11.120 - Pharmaceutics
ICS 11.120 Details
Pharmaceutics
Pharmazie
Pharmacie
Farmacija
General Information
Frequently Asked Questions
ICS 11.120 is a classification code in the International Classification for Standards (ICS) system. It covers "Pharmaceutics". The ICS is a hierarchical classification system used to organize international, regional, and national standards, facilitating the search and identification of standards across different fields.
There are 452 standards classified under ICS 11.120 (Pharmaceutics). These standards are published by international and regional standardization bodies including ISO, IEC, CEN, CENELEC, and ETSI.
The International Classification for Standards (ICS) is a hierarchical classification system maintained by ISO to organize standards and related documents. It uses a three-level structure with field (2 digits), group (3 digits), and sub-group (2 digits) codes. The ICS helps users find standards by subject area and enables statistical analysis of standards development activities.
e-Library Subscription
Create subscription and get permanent access to documents within 11.120 - Pharmaceutics
Currently subscription includes documents marked with .We are working on making all documents available within the subscription.
This document is applicable to type D and type SD hose assemblies with hoses made of elastomers and bonded plastics for the transport of gaseous, vaporous, liquid or powdery 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 Table 2 and Table 3). For hoses with a lining made of PTFE and derivatives, temperatures from −30 °C to +140 °C are permissible.
Hose assemblies in accordance with this document are classified into four types, A – D, A – SD. B – D, B – SD.
- Standard23 pagesEnglish languagee-Library read for1 day
This document specifies the general principles for the establishment of herbal reference substances, covering production, quality control, report, instruction and labelling, packaging, storage and transportation. This document applies to herbal reference substances that are sold and used as reference standards for the quality control of herbal medicines in international trade, including raw materials and finished products.
- Standard8 pagesEnglish languagesale 15% off
This document specifies the quality and safety requirements for cultivated Cistanche deserticola stem derived from the plant of Cistanche deserticola Y.C. Ma. It is applicable to cultivated Cistanche deserticola stem that is sold as natural medicine in international trade, including Chinese materia medica (whole medicinal materials) and decoction pieces derived from this plant.
- Standard15 pagesEnglish languagesale 15% off
This document specifies the general technical requirements for the process of cultivation and collection of medicinal plants, including selection of site, seeds and other propagation materials, cultivation, harvest and collection, post-harvest processing, packaging and labelling, storage and transportation. This document applies to the cultivation, harvest and collection of medicinal plants used as the source for herbal medicines, including certain post-harvest operations. This document also provides practical record formats for the entire process.
- Standard15 pagesEnglish languagesale 15% off
This document specifies the minimum quality and safety requirements for Crocus sativus stigma. It applies to Crocus sativus stigma that is sold and used as natural medicines in international trade, including in Chinese materia medica and decoction pieces.
- Standard11 pagesEnglish languagesale 15% off
This document specifies the quality and safety requirements for Anemarrhena asphodeloides rhizome. This document applies to Anemarrhena asphodeloides rhizome that is sold and used as natural medicines in international trade, including Chinese materia medica (whole medicinal materials) and decoction pieces derived from the plant.
- Standard10 pagesEnglish languagesale 15% off
This document specifies the quality, safety requirements and test methods for Euodia fruit. It is applicable to Euodia fruit that is sold and used as natural medicines in international trade, including Chinese materia medica (whole medicinal materials) and decoction pieces.
- Standard13 pagesEnglish languagesale 15% off
This document specifies requirements and test methods for Ganoderma lucidum fruiting body that is derived from Ganoderma lucidum (Leyss. ex Fr.) Karst. It is applicable to the Ganoderma lucidum fruiting body that is sold and used as Chinese materia medica (whole medicinal materials) and decoction pieces derived from this fungus.
