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CONSENSUS OPEN-ACCESSUNIMMAP-MMS PRODUCTSPECIFICATION1Product Description1The product defined by the following specification conforms to The United NationsInternational Multiple Micronutrient Antenatal Preparation (UNIMMAP) formula and is aMultiple Micronutrient Supplement (MMS) for pregnant women that is delivered in the formof a film coated tablet. 22Ingredients2.1Food/Dietary/Nutritional Ingredients3Table 1 shows the food/dietary/nutritional ingredients used in the UNIMMAP formulation andshould be prepared from ingredients that meet United States Pharmacopeia (USP) or otherglobally recognized pharmacopeia compendial standards. Where such standards do notexist, ingredients may be used in the UNIMMAP formulation if they have been shown to beof acceptable food grade quality using other suitable procedures.Table 1. Recommended Food/Dietary/Nutritional IngredientsComponentChemical Entity*AmountVitamin ARetinyl Acetate800 mcg RAEVitamin CAscorbic AcidVitamin DCholecalciferolVitamin EAlpha Tocopheryl SuccinateVitamin B1Thiamine Mononitrate1.4 mgVitamin B2Riboflavin1.4 mgVitamin B3NiacinamideVitamin B6Pyridoxine HClFolic AcidFolic AcidVitamin B12CyanocobalaminIronFerrous Fumarate30 mgIodinePotassium Iodide150 mcgZincZinc Oxide15 mgSeleniumSodium Selenite65 mcgCopperCupric Oxide70 mg5 mcg (200 IU)10 mg α-TE18 mg NE1.9 mg680 mcg DFE (400 mcg)2.6 mcg2 mg* These chemical entities may be replaced by other chemical entities if they demonstrateequal or better performance (e.g., stability).2.2ExcipientsExcipients used in the UNIMMAP formulation generally are prepared from ingredients thatmeet USP, NF, Food Chemical Codex, or other globally recognized pharmacopeia compendialUNIMMAP-MMS Product SpecificationVersion: 9.0 dated: 20-January-2020Page 1 of 15

CONSENSUS OPEN-ACCESSUNIMMAP-MMS PRODUCTSPECIFICATIONstandards. Where such standards do not exist, ingredients may be used in the UNIMMAPformulation if they have been shown to be of acceptable food grade quality using othersuitable procedures.Ingredients may be added to the UNIMMAP formulation provided that the ingredients complywith applicable regulatory requirements, and do not interfere with the assay and testsprescribed for determining compliance with the bulk or finished UNIMMAP-MMS productspecification.2.3Processing Aids or Other MaterialsProcessing aids or other materials used in the manufacture of the UNIMMAP formulation thatdo not end up in the finished product should be of acceptable food grade quality usingsuitable procedures.Potable water must meet, at minimum, all the requirements for drinking water promulgatedin the U.S. Environmental Protection Agency’s National Primary Drinking Water Regulations(40 CFR Part 141), and any applicable state and local drinking water requirements that aremore stringent. For manufacturers outside the U.S., potable water meeting equivalentrequirements may be acceptable with justification, for example, the drinking waterregulations of the European Union (European Commission Directive 98/93/EC) or JapanDrinking Water Quality Standards. Water not meeting such requirements should not bepermitted for use in the water purification system for Purified Water.3Stability StudiesThe UNIMMAP-MMS finished product labeling must state a shelf life (expiry) date that isindicative of the date before which the product is ensured to meet applicable specificationsof identity, strength, quality, and purity when stored under labeled conditions. The shelf life(expiry) date must be supported by suitable stability data, following the guidelines in ICHQ1A.A documented on-going testing program must be designed to monitor the stabilitycharacteristics of the UNIMMAP-MMS, and the results must be used to establish appropriatestorage conditions and shelf life (expiry) dates for the UNIMMAP-MMS finished product. Testprocedures used in stability testing must be validated and be stability indicating. Stabilitysamples should be stored in container-closure systems that simulate the packaging proposedto distribute the finished UNIMMAP-MMS for consumer/patient use. Stability studies shouldinclude testing of those attributes of the dietary supplement that are susceptible to changeduring storage and that influence the quality of the dietary supplement.The first three (3) production batch(s) should be placed on the stability monitoring programto establish the product shelf life (expiry) date. The lots should be those that aremanufactured at the regular manufacturing scale; however, two of the three productionbatches can be at least 1/10th the size of the manufacturing scale. Thereafter, at least one(1) batch per year of manufactured UNIMMAP-MMS should be added to the stabilitymonitoring program. All batches must comply with the finished product specificationthroughout the product shelf life (expiry) date.As appropriate, the stability storage conditions for temperature and relative humidity (RH)for product intended for use globally should be for Climate Zone IVb. hot and very humid.UNIMMAP-MMS Product SpecificationVersion: 9.0 dated: 20-January-2020Page 2 of 15

