Compliance Group

  Process Analytical Technology (PAT) in Pharma refers to a system for designing, analyzing, and controlling pharmaceutical manufacturing processes through the measurement and control of critical process parameters (CPPs) and critical quality attributes (CQAs). PAT aims to ensure product quality by integrating real-time data acquisition, process control, and analysis during manufacturing. It is part of a broader trend toward more efficient, flexible, and continuous production processes. Here’s an overview of PAT and its application in the pharmaceutical industry: 1. Key Components of PAT Critical Process Parameters (CPPs) : These are process variables that have a significant impact on product quality. Examples include temperature, pressure, mixing speed, and pH levels. Critical Quality Attributes (CQAs) : These are the physical, chemical, biological, or microbiological properties that must be within specific limits to ensure product quality. ...

Form 483 (vs) Warning Letter -All You Need to Know Form 483: This is issued by FDA inspectors after they conduct an inspection of a facility. It outlines any observations of conditions or practices that may constitute violations of the Food, Drug, and Cosmetic Act or related regulations. A Form 483 is not a final agency action or determination of violation; rather, it serves as a notification to the company of potential issues that need to be addressed. The recipient has the opportunity to respond to the observations and propose corrective actions. Warning Letter: A Warning Letter is a formal communication from the FDA to a company after it has conducted an inspection and determined that significant violations of regulations exist. It typically follows the issuance of a Form 483 Form 483 if the FDA finds that the company's response to the observations in the Form 483 is inadequate or if serious violations persist. A Warning Letter outlines specific violations identified during the...

21 CFR 820.70 specifically deals with "Production and Process Controls" within the Quality System Regulation (QSR) for medical devices. These controls are crucial for ensuring that medical devices are manufactured in a consistent and controlled manner, meeting the required quality standards and specifications.   Here's a more detailed breakdown of what 21 CFR 820.70 covers:   1. General Requirements: Establishing and maintaining procedures to ensure that devices are manufactured in accordance with their specifications.   2. Production Processes: Documenting procedures for controlling production processes, including those related to equipment, materials, and personnel.   3. Process Validation : Validating production processes to ensure that they consistently produce devices meeting predetermined specifications.   4. Monitoring and Control: Establishing procedures for monitoring and controlling process parameters to ensure product quality and consistency...

Introduction: In the highly regulated and fast-paced world of Life Sciences, effective Application Lifecycle Management (ALM) is paramount for ensuring product quality, regulatory compliance, and speed to market. Polarion ALM emerges as a leading solution, offering a comprehensive platform tailored to the unique needs of Life Sciences organizations. This guide delves into the intricacies of Polarion ALM and its transformative impact on Life Sciences processes. What is Polarion ALM? Polarion ALM is an integrated solution that facilitates end-to-end management of software development processes, from requirements gathering to release and beyond. It offers robust features such as requirement management, test management, and traceability, empowering Life Sciences companies to navigate complex regulatory landscapes with ease.  Key Benefits of Polarion ALM in Life Sciences In the Life Sciences sector, where compliance with regulations like FDA 21 CFR Part 11 is non-negotiable, Polar...

Polarion ALM (Application Lifecycle Management) is a software platform developed by Siemens Digital Industries Software. It is designed to help organizations manage the entire lifecycle of software development, from requirements management to testing and release. Here are some key features and functionalities of Polarion ALM: polarion-alm-software Requirements Management: Polarion ALM allows users to capture, manage, and trace requirements throughout the software development lifecycle. It provides tools for defining requirements, linking them to related artifacts, and tracking changes and approvals. Collaboration and Workflow: The platform facilitates collaboration among team members by providing centralized access to project data, documents, and discussions. It supports customizable workflows for managing tasks, approvals, and notifications. Version Control : Polarion ALM integrates with version control systems such as Git and Subversion,...

ISO 9001 is a widely recognized international standard for Quality Management Systems (QMS) . While ISO 9001 itself does not provide a checklist of requirements, it does outline specific criteria that organizations must meet to achieve certification. Scope of the Quality Management System (QMS): Determine the scope of your QMS, including the products, services, and processes it covers. Leadership: Demonstrate leadership commitment to the QMS. Establish a quality policy and quality objectives. Ensure the integration of quality objectives into the organization's strategic planning. Planning: Conduct risk-based thinking to identify and address risks and opportunities. Develop a quality management plan. Establish objectives to enhance customer satisfaction and meet quality requirements. Support: Provide adequate resources, including human resources, infrastructure, and...