Popup Cookie Consent Box

This website uses cookies to ensure you get the best experience on our website. More info.

CERTIFICATION

Open Imagination
Open Imagination

GMP

Good Manufacturing Practices (GMP) for the Pharmaceutical Industry

  • Quality Assurance: Ensure that every aspect of production maintains a high level of quality.
  • Thorough Documentation: Keep detailed records of all processes, materials, and changes for traceability.
  • Clean Manufacturing Environment: Maintain a clean and hygienic production area to prevent contamination.
  • Qualified Workforce: Employ properly trained and qualified staff to operate within GMP guidelines.
  • Quality Control Procedures: Implement stringent testing and validation procedures to ensure product quality.
  • Validated Manufacturing Processes: Validate processes to guarantee consistent product quality and safety.
  • Controlled Raw Materials: Strictly control the quality of raw materials and their sources.
  • Equipment Calibration and Maintenance: Regularly calibrate and maintain equipment to ensure proper functioning.
  • Handling of Complaints and Recalls: Establish protocols for efficiently handling product complaints and recalls.
  • Regulatory Compliance: Adhere to regulatory standards and guidelines set by health authorities like the FDA and ICH.

These practices are crucial to ensure the safety, efficacy, and quality of pharmaceutical products.

Open Imagination

ISO 9001:2015

is the latest version of the Quality Management System (QMS) standard that provides a framework for organizations to consistently meet customer and regulatory requirements and enhance customer satisfaction. Here are some key points:

  • Emphasis on Leadership: It highlights the importance of top management's involvement and leadership in the QMS.
  • Risk-Based Thinking: It introduces risk-based thinking to identify and address potential risks and opportunities.
  • Process Approach: It reinforces the use of a process approach to improve efficiency and effectiveness.
  • Customer Focus: It continues to emphasize meeting customer requirements and enhancing customer satisfaction.
  • Improved Compatibility: The standard is designed to be compatible with other management system standards, such as ISO 14001.
  • Continual Improvement: It encourages organizations to strive for continual improvement in their processes.
  • Documented Information: It provides more flexibility in maintaining documented information.
  • Performance Evaluation: It emphasizes monitoring and measuring performance to ensure effectiveness.
  • External Providers: It includes requirements for controlling external providers and ensuring their compliance.
  • Context of the Organization: It requires organizations to understand their context and stakeholders' needs and expectations.

ISO 9001:2015 helps organizations improve their processes, achieve consistent product quality, and enhance customer satisfaction.

ISO 14001:2015

is an international standard for Environmental Management Systems (EMS). It provides a framework for organizations to manage their environmental responsibilities systematically. Here are some key points about ISO 14001:2015:

  • Environmental Management: It helps organizations establish, implement, maintain, and improve an EMS.
  • Risk-Based Approach: It emphasizes a risk-based approach to identify and address environmental risks and opportunities.
  • Legal Compliance: It ensures organizations comply with applicable environmental laws and regulations.
  • Sustainable Resource Use: It promotes efficient use of resources, reducing waste and environmental impact.
  • Continual Improvement: Encourages ongoing improvement of environmental performance.
  • Context of the Organization: Requires understanding the organization's context and the needs of interested parties.
  • Leadership Commitment: Emphasizes the importance of leadership and commitment from top management.
  • Life Cycle Perspective: Considers the environmental aspects of products and services from a life cycle perspective.
  • Documentation Flexibility: Provides flexibility in how documented information is maintained.
  • Performance Evaluation: Focuses on monitoring, measuring, and evaluating environmental performance.

ISO 45001:2018

  • ISO 45001:2018: ISO 45001:2018 is an international standard for Occupational Health and Safety Management Systems (OHSMS). It provides a framework for organizations to manage and improve their occupational health and safety performance.
  • Health and Safety Management: Helps organizations establish, implement, maintain, and improve an OHSMS.
  • Risk-Based Approach: Emphasizes identifying and addressing workplace health and safety risks and opportunities.
  • Legal Compliance: Ensures organizations comply with applicable occupational health and safety laws and regulations.
  • Hazard Identification: Focuses on proactively identifying and mitigating hazards to prevent workplace injuries and illnesses.
  • Leadership Commitment: Stresses the importance of leadership and commitment from top management.
  • Employee Participation: Encourages active involvement and consultation of workers in health and safety matters.
  • Continual Improvement: Promotes continuous improvement in health and safety performance.
  • Performance Evaluation: Involves regular monitoring, measuring, and evaluating occupational health and safety performance.
  • Incident Investigation: Requires thorough investigation of incidents and implementation of corrective actions.

ISO 45001:2018 helps organizations create safer workplaces, reduce workplace accidents, and enhance overall employee well-being.

The USFDA audit for 2024 was conducted at Allchem Lifescience Pvt. Ltd.