CONSENSUS OPEN-ACCESSUNIMMAP-MMS PRODUCTSPECIFICATIONHowever, actual climatic conditions in the country of destination of the UNIMMAP-MMS mayrequire stability studies to be carried out under the conditions of a different climatic zone(e.g., Climatic Zone III, hot and dry). Table 2 below shows the recommended testingconditions appropriate to each climatic zone that might be required in a given country ofdestination of the product.Table 2: Recommended ICH Testing Conditions for All Climatic ZonesClimate DefinitionMean Temperature/Mean Partial WaterVapor Pressure†DerivedClimaticConditionsITemperateNMT 15 C / LT 11hPa21 C / 45%RHIISubtropical,MediterraneanGT 15 C & NMT22 C / GT 11 hPa &NMT 18 hPa25 C / 60%RHIIIHot, DryGT 22 C / LT 15hPa30 C / 35%RHIVaHot, HumidGT 22 C / GT 15hPa & NMT 27 hPa30 C / 65%RHIVbHot and VeryHumidGT 22 C / GT 27hPa30 C / 75%RHClimaticZone† NMT Not More Than ( ); LT Less Than ( ); GT Greater Than ( )Long TermStabilityAcceleratedStability25 C 2 C/ 60% RH 5% RH25 C 2 C/ 60% RH 5% RH30 C 2 C/ 35% RH 5% RH30 C 2 C/ 65% RH 5% RH30 C 2 C/ 75% RH 5% RH40 C 2 C /75% RH 5%RH40 C 2 C /75% RH 5%RH40 C 2 C /NMT 25%40 C 2 C /75% RH 5%RH40 C 2 C /75% RH 5%RHThe frequency of testing should be sufficient to establish the stability profile of the dietarysupplement. The storage conditions and length of studies chosen should be sufficient tocover storage, shipment, and subsequent use. Data from the accelerated storage conditioncan be used to evaluate the effect of short-term excursions outside the label storageconditions, such as might occur during shipping. The shelf life (expiry) period of theUNIMMAP-MMS should be 30 months, at minimum. The following testing frequencies arerecommended: Long term 0, 3, 6, 9, 12, 18, 24, 30, and 36 months; Accelerated 0, 3, and 6 months.Where an expectation (based on development experience) exists that results fromaccelerated studies are likely to approach significant change criteria, increased testingshould be conducted by adding samples at the 1 and 2 month time points. In general, asignificant change for a dietary supplement is defined as a 5% change in the assay fromits initial value; or failure to meet any of its product specification acceptance criteria.UNIMMAP-MMS Product SpecificationVersion: 9.0 dated: 20-January-2020Page 3 of 15

CONSENSUS OPEN-ACCESSUNIMMAP-MMS PRODUCTSPECIFICATION4Packaging4.1Package SizesThe UNIMMAP-MMS should be packaged, preferably, in bottles containing 180 tablets perbottle. Bottles containing 30 tablets per bottle are acceptable, but less desirable. 4Bulk Packaging for business-to-business transactions is acceptable with demonstratedstability. Bulk packaging for clinics (e.g., 500, 1000, etc. count bottles) should be avoideddue to health and safety concerns to avoid inadvertent child exposure to UNIMMAP-MMS;and to avoid re-packaging by clinic staff of MMS into other temporary less desirablepackaging (e.g., plastic bags and newspaper) which may cause premature productdeterioration.4.2BottlesBottles must be: White / opaque Screw cap High density polypropylene (HDPE) material (complying with InternationallyRecognized Pharmacopoeia Standards) Tamper-evident Child-resistantThe need for desiccant depends on tablet formulation and must be determined by themanufacturer based on experience and supporting stability data.4.3Blister PackagingBlister packaging may be used, but it is not recommended based on increased cost andenvironmental impact, and lack of evidence that a blister pack increases uptake,adherence rates, or clinic attendance. If blister packaging is used, a thermoformablemoisture barrier film, such as Aclar , should be used to ensure stability of the productthroughout the shelf life period of the product. Using a child-resistant version of a blisterpack is deemed impractical as the “child-resistant” requirement makes a blister packunusually difficult to dispense package contents.4.4LabelingLabeling must comply with applicable country of destination regulatory requirements for thefood/dietary/nutritional supplement.Quantitative label claims for the product must be truthful and accurately reflect the contentsof the declared food/dietary/nutritional ingredients; fortified or fabricated nutrients mustmeet 100% of the quantitative label claim throughout the shelf-life of the product forproducts that can be distributed in the United States. For products distributed outside theUnited States, fortified or fabricated nutrients must meet USP compendial assay acceptancecriteria. (See section 6.2 for details.)UNIMMAP-MMS Product SpecificationVersion: 9.0 dated: 20-January-2020Page 4 of 15

