Our Approach to Reliability Assurance

Accurate information is essential for the appropriate use of pharmaceuticals. Meiji Seika Pharma Co., Ltd. makes available to users all information related to our products, which we obtain during product development, clinical studies and post-marketing surveillance. We try our best to enhance the reliability of our products and activities in accordance with our Reliability Assurance Policy.

Our Approach to Reliability Assurance

  • QMS: Quality Management System
  • GQP: Good Quality Practice
  • GCP: Good Clinical Practice
  • GVP: Good Vigilance Practice
  • GMP: Good Manufacturing Practice
  • GPSP: Good Post-marketing Study Practice

The guideline and standards are established in accordance with our Reliability Assurance Policy.

Reliability Assurance Guideline

The reasons for establishing the Meiji Seika Pharma Reliability Assurance Guideline are to gain customer trust and contribute to society by assuring product reliability.

The Japanese Health, Labor and Welfare Ministry establishes strict standards for pharmaceutical products as regards development, manufacturing, shipping, collecting adverse reaction information, post-marketing surveillance and appropriate use. In addition to these standards, we have established our own standards based on our Reliability Assurance Guideline to improve product reliability.

Reliability Assurance System

We guarantee the reliability of a wide range of information, including efficacy and safety data obtained in non-clinical/ clinical studies, production and post-marketing as well as information concerning product quality.

Our Reliability Assurance Division periodically conducts internal audits and evaluates compliance with standards and policies to promote reliability assurance. Because the Reliability Assurance Division is independent from our Development, Production and Sales Divisions, objective assessments are ensured.

PDCA Cycle

Our Reliability Assurance Guideline includes Provision of Quality Management Review — operational rules to maintain and enhance the reliability of our products (i.e., PDCA procedures). This provision requires our Production Division to set up its own quality-related policies and goals, and for company executives to conduct periodic reviews. This ensures our reliability assurance activities are appropriate, valid and effective.

PDCA Cycle

Ensuring the Quality of Meiji Pharmaceuticals

To provide safe, high-quality products to patients and healthcare professionals, our Production Division has established a Quality Assurance Policy. By adhering to this policy, we eliminate any potential risk during manufacturing.

Based on our Quality Assurance Policy, we are working on quality assurance to cover the global supply chain, including raw-material procurement, manufacturing, distribution and post-marketing pharmacovigilance.

We monitor our outsourcing companies and raw-material suppliers to confirm that each product is manufactured according to strict quality-control standards. We also provide instructions and guidance when needed. The Quality Assurance Manager approves product release in compliance with relevant laws and regulations after confirming all batch records.

This ensures that only safe, high-quality products are delivered to customers.