Form 1: Proposal for a new field oftechnical activity
Circulation date:2016-05-05
Closing date f or v oting:2016-08-05
Proposer:Ref erence number(to be giv en by Central Secretariat)

SAC (China)

259

ISO/TS/P

A proposal f or a new f ield of technical activ ity shall be submitted to the Central Secretariat, which willassign it a ref erence number and process the proposal in accordance with the ISO/IEC Directiv es(part 1, subclause 1.5). The proposer may be a member body of ISO, a technical committee,
subcommittee or project committee, the Technical Management Board or a General Assemblycommittee, the Secretary -General, a body responsible f or managing a certif ication sy stem operating
under the auspices of ISO, or another international organization with national body membership.
Guidelines f or proposing and justif y ing a new f ield of technical activ ity are giv en in the ISO/IEC
Directiv es (part 1, Annex C).
The proposal (to be completed by the proposer)
Title of the proposed new committee (The title shall indicate clearly yet concisely the new
field of technical activity which the proposal is intended to cover.)Pharmaceutical preparation machinery

Scope statement of the proposed new committee (The scope shall precisely define thelimits of the field of activity. Scopes shall not repeat general aims and principles governing
the work of the organization but shall indicate the specific area concerned.)Standardization of pharmaceutical preparation machinery , including terminology , classif ication,requirements and test methods.

FORM 1 – Proposal f or a new f ield of technical activ ity
Version 01/2015

Proposed initial programme of work (The proposed programme of work shall correspond toand clearly reflect the aims of the standardization activities and shall, therefore, show the
relationship between the subjects proposed. Each item on the programme of work shall bedefined by both the subject aspect(s) to be standardized (for products, for example, theitems would be the types of products, characteristics, other requirements, data to besupplied, test methods, etc.). Supplementary justification may be combined with particular
items in the programme of work. The proposed programme of work shall also suggest
priorities and target dates.
The subject of the committee is to dev elop international standards f or preparation machinery , so
as to meet the need of international trade of preparation machinery manuf acturers in v arious
countries. It f ocuses on the terms and def initions of preparation machinery , classif ication,requirements (including material requirements, cleaning and disinf ection requirements, saf ety
requirements and quality requirements) and test methods.
First, the committee initially plans to dev elop the f ollowing basic standards f or preparation
machinery :1、Pharmaceutical preparation machinery -Terms and def initions
2、General rule of pharmaceutical preparation machinery conf orming to good manuf acturing
practice（GMP）
Second, the committee initially plans to dev elop the standards f or the f ollowing preparation
machinery :1、Pharmaceutical preparation machinery -Roller compaction dry granulator
2、Pharmaceutical preparation machinery -Rotary tablet press
3、Pharmaceutical preparation machinery -Capsule f illing machine
The new TC plans to propose two international standards in three y ears

Indication(s) of the preferred type or types of deliverable(s) to be produced under the
proposal (This may be combined with the "Proposed initial programme of work" if moreconvenient.)
As shown abov e

FORM 1 – Proposal f or a new f ield of technical activ ity
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A listing of relevant existing documents at the international, regional and national levels.
(Any known relevant document (such as standards and regulations) shall be listed,regardless of their source and should be accompanied by an indication of theirsignificance.)
1．China national standard：GB/T 15692-2008 Terms of pharmaceutical machinery
2..China national standard ： GB 28670-2012
conf orming to good manuf acturing practiceGeneral rule of pharmaceutical machinery