- Standard15 pagesEnglish languagesale 15% off
This document specifies requirements and test methods for Curcuma rhizome (Curcuma phaeocaulis, Curcuma kwangsiensis and Curcuma wenyujin rhizome). It is applicable to the Curcuma rhizome that is sold and used as a natural medicine in international trade, including Chinese materia medica (whole medicinal materials) and decoction pieces derived from the plant. This document does not apply to the processing methods and processed products of Curcuma rhizome.
- Standard18 pagesEnglish languagesale 15% off
This document specifies the quality and safety requirements of Gentiana scabra, Gentiana manshurica, and Gentiana triflora root and rhizome. This document applies to Gentiana scabra, Gentiana manshurica, and Gentiana triflora root and rhizome that is sold and used as natural medicines in international trade, including in Chinese materia medica, in its whole medicinal material, and in decoction pieces derived from these plants.
- Standard16 pagesEnglish languagesale 15% off
This document specifies minimum requirements and test methods for Dendrobium officinale stem that is derived from cultivated Dendrobium officinale Kimura et Migo. It is applicable to Dendrobium officinale stem that is sold and used as Chinese materia medica (whole medicinal materials) and decoction pieces derived from this plant.
- Standard13 pagesEnglish languagesale 15% off
This document specifies the quality and safety requirements of Pueraria lobata root. This document applies to Pueraria lobata root that is sold and used as natural medicine in international trade, including Chinese materia medica (whole medicinal materials) and decoction pieces derived from this root.
- Standard18 pagesEnglish languagesale 15% off
This document specifies the general requirements for the safety and quality of stick-type single-dose package for viscous extracts. This document does not apply to solid dosage forms.
- Technical specification6 pagesEnglish languagesale 15% off
This document specifies minimum requirements and test methods for Gastrodia elata tuber that is derived from cultivated and artificially propagated Gastrodia elata Bl. It is applicable to Gastrodia elata tuber that is sold and used as Chinese materia medica, specifically excluding the wild forms of the species.
- Standard17 pagesEnglish languagesale 15% off
This document specifies minimum requirements and test methods for Aconitum carmichaelii parent root tuber. This document applies to Aconitum carmichaelii parent root tuber that is sold and used as natural medicines in international trade, including Chinese materia medica (whole medicinal materials) and decoction pieces derived from this plant. Processing methods and processed products of Aconitum carmichaelii parent root tuber are excluded.
- Standard10 pagesEnglish languagesale 15% off
This document specifies the quality and safety requirements and test methods of Polygonum multiflorum root, which is derived from the dried root of Polygonum multiflorum Thunb. (Fam. Polygonaceae). This document is applicable to raw and processed Polygonum multiflorum root that are sold and used as natural medicines in international trade, including Chinese materia medica (whole medicinal material) and decoction pieces derived from this plant.
- Standard17 pagesEnglish languagesale 15% off
This document specifies the minimum requirements and test methods for Platycodongrandiflorus root. It is applicable to Platycodon grandiflorus roots that are sold and used as natural medicines in international trade, including Chinese material medica (whole medicinal material) and decoction pieces derived from this plant.
- Standard15 pagesEnglish languagesale 15% off
This document specifies requirements and test methods for sporoderm-broken Ganoderma lucidum spore powder that is derived from Ganoderma lucidum (Leyss. ex Fr.) Karst. It is applicable to sporoderm-broken Ganoderma lucidum spore powder that is sold and used as natural medicine and raw material for health products in international trade.
- Technical specification17 pagesEnglish languagesale 15% off
This document specifies the methods for microscopic examination of medicinal herbs. It covers the equipment, sampling, preparation and observation methods. This document is applicable to medicinal herbs used in traditional Chinese medicine, including Chinese materia medica (whole medicinal materials) and decoction pieces derived from plants. It is not applicable to medicinal materials derived from animals or minerals.
