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Quality

Quality Management System at Optimus comprises three primary departments - Quality Assurance, Quality Control and Regulatory Affairs. The role of each department is designed in such a way that each of them counter checks the manufacturing activity and ensures the strict quality practices as per the regulatory standards. Optimus established stringent Quality Compliance as per Schedule M and ICH Q7 for the production of APIs as per cGMP.

Quality Policy

OPTIMUS is committed to maintain best Quality standards in Research & Development and Manufacturing of pharmaceutical products through periodic reviews and continual improvement of Quality Management system and strives to enhance customer satisfaction.

Quality Assurance

Optimus’s Quality Assurance is responsible for the site specific maintenance, compliance, realization and further development of internal Quality Management Systems. Quality Assurance ensures that API's and Advanced Intermediates produced from various stages of manufacturing to comply with cGMP requirements. Following are few of the important activities handled by Quality Assurance team.

• Document control & Annual Product reviews.
• Monitoring of all validations including cleaning validations.
• Change control compliance, batch release & product recall.
• In-process and retrospective audits.
• GMP training .

Quality Control

A well-equipped advanced lab for precision and ruggedness of the quality testing according to the pre-determined MOA as per pharmacopeia or in-house developed and validated analytical methods, we experienced professionals heading the department and well qualified employees performing the analysis in compliance with the ICH guidelines. The key responsibilities of QC are:

• Raw material Analysis & Approval.
• Batch Analysis & Approval.
• Retaining samples (Control samples).

Regulatory Affairs

Highly competent team of professionals with avast knowledge of regulatory guidelines, the team is headed by a well experienced professional with expertise in regulatory filing, DMF compilation, product registration, agency registrations and regulatory training. Our RA team is always in direct reach to our customer for timely support.

Optimus Accreditation

About us


Optimus established in 2004 by a team of scientists who had a passion towards chemistry and to ensure a better healthcare to everyone.

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