3. China national standard：GB/T 28671-2012 Guidelines f or pharmaceutical machinery v alidation
4. China national standard ： GB/T 28258-2012 Classif ication and code f or pharmaceuticalmachinery products
5. China national standard：GB/T 30748-2014 Rotary tablet press
6. China national standard：GB/T 32239-2015 Chinese medicine pill making machine
7. China national standard：GB/T 32237-2015 Spray dry er f or the extract of traditional Chinese
medicine
8.International standard: Aseptic processing of health care products -- Part 1: General
requirements, ISO 13408-1:2008, International Organization f or Standardization(ISO)9. ISO standard: Aseptic processing of health care products -- Part 2: Filtration, ISO 13408-2:2003,
International Organization f or Standardization(ISO)
10. ISO standard: Aseptic processing of health care products -- Part 3: Ly ophilization, ISO 134083:2006, International Organization f or Standardization(ISO)
11. ISO standard: Aseptic processing of health care products -- Part 4: Clean-in-plac etechnologies, ISO 13408-4:2005, International Organization f or Standardization(ISO)
12. ISO standard: Aseptic processing of health care products -- Part 5: Sterilization in place, ISO
13408-5:2006, International Organization f or Standardization(ISO)
13. ISO standard: Aseptic processing of health care products -- Part 6: Isolator sy stems, ISO
13408-6:2005, International Organization f or Standardization(ISO)
14. 《Good Manuf acturing Practices-Medicinal products f or human and v eterinary use》,EU
15.《Good Manuf acturing Practice f or Pharmaceutical Products》,WHO
16.《Guide to Good Manuf acturing Practice f or Medicinal Products》,PIC/S
17.《Australian Code of Good Manuf acturing Practice f or Medicinal Products》,TGA
18.《Current Good Manuf acturing Practice f or Finished Pharmaceuticals》 Part211, FDA
19.《Drug Manuf acturing Inspections Program 7356.002》,FDA
20.《Drug Manuf acturing Inspections Program 7356.002-56002A Sterile products manuf acture》，FDA
21.《.Guide to Inspections of Dosage f orm Drug Manuf acturer’s – cGMP’s》，FDA
22.《Guide to Inspections of High Purity Water Sy stems》，FDA
23.《Guidance f or Industry Sterile Drug Products Produced by Aseptic Processing》，FDA
24.《Guide to Inspections Validation of Cleaning Processes》，FDA
25.《Guide to Inspections of Pharmaceutical Quality Control Laboratories》，FDA

