11.120.99 - Other standards related to pharmaceutics
ICS 11.120.99 Details
Other standards related to pharmaceutics
Weitere Aspekte der Pharmazie
Autres normes relatives a la pharmacie
Drugi standardi v zvezi s farmacijo
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This document specifies performance requirements and methods of test for non-reclosable packaging that have been designated child-resistant. This document is intended for type approval only (see 3.5) and is not intended for quality assurance purposes.
- Standard22 pagesEnglish languagesale 10% offe-Library read for1 day
This document describes the general specifications of temperature-sensitive medicinal packaging based on the principles of good distribution practice (GDP). It also specifies test methods to validate the package performance for temperature-sensitive medicinal products. This covers the procedures of temperature-recording and testing methods on the performance of insulated containers such as dimensions, weights, storage capacity and robustness in temperature-controlling. This document does not guarantee the quality and safety of all medicinal products. Under special circumstances where the weight or the characteristics of the products and environment show specific conditions, agreements are followed. This document does not cover the active packaging system, but only covers the passive packaging system able to control the desired temperature without any power sources.
- Standard16 pagesEnglish languagesale 15% off
This document specifies requirements and recommendations for organizations directly or indirectly involved in the cannabis supply chain, to enable them to: — plan, implement, operate, maintain and update a good production practice programme for providing products that are safe, according to their intended use; — demonstrate compliance with applicable statutory and regulatory requirements; — evaluate and assess mutually agreed customer requirements and demonstrate conformity to them; — effectively communicate with interested parties and demonstrate conformity to relevant interested parties; — demonstrate conformity to stated policies in a cannabis quality programme (CQP) for product safety, product quality, product security and facility safety; — support the evaluation of quality programmes by external organizations or to permit self-assessment or self-declaration of adherence to some or all of the guidance contained in this document. All requirements in this document are generic and intended to be applicable to all organizations in the cannabis supply chain, regardless of size and/or complexity. Organizations that are directly or indirectly involved include (but are not limited to) growers/cultivators, harvesters, primary processors, producers of cannabis, manufacturers of cannabis derivatives, cannabis edibles and/or cannabis products, testing providers, retailers and organizations providing transportation, storage and distribution services, suppliers of equipment, packaging materials and other contact materials. This document intended to enable any organization, including small and/or less developed organizations, to implement externally developed elements in its CQP. NOTE 1 Organizations in the cannabis supply chain are diverse in nature and not all the requirements specified in this document apply to each establishment or process. Justifications for exclusions or the use of alternative measures can be documented by a risk assessment/hazard analysis or other appropriate means. This document provides guidance related to the following categories of cannabis, cannabis derivatives and cannabis products: — cannabis plant seeds; — cannabis plants; — fresh cannabis; — dried cannabis; — cannabis derivatives; — cannabis topicals; — inhalable cannabis. NOTE 2 Annex B provides additional guidance on applying GPP to cannabis edibles with respect to requirements and recommendations in existing food safety standards. Where buildings or premises combine cultivation and processing of cannabis plants, including ancillary activities, along with other operational activities, the requirements and recommendations in this document apply only to that portion of the facility. NOTE 3 Where joint use activities are present in a common building, specific statutory and regulatory requirements can apply for each category. This document does not address the following: — requirements related to research and development activities for finished products; — general fire prevention or building construction features that are normally a function of local building and fire codes where applicable; — premises used exclusively for operational activities, such as office space, call centres and retail outlets, used for the distribution, marketing, or sale of cannabis; NOTE 4 Shipping and receiving of products from the production facility for further distribution are not considered as a retail outlet. — the safe consumption or use of the cannabis or cannabis products produced by organizations applying these good production practices; — occupational health and safety requirements governing cannabis workers and personnel except as identified in A.8.4 and A.8.6; — the protection of the environment; — security of the supply chain monitoring system, including cybersecurity and notifications; NOTE 5 Security and monitoring of the supply chain are dealt with specifically in IWA 37-2. — outdoor cultivation of cannabis and industrial hemp; — gr
- Standardization document66 pagesEnglish languagesale 15% off
This document specifies the shape, dimensions, fill capacities and performance requirements of moulded glass bottles for metering pumps. It also specifies the material for the manufacturing of such containers as well as the secondary packaging. This document also provides requirements for packaging of the moulded glass bottles and addresses nonsterile, ready to sterilize or sterile as three possible options. This document is applicable to colourless or amber glass containers moulded from borosilicate or soda-lime-silica glass and intended to be used in the packaging, storage or transportation of products intended for medicinal use.
