Quality Managment Managment(QM)
Biopharma maintains a robust quality system with harmonized processes and procedures. Our uncompromising commitment to quality and compliance begins with product realization and continues throughout the product lifecycle. Biopharma is committed to developing, manufacturing, and supplying medicinal products with the highest quality, safety, and efficacy required for their intended use. Our quality management system follows the best practices that are proven effective to ensure the delivery of consistent, high-quality products to patients. We validate and continually monitor our manufacturing processes to ensure performance at the expected level. We believe in continuous improvement to keep processes up-to-date. A strong Quality mindset is reflected in our systems, processes, and company culture keeping our customers and patients in focus. An excellent team of professionals with having good understanding of concepts of quality systems and cGMP is working to ensure quality assurance at each stage right from receiving starting materials to finished products to assure the highest international standards.
The Quality Assurance Department is assigned with the following responsibilities:
Ensure compliance with national and international regulations like WHO, cGMP & ISO requirements. Approve and verify the implementation of defined systems, standards, and procedures.
- Ensure the availability of approved procedures and specifications for reference.
- Review batch manufacturing and testing records before giving product release.
- Review and authorize Protocols and provide support for validation activities.
- Ensure compliance with change control procedures.
- Ensure induction and on-the-job training of employees as per policy.
- Carry out process controls, including in-process checks/inspections/line clearances.
- Inspection of final packed stock before release.
- Investigate complaints, deviations, quality incidents, and non-conformances.
- Handling of regulatory inspections at the site.
- Take action on product recalls and investigate the reasons.
- Ensure implementation of amendments in specifications and procedures as per current pharmacopeia standards.
- Review product stability reports.
- Review batch manufacturing records, verify reconciliation of batch inputs and batch yields, and finally release the product.
- Document control.
- Ensure WHO-GMP / cGLP training for the staff.
- Ensure proper storage and fast retrieval of records.
- Annual Product Quality Review
- We are developing quality policies & standards.
- Analytical method development
- Vendor development and approval
- Internal audit/self-inspection.
- Review and approve the equipment and facilities of FAT, URS, DQ, IQ, OQ & PQ.
- To investigate out-of-specification results or failure investigation related to testing or manufacturing, etc.
- To review and upgrade the quality systems as per the latest regulatory requirements.
- To review and approve the artwork of all finished packaging material.
- To review SOPs of all departments like Quality Assurance, Production, Engineering, Product and Process Development, Quality Control, EHS, HR, and administration.