FORM 1 – Proposal f or a new f ield of technical activ ity
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A statement from the proposer as to how the proposed work may relate to or impact on
existing work, especially existing ISO and IEC deliverables. (The proposer should explain how
the work differs from apparently similar work, or explain how duplication and conflict will beminimized. If seemingly similar or related work is already in the scope of other committees ofthe organization or in other organizations, the proposed scope shall distinguish between the
proposed work and the other work. The proposer shall indicate whether his or her proposal
could be dealt with by widening the scope of an existing committee or by establishing a newcommittee.)
There is no existing ISO/TC and IEC/TC cov ering pharmaceutical preparation machinery . Thus it isurgent to establish a new pharmaceutical preparation machinery TC.
Technical Committees of ISO associated with newly established TC-PPM are: TC 76 Transf usion,
inf usion and injection, and blood processing equipment f or medical and pharmaceutical use, TC 84
Dev ices f or administration of medicinal products and catheters, TC150 Implants f or Surgery ,TC 198
Sterilization of health care products, TC 199 Saf ety of machinery ， TC209 Cleanrooms andassociated controlled env ironment, TC215 Health inf ormatics,TC249 Traditional Chinese medicine.
Technical Committee of IEC associated with newly established TC-PPM areTC 62 Electricalequipment in medical practice and its SCs.
TC 76 is in charge of standards on transf usion, inf usion and injection, and blood processing
equipment f or medical and pharmaceutical use, which scope is: Standardization of containers (suchas inf usion bottles and bags, injection v ials, ampoules, glass cy linders, cartridges, pref illable
sy ringes, etc.) application sy stems (such as giv ing sets, non-electrically driv en portable inf usiondev ices, blood collection sy stems, etc.) and accessories f or inf usion, transf usion, injection and bloodprocessing in blood banks, terms, def initions, requirements and test methods f or these dev ices,
specif ications and test methods f or quality and perf ormance of their materials and components (suchas elastomeric closures, caps and ports, pipettes, etc.) and quality management sy stems f or primary
packaging materials. The scope of TC 76 does not ov erlap with that of the newly established TCPPM.
Scope of TC 84, Standardization of the perf ormance of metered dev ices and supplies intended f oradministration of medicinal products, and standardization of sy ringes, needles and catheters, does
not ov erlap with that of the newly established TC-PPM.
Scope of TC150, Standardization in the f ield of implants f or surgery and their required
instrumentation, cov ering terminology , specif ications and methods of tests f or all ty pes of implants,
and f or the materials both basic and composite used in their manuf acture and application. Objects
or dev ices which are surgically implanted in the body either temporarily or permanently f or diagnostic
or therapeutic purposes. TC 150 has a f ew standards that deal in producing drugs and implants (ISO14630, 12417) e.g. dealing in saf ety, design attributes, materials, design ev aluation, manuf acture,sterilization, packaging and inf ormation supplied by the manuf acturer, and tests. The newly
established TC-PPM does not include the scope of TC150.
TC 198 is in charge of standards on Sterilization of health care products, which scope is:Standardization of processes and equipment f or sterilization of health care products. The newly
established TC-PPM does not include the scope of TC 198.
TC 199 is in charge of standards on Saf ety of machinery , which scope is: Standardization of basic
concepts and general principles f or saf ety of machinery incorporating terminology , methodology ,guards and saf ety dev ices within the f ramework of ISO / IEC Guide 51 and in cooperation with other
ISO and IEC technical committees. The newly established TC-PPM can access the documents ofthis TC.
TC 209 is in charge of standards on Cleanrooms and associated controlled env ironments, whic hscope is Standardization of equipment, f acilities, and operational methods f or cleanrooms andassociated controlled env ironments. This includes procedural limits, operational limits and testingprocedures to achiev e desired attributes to minimize micro contamination. Topics of interest are nonv iable particles, v iable particles, surf ace cleanliness, room temperature and humidity prof iles, airf low
patterns and v elocities, room v ibration prof iles, room light lev els, room inf iltration leakage, personnel
procedures, personnel cleanroom clothing, equipment preparation, and any other topics related to
optimizing cleanroom operations. Normally this is obligatory f or pharmaceutical manuf acturing,
especially GMP. The newly established TC-PPM can access the documents of this TC.
TC 215 is in charge of standards on Health inf ormatics, which scope is Standardization in the f ieldof health inf ormatics, to f acilitate the coherent and consistent interchange and use of health-relat ed

FORM 1 – Proposal f or a new f ield of technical activ ity
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data, inf ormation, and knowledge to support and enable all aspects of the health sy stem. TC 215
has a series of documents which do not describe the pharmaceutical manuf acturing equipment but
do describe a lot of terminology and concepts used in the pharmaceutical area with their IDMP seriesof documents: pharmaceutical dose f orm, unit of presentation, route of administration, packaging.
The newly established TC-PPM can access the documents of this TC.
Scope of TC 249, Standardization in the f ield of medical sy stems deriv ed f rom ancient Chinese
medicine which shall be able to share one common set of standards. Both traditional and modern
aspects of these sy stems are cov ered. The committee f ocuses on quality and saf ety of raw materials,
manuf actured products and medical dev ices and of inf ormatics, including serv ice standards limited
to inv olv ing the saf e use and deliv ery of dev ices & medicine, but not into the clinical practice orapplication of those products, does not ov erlap with that of the newly established TC-PPM.
Scope of IEC/TC 62 and its SCs, To prepare international standards and other publications
concerning electrical equipment, electrical sy stems and sof tware used in healthcare and their ef f ects
on patients, operators, other persons and the env ironment. The newly established TC-PPM canaccess the documents of this TC and its SCs.
There are no ISO standards on pharmaceutical preparation machinery y et.
The new committee will work closely with related committees in order to identif y standardizationneeds and gaps, and collaborate with other organizations to av oid duplications and ov erlapping
standardization activ ities.