- Standard17 pagesEnglish languagesale 15% off
This document specifies the shape, dimensions, fill capacities and performance requirements of plastic bottles for metering pumps. It also specifies the material for the manufacturing of such containers as well as the secondary packaging. The document provides requirements for packaging of the plastic bottles and addresses nonsterile, ready to sterilize or sterile as three possible options. This document is applicable to colourless or coloured containers moulded from plastic and intended to be used in the packaging, storage or transportation of products intended for medicinal use.
- Standard18 pagesEnglish languagesale 15% off
This document specifies the shape, dimensions, fill capacities and performance requirements of tubular glass vials for metering pumps. It also specifies the material for the manufacturing of such containers as well as the secondary packaging. This document provides also requirements for packaging of the tubular glass vials and addresses nonsterile, ready to sterilize or sterile as three possible options. This document is applicable to colourless or amber containers made of tubular glass and intended to be used for packaging, storage or transportation of products intended for medicinal use.
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This document specifies requirements and test methods for sterilized single-use transfer sets that are used for pharmaceutical preparations.
- Standard23 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies requirements and provides guidance for the application, use and check of tamper verification features to the packaging of medicinal products.
- Standard25 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies requirements and provides guidance for the application, use and check of tamper verification features to the packaging of medicinal products.
- Standard25 pagesEnglish languagesale 10% offe-Library read for1 day
This document is the base standard for a number of other standards dealing with water treatment
equipment, water, dialysis water, concentrates, and dialysis fluid (ISO 23500 series) and provides
dialysis practitioners with guidance on the preparation of dialysis fluid for haemodialysis and
related therapies and substitution fluid for use in online therapies, such as haemodiafiltration and
haemofiltration. As such, this document functions as a recommended practice.
This document does not address clinical issues that might be associated with inappropriate usage of the
water, dialysis water, concentrates, or dialysis fluid. Healthcare professionals involved in the provision
of treatment for kidney failure should make the final decision regarding the applications with which
these fluids are used, for example, haemodialysis, haemodiafiltration, high-flux haemodialysis, and the
reprocessing of dialysers, and need to be aware of the issues that the use of inappropriate fluid quality
raises in each of the therapies.
The concepts incorporated in this document should not be considered inflexible or static. The
recommendations presented here should be reviewed periodically in order to assimilate increased
understanding of the role of dialysis fluid purity in patient outcomes and technological developments.
- Standard96 pagesEnglish languagesale 10% offe-Library read for1 day
This document is addressed to the manufacturer and/or supplier of water treatment systems and/or
devices used for the express purpose of providing water for haemodialysis or related therapies.
- Standard43 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies requirements and provides guidance for the application, use and check of tamper verification features to the packaging of medicinal products.
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This draft European Standard applies to type D and type SD hose assemblies with hoses made of elastomers and plastics for the transport of gaseous, vaporous, liquid or powdry substances in the pharmaceutical and the biotechnological industries. It specifies the classification, manufacturing and testing of as well as the materials, requirements and quality surveillance for hose assemblies.
These hose assemblies are intended to be used with the relevant substances at temperatures in the range from −30 °C to +100 °C, depending on the medium, and at operating pressures from −0,9 bar (vacuum) to 10 bar (see Tables 2 and 3). For hoses with inliners made of PTFE and derivatives, temperatures from −30 °C to +140 °C are permissible.