CONSENSUS OPEN-ACCESSUNIMMAP-MMS PRODUCTSPECIFICATIONThe UNIMMAP-MMS product label should list: The term “food supplement”, “dietary supplement” or “nutritional supplement”; The quantity of each dietary ingredient and the correct reference daily intake, listedas % Daily Value, as necessary; List the common or usual name of each ingredient in descending order ofpredominance by weight, except that dietary ingredients listed in the nutrition labelsupplement facts need not be repeated in the ingredient list; incidental additivesincluding water, present in a dietary supplement at insignificant levels areexempted from this requirement.Labels for the UNIMMAP-MMS containing iron or iron salts for use as an iron source mustinclude the following required cautionary statement: “WARNING: Accidental overdose ofiron-containing products is a leading cause of fatal poisoning in children under 6. Keep thisproduct out of reach of children. In case of accidental overdose, call a doctor or poisoncontrol center immediately.”The label must include a statement of the necessary storage requirements for the UNIMMAPMMS. The label must accurately state the country of origin for any product of foreign originimported into the country of destination.The name and place of business of the manufacturer, packer, or distributor, and theexpiration date must be located to the right of the principle display panel. When the nameappearing on the label is not that of the actual manufacturer, the name should be qualifiedin a manner to accurately reflect this relationship (e.g., “Manufactured for ”, “Distributedby ”). The label must include a domestic address or phone number through which anadverse event report for a dietary supplement may be received.The label shown below illustrates the minimum recommended information that shouldappear on the label of the UNIMMAP-MMS.5Manufacturing Standards and Certificates5.1Pharmacopoeia StandardsCompliance to the following international pharmacopoeial standards are acceptable forfood/dietary/nutritional supplement ingredients and finished product:UNIMMAP-MMS Product SpecificationVersion: 9.0 dated: 20-January-2020Page 5 of 15

CONSENSUS OPEN-ACCESSUNIMMAP-MMS PRODUCTSPECIFICATION1. United States Pharmacopoeia (USP)2. European Pharmacopoeia (Ph.Eur.)3. International Pharmacopoeia (Ph.Int.)4. British Pharmacopoeia (BP)5. Japanese Pharmacopoeia (JP)5.2Manufacturing Practices and ConditionsThe UNIMMAP-MMS must be manufactured under current Good Manufacturing Practice(cGMP) regulations promulgated by an internationally recognized regulatory authority (e.g.,U.S. FDA, MHRA), or other GMP guidelines by a stringent authority (e.g., WHO), by a PIC/Smember, or by a globally recognized pharmacopeia (e.g., USP), including but not limited to: U.S. FDA 21 CFR Part 111 Current Good Manufacturing Practice in Manufacturing,Packing, Labeling, or Holding Operations for Dietary Supplements; andUSP–NF general chapter 〈2750〉 Manufacturing Practices for Dietary Supplements.The manufacturing site and operations should be audited by an accredited third-partycertification body.5.3Certificates of AnalysisCertificates of Analysis (CoA) must be issued for each batch of UNIMMAP-MMS product. TheCoA should list the name and item code of the UNIMMAP-MMS product, the batch number,the date tested and released, and the expiry date. The CoA should list each test performed,the specific identity of the test procedure, the acceptance limits or criteria, and the resultswith numerical units, as appropriate. The CoA should be dated and signed by authorizedquality unit personnel. For CoAs issued for external use, the CoA should list the name,address and telephone number of the manufacturer.The testing protocol should include the performance of full specification testing. However, areduced level of testing (or sampling) for particular specified parameters may be allowedbased upon one or more of the following: statistical analysis of an adequate quantity ofhistorical test data; statistical confidence in the capability of the manufacturing process asdetermined by suitable verification; or ongoing monitoring of the process using recognizedstatistical process control (SPC) techniques. The manufacturer must notify the purchaser ofthe UNIMMAP-MMS product in writing of any change to the testing protocol.5.4Halal CertificationThe UNIMMAP-MMS product may be manufactured meeting Halal requirements. The exactrequirements shall be obtained from local authorities or from an accredited source.5.5Change ControlA manufacturer might make changes to the UNIMMAP-MMS product’s specification, rawmaterial source, manufacturing processing steps and/or equipment, testing protocols, orany other criteria deemed by the participant to be essential or significant to productquality. Manufacturers must notify the purchaser of the UNIMMAP-MMS product of anyUNIMMAP-MMS Product SpecificationVersion: 9.0 dated: 20-January-2020Page 6 of 15