A listing of relevant countries where the subject of the proposal is important to theirnational commercial interests.
There are ov er 20 pharmaceutical preparation machinery producer countries, including Germany,
Italy ，United Kingdom，USA，France，India，South Korea，Japan，China. Main consumer
markets f or pharmaceutical preparation machinery are all ov er the world

A listing of relevant external international organizations or internal parties (other ISO and/or
IEC committees) to be engaged as liaisons in the development of the deliverable(s). (Inorder to avoid conflict with, or duplication of efforts of, other bodies, it is important toindicate all points of possible conflict or overlap. The result of any communication withother interested bodies shall also be included.)
ISO/TC76, ISO/TC84, ISO/TC150, ISO/TC194, ISO/TC198, ISO/TC 199, ISO/TC209, ISO/TC215,
ISO/TC249, IEC/TC62.
The committee will not pursue subjects within the scope of other TCs including but not limited to
ISO/TC76, ISO/TC84, ISO/TC150, ISO/TC194, ISO/TC198, ISO/TC 199, ISO/TC209, ISO/TC215,
ISO/TC249, IEC/TC62.

FORM 1 – Proposal f or a new f ield of technical activ ity
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A simple and concise statement identifying and describing relevant affected stakeholder
categories (including small and medium sized enterprises) and how they will each benefit
from or be impacted by the proposed deliverable(s).
Stakeholders of pharmaceutical preparation machinery ref er to producers and consumers that will
be af f ected or may be af f ected by implementation of pharmaceutical preparation machinery
standards. International standards of pharmaceutical preparation machinery will bring the f ollowing
benef its and impacts to the abov e stakeholders: consumers will gain access to pharmaceuticalpreparation machinery with reliable quality and security ; the interests of consumers will also be
saf eguarded.
For producers, these standards will help manuf acturing enterprises and small and medium
enterprises to improv e the technical lev el of product, so as to make them produce preparat ion
machinery which meets the requirements of international standards and increase exports.

An expression of commitment from the proposer to provide the committee secretariat if the
proposal succeeds.
If the proposal succeeds, China is willing to undertake the work of secretariat of new TC. The
proposer will prov ide of f ice space, necessary of f ice f acilities and staf f to the Committee Secretariat
and will prov ide necessary f unding to support the activ ities of the committee.

FORM 1 – Proposal f or a new f ield of technical activ ity
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Purpose and justification for the proposal. (The purpose and justification for the creation ofa new technical committee shall be made clear and the need for standardization in this fieldshall be justified. Clause C.4.13.3 of Annex C of the ISO/IEC Directives, Part 1 contains a menu
of suggestions or ideas for possible documentation to support and purpose and justificationof proposals. Proposers should consider these suggestions, but they are not limited to them,nor are they required to comply strictly with them. What is most important is that proposers
develop and provide purpose and justification information that is most relevant to their
proposals and that makes a substantial business case for the market relevance and the needfor their proposals. Thorough, well-developed and robust purpose and justification
documentation will lead to more informed consideration of proposals and ultimately their
possible success in the ISO IEC system.)With the rapid dev elopment of pharmaceutical industry in the world and the continuous emergenc eof innov ativ e drugs, the v olume of international trade of pharmaceutical preparation machinery has
increased sharply . Currently , there are more than 20 main producers f or pharmaceutical machinery
such as Germany , Italy , the United Kingdom (UK), the United States (US), Japan, Korea, India, etc.
Consumers of pharmaceutical preparation machinery are almost all ov er the world. The total global
trade v olume of pharmaceutical preparation machinery is v ery huge. Howev er, lack of unif ied
standards has hindered the dev elopment of international trade on pharmaceutical preparation
machinery .
Quality of pharmaceutical production is directly related to human lif e and health. Preparat ion
machinery , as the primary machinery f or drug production, directly af f ects the saf ety and quality ofpharmaceutical production. So v arious countries and regions hav e strict laws, regulations and Good
Manuf acturing Practices (ref erred to GMP), and also hav e the corresponding requirements f or
pharmaceutical manuf acturing machinery (such as the US CGMP, European EUGMP and GMP
promulgated in v arious countries).
But because of the dif f erences in the lev el of science and technology and industry , there are dif f erent
requirements f or the saf ety and quality of pharmaceutical preparation machinery in v arious countries
and region. The pharmaceutical preparation machinery manuf acturers must prov ide products
according to their requirements. It increases their costs of production and is harmf ul to international
trade, thus proposes more pressing needs f or unif y ing international standards to ensure the qualityof pharmaceutical production, eliminate trade barriers, and reduce cost of international trade.
The new committee will dev elop relev ant international standards and unif y the requirements ofmaterials, cleaning and disinf ection f or pharmaceutical preparation machinery in v arious countries
and regions, so as to ensure the health and saf ety requirements f or producing pharmaceuticals. It
will encourage manuf acturers to adopt the new technology (such as serv o technology , computer
control technology , digital technology ), so as to improv e the technical requirements, such astechnological lev el of products, env ironmental protection and personnel saf ety etc. It will meet therequirements of regulatory and manuf acturing practices f or pharmaceutical preparation machineryin v arious countries and regions, which will help manuf acturing enterprises and SMEs in dev eloping
countries to improv e the technical lev el of products, so as to make them produce pharmaceuticalpreparation machinery which meets the requirements of international trade, and to increase exports.