Hose assemblies in accordance with this standard are classified into two designs, A and B (see 3.3).
Attention is called to the fact that for certain applications the relevant legal regulations such as the Pressure Equipment Directive 97/23/EC (PED) need to be complied with.
- Standard27 pagesEnglish languagesale 10% offe-Library read for1 day
This draft European Standard applies to type 1 to type 3 hose assemblies with hoses made of silicone rubber for the transport of liquid or powdry substances in the pharmaceutical and the biotechnological industries. It specifies the classification, manufacturing and testing of as well as the materials, requirements and quality surveillance for hose assemblies.
These hose assemblies are intended to be used with the relevant substances at temperatures in the range from −40 °C ) to +150 °C and at operating pressures from −0,9 bar (vacuum) to 10 bar (see Table 1). These hose assemblies are not electrically conductive. The danger of static charging shall be considered on a case-by-case basis.
Hose assemblies in accordance with this standard are classified into two designs, A and B (see 3.2).
Attention is called to the fact that for certain applications the relevant legal regulations such as the Pressure Equipment Directive 97/23/EC (PED) need to be complied with.
- Standard17 pagesEnglish languagesale 10% offe-Library read for1 day
ISO 11418-1:2016 specifies the design, dimensions, material and requirements of drop-dispensing glass bottles. Drop-dispensing glass bottles are applicable to primary packs used in direct contact with a drug. It is applicable to drop-dispensing glass bottles used in pharmacy. Together with the corresponding closure systems, they serve for packaging of pharmaceutical preparations which are not intended for parenteral use.
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ISO 11418-2:2016 specifies the design, dimensions, material and requirements of screw-neck glass bottles for pharmaceutical preparations in liquid form (syrups). Screw-neck glass bottles are applicable to primary packs used in direct contact with a drug. It is applicable to screw-neck glass bottles used in pharmacy. Together with the corresponding closure systems, they serve for packaging of pharmaceutical preparations which are not intended for parenteral use.
- Standard6 pagesEnglish languagesale 15% off
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ISO 11418-3:2016 specifies the design, dimensions, material and requirements of screw-neck glass bottles (veral) for pharmaceutical preparations in solid and liquid dosage forms. Screw-neck glass bottles are applicable to primary packs used in direct contact with a drug. It is applicable to screw-neck glass bottles (veral) used in pharmacy. Together with the corresponding closure systems, they serve for packaging of pharmaceutical preparations in solid and liquid dosage forms which are not intended for parenteral use.
- Standard6 pagesEnglish languagesale 15% off
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ISO 11418-7:2016 specifies the design, dimensions, material and requirements of screw-neck vials for pharmaceutical preparations. Screw-neck vials are applicable to primary packs used in direct contact with a drug. It applies to colourless or amber glass vials made from borosilicate or soda-lime-silica glass, made from glass tubing and intended to be used in the packaging, storage or transportation of pharmaceutical products. NOTE The potency, purity, stability and safety of a drug during its manufacture and storage can be strongly affected by the nature and performance of the primary pack.
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ISO 11418-5:2015 specifies the design, dimensions, material, and requirements of dropper assemblies consisting of a screw cap, dropper bulbs, and pipettes for the application and dosage of liquid pharmaceutical preparations. This part of ISO 11418 is applicable to dropper assemblies used in the medical field in order to deliver pharmaceutical preparations contained in screw neck bottles according to ISO 11418-1. Dropper assemblies are applicable to primary packs used in direct contact with the drug. NOTE The potency, purity, stability, and safety of a drug during its manufacture and storage can be strongly affected by the nature and performance of the primary pack.
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This European Technical Report addresses the provision of information for medicinal products in alternative formats suitable for blind and partially sighted people.
