Name: | Annex 15: Qualification and Validation |
| Doc.# / Rev#: | Ref. Ares(2015)1380025 – 30/03/2015 |
| Author/s: | NA |
| Date: | March 30, 2015 |
| Web Link: | European Commission Health and Consumers Directorate |
| Logo: | |
| Attachments: | |
| Summary: | In accordance with EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use, formal risk assessments for ascertaining the appropriate good manufacturing practice for excipients of medicinal products for human use must be conducted by March 2016. |
| Highlights: | •Not Available |
| Revision History: | [6-26-15]Record Added |
| INDIA | |
|---|---|
| Organization: | Organization of Pharmaceutical Producers of India (OPPI – Non-Governmental but Government Endorsed) |
| Country: | India |
| Name: | OPPI Guidelines – Cold Chain Pharmaceutical Products |
| Doc.# / Rev#: | NA |
| Author/s: | •Mr. Ashok Bindumadhavan, Elli Lilly (Project Leader) •Mr. Sikander Yarkhan, Chiron Panacea •Mr. Vasanth Kumar, GSK •Mr. Rakesh Prasher, Ranbaxy •Mr. Arun Manjeshwar, Roche •Mr. Avinash Baadkar, Sanofi-Aventis •Mr. Krishna Parab, Sanofi-Aventis •Mr. Vishwanath Lyer, Wyeth |
| Date: | June 2010 |
| Web Link: | OPPI Guidelines |
| Logo: | NA |
| Attachments: | OPPI Guidelines – Cold Chain Pharmaceutical Products |
| Summary: |
Standard GDP’s for Cold Chain Pharmaceutical Products:
•Storing and Handling (seaports/airports, Stockist/Distributors, Retailers/Chemists)
•Custom Clearance and Sample testing
•Transportation using refrigerated Vans
|
| Highlights: |
•Temperature loggers in cold rooms
•Practice FEFO ( First Expired First Out) in storage facility.
•Temperature monitoring device with alarm
|
| Revision History: | [3-14-11]Record Added |
| Organization: | Central Drugs Standard Control Organization (CDSCO) |
| Country: | India |
| Name: | Guidelines on Good Distribution Practices for Biological Products |
| Doc.# / Rev#: | CDSCO / GDP.BP Ver. 00 |
| Author/s: | NA |
| Date: | 08/10/2012 |
| Web Link: | Central Drugs Standard Control Organization |
| Logo: | NA |
| Attachments: | Guidelines on Good Distribution Practices for Biological Products |
| Summary: |
NA
|
| Highlights: |
NA
|
| Revision History: | [7-1-15]Record Added |
| INDONESIA | |
|---|---|
| Organization: | ASEAN GMP |
| Country: | Indonesia |
| Name: | Asean GMP Guidelines |
| Doc.# / Rev#: | NA |
| Author/s: | NA |
| Date: | NA |
| Web Link: | Asean (Associatiation of South East Asian Nations) |
| Logo: | NA |
| Attachments: | Asean GMP Guidelines Point 3 |
| Summary: |
•ASEAN GMP guidelines describe requirements for:
•Warehouse facility (temperature monitoring for special storage conditions)
•Handling of product recalls and returned drug products (report and record)
•Quality control
•Documentation ( inventory card, record of distribution)
|
| Highlights: | NA |
| Revision History: | [3-20-11]Record Added |
| IRELAND | |
|---|---|
| Organization: | Irish Medicines Board |
| Country: | Ireland |
| Name: | Guide to Control and Monitoring of Storage and Transportation Temperature Conditions for Medicinal Products and Active Substances |
| Doc.# / Rev#: | NA |
| Author/s: | NA |
| Date: | March 2006 |
| Web Link: | Irish Medicines Board |
| Logo: |  |
| Attachments: | Guide to Control and Monitoring of Storage and Transportation Temperature Conditions for Medicinal Products and Active Substances |
| Summary: |
Standard GDP’s compliant to EU guidelines on GDP’s:
•Storage (for temperature controlled products)
•Transportation of cold chain products: (insulated container may be used for small volumes, refrigerated transport vehicles for larger volumes).
•Temperature mapping and monitoring
•Returns of Cold chain products (only if cold chain has not been compromised, batch number is known, and entire process is validated).