Signature of the proposer
Li Y ubing
Director General
Department of International Cooperation,
SAC

Further information to assist with understanding the requirements for the items above can be foundinthe Directives, Part 1, Annex C.

FORM 1 – Proposal f or a new f ield of technical activ ity
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Proposal to Establish ISO Technical Committee for Pharmaceutical Preparation
Machinery

Since there is no technical committee of standardization (TC or PC) directly
related to pharmaceutical preparation machinery in ISO and IEC. China
proposes to establish Technical Committee for Pharmaceutical Preparation
Machinery (TC-PPM), ISO, as follows:
I. Purpose of Establishing a New TC
A. To meet the needs of international trade
With the rapid development of pharmaceutical industry in the world and thecontinuous emergence of innovative drugs, the volume of international trade ofpharmaceutical preparation machinery has increased sharply. Currently, there are
more than 20 main producers for pharmaceutical machinery such as Germany,
Italy, the United Kingdom (UK), the United States (US), Japan, Korea, India, etc.
Consumers of pharmaceutical preparation machinery are almost all over theworld. The total global trade volume of pharmaceutical preparation machinery isvery huge. However, lack of unified standards has hindered the development ofinternational trade on pharmaceutical preparation machinery.
Quality of pharmaceutical production is directly related to human life and health.
Preparation machinery, as the primary machinery for drug production, directly
affects the safety and quality of pharmaceutical production. So various countries1and regions have strict laws, regulations and Good Manufacturing Practices(referred to GMP), and also have the corresponding requirements forpharmaceutical manufacturing machinery (such as the US CGMP, European
EUGMP and GMP promulgated in various countries).
But because of the differences in the level of science and technology andindustry, there are different requirements for the safety and quality ofpharmaceutical preparation machinery in various countries and region. The
pharmaceutical preparation machinery manufacturers must provide products
according to their requirements. It increases their costs of production and isharmful to international trade, thus proposes more pressing needs for unifying
international standards to ensure the quality of pharmaceutical production,
eliminate trade barriers, and reduce cost of international trade.
B. To promote technological development in developing countries and SMEs
and to increase exports
The new committee will develop relevant international standards and unify therequirements of materials, cleaning and disinfection for pharmaceuticalpreparation machinery in various countries and regions, so as to ensure thehealth and safety requirements for producing pharmaceuticals. It will encourage
manufacturers to adopt the new technology (such as servo technology, computer
control technology, digital technology), so as to improve the technicalrequirements, such as technological level of products, environmental protection2and personnel safety etc. It will meet the requirements of regulatory andmanufacturing practices for pharmaceutical preparation machinery in various
countries and regions, which will help manufacturing enterprises and SMEs indeveloping countries to improve the technical level of products, so as to makethem produce pharmaceutical preparation machinery which meets therequirements of international trade, and to increase exports.
II. Relations and differences with relevant existing ISO/TCs
There is no existing ISO/TC covering pharmaceutical preparation machinery.
Thus it is urgent to establish a new pharmaceutical preparation machinery TC.
Technical Committees of ISO associated with newly established TC-PPM are:
TC 76 Transfusion, infusion and injection, and blood processing equipment for
medical and pharmaceutical use，TC 84 Devices for administration of medicinal
products and catheters, TC 198 Sterilization of health care products, TC 199
Safety of machinery.
TC 76 is in charge of standards on transfusion, infusion and injection, and bloodprocessing equipment for medical and pharmaceutical use, which scope is:Standardization of containers (such as infusion bottles and bags, injection vials,
ampoules, glass cylinders, cartridges, prefillable syringes, etc.) application
systems (such as giving sets, non-electrically driven portable infusion devices,
blood collection systems, etc.) and accessories for infusion, transfusion, injection
and blood processing in blood banks, terms, definitions, requirements and test3

