ISO 4802 — Standard

About the Standard

Scope title: hydrolytic resistance of the interior surfaces of glass containers

ISO 4802 is a standard published by International Organization for Standardization (ISO). The international standards organisation; it publishes the widest body of management system, test method and product standards.

See the other 310 codes from ISO

Coverage areas

Pharmaceutical Analysis — What Does This Testing Field Cover?

The section below describes the field that code ISO 4802 belongs to; it is not the text of the standard or the regime itself. The scope title of the code is given above, and technical requirements are shared at the quotation stage.

Pharmaceutical analysis determines the identity, purity, quantity and behaviour of an active substance and of the finished product. What sets this family apart is that the methods are largely defined in PHARMACOPOEIAS: the European Pharmacopoeia (Ph. Eur.) and the United States Pharmacopeia (USP) give both the method and the acceptance framework together.

The binding nature of the pharmacopoeial method shapes how the field works. In other sectors a laboratory can choose a suitable method, whereas here the method in the monograph governs; if an alternative method is to be used, its equivalence must be demonstrated. This is what makes results comparable worldwide.

Analyses are carried out in several groups. Identity and assay (HPLC, UV, titration) show what the product is and how much active substance it contains. The impurity profile and residual solvents look for unwanted compounds arising from the manufacturing process. Elemental impurities address metals originating from catalysts and equipment. Dissolution and disintegration behaviour is the most important in vitro indicator of how the drug will be released in the body.

The DISSOLUTION TEST is one of the most critical measurements in the field. It is not enough for a tablet to contain the right amount of active substance; that substance must dissolve at a suitable rate. The dissolution profile is used to assess the effect of formulation changes on bioavailability and holds a central place in generic drug licensing.

METHOD VALIDATION is a mandatory step in this family. If a pharmacopoeial method is used, it is verified that the method works properly under that laboratory's conditions. If an in-house method has been developed, it is validated against parameters such as linearity, precision, accuracy, specificity, limits of detection and quantification, and robustness. A result produced with an unvalidated method cannot be used in a licence dossier.

Stability studies determine shelf life and are the longest-running work in the field. The product is held under defined temperature and humidity conditions, analysed at set intervals, and the results become the basis of the shelf life and storage condition claims. Accelerated conditions give preliminary information but real-time data is what counts.

The microbiological side is a separate body of work: microbial enumeration, testing for specified microorganisms, sterility testing for sterile products and the bacterial endotoxin test. For sterile products, packaging integrity and sterilisation validation also come into play.

Data integrity has moved to the centre of inspections in recent years. It is not enough for the result to be correct; the raw data must be traceable, unalterable and auditable. Validation of electronic record systems has therefore become an inseparable part of analysis.

Method groups in this field

Identity and assay
HPLC, UPLC, UV-Vis spectrophotometry, titration, identity confirmation by FTIR.
Impurities and residues
Related impurities, degradation products, residual solvents (GC headspace), nitrosamine screening.
Elemental impurities
Determination of elemental impurities by ICP-MS and ICP-OES and the associated risk assessment.
Physicochemical
Dissolution and disintegration, hardness, friability, uniformity of dosage units, water content (Karl Fischer), particle size.
Microbiological
Microbial enumeration, specified microorganisms, sterility, bacterial endotoxin, preservative efficacy.
Stability
Real-time and accelerated stability studies; photostability and in-use stability.

Commonly confused in this field

The pharmacopoeial method is binding; an alternative method may be used only by demonstrating its equivalence.
A result produced without method validation cannot be used in a licence dossier.
Accelerated stability does not replace real-time data; shelf life is supported by real-time results.
The dissolution profile is sensitive to apparatus type, agitation rate and medium; the conditions must be complete in the report.
A shortcoming in data integrity produces a non-conformity in an inspection even when the result is correct.
A change of formulation or supplier requires analytical comparison and, where necessary, a new stability study.

Which decisions these results support

The licence dossier and batch release
Determining shelf life and storage conditions
Method transfer and method validation
Incoming raw material acceptance control from suppliers
Assessing the effect of a formulation change on bioequivalence

Structure of the Code

Published by: ISO
Serial number: 4802
Part: without partition

Codes in the library without release year is kept. The current version changes over time; If the year is specified in your specification, that version is taken as basis, if not specified, the most current version is applied.

Scope

Related Tests and Services

A separate test page based on this code has not yet been released. The code falls within the scope of the following test families.

Technical Requirements

Standard texts are copyright of the relevant organization; test condition, sample and acceptance criteria cannot be fitted here.

Technical requirements specific to your product, once we clarify the scope At offer stage shared in writing.

Relevant Product Groups and Legislation

This code is included in the standard tag of the product pages below.

These product pages carry notes for the following markets: European Union, United Kingdom, USA. Whether the standard is mandatory in the relevant market varies depending on the product group and the applicable legislation.

Regulations published with this code on the same product pages:

(AB) 2018/858Vehicle Type-Approval FrameworkApproval of motor vehicles and their components. Component and separate technical unit approval run under this framework; the E mark arises from it.
UNECEUNECE 1958 AgreementType-approval under component-specific UNECE regulations (e.g. R10 EMC, R30/R54 tyres, R43 glazing).
UNECE R10UNECE R10Electromagnetic compatibility approval for vehicles and their components.
2011/65/EURoHSRestriction of hazardous substances in electrical and electronic equipment.
2000/53/ATELVEnd-of-life vehicles. Sets heavy-metal restrictions and recoverability targets.
(EU) 2017/745MDRThe Medical Device Regulation. Classification (I, IIa, IIb, III), clinical evaluation, technical documentation and post-market surveillance obligations; the notified body's role grows as the class rises.
(EU) 2017/746IVDRThe In Vitro Diagnostic Medical Devices Regulation. In vitro diagnostic devices fall under this regulation instead of the MDR.
(AB) 2017/745 art. 33EUDAMEDThe European medical device database. From 28 May 2026, the actor registration, UDI/device, certificate and market surveillance modules are mandatory; placing on the market is not possible without a valid SRN.
2006/42/ATMachinery Directive (overlap)Relevant essential requirements also apply to medical devices that also qualify as machinery.
(EC) 1907/2006REACHRegistration, evaluation, authorisation and restriction of chemicals; SVHC notification.
(EU) 2023/1230Machinery RegulationReplaces 2006/42/EC and becomes mandatory on 20 January 2027 with no further transition period. Requires notified-body involvement for Annex I high-risk machinery.
2014/35/EULVDThe Low Voltage Directive. Governs electrical safety in the 50–1000 V AC range.
2014/30/EUEMCThe Electromagnetic Compatibility Directive. Emission and immunity are covered together.
2014/34/ABATEXEquipment and protective systems used in explosive atmospheres. The category and conformity route are determined by zone classification.
2000/14/ATNoise EmissionNoise emitted into the environment by outdoor equipment. Machinery within scope requires a sound-power-level declaration and marking.
2014/68/EUPEDThe Pressure Equipment Directive for pressurised parts; the category is determined by pressure and volume.
(EU) 2024/573F-GasRefrigerant type, GWP value and leak-tightness obligations for systems containing a refrigerant.
(AB) 547/2012Ecodesign (water pumps)Ecodesign requirements for water pumps. Sets minimum efficiency index and product-information requirements.
(AB) 2019/1781Ecodesign (electric motors)Efficiency class requirements for electric motors and variable-speed drives.
(AT) 1935/2004Food Contact MaterialsGeneral requirements for equipment in contact with food; material conformity is required for valves in food lines.
(AB) 2020/2184Drinking Water Contact ProductsHygiene requirements for materials in contact with water under the Drinking Water Directive.
2014/29/ABSimple Pressure VesselsA separate directive for series-produced simple pressure vessels; its scope must be distinguished from the PED.
2010/35/ABTransportable Pressure EquipmentThe pi mark and periodic inspection regime for transportable pressure equipment.
2009/48/ECToy SafetyThe Toy Safety Directive. Regulates mechanical, physical, flammability, chemical and electrical safety requirements together; a technical file and safety assessment are mandatory.
EN 62115Electrical toysSafety for electric toys; applies to mains-connected or battery-powered toys.
(AT) 1907/2006 Annex XVII item 51-52Phthalate RestrictionRestriction of certain phthalates in toys and childcare articles.
(EU) 2023/1542Batteries RegulationBattery obligations and a removability requirement for toys containing a battery.
(AB) 1007/2011Textile LabellingTextile fibre names and labelling. Declaration of fibre composition and regulation of the label language.
(AT) 1907/2006 Annex XVII item 43Azo Dye RestrictionRestriction of certain azo dyes in textiles in contact with skin.
(AB) 2019/1021PFAS / PFOA RestrictionRestriction of PFOA and its derivatives under the Persistent Organic Pollutants Regulation.
(EU) 2023/988GPSRThe General Product Safety Regulation. The safety framework for consumer products not covered by sector-specific legislation.
(EU) 2016/425Personal Protective Equipment (overlap)The PPE Regulation's scope and category are determined for textiles with a protective function.
(AB) 10/2011Plastics in Food ContactPlastic materials in contact with food. The list of authorised substances, and overall and specific migration limits.
(AT) 2023/2006Good Manufacturing PracticeGood manufacturing practice (GMP) for food-contact materials.
(AB) 2025/40Packaging and Packaging WasteThe Packaging and Packaging Waste Regulation. Recyclability, recycled-content and packaging-reduction obligations; replaces 94/62/EC.
(AB) 2022/1616Recycled PlasticRecycled plastic materials in contact with food.
(EU) 2024/3110Construction Products RegulationDeclaration of performance and CE marking for construction products. Most provisions apply from 8 January 2026; it progressively replaces (EU) 305/2011.
(AB) 305/2011CPR (transition)Continues to apply during the transition period for product groups where a new harmonised standard has not been published.
EN 13501-1Reaction-to-Fire ClassificationReaction-to-fire class for construction products; a mandatory item of the declaration of performance.
(EU) 2023/1115Deforestation (wood-based)A deforestation-free supply declaration for wood and derived construction materials.
(AT) 1223/2009Cosmetic Products RegulationThe Cosmetic Products Regulation. Appointing a responsible person, the product information file (PIF), the safety assessment (CPSR) and CPNP notification are mandatory; there is no product approval, and responsibility rests with the manufacturer.
(AT) 1223/2009 Annexes II-VIProhibited and Restricted SubstancesLists of prohibited substances, restricted substances, and permitted preservatives, colorants and UV filters.
(AT) 1223/2009 art. 16Nanomaterial NotificationA separate notification six months before placing on the market for products containing nanomaterials.
(AT) 1223/2009 art. 18Animal Testing BanA ban on animal testing of finished products and ingredients, and on placing animal-tested products on the market.
(AT) 178/2002General Food LawThe general principles of food law, traceability and food safety responsibility.
(AT) 852/2004Food HygieneHygiene rules for food businesses and the obligation for a HACCP-based system.
(AB) 1169/2011Food Information to ConsumersFood labelling; nutrition declaration, allergen information and origin information.
(AB) 2023/915ContaminantsMaximum levels of contaminants in food.
(AT) 396/2005Pesticide residuesMaximum residue limits in food of plant and animal origin.
(AT) 2073/2005Microbiological CriteriaMicrobiological criteria for foodstuffs.

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