CONSENSUS OPEN-ACCESSUNIMMAP-MMS PRODUCTSPECIFICATIONsignificant changes that might affect product quality, in writing upon implementation,along with the rationale for the change(s).A manufacturer must also notify the purchaser of the UNIMMAP-MMS product of any changeto its manufacturing site, including any changes to the certification status held by themanufacturer from a GMP issuing authority.5.6Quality AgreementThere should be a written and approved contract or quality agreement between thecontract giver and the contract acceptor that defines in detail the GMP responsibilities,including the quality measures, of each party. The contract should permit the purchaser toaudit the manufacturer’s (seller’s) facilities for compliance with GMPs. Wheresubcontracting is allowed, the seller should not pass to a third party any of the workentrusted to it under the contract without the buyer’s prior evaluation and approval of thearrangements.6Finished Product SpecificationThe United Nations International Multiple Micronutrient Antenatal Preparation (UNIMMAP) isa formulation for use by pregnant women. UNIMMAP – MMS was developed during aworkshop of experts organized by the World Health Organization (WHO), UNICEF, and theUnited Nations University in 1999 specifically to identify an MMS formula for efficacy clinicaltrials. It contains 15 micronutrients at dosages that approximate the recommended dietaryallowances for pregnancy.The tables in section 6.1 and 6.2 show criteria and requirements for tablet characterizationand purity as well as the potency assay requirements.UNIMMAP-MMS Product SpecificationVersion: 9.0 dated: 20-January-2020Page 7 of 15

CONSENSUS OPEN-ACCESSUNIMMAP-MMS PRODUCTSPECIFICATION6.1Tablet Characterization and Purity – Table 3Table 3TestTest MethodAcceptance CriteriaPhysical CharacteristicsAppearanceVisualTBD by ManufacturerShapeVisualTBD by ManufacturerTablet ThicknessMicrometerTBD by ManufacturerTablet LengthMicrometerTBD by ManufacturerTablet FriabilityUSP 1216 TBD by ManufacturerTablet Breaking ForceUSP 1217 TBD by ManufacturerPerformanceAverage Tablet WeightTBD by ManufacturerUSP 2091 Weight VariationEach of the individual weights is within95% - 105% of the average weightUSP 2040 Dissolution for Vitamin A(Index for oil-soluble Vitamins)Apparatus 2,at 75 rpm, in0.05 M phosphatebuffer pH 6.8, w/1% (w/v) sodiumascorbate and1% (w/v)octoxynol 9,900 mLNLT 75% of the labeled amount ofVitamin Adissolved in 45 minutesUSP 2040 Apparatus 2,at 75 rpm, inwater or 0.05MpH 6.0 citratebuffer, 900 mLDissolution for Folic AcidUSP 2040 Dissolution for Riboflavin(Index for water-soluble vitamin)Dissolution for Iron(Index element)Apparatus 2,at 75 rpm, in0.1 N hydrochloricacid, 900 mLNLT 75% of the labeled amount of FolicAciddissolved in 1 hourNLT 75% of the labeled amount ofRiboflavindissolved in 1 hourNLT 75% of the labeled amount of Irondissolved in 1 hourElemental ImpuritiesArsenic (inorganic)CadmiumLeadUSP 233 NMT 15 mcg/day&NMT 5 mcg/dayUSP 2232 NMT 5 mcg/dayUNIMMAP-MMS Product SpecificationVersion: 9.0 dated: 20-January-2020Page 8 of 15

