1079 GOOD STORAGE AND DISTRIBUTION PRACTICES FOR …

1 USP 36 General Information / 1079 good STORAGE and Shipping Practices1 Internationally harmonized documents intended to assistthe pharmaceutical industry. 1079 good STORAGE ANDMean Kinetic Temperature (MKT):The single calcu-lated temperature at which the total amount of degrada- DISTRIBUTION PRACTICES FORtion over a particular period is equal to the sum of theindividual degradations that would occur at various tem-DRUG actions:The measures to eliminate thecause of a potential nonconformity or other undesirablepotential :The physical, chemical, microbiological, bio-logical, bioavailability, and stability attributes that a drugINTRODUCTION product should maintain in order to be deemed suitablefor therapeutic or diagnostic use.

2 In this chapter, theThis general information chapter describes good storageterm is also understood to convey the properties ofand DISTRIBUTION PRACTICES to ensure that drug productssafety, identity, strength, quality, and purity.(medicines) reach the end user (practitioners and patient/Quality Management System (QMS):In the contextconsumers) with quality this chapter, minimally a set of policies, processes,In the context of this chapter, the following definitionsand procedures that enable the identification, measure-are , control, and improvement of the DISTRIBUTION andstorage of drug product. It is the management systemDefinitionsused to direct and control a company with regard toquality (see ICH Q10 model and Quality System Funda-Adulteration:FDA FDC Act, SEC.)

3 501 (351), A drugmentals and Vocabulary, ISO Standard 9000:2005).or device shall be deemed to be adulterated, if (2)(A) ItRisk Management System:A systematic process usedhas been prepared, packed, or held under insanitaryto assess, control, communicate, and review risks to theconditions it may have been contaminated with filth, orquality of a drug product across the product it may have been rendered injurious to health;Integral to an effective pharmaceutical quality system, itor (B) the methods used in, or the facilities or controlsis a systematic and proactive approach to identifying, sci-used for, its manufacture, processing, packing, or hold-entifically evaluating, and controlling potential risks toing do not conform to or are not operated or adminis-quality as described in ICH Q10.

4 It facilitates continualtered in conformity with current good manufacturingimprovement of process performance and product qual-practice to assure that such drug meets the requirementsity throughout the product lifecycle. ICH Q9 Quality Riskof this Act as to safety and has the identify and strength,Management provides principles and examples of toolsand meets the quality and purity characteristics, which itthat can be applied to different aspects of pharmaceuti-purports or is represented to improvement:Recurring activity to in-Written Agreement or Contract (commonly referredcrease the ability to fulfill requirements (see Quality Man-to as a Quality Agreement, Technical Agreement, Ser-agement Systems Fundamentals and Vocabulary.))

5 ISOvice Level Agreement, or other):A negotiated, docu-Standard 9000:2005).mented agreement between the drug product ownerDistribution: Refers to elements such as shipping andand service provider that defines the common under-transportation activities that are associated with thestanding about materials or service, quality specifications,movement and supply of drug , guarantees, and communication mecha- DISTRIBUTION Management System: A program thatnisms. It can be either legally binding or an informationcovers the movement, including STORAGE and transporta-agreement. A Service Level Agreement may also specifytion, of drug target and minimum level of performance, opera-Documentation:Recorded , or other service products:Medicines, including marketed humanStorage Management System:A program that is usedand veterinary prescription finished dosage medications,to control the STORAGE of drug materials, drug productSupply chain:The continuum of entities spanning thesamples, clinical trial materials, over-the-counter productsstorage and DISTRIBUTION lifecycle of a product to the end(OTC).

6 User:The patient as well as the healthcare pro-Temperature stabilizer: A material or combination ofvider administering the drug product to the that stores and releases thermal energy used toEnvironmental Management System:A managementmaintain a specified temperature range within an activesystem that allows for the identification of quality criticalor passive packaging container or system ( , water-,environmental aspects (such as temperature, humidity,chemical-, or oil-based phase change material, such asand/or other environmental factors) for the drug productcarbon dioxide solid/dry ice and liquid nitrogen).and ensures that adequate processes to maintain thatTransport vehicles:Vehicles used in the supply chainenvironment are in semitrailer trucks, vans, trains, airplanes, seaHazardous materials and/or dangerous goods:Anyvessels, and mail delivery vehicles.

7 Other vehicles, whenitem or chemical which, when being transported orused to transport drug products are included here, suchmoved, is a risk to public safety or the environment, andas emergency medical service vehicles and industry rep-is regulated as such under any of the following: Hazard-resentatives Materials Regulations (49 CFR 100 180); Interna-tional Maritime Dangerous Goods Code; DangerousGoods Regulations of the International Air Transport As-SCOPE sociation; Technical Instructions of the International CivilAviation Organization; or the Air Force Joint Manual, good STORAGE and DISTRIBUTION PRACTICES apply to all orga-Preparing Hazardous Materials for Military Air and individuals involved in any aspect of the stor-International Conference on Harmonization (ICH)age and DISTRIBUTION of all drug products, including but notGuidance for Industry, Q10 Pharmaceutical Quality Sys-limited to the following:tem; ICH Q9, Quality Risk Management.

8 And, ICH Q1A R2, Manufacturers of drug products for human and veteri-Stability Testing of New Drug Substances and Products:nary use where manufacturing may involve operationsat the application holder s facilities ( , facilities that2 1079 good STORAGE and Shipping PRACTICES / General InformationUSP 36belong to the holder of an approved New Drug Appli-documented with scientific evidence, the appropriatecation or Abbreviated New Drug Application) or atentity should consider action with the product to en-those of a contractor for the applicant holdersure the public safety. Packaging operations by the manufacturer or a desig- Determining proper STORAGE and handling practicesnated contractor for the applicant holder Communicating STORAGE and DISTRIBUTION PRACTICES Repackaging operations in which the drug product maythrough the supply chainbe owned by an organization other than the primary Drug product stability profiles or the associated stabilitymanufacturerinformation from the holder, inclusive of DISTRIBUTION Laboratory operations at the manufacturer s or at theconditions and excursions that may be allowable shouldcontractor s sitethey occur.

9 These stability profiles include the approved Physician and veterinary officesstorage conditions for the shelf life of the drug product Pharmacies including but not limited to retail, com-and, where appropriate, supporting data for the distri-pounding, specialty, mail order, hospital, and nursingbution conditions, if these differ from the storagehome pharmaciesconditions. Importers and exporters of Record Appropriate firms, such as an applicant holder, are to Wholesale distributors; DISTRIBUTION companies involvedconvey relevant environmental requirements ( ,in automobile, rail, sea, and air serviceswhen appropriate, product-specific lifecycle stability Third-party logistics providers, freight forwarders, anddata), when needed to support deviations or tempera-consolidatorsture excursions.

10 If stability data cannot be reviewed or Health care professional dispensing or administering theis not shared, an assessment may be needed to con-drug product to the end usersider regulatory review or other appropriate actions Mail distributors including the Postal Service (USPS)( , destruction of product or additional stabilityand other shipping services including expedited ship-testing).ping services Recalling the drug product if it is found to be adulter-The information is intended to apply to all drug productsated in any part of the supply chainregardless of environmental STORAGE or distributionHowever, all organizations along the supply chain for ensuring that they handle drug productsIt is recognized that conceivably there are special caseswithin adequate STORAGE and DISTRIBUTION parameters thatand many alternative means of fulfilling the intent of thiswill not affect the drug product identity, strength, quality,chapter and that these means should be scientifically justi-purity.