Major strengths of Indian pharmaceutical industry is a well-regarded local regulatory and surveillance framework. The manufacturing of pharmaceutical products in India is very well regulated. The principal regulatory authority on the production, import and sale of pharmaceuticals (including traditional medicines) in India is the Food and Drugs Control Authority (FDA) of the state. All manufacturers, importers and wholesalers are required to be licensed by FDA. Further WHO GMP is regulated by the central drug authorities.
Any pharmaceutical company's potential and objective are reflected from the products it manufactures, along with the manufacturing competencies, facilities, and the ability to implement it for the best of the market it targets.
Before selecting Manufacturer we at Cariesco evaluate on the basis of parameters like quality standards, formulation techniques, financial stability and delivery schedules.
All our manufacturer are WHO GMP certified and follows a few basic principles:
Manufacturing facilities must maintain a clean and hygienic manufacturing area.
Controlled environmental conditions in order to prevent cross contamination of food or drug product from adulterants that may render the product unsafe for human consumption.
Manufacturing processes are clearly defined and controlled. All critical processes are validated to ensure consistency and compliance with specifications.
Instructions and procedures are written in clear and unambiguous language. Operators are trained to carry out and document procedures.
Cross contamination with unlabeled major allergens is prevented.
Records are made manually or by instruments, during manufacture that demonstrate that all the steps required by the defined procedures and instructions were in fact taken and that the quantity and quality of the food or drug was as expected. Deviations are investigated and documented.
Records of manufacturing that enable the complete history of a batch to be traced are retained in a comprehensible and accessible form.
The distribution of the food or drugs minimizes any risk to their quality.
A system is available for recalling any batch from sale or supply.
Complaints about marketed products are examined, the causes of quality defects are investigated, and appropriate measures are taken with respect to the defective products and to prevent recurrence.
We at Cariesco Exports are constantly seeking ways to achieve more precise control over the manufacturing process. With incredibly high quality control standards resulting from the important role that pharmaceuticals play in public health, extreme measures are often taken to ensure that products are of the highest quality and consistency possible.
We at Cariesco Exports believes in choosing Right Factory for manufacturing of our products and as we see, there are five component and all five must be met. They are
Right Equipment in Manufacturing and Quality Control Department
It's the ability to monitor conditions and operations, and respond to events by taking appropriate action. This means right equipment can do some sort of self-triggered response like shut down, request a diagnostic evaluation or alert personnel to production events where specified specs are trending out of limits .
Right process are whereby processes that manage operations have the capability to perform actions that are triggered by others. Right processes generally require right equipment to provide the data for decision-making.
Of course, humans are a very important part of the production equation. Employees should be empowered to perform a corrective or preventive action or address an issue they see in real-time? What systems or procedures are in place to leverage the intelligent operators working on the "front line" such that significant quality, tracking or performance issues can be immediately addressed? Can they take action through the system? How easily can they do it? And, importance is given and procedure is well placed so that suggestions don't get lost in a corporate approval process "dead end".
Right people should be always well informed people. All the production information captured by Right equipment and processes should readily be available to everyone when they need it and in the right context.
Right Suppliers and Vendors
In global enterprises, the supply chain can be more critical than your own production systems precisely because they often operate outside of your visibility and control. A Right supplier or a vendor is one who provides you with visibility into their operations and gives you the ability to take prompt and appropriate action in response to real-time events more importantly, maintains consistency in quality for their supplies.
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