•Controlled temperature storage/transportation (temperature mapping of warehouse, MKT)
|
| Highlights: | MKT usage |
| Revision History: | [3-20-11]Record Added |
| Organization: | Irish Medicines Board |
| Country: | Ireland |
| Name: | Guide to Good Distribution Practice of Medicinal Products for Human Use |
| Doc.# / Rev#: | NA |
| Author/s: | NA |
| Date: | April 10 2014 |
| Web Link: | Irish Medicines Board |
| Logo: | |
| Attachments: | Guide to Good Distribution Practice of Medicinal Products for Human Use |
| Summary: |
NA |
| Highlights: | NA |
| Revision History: | [6-30-15]Record Added |
| JAPAN | |
|---|---|
| Organization: | Pharmaceutical and Food Safety Bureau |
| Country: | Japan |
| Name: | Biological Pharma revision H15.5.15 |
| Doc.# / Rev#: | H15.5.15 |
| Author/s: | NA – Director of Pharmaceutical and Food Safety Bureau |
| Date: | May 2003 |
| Web Link: | Pharmaceutical and Food Safety Bureau |
| Logo: |  |
| Attachments: | Biological Pharma revision H15.5.15 |
| Summary: |
•‘Ministerial Ordinance to Partially Revise the Enforcement Regulations of the Pharmaceutical (rPAL) Affairs Law (MHLW Ministerial Ordinance No. 89, 2003)’ was promulgated together with the ‘Partial Revision of Medicines Designated by the Minister of Health, Labour and Welfare as stipulated in Article 15-4 Paragraph 2 Item 2b and e of the Enforcement Regulations of the Pharmaceutical Affairs Law (MHLW 2 Notification No. 205, 2003)’, and the ‘Complete Revision of Medical Devices Designated by the Minister of Health, Labour and Welfare as stipulated in Article 15-4 Paragraph 2 Item 2 of the Enforcement Regulations of the Pharmaceutical Affairs Law (MHLW Notification No. 206, 2003)’.
•Record and storage
•Handling of medicine with mandatory registration
|
| Highlights: | NA |
| Revision History: | [3-20-11]Record Added |
| MALAYSIA | |
|---|---|
| Organization: | NPCB (National Pharmaceutical Control Bureau) |
| Country: | Malaysia |
| Name: | Guidelines on Good Distribution Practice (GDP) |
| Doc.# / Rev#: | 2nd Edition |
| Author/s: | NA |
| Date: | 2013 |
| Web Link: | NPCB |
| Logo: |  |
| Attachments: | Guidelines on Good Distribution Practice (GDP) |
| Summary: |
NA
|
| Highlights: | NA |
| Revision History: | [7-15-15]Record Added |
| PAKISTAN | |
|---|---|
| Organization: | Pakistan Ministry of Health |
| Country: | Pakistan |
| Name: | The Drug Act of 1976 |
| Doc.# / Rev#: | NA |
| Author/s: | NA |
| Date: | 1976 |
| Web Link: | Pakistan MOH |
| Logo: |  |
| Attachments: | Pakistan Drug Act 1976 |
| Summary: |
Drug Act not updated since 1976
•Temperature
•Storage
•Distribution records
•Recording of Progress for recall
|
| Highlights: | NA |
| Revision History: | [3-20-11]Record Added |
| ROMANIA | |
|---|---|
| Organization: | Romanian NMA |
| Country: | Romania |
| Name: | Romanian Directive |
| Doc.# / Rev#: | NMA No. 30/24.09.2009 |
| Author/s: | NA |
| Date: | December 2009 |
| Web Link: | NA |
| Logo: | NA |
| Attachments: | NA |
| Summary: |
NMA No. 30/24.09.2009 was updated with the following changes:
– a certificate of conformity is no longer requested to be attached to each shipment of medicines.
– records for temperature and relative humidity measurements during transport should be provided , if applicable, in the conditions imposed by the manufacturer.
– the copies of the Marketing Authorizations provided to the distributors should be accompanied by the approval letters for variations.
-distributors should maintain the records for temperature and relative humidity measurements, if applicable, during the transport of medicines from the supplier, so that, when receiving the goods, the conformity of the results of measurements could be verified against the requirements stated in the Marketing Authorization and against the additional information regarding the transport conditions provided by the manufacturer.
|
| Highlights: | Changes were made to Romanian NMA Instruction No. 30/24.09.2009 in December 2009 regarding temperature and humidity monitoring during transportation. |
| Revision History: | [3-14-11]Record Added |
| SAUDI ARABIA | |
|---|---|
| Organization: | Saudi Food & Drug Authority |
| Country: | Saudi Arabia |
| Name: | Urgent Circular |
| Doc.# / Rev#: | A/3038 9/2/1431H |
| Author/s: | Prof. Dr. Saleh. Bawazeer (Vice President for Drug Affairs) |
| Date: | NA |
| Web Link: | NA |
| Logo: | NA |
| Attachments: | Saudi Arabia Letter |
| Summary: |
•Pharmaceutical products imported in Saudi must be transported in cooled containers and stored accordingly in order to be accepted.