- Technical specification10 pagesEnglish languagesale 15% off
This document specifies the requirements and test methods of Glycyrrhiza uralensis and Glycyrrhiza glabra seeds and seedlings. This document is applicable to Glycyrrhiza uralensis and Glycyrrhiza glabra seeds and Glycyrrhiza uralensis seedlings that are sold for the production of Glycyrrhiza uralensis and Glycyrrhiza glabra root as natural medicines in international trade including Chinese materia medica (whole medicinal materials) and decoction pieces.
- Standard11 pagesEnglish languagesale 15% off
This document specifies the quality and safety requirements and test methods of Dioscorea opposita rhizome (dried rhizome of Dioscorea opposita Thunb.). It is applicable to Dioscorea opposita rhizomes that are sold and used as natural medicines in international trade, including Chinese materia medica (whole medicinal material) and decoction pieces derived from this plant.
- Standard10 pagesEnglish languagesale 15% off
This document specifies the minimum requirements and test methods for Polygala tenuifolia and Polygala sibirica root. It applies to Polygala tenuifolia and Polygala sibirica root that are sold and used as natural medicines in international trade, including Chinese materia medica (whole medicinal materials) and decoction pieces.
- Standard15 pagesEnglish languagesale 15% off
This document specifies the quality and safety requirements for Cinnamomum cassia branch derived from Cinnamomum cassia Presl. This document is applicable to Cinnamomum cassia branch that is sold as natural medicines in international trade including Chinese materia medica (whole medicinal materials) and decoction pieces derived from Cinnamomum cassia Presl.
- Standard15 pagesEnglish languagesale 15% off
This document provides a reference of single herbal medicines in order of their priority in the development of international standards. This document also provides a reference of the principles and the methodology for the priority evaluation of single herbal medicines. In addition to text written in the official ISO languages (English, French, Russian), this document gives text in Chinese. This text is published under the responsibility of the Member Body for China (SAC) and is given for information only. Only the text given in the official languages can be considered as ISO text.
- Technical report97 pagesEnglish languagesale 15% off
This document specifies the minimum requirements and test methods for Carthamus tinctorius flower that is derived from Carthamus tinctorius Linné. It is applicable to Carthamus tinctorius flower that is sold and used as Chinese materia medica.
- Standard16 pagesEnglish languagesale 15% off
This document specifies the quality and safety requirements for Glycyrrhiza root and rhizome that is derived from the root and rhizome of Glycyrrhiza uralensis Fisch., Glycyrrhiza inflata Bat or Glycyrrhiza glabra L. (Fam. Fabaceae). This document applies to Glycyrrhiza root and rhizome that is sold and used as natural medicines in international trade, including Chinese materia medica (whole medicinal materials) and decoction pieces derived from this plant.
- Standard15 pagesEnglish languagesale 15% off
This document specifies the application of simplified accelerated stress simulation methods for stress tests of finished products, used in and as Traditional Chinese medicine (TCM). Testing for stability or degradation under the influence of daylight or sunlight is outside the scope of this document.
- Standard23 pagesEnglish languagesale 15% off
This document specifies the minimum requirements and test methods for Eucommia ulmoides stem bark. It is applicable to Eucommia ulmoides stem bark that is sold and used as natural medicines in international trade, including Chinese materia medica (whole medicinal materials) and raw decoction pieces. It is not applicable to processed decoction pieces of Eucommia ulmoides stem bark.
- Standard16 pagesEnglish languagesale 15% off
This document specifies requirements and test methods for Atractylodes macrocephala rhizome that is derived from Atractylodes macrocephala Koidz. It is applicable to Atractylodes macrocephala rhizome that is sold and used as a natural medicine in international trade, including Chinese materia medica (whole medicinal materials) and decoction pieces derived from the plant.
- Standard12 pagesEnglish languagesale 15% off
This document specifies the quality and safety requirements for Curcuma longa rhizome. This document applies to the production and sale of cultivated Curcuma longa rhizome that is sold and used as natural medicine in international trade, including Chinese materia medica (whole medicinal materials) and decoction pieces derived from this rhizome.
