In recent years, the Contract Manufacturing Organizations (CMO) and Contract Development and Manufacturing Organization (CDMO) are becoming an integral part of the Indian pharmaceutical industry. Developing and manufacturing a new drug substance is a prolonged process that requires a complex methodology, infrastructure, resources, and a significant investment. Therefore, both CMO and CDMO are feasible alternatives of outsourcing in comparison to in-house manufacturing and development. Many pharmaceutical companies collaborate with CMOs and CDMOs to increase operational efficiencies and reduce costs.
Why is Contract Manufacturing beneficial?
Collaborating with CMO and CDMO gives multiple benefits to pharmaceutical companies in addition to cost-effectiveness. Pharmaceutical companies can utilize their expertise, innovation, and insight to become more successful in the market. In addition, companies get access to their facilities and equipment, add a drug variation, and meet the market demands by improving the scale-up of the business.
Critical considerations for choosing the right partner for CMO and CDMOs:
Following are a few questions to ask and some factors to consider while choosing a CMO and CDMO partner to make the partnership most beneficial.
Identifying your company’s needs and expectations from the contract company:Analysis of the company’s needs is the first step towards selecting a partner. Are you looking for a long-term relationship for the resources or just for one single project? Are you interested in only API manufacturing or clinical trials? Are you seeking a partner for the formulation, manufacturing, and packaging as well? Ask these questions and focus on the strategic partnership with a CMO or CDMO. After that, look for companies that have the experience and technical expertise to meet your needs.
Will this collaboration help to achieve your company’s goals?Evaluation of CMO and CDMO should be based on their commitment to client satisfaction and quality. Moreover, check and verify their range of products from API to finished dosages, method development techniques, equipment, staff training, outsourcing services, and commercial-scale production. Finally, the contract company should have the financial stability and flexibility to handle your product growth. If there are any uncertainties with the contract companies, then it may impact the company’s goals.
Transparency in communication:Effective and strong communication is a key to the success of any relationship. Hence, transparency and a clear vision of communication with your CMO or CDMO partner is vital. In addition, it is essential to establish a flow of data between two organizations like the contact person’s details for technical discussions, handling product strategies, handling any deficiencies, etc. Contract companies should also be easily approachable and involve pharmaceutical companies in their step-by-step process.
Is the contract company in compliance with your quality standards?Here are some points to look for in the quality and compliance of CMO and CDMO.
- Check for the robustness of the quality system of the company.
- Visit the facility and check for any irregularities.
- Check whether the site is inspected and approved by the requisite agencies.
- Is the company undergoing regular internal quality audits?
- Is the company taking care of method transfers, validations, and stability testing?
- Are adequate documents maintained for quality submissions?
- Can the company cope up with the constantly changing regulatory environment?
- Check for their safety and maintenance procedures.
Working cohesively for the contract agreement:The contract agreement should comprise a detailed list of manufacturing, delivery, quality checks, and safety procedures. In addition, both organizations should clearly state in the agreement who is responsible for what.
Maintaining confidentiality is another important aspect while partnering with contract companies. A confidentiality agreement should also be there. This would preclude using client names or initials, lock information in a secure area, and send the separate client passwords for electronic access to documents for the benefit of both parties.
In this blog have discussed some parameters for the selection of your CMO and CDMO partner.
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