•March 1st, 2011 all 2-8C products have to have temperature monitoring for import compliance.
•By June 1st, 2011 all CRT products have to have temperature monitoring for import compliance
|
| Highlights: | “No shipment of pharmaceutical products imported to the Kingdom will be cleared if it was proved that they were transported in non-cooled containers or stored in such a way contrary to the conditions recommended”. |
| Revision History: | [3-14-11]Record Added |
| SINGAPORE | |
|---|---|
| Organization: | Health Sciences Authority |
| Country: | Singapore |
| Name: | Guidance Notes on Good Distribution Practice |
| Doc.# / Rev#: | NA |
| Author/s: | NA |
| Date: | August 2010 |
| Web Link: | Guidance Notes on Good Distribution Practice |
| Logo: | NA |
| Attachments: | Guidance Notes on Good Distribution Practice |
| Summary: |
•Receiving and incoming checks
•Labels/means to identify cold chain products
•Temperature mapping
•Thermometer and records
•Maintenance program
•Alarm system for temperature excursion
•Backup generator/plan
•Packing procedure and records, and independent check
•Temperature mapping for vehicles or qualified/validated containers
•Monitoring of storage conditions during transportation or simulation study
•Delivery procedure
•Procedure to handle temperature excursion
•Procedure for handling returned products
•Contracts
•Training program and records
|
| Highlights: | NA |
| Revision History: | [3-14-11]Record Added |
| REPUBLIC OF SOUTH AFRICA | |
|---|---|
| Organization: | Department of Health |
| Country: | Republic of South Africa |
| Name: | Good Wholesaling Practice for Wholesalers, Distributors and Bonded Warehouses (Draft) |
| Doc.# / Rev#: | Version 2 |
| Author/s: | MS M Hela |
| Date: | March 2011 |
| Web Link: | Department of Health Republic of South Africa |
| Logo: |  |
| Attachments: | Good Wholesaling Practice for Wholesalers, Distributors and Bonded Warehouses (Draft) |
| Summary: |
NA
|
| Highlights: | NA |
| Revision History: | [7-1-15]Record Added |
| TAIWAN | |
|---|---|
| Organization: | TFDA |
| Country: | Taiwan |
| Name: | Precaution of on-site sampling for vaccine testing and sealing operation |
| Doc.# / Rev#: | Precaution |
| Author/s: | Chief Dr. Wang of TFDA |
| Date: | 04/29/2010 |
| Web Link: | NA |
| Logo: | NA |
| Attachments: | Taiwan Letter |
| Summary: |
•Electronic temperature monitor device should be introduced for cold chain temperature monitoring by the deadline of 31 Dec 2010.
•Standard GDPs
|
| Highlights: | “ By the deadline of 31 Dec 2010, electronic temperature monitor device should be introduced for cold chain temperature monitoring. After 31 Dec 2010, TFDA will not process sampling for those use other device for temperature monitoring”. |
| Revision History: | [3-14-11]Record Added |
| UNITED KINGDOM | |
|---|---|
| Organization: | MHRA |
| Country: | United Kingdom |
| Name: | GDP Risk Assessment Strategy |
| Doc.# / Rev#: | NA |
| Author/s: | Peter Coombs |
| Date: | November 2009 |
| Web Link: | MHRA |
| Logo: |  |
| Attachments: | GDP Risk Assessment Strategy (November 2009) |
| Summary: |
•Assessment is based on the outcome of an inspection and the classification of any deficiencies found
•Other factors such as a persistently poor inspection history or action by enforcement may also affect the assessment.
Current full license holders
•Inspection frequency will be a minimum of six months to a maximum of four years, dependant on inspection outcome and range of activities.
•Companies awaiting routine inspection will be entered into the risk assessment system following their next inspection.
New applicants
•Most full license holders will be re-inspected in a maximum of 15 months. At this point they are risk assessed and their inspection frequency determined
|
| Highlights: | NA |
| Revision History: | [3-20-11]Record Added |
| Organization: | MHRA |
| Country: | United Kingdom |
| Name: | Updated Policy on returns of non-defective refrigerated (2-8c) medicinal products |
| Doc.# / Rev#: | NA |
| Author/s: | Steve Todd |
| Date: | April 2010 |
| Web Link: | MHRA |
| Logo: | |
| Attachments: | Updated Policy on returns of non-defective refrigerated (2-8c) medicinal products |
| Summary: |
•Wholesalers to comply with the principles of GDP is stated in European Directive 92/25/EEC Article 10 and Rules and Guidance for Pharmaceutical Distributors 2007.
