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When the design of trusses has been approved from engineer, trusses fabrication will commence. Upon completion of fabrication, trusses will deliver to site for construction. As a ci

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

vil and structural engineer, one of the duties of engineer is to inspect the trusses. Engineer has to ensure the trusses has been construction according to design drawing.

After

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

Examples of combination products may in

russes deliver to site, site agent or engineer needs to verify the quality of timber product. Timber has to be treated to avoid attack by termite. Normally the color of pressure tre

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

ated wood is in green color. Whenever a section of timber is being cut, it will show that the green color will penetrate into certain depth of timber. Certificate of treated timber

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

ust be obtained from timber supplier. It needs for record purpose.

Then timber trusses have to check on the timber defect such as rotten timber, damage timber. Any defect found mus

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

Combination pro

be rejected immediately. The checking on timber is done by visual inspection. Whenever timber quality not to satisfaction, engineer can request for sample testing to any approved l

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

aboratory.

Timber sizing is important. Engineer needs to check the timber sizes. It to ensure that the sizes provided are according to trusses design sizes. It can carry out by usi

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

g measuring tape. Sometime, it is impossible to insect every single item of timber. Therefore, engineer has to base on his best knowledge to have random sampling inspection. One of

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

the ways is to inspection on the critical trusses such as big truss.

Engineer needs to check on trusses connection. There are two types of connection. First is gang nail plate and

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

onventional bolts and nuts. For the later case, engineer must visually inspection the bolt holes. It is common that contractor simply drill holes for bolts. Unfortunately, some inex

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

erience contractor drills the hole just near to edge of timber member (5-10mm from edge of member). This hole will easy loosen out from timber and affect the integrity of timber tr

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

Following aspects would a

uss structure. The position of bolt holes on timber is important. It must according to trusses design.

Before erection of trusses to roof structure such as roof beams, the level of

dd to the challenges in developing combination products:

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

roof beams has to adjust to allow trusses to rest on roof beams. Inconsistency of roof level has to avoid.

After the trusses have been erected up to roof structure, engineer must e

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

nsure that the vertically of trusses have been achieved. Position of trusses such as trusses spacing must according to design drawing. Trusses supports are important. As for example

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

if a truss has four supports, engineer has to ensure that these four supports have been installed. It to ensure that roof loading has been transferred to roof structure. If roof l

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

vel is inconsistency; in order to achieve supports condition for truss, some irresponsible contractor will use small element such as broken timber to insert between timber truss and

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

Professional from academic institutions, pharmaceutical industries, health care indust

roof structure. It is not a permanent structure. After the trusses have been erected, the broken timber will be loosen some days.

Truss to truss connection must has special precau

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

ion. Trusses have to connect by using MS plate or other proper structure. Nailing has to avoid in trusses.

Any change in timber structure arrangement need to has attention of desig

.

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

ner. Do not allow any modification of trusses without approval from design office.

Whenever there is some dispute at site cannot be resolved, try to work it out at office. If contr

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

Companies that provide selfless information through particip

ctor at site do not want to follow engineer instruction, do not argue with contractor. Else it may end up with quarrel; sometime with fighting. Therefore, leave the site immediately

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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