methods for these devices, specifications and test methods for quality andperformance of their materials and components (such as elastomeric closures,
caps and ports, pipettes, etc.) and quality management systems for primary
packaging materials. The scope of TC 76 does not overlap with that of the newly
established TC-PPM.
Scope of TC 84, Standardization of the performance of metered devices andsupplies intended for administration of medicinal products, and standardizationof syringes, needles and catheters, does not overlap with that of the newly
established TC-PPM.
TC 198 is in charge of standards on Sterilization of health care products, which
scope is: Standardization of processes and equipment for sterilization of healthcare products. The newly established TC-PPM does not include the scope of TC198.
TC 199 is in charge of standards on Safety of machinery, which scope is:Standardization of basic concepts and general principles for safety of machineryincorporating terminology, methodology, guards and safety devices within theframework of ISO / IEC Guide 51 and in cooperation with other ISO and IEC
technical committees. The newly established TC-PPM can access the documentsof this TC.
Scope of TC 249, Standardization in the field of medical systems derived fromancient Chinese medicine which shall be able to share one common set of4standards. Both traditional and modern aspects of these systems are covered. The
committee focuses on quality and safety of raw materials, manufactured
products and medical devices and of informatics, including service standards
limited to involving the safe use and delivery of devices & medicine, but not into
the clinical practice or application of those products，does not overlap with thatof the newly established TC-PPM.
There are no ISO standards on pharmaceutical preparation machinery yet.
III. Work Plan of the New TC
The subject of the proposed TC-PPM is to develop international standards forpharmaceutical preparation machinery, so as to meet international trade need ofpharmaceutical preparation machinery manufacturers in various countries. It
focuses of the terms and definitions of pharmaceutical preparation machinery,classification, requirements (including material requirements, cleaning anddisinfection requirements, safety requirements and quality requirements) and test
methods.
First, the committee initially plans to develop the following basic standards for
preparation machinery:
1、Pharmaceutical preparation machinery-Terms and definitions
2、General rule of pharmaceutical preparation machinery conforming to good
manufacturing practice（GMP）
5

Second, the committee initially plans to develop the standards for the following
preparation machinery:
1、Pharmaceutical preparation machinery-Dry Granulator
2、Pharmaceutical preparation machinery-Rotary Tablet Press
3、Pharmaceutical preparation machinery-Capsule Filling Machine
IV. Strengthening Global Cooperation
As global pharmaceutical industry rapidly develops, an increasing number ofcountries and regions join in the production, consumption and trade ofpharmaceutical preparation machinery, thus generating a promising international
market. The newly established TC-PPM will work with producers, consumers,
related ISO/TCs, etc. to strengthen cooperation, develop international standards
related to pharmaceutical preparation machinery, and promote global trade.

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