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Advice You - Risk Management - Selecting Potential Sub-Contractors
The risk management of a project at the top level is complex enough, but when the infeed from outside companies has to be considered as well, it becomes even
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
more so.
Starting with the receipt of an invitation to tender from a potential customer, the steps to be taken to manage the risk associated with selecting
Starting with the receipt of an invitation to tender from a potential customer, the steps to be taken to manage the risk associated with selecting
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
suppliers are as follows.
The project technical lead must review all the technical documentation received from the customer. Following the project team's d
The project technical lead must review all the technical documentation received from the customer. Following the project team's d
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
cision that certain items need to be sub-contracted, the technical lead will write, or have a representative write, a technical requirements specification fo
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
each item to be sub-contracted, which will form part of the sub-contractor invitation to tender.
In addition, all other members of the project team will re
In addition, all other members of the project team will re
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
iew the areas of their own particular discipline (quality assurance, configuration management, etc.) and write their own specifications for flowing down to t
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
he sub-contractor invitation to tender.
For each item to be sub-contracted, a procurement package will be compiled. This will contain whatever documents ar
For each item to be sub-contracted, a procurement package will be compiled. This will contain whatever documents ar
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
deemed necessary depending on the complexity of the item in question, but as a minimum the aforementioned technical specification.
To start the risk manage
To start the risk manage
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
ent process, all documents to be included in the procurement package will be peer reviewed. This involves at least one person of the same discipline compari
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
g the customer requirements with those included in the sub-contractor specification to ensure that nothing has been omitted.
A list of potential suppliers f
A list of potential suppliers f
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
r each item of supply is then drawn up. Ideally, in terms of risk mitigation, there will be a minimum of three companies thought to be capable of fulfilling
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
the technical requirement for each item, preferably more in the first instance. This list is then reduced to a manageable number (the ideal three) by revie
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
ing the possible sub-contractors in terms of the following.
Companies who have supplied goods in the past:
- Quality and reliability of items supplied
Companies who have supplied goods in the past:
- Quality and reliability of items supplied
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
- Timeliness of delivery
- Adequacy of documentation
- Attitude, flexibility and co-operation of personnel
- Ease of contract negotiation
- Adequacy of documentation
- Attitude, flexibility and co-operation of personnel
- Ease of contract negotiation
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
- Pricing policy
- After sales service, including warranty
Companies who have not supplied goods in the past
- Reputation in the market place
- Q
- After sales service, including warranty
Companies who have not supplied goods in the past
- Reputation in the market place
- Q
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
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
ality assurance certification
- Financial stability
This list is not exhaustive but contains the most important areas to be considered. The most objec
- Financial stability
This list is not exhaustive but contains the most important areas to be considered. The most objec
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
tive way of reviewing the above, is to weight each one in order of importance, devise a scoring mechanism, create a grid to be completed by each member of th
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
review team and calculate the numbers. This method isn't foolproof but is as close as it possibly can be.
At this stage, the project risk has already been
At this stage, the project risk has already been
.
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
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
reduced because the best few of the potential sub-contractors have been chosen to compete for the sub-contract.
Alternatively, the selection process has sho
Alternatively, the selection process has sho
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
n that there is only one supplier capable of fulfilling the requirements. This requires quite different handling and will be the subject of a future article
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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