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					                                    ASTM E55
                        Notes for New Work Item Proposers

These notes are intended to be an informative guide to assist New Work Item (NWI)
proposers in completing the NWI Submission form for E55 which will be required
from November 2007.

The NWI Submission form is intended to assist the E55 Executive committee in
making decisions regarding the relative importance, urgency and priority of the work,
and in assessing the capability within E55 (or upon which E55 can draw) to complete
the work in a satisfactory and timely manner.

1.     Outline of the Process

The approval of an E55 NWI will go through a number of stages as follows :
   a)     The NWI Submission form is completed as thoroughly as possible by the
   b)     The proposer informally approaches the chair of the likely ‘home’ sub-
          committee for the work and reviews the submission.
          Current committee chairs are :-
          E55.01 Duncan Low
          E55.02 Steve Simmons
          E55.03 Dave Radspinner
   c)     The submission is formally presented to the E55 executive committee.
          This committee will determine the relative importance and priority of the
          proposed work in the context of the published E55 roadmap. Proposals
          may be given one of four statuses :-
          i)      Approved for immediate start
          ii)     Approved for delayed start (tied either to a specific time, or a set of
                  conditions, such as completion of an existing work item.)
          iii)    Held for further review (either for lack of time, or because the
                  committee wants additional information or requires additional
                  commitments before work is approved).
          iv)     Declined (because the committee does not feel E55 is the
                  appropriate ‘home’ for the work, or because required conditions are
                  not met).

Whilst individuals are free to undertake work in an unofficial capacity, formal work
on an E55 document may only be started once approval for the work item has been
granted and any attached conditions have been met.

2.     Targets for the NWI

It is the objective of the E55 Executive committee to ensure that NWIs meet the
following conditions :-
    a)     They are a good fit to the E55 Vision and Mission statements
     b)      They can be mapped as a priority item on the E55 roadmap
     c)      That the work is best done within E55 (that is it is not being done
             elsewhere, and would not be better done elsewhere).
     d)      That the appropriate resource (manpower) and capability (experience
             and/or knowledge) to undertake the work is available within E55, or within
             a body prepared to work with the ASTM process.
     e)      That the work will not unduly affect other work already occurring within
             E55 which has a higher priority

3.        Filling in the Submission form

This section seeks to provide additional information for the proposer to assist in the
process of preparing for submission.

Proposers are advised to prepare the form in draft as far as possible, and then to
approach the chair of the sub-committee they feel is likely to be the ‘home’ of the
work. In some cases the chair may redirect them to an alternative committee chair,
but normally they will work with them to ensure that the submission is sufficiently
complete to be formally presented to the E55 Executive Committee.

The objective is to provide all the information need to the Executive committee to
make a quick decision on proposal status and priority.

Question 1

This is general contextual information. The proposer should include information on
who (which individuals, which companies, which sectors) need the proposed work,
why the work is needed, and what benefit it will provide in terms of consistency,
understanding, quality, cost, etc.

Question 2

The Executive committee will review each Work Item Proposal against both the
vision and mission statements (the key aspects of which are bulleted in the form).
Whilst it is not necessary for a proposal to be a perfect match, the better the match,
the more likely the proposal is to be accepted. The proposer should seek to address
each of the bulleted items.

Questions 3, 4 and 5

These questions focus upon whether work has already been done (E55 does not wish
to reinvent the wheel!) and on whether E55 is the best home for such work (that is
does it meet E55 objectives, is it an appropriate work-item for E55, and is E55 able to
support the work).

Question 3 seeks to ensure that the proposer has performed the necessary ‘due-
diligence’ in assessing the strengths and weaknesses of any work already in the public
domain which may address the same subject matter.
Question 4 requests a clear justification for the NWI if work is already underway
elsewhere on the subject. It would normally be expected that such justification would
only be accepted if E55 could offer something not available elsewhere (e.g. other
work will not need to a consensus standard and such a standard is urgently needed by
the industry)

Question 6
The proposer should clearly state what type of document is being proposed and why.
Available document types are standard guides, standard practices, test methods and
specifications. All E55 terminology has, to date, been kept in a central terminology
document maintained by E55.91.