•“products that have left the care of the wholesaler, should only be returned to saleable stock if………it is known that the goods have been stored and handled under proper conditions” (paragraph 23b) and, “they have been examined and assessed by a person authorized to do so” (paragraph 23d).
•Return of non-defective refrigerated medicinal products for those products returned from a customer operating from a licensed WL site should be completed as expeditiously as possible. With evidence of “full knowledge”
•For those refrigerated medicinal products returned from unlicensed sites, the return should be completed within 24 hours including transport.
|
| Highlights: | •By “ proper conditions” can only be interpreted as being under full GDP control by licensed sites. •“The Responsible Person or the authorized person must be able to demonstrate evidence of “full knowledge” of the storage whilst at the unlicensed site, including transportation”. |
| Revision History: | [3-20-11]Record Added |
| Organization: | MHRA |
| Country: | United Kingdom |
| Name: | GDP Risk Assessment Strategy |
| Doc.# / Rev#: | NA |
| Author/s: | Cheryl Blake |
| Date: | January 2008 |
| Web Link: | MHRA |
| Logo: | |
| Attachments: | GDP Risk Assessment Strategy (Jan 2008) |
| Summary: |
•Guidance on the regulatory requirement sand points to consider when developing a distribution strategy (based on the MHRA guidance note 6)
•Control of storage and transportation temperature
•Standard GDP’s:
-Storage and shipping temperature (controlled, compliance, temperature monitoring, temperature mapping, alarms, calibration etc.)
-Risk assessment
-Quality management system
|
| Highlights: | Distributors should have in place:
•A comprehensive quality system
•A process for continual quality improvement
•A cold chain distribution strategy
•An ambient and cold chain distribution strategy
•A risk assessment program
|
| Revision History: | [3-20-11]Record Added |
| UNITED STATES | |
|---|---|
| Organization: | FDA – Food and Drug Administration (U.S. Government) |
| Country: | United States |
| Name: | Guidance for IndustryCurrent Good Manufacturing Practice — Interim Guidance for Human Drug Compounding Outsourcing Facilities UnderSection 503B of the FD&C Act |
| Doc.# / Rev#: | Draft Guidance – July 2014 |
| Author/s: | NA |
| Date: | July 2014 |
| Web Link: | Food and Drug Administration |
| Logo: |  |
| Attachments: | Guidance for Industry – Current Good Manufacturing Practice — Interim Guidance for Human Drug Compounding Outsourcing Facilities Under – Section 503B of the FD&C Act |
| Summary: |
•Interim guidance on expectations with current GMP requirements for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act. Recommendations included specifications on stability programs used to assess the stability of finished drug products and determine the correct expiry date and storage conditions.
|
| Highlights: |
NA |
| Revision History: | [6-25-15]Record Added |
| World Health Organization (WHO) | |
|---|---|
| Organization: | WHO – World Health Organization |
| Country: | Switzerland |
| Name: | Model guidance for the storage and transport of timeand temperature-sensitive pharmaceutical products (WHO Technical Report Series, No. 961, 2011), Annex 9 |
| Doc.# / Rev#: | Annex 9, No. 961, 2011 |
| Author/s: | NA |
| Date: | 2011 |
| Web Link: | WHO |
| Logo: |  |
| Attachments: | Model guidance for the storage and transport of timeand temperature-sensitive pharmaceutical products (WHO Technical Report Series, No. 961, 2011), Annex 9 |
| Summary: | These guidelines set out the principal requirements for the safe storage and distribution of time- and temperature-sensitive pharmaceutical products (TTSPPs). They are based upon existing regulations and best practice guidance from a wide range of international sources, while accepting that local legislation and regulations will continue to take precedence. The target audience includes regulators, logisticians and pharmaceutical professionals in industry, government and the international agencies. |
| Organization: | WHO – World Health Organization |
| Country: | Switzerland |
| Name: | Technical supplements to Model guidance for the storage and transport of timeand temperature-sensitive pharmaceutical products (WHO Technical Report Series, No. 961, 2011), Annex 9 |
| Doc.# / Rev#: | NA |
| Author/s: | NA |
| Date: | 2015 |
| Web Link: | WHO |
| Logo: | |
| Attachments: | Technical supplements to Model guidance for the storage and transport of timeand temperature-sensitive pharmaceutical products (WHO Technical Report Series, No. 961, 2011), Annex 9 |
| Summary: |
These supplements offer principal requirements for safe storage and distribution of pharmaceutical products.
|
| Highlights: |
NA |
| Revision History: | [6-31-15]Record Added |