- Technical report11 pagesEnglish languagesale 10% offe-Library read for1 day
ISO 11418-4:2005 specifies the design, dimensions, material and requirements of tablet glass bottles. Tablet glass bottles are applicable to primary packs used in direct contact with a drug. ISO 11418-4:2005 is applicable to tablet glass bottles used in pharmacy. Together with the corresponding closure systems, they serve for packaging of pharmaceutical preparations in solid and liquid dosage forms which are not intended for parenteral use.
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This document specifies minimum requirements for concentrates used for haemodialysis and related
therapies.
This document is addressed to the manufacturer of such concentrates. In several instances in this
document, the dialysis fluid is addressed, which is made by the end user, to help clarify the requirements
for manufacturing concentrates. Because the manufacturer of the concentrate does not have control
over the final dialysis fluid, any reference to dialysis fluid is for clarification and is not a requirement of
the manufacturer.
This document includes concentrates in both liquid and powder forms. It also includes additives, also
called spikes, which are chemicals that can be added to the concentrate to supplement or increase the
concentration of one or more of the existing ions in the concentrate and thus in the final dialysis fluid.
This document also specifies requirements for equipment used to mix acid and bicarbonate powders
into concentrate at the user's facility.
Concentrates prepared from pre-packaged salts and water at a dialysis facility for use in that facility
are excluded from the scope of this document. Although references to dialysis fluid appear herein,
this document does not address dialysis fluid as made by the end user. This document also excludes
requirements for the surveillance frequency of water purity used for the making of dialysis fluid by the
dialysis facility. This document does not address bags of sterile dialysis fluid or sorbent dialysis fluid
regeneration systems that regenerate and recirculate small volumes of the dialysis fluid.
This document does not cover the dialysis fluid that is used to clinically dialyse patients. Dialysis fluid
is covered in ISO 23500-5. The making of dialysis fluid involves the proportioning of concentrate and
water at the bedside or in a central dialysis fluid delivery system. Although the label requirements
for dialysis fluid are placed on the labelling of the concentrate, it is the user's responsibility to ensure
proper use.
This document does not cover haemodialysis equipment, which is addressed in IEC 60601-2-16:2012.
- Standard31 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies minimum requirements for water to be used in haemodialysis and related
therapies.
This document includes water to be used in the preparation of concentrates, dialysis fluids for
haemodialysis, haemodiafiltration and haemofiltration, and for the reprocessing of haemodialysers.
This document excludes the operation of water treatment equipment and the final mixing of treated
water with concentrates to produce dialysis fluid. Those operations are the sole responsibility of
dialysis professionals. This document does not apply to dialysis fluid regenerating systems.
- Standard27 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies minimum quality requirements for dialysis fluids used in haemodialysis and
related therapies.
This document includes dialysis fluids used for haemodialysis and haemodiafiltration, including
substitution fluid for haemodiafiltration and haemofiltration.
This document excludes the water and concentrates used to prepare dialysis fluid or the equipment
used in its preparation. Those areas are covered by other International Standards.
Sorbent-based dialysis fluid regeneration systems that regenerate and recirculate small volumes of
dialysis fluid, systems for continuous renal replacement therapy that use pre-packaged solutions, and
systems and solutions for peritoneal dialysis are excluded from this document.
- Standard22 pagesEnglish languagesale 10% offe-Library read for1 day
This European Standard specifies performance requirements and methods of test for non-reclosable packaging that have been designated child-resistant. This European Standard is intended for type approval only (see 3.5) and is not intended for quality assurance purposes.
- Standard17 pagesEnglish languagesale 10% offe-Library read for1 day
This International Standard applies to sterilized single use transfer sets that are used for pharmaceutical preparations.
- Standard24 pagesEnglish languagesale 10% offe-Library read for1 day
ISO 22413:2010 applies to sterilized single use transfer sets that are used for pharmaceutical preparations.