- Standard15 pagesEnglish languagesale 15% off
This document specifies the quality and safety requirements and test methods of Gardenia jasminoides fruit, which is derived from the dried fruit of Gardenia jasminoides Ellis (Fam. Rubiaceae). This document is applicable to Gardenia jasminoides fruit that are sold and used as natural medicines in international trade, including Chinese materia medica (whole medicinal material) and decoction pieces derived from this plant.
- Standard13 pagesEnglish languagesale 15% off
This document specifies the quality and safety requirements of Angelica dahurica root [the dried root of Angelica dahurica (Fish.ex Hoffm.) Benth. et Hook. f. ex Franch. et Sav.]. This document applies to Angelica dahurica root that is sold and used as natural medicine in international trade, including Chinese materia medica (whole medicinal materials) and decoction pieces derived from the plant.
- Standard12 pagesEnglish languagesale 15% off
This document specifies general requirements for ultrafine powder of herbs to ensure their quality and safety. This document applies to ultrafine powder of herbs that are sold and used as natural medicines in international trade, including finished products derived from this powder.
- Standard6 pagesEnglish languagesale 15% off
This document specifies minimum requirements and a test method for the antimicrobial (microbicidal or microbistatic) activity of wound dressing products. It applies to all wound dressing products that specifically claim antimicrobial activity according to this document.
- Standard47 pagesEnglish languagee-Library read for1 day
This document specifies minimum requirements and a test method for the antimicrobial (microbicidal or microbistatic) activity of wound dressing products. It applies to all wound dressing products that specifically claim antimicrobial activity according to this document.
- Standard47 pagesEnglish languagee-Library read for1 day
This document specifies the quality requirements of Ligusticum chuanxiong rhizome (rhizome of Ligusticum chuanxiong Hort.). This document applies to Ligusticum chuanxiong rhizome that is sold and used as natural medicine in international trade, including Chinese materia medica (whole medicinal materials) and decoction pieces derived from this rhizome.
- Standard14 pagesEnglish languagesale 15% off
SIGNIFICANCE AND USE
5.1 As patient use of cannabis and hemp for medical purposes increases and medical professionals are increasingly called upon to provide medical advice, the following requirements and expectations within the medical profession are increasingly significant, requiring:
5.1.1 Availability by patients to qualified medical professionals who can provide safe and objective advice on the medical use of cannabis and hemp,
5.1.2 Clarity by medical professionals on the legal restrictions in their area of jurisdiction to ensure compliance, and
5.1.3 Development of qualified training and certificate programs to ensure safe and quality healthcare for patients.
5.2 The primary objectives of this guide are as follows:
5.2.1 Provide a general overview of the BoK required for the professions listed in Section 7; and
5.2.2 Provide recommendations to form the foundation for training and subsequent recognition/certificate systems that enable consumers, employers, organizational management, government agencies, and others who rely upon medical professionals to distinguish between qualified and non-qualified workers.
5.2.3 Recommend requirements that agencies can use to develop and document the specific criteria used for training or certificate programs.
5.3 Users of this guide shall document deviations from the recommended requirements to inform their clients of the criteria applied in either the training or the certificate programs offered. As the cannabis and hemp industries and medical guidelines mature, this guide will be updated to reflect current thinking and requirements.
5.4 The Bok elements are applicable to certificate programs, while the BoK, experiential and educational elements are applicable to certification process requirements.
SCOPE
1.1 This guide can provide certification bodies, training providers, employers, and certificate issuers, with best-practice guidance for administering their respective programs for medical-related professions within the cannabis and hemp industries.
1.2 This guide recommends requirements for experience, training, education, and the body of knowledge (BoK) necessary for medical-related professions within the cannabis and hemp industries listed in Table 1.
1.3 For purposes of this guide, a medical professional is defined as a person qualified and licensed as required by the jurisdiction to provide guidance or recommendations regarding a person's health or fitness.