CONSENSUS OPEN-ACCESSUNIMMAP-MMS PRODUCTSPECIFICATIONTestTest MethodAcceptance CriteriaMercury (total)NMT 15 mcg/dayMethylmercury (as Hg) 1NMT 2 mcg/dayMicrobial ContaminantsTotal Aerobic Microbial Count (TAMC)USP 2021 NMT 3 x 103 CFU/gTotal Combined Yeast & Mold (TCYM)USP 2021 NMT 3 x 102 CFU/gAbsence of Escherichia coliUSP 2022 Absent in 10 gAbsence of Salmonella spp.USP 2022 Absent in 10 gAbsence of Staphylococcus aureusUSP 2022 Absent in 10 gUSP 2021 NMT 10 CFU/gEnterobacterial Count(Bile-Tolerant Gram-Negative Bacteria)NMT Not More Than ( ); NLT Not Less Than ( )USP 233 Elemental Impurities-Procedures;USP 2232 Elemental Contaminants in Dietary Supplements;USP 2021 Microbial Enumeration Tests – Nutritional and Dietary Supplements;USP 2022 Microbiological Procedures for Absence of Specified Microorganisms – Nutritional and Dietary Supplements;CFU Colony Forming Unit.6.2Potency Assay (per tablet) – Table 4Table 4IngredientTest Method†Label ClaimUSPUS-FDA††Vitamin A,Method 1800 mcgNLT 90.0%NMT 165.0%NLT 100.0%NMT 175.0%Vitamin C(as Ascorbic Acid)Vitamin C Assay 580 Method II70 mgNLT 90.0%NMT 150.0%NLT 100.0%NMT 160.0%Vitamin D(as Cholecalciferol)Cholecalciferol orErgocalciferolMethod 15 mcg(200 IU)NLT 90.0%NMT 165.0%NLT 100.0%NMT 175.0%Vitamin E,Method 110 mgNLT 90.0%NMT 165.0%NLT 100.0%NMT 175.0%Vitamin A(as Retinyl Acetate)Vitamin E(as dl-alpha TocopherylSuccinate)Methylmercury determination is not necessary when the content of total Mercury is lessthan the limit for methylmercury.1UNIMMAP-MMS Product SpecificationVersion: 9.0 dated: 20-January-2020Page 9 of 15

CONSENSUS OPEN-ACCESSUNIMMAP-MMS PRODUCTSPECIFICATIONIngredientTest Method†Label ClaimUSPUS-FDA††1.4 mgNLT 90.0%NMT 150.0%NLT 100.0%NMT 160.0%1.4 mgNLT 90.0%NMT 150.0%NLT 100.0%NMT 160.0%18 mgNLT 90.0%NMT 150.0%NLT 100.0%NMT 160.0%1.9 mgNLT 90.0%NMT 150.0%NLT 100.0%NMT 160.0%Folic acid,Method 1680 DFE(400 mcg folicacid)NLT 90.0%NMT 150.0%NLT 100.0%NMT 160.0%Vitamin B12(as Cyanocobalamin)CyanocobalaminMethod 12.6 mcgNLT 90.0%NMT 150.0%NLT 100.0%NMT 160.0%Iodine(as Potassium Iodide)Iodide150 mcgNLT 90.0%NMT 160.0%NLT 100.0%NMT 170.0%30 mgNLT 90.0%NMT 125.0%NLT 100.0%NMT 135.0%15 mgNLT 90.0%NMT 125.0%NLT 100.0%NMT 135.0%65 mcgNLT 90.0%NMT 160.0%NLT 100.0%NMT 170.0%2 mgNLT 90.0%NMT 125.0%NLT 100.0%NMT 135.0%Vitamin B1: Thiamine(as Thiamine Mononitrate)Vitamin B2:RiboflavinVitamin B3: Niacin(as Niacinamide)Niacin orNiacinamide,PyridoxineHydrochloride,Riboflavin andThiamineMethod 1Vitamin B6:Pyridoxine Hydrochloride:Folate(as Folic Acid)Iron(as Ferrous Fumarate)Zinc(as Zinc Oxide)Selenium(as Sodium Selenite)Copper(as Cupric Oxide)Copper, Iron,and Zinc,Method 2;Selenium,Method 3PlasmaSpectrochemistry 730 NMT Not More Than ( ); NLT Not Less Than ( )† All tests to be performed per current USP-NF, Oil- and Water-Soluble Vitamins with Minerals Tablets.†† USP General Notices 4.10.20. Acceptance Criteria: An official product shall be formulated with theintent to provide 100% of the quantity of each ingredient declared on the label. Where the minimumamount of a substance present in a dietary supplement is required by law to be higher than the loweracceptance criterion allowed for in the monograph, as per 21 CFR 101.36(f)(1) and 21 CFR 101.9(g)(3)and (g)(4), the upper acceptance criterion in the monograph may be increased by a correspondingamount.UNIMMAP-MMS Product SpecificationVersion: 9.0 dated: 20-January-2020Page 10 of 15