- Standard24 pagesEnglish languagesale 10% offe-Library read for1 day
This International Standard specifies minimum requirements for concentrates used for haemodialysis and related therapies. For the purpose of this International Standard, “concentrates” are a mixture of chemicals and water, or chemicals in the form of dry powder or other highly concentrated media, that are delivered to the end user to make dialysis fluid used to perform haemodialysis and related therapies.
This International Standard is addressed to the manufacturer of such concentrates. In several instances in this International Standard, it became necessary to address the dialysis fluid, which is made by the end user, to help clarify the requirements for manufacturing concentrates. Because the manufacturer of the concentrate does not have control over the final dialysis fluid, any reference to dialysis fluid is for clarification and is not a requirement of the manufacturer.
This International Standard includes concentrates in both liquid and powder forms. Also included are additives, also called spikes, which are chemicals that may be added to the concentrate to increase the concentration of one or more of the existing ions in the concentrate and thus in the final dialysis fluid. This International Standard also gives requirements for equipment used to mix acid and bicarbonate
powders into concentrate at the user’s facility.
Concentrates prepared from prepackaged salts and water at a dialysis facility for use in that facility are excluded from the scope of this International Standard. Although references to dialysis fluid appear herein, this International Standard does not address dialysis fluid as made by the end user. Also excluded from the scope of this International Standard are requirements for the monitoring frequency of water purity used for the making of dialysis fluid by the dialysis facility. Recommendations from the technical committee responsible for this International Standard for monitoring water quality are contained in ISO 23500. This International Standard does not address bags of sterile dialysis fluid or sorbent dialysis fluid regeneration systems that regenerate and recirculate small volumes of the dialysis fluid.
- Standard37 pagesEnglish languagesale 10% offe-Library read for1 day
This International Standard specifies minimum requirements for water to be used in haemodialysis and related therapies.
This International Standard includes water to be used in the preparation of concentrates, dialysis fluids for haemodialysis, haemodiafiltration and haemofiltration, and for the reprocessing of haemodialysers.
The operation of water treatment equipment and the final mixing of treated water with concentrates to produce dialysis fluid are excluded from this International Standard. Those operations are the sole responsibility of dialysis professionals. This International Standard does not apply to dialysis fluid regenerating systems.
- Standard25 pagesEnglish languagesale 10% offe-Library read for1 day
This European Standard specifies requirements for dry and liquid concentrates to be diluted for use as dialysing fluids in haemodialysis or related therapies. It addresses chemical and microbiological quality and purity, handling and labelling of concentrates, the requirements for containers and the tests to monitor chemical and microbiological contents and quality of such concentrates.
This European standard does not address the final mixing and use of these concentrates or the treated water used in connection with haemodialysis and related therapies.
This European standard does not apply to dialysing fluid regeneration systems.
- Standard14 pagesEnglish languagesale 10% offe-Library read for1 day
This European Standard specifies requirements for dry and liquid concentrates to be diluted for use as dialysing fluids in haemodialysis or related therapies. It addresses chemical and microbiological quality and purity, handling and labelling of concentrates, the requirements for containers and the tests to monitor chemical and microbiological contents and quality of such concentrates.
This European standard does not address the final mixing and use of these concentrates or the treated water used in connection with haemodialysis and related therapies.
This European standard does not apply to dialysing fluid regeneration systems.
- Standard14 pagesEnglish languagesale 10% offe-Library read for1 day
This European Standard specifies requirements and provides guidance for the application of Braille to the labelling of medicinal products.
NOTE 1 The labelling of medicinal products placed on the market and incorporating Braille in accordance with this European Standard meets the requirements of European Directive 2001/83/EC, Article 56, (a) as amended by Directive 2004/27/EC [1].
NOTE 2 The principles in this European Standard can be applied in other sectors, as appropriate.
- Standard18 pagesEnglish languagesale 10% offe-Library read for1 day
ISO 22413:2010 applies to sterilized single use transfer sets that are used for pharmaceutical preparations.
