Quality Assurance
Upholding the Highest Standards of Safety, Efficacy, and Consistency in Pharmaceutical Manufacturing.
Quality Assurance : Ensuring Excellence in Every Medicine
In the highly competitive realm of pharmaceutical manufacturing, ensuring safety, efficacy, and quality of tablets, capsules, and granules is of absolute importance.
At the Holden facility, we take pride in our commitment to excellence, maintained by the Quality Assurance (QA) department. The facility is accredited with CDSCO WHO-GMP certification and for ISO 9001, 14001 and OSHA 45001 Systems requirements.
The QA department adheres rigorously to WHO-GMP, FDA and ISO 9001 Quality standards, ensuring that every step of the manufacturing process aligns with the regulatory guidelines.
- The QA team maintains uncompromising standards of quality for raw materials, intermediates, and finished products to guarantee their purity, potency, and uniformity with comprehensive documentation forming the backbone of QA practices. From batch records to validation protocols, all aspects of the manufacturing process are documented and archived to facilitate regulatory compliance and traceability.
- Continuous improvement is ensured through foreign regulatory inspections and regular client audits, in addition to internal audits, reviews, and corrective actions.
- With ISO 14001 and OSHA 45001 certifications, Holden prioritizes environmental compliance, occupational health and safety within the manufacturing operations. From waste management to employee training, every aspect of Holden operations are designed with sustainability and safety in mind.