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It is common that civil engineer needs to prepare drawings. It is carried out after the design of structure or civil works has been compl

According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product

eted. How to have a proper drawing numbering system in order to has better presentation? Below are some tips on drawing numbering system.

1. Time control.

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

It is useful that a project starts with month and year. As for example, if an awarded project on say 12 April 2007 than your drawing number may 042007 and not 1

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

20402007, because it may become to complicate. On the other hand, you can select year as control item 2007. Initial drawing number will be 042007

2. Client name

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

ontrol.
Let say, your client is ABC Company and with item 1; your drawing number will be ABC/042007.

3. Engineering field control.
Say your proje

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

ct is building a unit of structural building. You may further add with "ST". "ST" is abbreviate for structural. You can use other abbreviation as your preference.

ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc

Then drawing number will be ABC/042007/ST. For civil works such as earthwork, you can use "EW", water work use "WT", sewer work use "SW", drainage work use "DR"

easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi

etc.

4. Type of structural element control.
When you design the building structure, the structural elements may consist of pad footing foundation,

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

olumn, beam, slab etc. You have to use a list of abbreviation for the structural elements such as pad footing foundation-"PF", column-"COL", beam-"BM" and slab-"S

and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ

B". For instance your drawing is showing beam details, then your drawing number will be ABC/042007/ST/BM01 (first drawing), ABC/042007/ST/BM02 (second drawing) an

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

d continue with this notation. This type of arrangement is good for adding any new drawing into every section without disturbing the overall drawing number. As fo

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

r example, you are using only one type of notation say ST for all structural elements, then your drawing number will be ABC/042007/ST/01, ABC/042007/ST/02, ABC/04

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

007/ST/03 …
When or during the project in progress, there will be tendency of amendment happened. If you need to add one sheet of beam drawing into your p

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

roject drawing number and the beam drawing numbers are in the range of ABC/042007/ST/03 to ABC/042007/ST/04. Total number of drawings says 10 numbers; last drawin

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

g number will be ABC/042007/ST/10. How to add a drawing after ABC/042007/ST/05? You have to add it after ABC/042007/ST/10 i.e. ABC/042007/ST/11. However, it will

t?

As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel

not in the sequence of beam drawing arrangement. If you have more break down as mention earlier, then it is easy to add a new drawing into each section and for th

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

current case is ABC/042007/ST/BM03. It will not affect the presentation of drawings.

5. Drawing amendment.
When there is an amendment on a partic

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

ular sheet of drawing say drawing number is ABC/042007/ST/02. How will be the amendment to be shown on drawing number? One suggestion is using abc notation. ABC/0

.

As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de

42007/ST/02a is first amendment; ABC/042007/ST/02b is second amendment etc.

In short, the formula for drawing number will be
[name]/[time]/[engineering f

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

ield]/[type of element][numbering][amendment].

When you follow the numbering system as mention, your project drawing numbering can be easily to be interpretation

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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