Quality Statement

At Innova, we strive to create positive client experiences. We are constantly on our feet to adapt to new techniques, compliances, and standards. Our Quality Assurance team is regularly trained and consistently updated on new regulatory compliances.

Quality Process

We prioritise quality and always work towards achieving this quality. With two departments — Quality Assurance and Quality Control — Innova has implemented an efficient double-check system. Each department is designed to counter check the manufacturing activity and follow strict quality practices as per the regulatory standards.
For the production of APIs, our Quality Compliance is as per cGMP, Schedule M, and
ICH Q7.

Quality Assurance

Innova’s Quality Assurance team is responsible for monitoring site-specific maintenance; prevention of cross-contamination; and compliance, resulting in further development of internal Quality Management Systems. This ensures our APIs and Intermediates — produced from various stages of manufacturing — comply with regulatory requirements. The Quality Assurance team controls and monitors following activities:

• Document review, control and annual product reviews
• Document review, control and annual product reviews
• Qualifications and validations, including process and cleaning validations
• Changing control compliance, batch release and product recall
• In-process and retrospective audits
• Good manufacturing practice (GMP) training
• Standard operating procedures (SOPs)
• Total quality management (TQM)
• Raw material analysis and approval
• Batch analysis & approval
• Retaining samples (control samples)
• Stability plan preparing and monitoring.

Quality Control

Innova has an advanced, well-equipped lab for precision and ruggedness of the quality testing. This is conducted as per pharmacopoeia, and various in-house developed and validated analytical methods.
The department is headed by experienced professionals and well-qualified employees, who perform the analysis in ICH guidelines. The key responsibilities of the QC team are analysis and release of raw materials, intermediates, in-process and finished products; to perform calibration; to assist in the stability studies; to perform microbial analysis; and to assist in new vendor development. The QC team ensures that our manufacturing processes and products meet our quality specifications. Their efforts promise us efficacy, safety, and quality.

Regulatory Affairs

Our Regulatory Affairs team is easily accessible and prompt with responses to customer queries. Supported and backed by a highly competent team of professionals, our team promises exceptional expertise in regulatory guidelines, regulatory filing, DMF compilation, product registration, agency registrations and regulatory awareness training within the organisation.