Certification
ISO 9001 Certified CDMOs
Compare CDMOs with ISO 9001 quality management system certification. Filter by manufacturing type and regulatory approvals.
2 companies listed
About ISO 9001 in Pharmaceutical Manufacturing
ISO 9001 is the international standard for quality management systems (QMS). In pharmaceutical manufacturing, it provides a framework for consistent processes, continuous improvement, and customer focus that complements GMP requirements. While GMP is mandatory for pharmaceutical manufacturing, ISO 9001 certification demonstrates a broader organizational commitment to quality.
ISO 9001 certification requires: documented quality policy and objectives, risk-based process management, internal audit programs, management review, corrective and preventive action systems, and evidence of continuous improvement. Third-party certification bodies audit compliance every 1-3 years.
Companies (2)
INA PHARMACEUTICALS PVT.LTD
INDIA
INA Pharmaceuticals is an India-based pharmaceutical manufacturing and CDMO company specializing in pharmaceutical intermediates, advanced intermediates and custom synthesis solutions for global pharmaceutical partners. We support customers from route development and process optimization through scale-up and commercial manufacturing, with a focus on consistent quality, reliable supply and long-term partnerships. Our capabilities include: - Pharmaceutical intermediates and advanced intermediates - Custom synthesis and contract manufacturing - Process development and optimization - Route scouting and scale-up - Commercial-scale manufacturing - Technology transfer - Impurity and related-substance synthesis - Customized manufacturing solutions based on customer requirements We work with pharmaceutical companies, generic manufacturers, CDMOs, CROs and sourcing organizations seeking reliable manufacturing partners in India. We are actively looking for: - Long-term supply partnerships - Custom synthesis projects - CDMO collaborations - Technology-transfer opportunities - Joint development projects - Strategic partnerships with overseas pharmaceutical companies Our objective: to become a reliable long-term manufacturing partner for pharmaceutical companies seeking high-quality intermediates and flexible CDMO solutions from India.
Small Molecule APIPeptide APIOligonucleotide API
Frequently Asked Questions
Is ISO 9001 required for pharmaceutical manufacturing?+
No, ISO 9001 is not legally required for pharmaceutical manufacturing -- GMP compliance (FDA, EMA, etc.) is the regulatory requirement. However, ISO 9001 provides a complementary quality management framework that many CDMOs adopt to demonstrate organizational quality maturity. Clients often view ISO 9001 certification as a positive indicator of a CDMO's quality culture.
How does ISO 9001 complement GMP?+
GMP focuses on pharmaceutical-specific manufacturing controls (equipment qualification, process validation, batch records, etc.). ISO 9001 provides a broader management system framework covering: strategic planning, resource management, customer communication, supplier management, and organizational learning. Together, they create a more comprehensive quality system than either alone.
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