- Standard24 pagesEnglish languagesale 10% offe-Library read for1 day
ISO 22413:2010 applies to sterilized single use transfer sets that are used for pharmaceutical preparations.
- Standard24 pagesEnglish languagesale 10% offe-Library read for1 day
This European Standard applies to dry and liquid concentrates to be diluted for use as dialysing fluids in haemodialysis or related therapies. It addresses chemical and microbiological quality and purity, handling and labelling of concentrates, the requirements for containers and the tests to monitor chemical and microbiological contents and quality of such concentrates. This Standard does not address the final mixing and use of these concentrates or the treated water used in connection with haemodialysis and related therapies. This European Standard does not apply to dialysing fluid regeneration systems.
- Standard14 pagesEnglish languagesale 10% offe-Library read for1 day
This European Standard applies to dry and liquid concentrates to be diluted for use as dialysing fluids in haemodialysis or related therapies. It addresses chemical and microbiological quality and purity, handling and labelling of concentrates, the requirements for containers and the tests to monitor chemical and microbiological contents and quality of such concentrates. This Standard does not address the final mixing and use of these concentrates or the treated water used in connection with haemodialysis and related therapies. This European Standard does not apply to dialysing fluid regeneration systems.
- Standard14 pagesEnglish languagesale 10% offe-Library read for1 day
ISO 11418-3:2005 specifies the design, dimensions, material and requirements of screw-neck glass bottles (veral) for pharmaceutical preparations in solid and liquid dosage forms. Screw-neck glass bottles are applicable to primary packs used in direct contact with a drug. ISO 11418-3:2005 is applicable to screw-neck glass bottles (veral) used in pharmacy. Together with the corresponding closure systems, they serve for packaging of pharmaceutical preparations in solid and liquid dosage forms which are not intended for parenteral use.
- Standard4 pagesEnglish languagesale 15% off
ISO 11418-1:2005 specifies the design, dimensions, material and requirements of drop-dispensing glass bottles. Drop-dispensing glass bottles are applicable to primary packs used in direct contact with a drug. ISO 11418-1:2005 is applicable to drop-dispensing glass bottles used in pharmacy. Together with the corresponding closure systems, they serve for packaging of pharmaceutical preparations which are not intended for parenteral use.
- Standard4 pagesEnglish languagesale 15% off
ISO 11418-2:2005 specifies the design, dimensions, material and requirements of screw-neck glass bottles for pharmaceutical preparations in liquid form (syrups). Screw-neck glass bottles are applicable to primary packs used in direct contact with a drug. ISO 11418-2:2005 is applicable to screw-neck glass bottles used in pharmacy. Together with the corresponding closure systems, they serve for packaging of pharmaceutical preparations which are not intended for parenteral use.
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Specifies the design, dimensions, materials and requirements of screw-neck bottles used in pharmacy. Together with the corresponding closure systems, they serve for packaging of solid and liquid pharmaceutical preparations which are not intended for parenteral use.
- Standard4 pagesEnglish languagesale 15% off
- Standard4 pagesFrench languagesale 15% off
- Standard4 pagesFrench languagesale 15% off
Specifies the design, dimensions, materials and requirements of drop-dispensing bottles used in pharmacy. Together with the corresponding closure systems, they serve for packaging of pharmaceutical preparations which are not intended for parenteral use.
- Standard4 pagesEnglish languagesale 15% off
- Standard4 pagesFrench languagesale 15% off
- Standard4 pagesFrench languagesale 15% off
Specifies the design, dimensions, materials and requirements of screw-neck bottles used for pharmaceutical preparations in liquid form (sirups). Together with the corresponding closure systems, they serve for packaging of pharmaceutical preparations which are not intended for parenteral use.
- Standard4 pagesEnglish languagesale 15% off
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- Standard4 pagesFrench languagesale 15% off
Specifies the design, dimensions, materials and requirements of tablet bottles used in pharmacy. Together with the corresponding closure systems, they serve for packaging of tablets which are not intended for parenteral use.
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