Reduce Risk in Contract Manufacturing with these Five Tips

by

Nuera Nutraceutical

In the pharmaceutical industry, contract manufacturing plays a vital role in meeting the specifications of the customers. It is equally responsible for meeting the requirements for standard processes in specific segments. This is addition to the fact that it helps the medicine manufacturers to cut cost and focus on their core products. Reliable and efficient contractors can make a huge difference in the market performance of products.

Possibly, all the stakeholders would benefit if there were a system in place to reduce the risk in contract manufacturing. For instance, a medicine manufacturer who needs encapsulation could turn a profit if they can assure if the contractors have the expertise and facilities, compatible for the production of hard-shelled or soft-shelled capsules. Let us see the five tips:

1.Choose only the most reliable and credible company dealing in contract manufacturing. It would be even better if its strategies in controlling risks were compatible with those of the medicine manufacturers. Regulatory standards spell out that any company should streamline its process of risk management in black and white. This applies throughout the product realization and product lifecycle stages.

2.Root cause analysis is a method of responding to a disruption. It is essential to evaluate the contractors response to perturbation in their manufacturing operation. Generally, a quick evaluation or their ability to identify problems and to find the root causes and effective methods to hold back and overcome the issues all these factors mark their competency.

3.Core competency is always the hallmark of an authentic enterprise. This can be effectively measured with the quality issues. These issues, in turn, depend on its qualification, equipment calibration, process validation, preventive maintenance and the like. We can take another example in encapsulation as in how the enterprise handles assembly processes, packaging, labeling and even distribution of the capsules.

4.Another key factor that can measure the quality and reduce the risk is to ascertain, how much the contractors comply to the quality system regulations. One of the ubiquitous yardsticks is the International Organization for Standardization or ISO. An analysis or an audit would show if they follow the standard processes throughout their facilities.

5.The contractors must meet design control requirements that are in accordance with the standard procedures from formulation and encapsulation to labeling and distribution. A few factors can ensure full compliance, as in checking whether they have design control procedures to drive continuous improvement, whether the procedures end with product launch and so on.

NuEra Nutraceutical Inc has specializes in

contract manufacturing

. It deals in custom formulation, encapsulation, tableting,

packaging and labeling

, with strict adherence to cGMP guidelines and the Health Canada NHPD.

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