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Our Standards

Commitment to Quality Excellence

At Hitzelberger Life Sciences, quality is not just a policy - it's the foundation of everything we do. Our unwavering commitment to excellence ensures that every product we manufacture meets the highest international standards.

Quality Policy Statement

"Hitzelberger Life Sciences is committed to providing safe, effective, and high-quality pharmaceutical products that consistently meet customer requirements and regulatory standards. We continuously improve our quality management system to enhance customer satisfaction and ensure the well-being of patients worldwide."

Management Team
Hitzelberger Life Sciences (P) Ltd

Quality Objectives

Customer Satisfaction

Achieve and maintain high levels of customer satisfaction through consistent product quality and reliable service delivery.

Regulatory Compliance

Ensure 100% compliance with all applicable regulatory requirements and international quality standards.

Continuous Improvement

Implement ongoing improvements in our processes, products, and quality management system.

Patient Safety

Prioritize patient safety in every aspect of our manufacturing and quality control processes.

Quality Management System

Our Quality Management System (QMS) is designed to ensure consistent quality across all aspects of our operations. Built on international standards and best practices, our QMS encompasses:

  • ISO 9001:2015 certified quality management
  • WHO-GMP compliant manufacturing
  • ICH-Q10 pharmaceutical quality system
  • Risk-based quality approach
  • Continuous monitoring and improvement
  • Comprehensive documentation system
Quality Management System

Manufacturing Standards

Good Manufacturing Practices (GMP)

Our facilities operate under strict GMP guidelines ensuring product quality, safety, and consistency from raw materials to finished products.

Analytical Testing

Comprehensive testing protocols including identity, purity, potency, and stability testing using validated analytical methods.

Quality Control

Multi-tiered quality control system with in-process monitoring, finished product testing, and release procedures.

Documentation Control

Comprehensive documentation and record-keeping system ensuring traceability and accountability throughout production.

Quality Control Laboratory

Quality Control Laboratory

Our state-of-the-art quality control laboratory is equipped with advanced analytical instruments and staffed by qualified scientists.

Advanced Instrumentation

HPLC, GC-MS, UV-Vis spectrophotometry, and other modern analytical equipment

Qualified Personnel

Experienced analysts with specialized training in pharmaceutical testing

Validated Methods

All testing methods are validated according to ICH guidelines

Certifications & Compliance

ISO 9001:2015

Quality Management System certification ensuring consistent quality delivery

WHO-GMP

World Health Organization Good Manufacturing Practices compliance

Schedule M Compliance

Indian regulatory compliance for pharmaceutical manufacturing

Pharmacovigilance

Robust adverse event monitoring and reporting system

Quality Culture

Quality culture is ingrained in every aspect of our organization. We foster an environment where:

  • Every employee is responsible for quality
  • Continuous learning and improvement are encouraged
  • Open communication about quality issues is promoted
  • Quality decisions are based on scientific evidence
  • Patient safety is the top priority

Training Programs

Employee Training

Regular training on GMP, quality standards, and regulatory requirements

Continuous Education

Ongoing education programs to keep staff updated with latest developments

Cross-functional Teams

Quality improvement teams involving multiple departments

Quality Metrics & Performance

99.8%

First Time Right

Manufacturing success rate

100%

Regulatory Compliance

Inspection pass rate

0.02%

Customer Complaints

Quality-related issues

24hrs

Response Time

Quality issue resolution

Partner with Quality

Experience the Hitzelberger difference with our commitment to uncompromising quality standards. Join the growing network of healthcare professionals who trust our pharmaceutical solutions.