CONSENSUS OPEN-ACCESSUNIMMAP-MMS PRODUCTSPECIFICATION7Analytical Test MethodsTests and examinations that are used to determine whether UNIMMAP-MMS specificationsare met must be appropriate for their intended use, and scientifically validated methods.Tests methods or procedures must meet proper standards of accuracy and reliability.If the test procedure is not in an official compendium, the procedure must be validatedaccording to USP general chapter 1225 Validation of Compendial Procedures, or ICHQ2(R1) Validation of Analytical Procedures: Text and Methodology. Method performancecharacteristics include specificity, linearity, range accuracy, precision, detection limit, andquantitation limit, and those of interest may vary depending on the type of test:identification, assay, impurities, or performance.If the test procedure is in an official compendium, such as USP-NF, the procedure only needsto be verified for its suitability under actual conditions of use, according to USP generalchapter 1226 Verification of Compendial Procedures. Verification requirements should bebased on an assessment of the complexity of both the procedure and the material to whichthe procedure is applied. Verification is not required for basic compendial procedures, suchas loss on drying, residue on ignition, and simple instrumental determinations, such as pHmeasurements.An alternative method or procedure is defined as any method or procedure other than thecompendial method or procedure for the article in question. The alternative method orprocedure must be fully validated and must produce comparable results to the compendialmethod or procedure within allowable limits established on a case-by-case basis. Alternativemethods or procedures can be developed for any number of reasons not limited tosimplification of sample preparation, enhanced precision and accuracy, improved(shortened) run time, or being better suited to automation than the compendial method orprocedure. Only those results obtained by the methods and procedures given in thecompendia are conclusive.8Storage and Transportation RequirementsThe UNIMMAP-MMS product must be held under appropriate conditions of temperature,humidity, and light so that its identity, purity, strength, and composition are not affected(e.g., NLT 15 C and NMT 30 C, protected from humidity and light).The UNIMMAP-MMS product must be distributed under conditions that will protect it againstcontamination and deterioration. The manufacturer and purchaser need to work together toensure this requirement is met.All transportation operation must be conducted under such conditions and controlsnecessary to prevent UNIMMAP-MMS product from becoming adulterated duringtransportation. Responsibility for ensuring that transportation operations are carried outadequately must be assigned to competent supervisory personnel. Shippers, receivers,loaders, and carriers engaged in transportation must conduct all transportation operationsunder such conditions and controls necessary to protect the UNNIMAP-MMS product frombecoming adulterated during transportation. Such operations include, but are not limited to,taking effective measures such as:UNIMMAP-MMS Product SpecificationVersion: 9.0 dated: 20-January-2020Page 11 of 15