1.4 This guide provides recommendations for articulating professional requirements for training and education or earning certificates. It is part of a series of guides denoting certification requirements for professions within the cannabis and hemp industries (Guides D8346, D8347, D8348), and supporting Practice D8403 for associated certificate programs.
1.5 This guide's content does not supersede requirements for training or earning a certificate defined by jurisdictional entities such as government or other regional regulatory bodies.
1.6 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.7 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
- Guide4 pagesEnglish languagesale 15% off
- Guide4 pagesEnglish languagesale 15% off
This document reports on the global industry and standardization development of Panax ginseng. It includes its origin and application history, medicinal value, geographical distribution, cultivation and processing methods, industry development, international trade, current status and development demands for standardization.
- Technical report32 pagesEnglish languagesale 15% off
This document specifies the quality, safety requirements and test methods for Poria cocos sclerotium that is derived from the fungus Poria cocos (Schw.) Wolf. It is applicable to Poria cocos sclerotium sold and used as natural medicines in international trade, including Chinese materia medica (whole medicinal materials) and decoction pieces.
- Standard13 pagesEnglish languagesale 15% off
This document specifies test methods for the evaluation of aspects of absorption of wound dressings, test methods for the evaluation of moisture vapour transmission rate of permeable film wound and fixation dressings, and test methods to assess waterproofness and extensibility.
- Standard70 pagesEnglish languagee-Library read for1 day
SIGNIFICANCE AND USE
5.1 This test method offers a procedure for evaluating medical face mask resistance to synthetic blood penetration that is useful in establishing claims for penetration resistance performance of medical face masks and ranking their performance. However, this test method does not define acceptable levels of penetration resistance because this determination must be made by each responsible user organization based on its own specific application and conditions. Therefore, when using this test method to make claims for the performance of medical face masks, the specific conditions under which testing is conducted must be described.
5.2 Medical face masks may be intended to resist liquid penetration from the splatter or splashing of blood, body fluids, and other potentially infectious materials. Many factors affect the wetting and penetration characteristics of body fluids, such as surface tension, viscosity, and polarity of the fluid, as well as the structure and relative hydrophilicity or hydrophobicity of the materials and the design of the mask itself. The surface tension range for blood and body fluids (excluding saliva) is approximately 0.042 to 0.060 N/m.6 To help simulate the wetting characteristics of blood and body fluids, the surface tension of the synthetic blood is adjusted to approximate the lower end of this surface tension range. The resulting surface tension of the synthetic blood is 40 ± 5 dyn/cm (0.040 ± 0.005 N/m).
5.3 The synthetic blood mixture is prepared with a red dye to aid in visual detection and a thickening agent to simulate the flow characteristics of blood. The synthetic blood will not always duplicate the polarity, and thus the wetting behavior and subsequent penetration, of real blood and other body fluids through protective clothing materials.
5.4 During a medical procedure, a blood vessel is occasionally punctured, resulting in a high-velocity stream of blood impacting a protective medical face mask. The impact velocity depends...
SCOPE
1.1 This test method is used to evaluate the resistance of medical face masks to penetration by the impact of a small volume (~2 mL) of a high-velocity stream of synthetic blood. Medical face mask pass/fail determinations are based on visual detection of synthetic blood penetration.
1.2 This test method does not apply to all forms or conditions of blood-borne pathogen exposure. Users of the test method must review modes for face exposure and assess the appropriateness of this test method for their specific application.
1.3 This test method is primarily intended to address the performance of finished medical face masks. While this test method may also be used to assess performance of materials or certain material constructions used in medical face masks, it is important to note the performance of finished medical face masks may be impacted by the interaction of the materials used and how they have been assembled. Results can differ depending on testing a final finished medical face mask or materials taken from manufactured medical face masks.
1.4 This test method does not address other factors with the potential to affect the overall protection offered by the medical face mask and its operation (such as filtration efficiency and pressure drop).