Question 7

These are the proposed title and Scope of the document. The title should clearly state
the subject area of the document. The scope is generally formatted to allow some
flexibility in the development and eventual contents of the document. Once approved,
changes to the title or scope will require formal approval by the E55 Executive

Question 8

Details of the proposed team leader. This should include contact information, and
detail of experience which is appropriate to the task in hand – that is experience in the
area covered by the proposed document, experience in preparing such documents (for
any organisation), and experience as a team-leader.

Question 9

Details of those individuals likely to participate in the preparation of the document.
Experience within E55 suggests that an ideal workgroup is 4-5 people (with fewer
people the workload becomes onerous and input is restricted, with more people the
workgroup becomes unwieldy and consensus difficult to achieve quickly.) The actual
size of the workgroup is up to the team leader in consultation with the relevant sub-
committee chair.

This list will be reviewed for :-
        - range of experience
        - formal balance (i.e. customers/suppliers/others)
        - availability

Question 10

This is intended to demonstrate the wider interest in the document both within and
outside E55. Where outside bodies or individuals are listed, some comment about the
mechanism of communication with them will be required.

Question 11
The executive committee will expect each proposed NWI to have a project plan
giving, as a minimum, target dates for each of the major milestones in preparing the
document. These should include at least :
        - first ballot
        - 2 rounds of revision as a result of comments and ballot
        - Final approval

It is an objective of the E55 Executive committee that all work items should reach
final approval within 2 years of approval of the NWI. Whilst it is possible that very
important items may be accepted with longer timescales, these will be very much the

Questions 12, 13 and 14

These will be completed by the sub-committee chair presenting the proposal.

It is the objective of the E55 Executive committee that responses to NWI proposals
will be made promptly and clearly. It is hoped that in all cases a decision will be
made at the first Executive committee meeting following the submission. This
decision, and the associated reasoning, will be formally recorded in the minutes, and
will be the subject of a specific notification to the membership (the form of which has
yet to be decided).

Should the E55 Executive committee decide not to proceed with a particular item,
individuals are, of course, free to approach other ASTM committees and/or other
organisations with the proposal.

                       ASTM E55 New Work Item Proposal
1   Please provide a summary of the need for the proposed Who?     What industry sector?
    document?                                             Why?     How will it improve
                                                          matters? Etc.
General summary of need.

2     Describe how you believe the proposed work fits with Comment on each phrase of the
      the E55 Vision and Mission statements.               statements.
Vision statement
     Design
     Development
     Understanding
     Evaluation
     Control
     Optimisation
Of modern
pharmaceutical processes

Supports the community
in providing
     Cost Effective
     Transparent
Development          and
manufacture of high
quality pharmaceutical

Mission statement
Documents that
    Directly Support
    Add Value
    Are Cost-Effective
In     developing   and
manufacturing      high
quality pharmaceutical

Standards which codify
existing practices will be
adopted only if there is
     Added Value
     Understanding

3    Is this general area addressed outside ASTM E55?       What      committees?       What
                                                            documents already exist? Are they
                                                            insufficient? Etc
By consensus standards bodies (e.g. ISO, , etc.)

By other organisations (e.g. ISPE, PDA, Pharma, etc)

4    If the answer to 3 is yes, then what is the justification What distinguishes E55 for this
     for this work being done within E55?                      work ?

5    If the answer to 3 is no, are there specific reasons why Are there good reasons why work
     this work has not been undertaken?                       has not been undertaken (lack of
                                                              consensus, commercial interests,
                                                              etc) ?

6     What type of document is being proposed? Why?
Tick one of the following :
 Standard Guides
 Standard Practices
 Test Methods
Why ?

7    What is the proposed Title and Scope of the document?
Proposed Title

Text of proposed scope

8    Who is the proposed Work Item Leader?                   Name,    Company,        Relevant

9    List of likely Work Group Members                       Name,    Company,        Relevant

10   List of known interested parties                        Companies,          Organisations,
                                                             Individuals, Etc.
                                                             Inside and outside E55.

11   Proposed Timescale/Project Plan                         Key deliverables and stage timing
12   Sub-Committee Chair comments

13   Suggested Work Item mentor

14   Interactions with other work-items