CONSENSUS OPEN-ACCESSUNIMMAP-MMS PRODUCTSPECIFICATION Segregation, isolation, or the use of packaging to protect the UNNIMAP-MMSproduct from contamination from other articles in the same load; Use of vehicles and transportation equipment that are adequately designed andmaintained in a sanitary condition to prevent the UNIMMAP-MMS product frombecoming contaminated during transportation operations; and Use of vehicles and transportation equipment that are adequately designed,maintained, and equipped to transport UNNIMAP-MMS product under adequatetemperature and humidity control to prevent UNNIMAP-MMS product frombecoming adulterated during transportation.The first manufactured batch of the UNIMMAP-MMS product should be distributed first.Distributing operations must be designed to facilitate its recall, if necessary.9Definitions and AcronymsTerm / AbbreviationDefinition / Long FormAccredited Third-PartyCertification BodyAn accredited third-party certification body means a third-partycertification body that meets the applicable requirements of ISO/IEC17020:2012 and/or ISO/IEC 17065:2012, and is accredited toconduct audits or inspections according to the applicable standard orregulatory requirements.ArticleArticle includes substances (such as excipients,food/dietary/nutritional ingredients, in-process material), products(such as food/dietary/nutritional supplements), and materials (suchas packaging containers and closures, and labels).BatchBatch is a specific quantity of a food/dietary/nutritional supplementor other article that is intended to be uniform; that is intended tomeet specifications for identity, purity, strength, and composition;and that is produced during a specified time period according to asingle manufacturing record during the same cycle of manufacture.CompositionComposition is the specified mix of food/dietary/nutritionalingredients and excipients in a food/dietary/nutritional supplement.Code of FederalRegulations (CFR)The CFR annual edition is the codification of the general andpermanent rules and regulations published in the Federal Register bythe executive departments and agencies of the Federal Governmentof the United States. It is structured into 50 subject matter titles;title 21 applies to food and drugs. Titles are broken down into parts,subparts, sections and paragraphs.Certificate of Analysis(CoA)CoA is a document relating specifically to the results of testing arepresentative sample drawn from a batch of material. The CoAshould list each test performed in accordance with compendial ormanufacturer requirements, including reference to the testprocedure, the acceptance limits and the results obtained.Country of DestinationThe country in which the product is intended to be marketed/ used.ExcipientsExcipients are substances other than food/dietary ingredients thathave been appropriately evaluated for safety and are intentionallyincluded in a food/dietary supplement to do one or more of thefollowing: aid in the manufacture of a food/dietary supplement;protect, support, or enhance stability, bioavailability, or userUNIMMAP-MMS Product SpecificationVersion: 9.0 dated: 20-January-2020Page 12 of 15

CONSENSUS OPEN-ACCESSUNIMMAP-MMS PRODUCTSPECIFICATIONacceptability; assist in product identification; and/or enhance anyother attribute of the overall safety or delivery of the food/dietarysupplement during storage or use. The term excipient is sometimesused synonymously with the term inactive ingredients and tFood/dietary/nutritional ingredients are ingredients with anestablished nutritional value, namely vitamins and minerals in theirrespective chemical tFood/dietary supplement ingredient includes food/dietary ingredientsand dietary/nutritional supplement is a product intended tosupplement the diet that contains one or morefood/dietary/nutritional ingredients, that is intended for ingestion in atablet, capsule, or liquid form, that is not represented for use as aconventional food or as the sole item of a meal or the diet, and islabeled as a food/dietary/nutritional supplement, and that sometimesreferred to as a Multi-Micronutrient Supplement (MMS).Globally RecognizedPharmacopeia CompendialStandardThe following international pharmacopoeia’s official compendialstandards are considered globally recognized:1. British Pharmacopoeia (BP)2. European Pharmacopoeia (Ph.Eur.)3. International Pharmacopoeia (Ph.Int.)4. Japanese Pharmacopoeia (JP)5. United States Pharmacopeia (USP)International Conferenceon Harmonization (ICH)The International Conference on Harmonization (ICH) of TechnicalRequirements for Registration of Pharmaceuticals for Human Usebrings together regulatory authorities and pharmaceutical industry todiscuss scientific and technical aspects of drug registration.Micronutrient Forum(MN Forum)The Micronutrient Forum serves as a global catalyst and convener forsharing expertise, insights and experience relevant to micronutrientsin all aspects of health promotion and disease prevention, withspecial emphasis on the integration with relevant sectors.Not Less Than (NLT)NLT is equal to, but not less than a given value.Not More Than (NMT)NMT is equal to, but not more than a given value.Pharmaceutical InspectionCo-operation Scheme(

Table 2: Recommended ICH Testing Conditions for All Climatic Zones . Climatic Zone . Climate Definition . Mean Temperature / Mean Partial Water Vapor Pressure† Derived Climatic Conditions . Long Term Stability . Accel