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10: Global Regulations and Guidance Documents

CoolPack thanks David Ulrich, from Abbott Pharma Distribution QA for providing the following information:

Regulatory Guidances by Countries:

• A ustralia

• Brazil

• Canada

• Czech Republic

• E gypt

• I ndia

• Indonesia

• Ireland

• Japan

• P akistan

• Romania

• Saudi Arabia

• Si ngapore

• Taiwan

• U nited Kingdom

Standard Based Guidances by Organization:

• AFF

• IATA

• PDA

• USP

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:	D epartment 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:	D epartment 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

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

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:
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:
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

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:	E gypt MOH
Logo:
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

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 - Cold Chain Pharmaceutical Products
Logo:
Attachments:	Government Endorsement (06-08-2009)
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

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:
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

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

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:
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

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