1.5 This test method does not address breathability of the medical face mask materials or any other properties affecting the ease of breathing through the medical face mask. This test method evaluates medical face masks as an item of protective clothing. This test method does not evaluate the performance of medical face masks for airborne exposure pathways or in the prevention of the penetration of aerosolized body fluids deposited on the medical face mask.
1.6 The values stated in SI units or inch-pound units are to be regarded separately as standard. The values stated in each system may not be exact equivalents; therefore, each system shall be used independently of...
- Standard21 pagesEnglish languagesale 15% off
- Standard21 pagesEnglish languagesale 15% off
SIGNIFICANCE AND USE
5.1 This test method measures the initial filtration efficiency of materials by sampling representative volumes of the upstream and downstream latex aerosol concentrations in a controlled airflow chamber.
5.2 This test method provides specific test techniques for both manufacturers and users to evaluate materials when exposed to aerosol particle sizes between 0.1 and 5.0 μm.
5.2.1 This test method establishes a basis of efficiency comparison between materials.
SCOPE
1.1 This test method establishes procedures for measuring the initial particle filtration efficiency of materials using monodispersed aerosols.
1.1.1 This test method utilizes light-scattering particle counting in the size range of 0.1 to 5.0 μm and airflow test velocities of 0.5 to 25 cm/s.
1.2 The test procedure measures filtration efficiency by comparing the particle count in the feed stream (upstream) to that in the filtrate (downstream).
1.3 The values stated in SI units or in other units shall be regarded separately as standard. The values stated in each system must be used independently of the other, without combining values in any way.
1.4 The following precautionary caveat pertains only to the test methods portion, Section 10, of this specification. This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.5 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
- Standard8 pagesEnglish languagesale 15% off
- Standard8 pagesEnglish languagesale 15% off
This document specifies the requirements and test methods for dried Rehmannia glutinosa root that is derived from Rehmannia glutinosa Libosch. Fresh Rehmannia glutinosa Libosch. and processed Rehmannia glutinosa Libosch. are excluded. This document is applicable to Rehmannia glutinosa root that is sold and used as a natural medicine in international trade, including Chinese materia medica (whole medicinal materials) and decoction pieces derived from this plant.
- Standard20 pagesEnglish languagesale 15% off
This document specifies the minimum requirements and test methods of Artemisia argyi leaf for medicinal use. It is suitable for identification and quality control of this herbal medicine.
- Standard15 pagesEnglish languagesale 15% off
SIGNIFICANCE AND USE
4.1 The methodology was originally developed (1-4)6 for use in drug content uniformity and dissolution but has general application to any multistage test with multiple acceptance criteria. Practice E2709 summarizes the statistical aspects of this methodology. This practice applies the general methodology of Practice E2709 specifically to the UDU test.
4.1.1 While other methods can be used to estimate the probability of passing the UDU test, they are outside the scope of this practice.
4.2 The UDU test procedure describes a two-stage sampling test, where at each stage one can pass or continue testing, and the decision to fail is deferred until the second stage. At each stage there are acceptance criteria on the test results as outlined in Table 1.
4.3 The UDU test is a market standard. The USP General Notices include the following statement about compendial standards. “The similarity to statistical procedures may seem to suggest an intent to make inference to some larger group of units, but in all cases, statements about whether the compendial standard is met apply only to the units tested.” Therefore, the UDU procedure is not intended for inspecting uniformity of finished product for lot/batch release or as a lot inspection procedure.
4.3.1 The UDU test defines a product requirement to be met at release and throughout the shelf-life of the product.
4.3.2 Passing the UDU test once does not provide statistical assurance that a batch of drug product meets specified statistical quality control criteria.
4.4 This practice provides a practical specification that may be applied when uniformity of dosage units is required. An acceptance region for the mean and standard deviation of a set of test results from the lot is defined such that, at a prescribed confidence level, the probability that a future sample from the lot will pass the UDU test is greater than or equal to a prespecified lower probability bound. Having test results fall in the acceptance r...
SCOPE
1.1 This practice provides a general procedure for evaluating the capability to comply with the Uniformity of Dosage Units (UDU) test. This test is given in General Chapter Uniformity of Dosage Units of the USP, in 2.9.40 Uniformity of Dosage Units of the Ph. Eur., and in 6.02 Uniformity of Dosage Units of the JP, and these versions are virtually interchangeable. For this multiple-stage test, the procedure computes a lower bound on the probability of passing the UDU test, based on statistical estimates made at a prescribed confidence level from a sample of dosage units.
1.2 This methodology can be used to generate an acceptance limit table, which defines a set of sample means and standard deviations that assures passing the UDU test for a prescribed lower probability bound, confidence level, and sample size.
1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.4 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
- Standard20 pagesEnglish languagesale 15% off
- Standard20 pagesEnglish languagesale 15% off
This document specifies the quality and safety requirements of Ephedra herbaceous stem, which is the dried herbaceous stem of Ephedra sinica Stapf, Ephedra intermedia Schrenk et C. A. Mey. or Ephedra equisetina Bge. (Fam. Ephedraceae). This document applies to Ephedra herbaceous stem that is sold and used as natural medicine in international trade, including Chinese materia medica (whole medicinal materials) and decoction pieces derived from the plant.
- Standard15 pagesEnglish languagesale 15% off
SCOPE
1.1 The purpose of this guide is to establish a framework and context for process understanding for pharmaceutical manufacturing using the principles of quality by design (QbD) (Juran, 1992;2 ICH Q8). The framework is applicable to both drug substance (DS) and drug product (DP) manufacturing. High (detailed) level process understanding can be used to facilitate production of product which consistently meets required specifications. It can also play a key role in continual process improvement efforts.
1.2 Process Analytical Technology (PAT) is one element that can be used for achieving control over those inputs determined to be critical to a process. It is important for the reader to recognize that PAT is defined as:
“…a system for designing, analyzing, and controlling manufacturing through timely measurements (i.e., during processing) of critical quality and performance attributes of raw and in process materials and processes, with the goal of ensuring final product quality. It is important to note that the term analytical in PAT is viewed broadly to include chemical, physical, microbiological, mathematical, and risk analysis conducted in an integrated manner. The goal of PAT is to enhance understanding and control the manufacturing process…” (USFDA PAT)
1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.4 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
- Guide7 pagesEnglish languagesale 15% off
- Guide7 pagesEnglish languagesale 15% off
This document specifies the quality and safety requirements and test methods of Pinellia ternata tuber, including raw and processed Pinellia ternata tuber [dried tuber of Pinellia ternata (Thunb.) Breit.]. This document does not cover processing methods of Pinellia ternata tuber. This document is applicable to raw and processed Pinellia ternata tuber that are sold and used as natural medicines in international trade, including Chinese materiamedica (whole medicinal material) and decoction pieces derived from this plant.
- Standard16 pagesEnglish languagesale 15% off
This document specifies test methods for the evaluation of aspects of absorption of wound dressings, test methods for the evaluation of moisture vapour transmission rate of permeable film wound and fixation dressings, and test methods to assess waterproofness and extensibility.
- Standard70 pagesEnglish languagee-Library read for1 day
This document specifies the quality and safety requirements of Rheum root and rhizome (the dried root and rhizome of Rheum palmatum Linne., Rheum tanguticum Maxim. ex Balf. and Rheum officinale Baill.). This document applies to Rheum root and rhizome that is sold and used as natural medicines in international trade, including Chinese materia medica (whole medicinal materials) and decoction pieces derived from these plants. This document does not apply to the processing methods and processed products of Rheum root and rhizome.
- Standard21 pagesEnglish languagesale 15% off