Author: digi

Embracing Schedule M: Pioneering Quality in Pharmaceutical Manufacturing

August 11, 2023 digi

Schedule M: Ensuring Quality in Pharmaceutical Manufacturing As we delve into the intricate realm of pharmaceutical manufacturing, we encounter a regulatory framework that serves as the backbone of our operations – Schedule M of the Indian Drugs and Cosmetics Act. This comprehensive set of guidelines lays the foundation for ensuring the safety, efficacy, and quality…

GMP Blog

Comparative study between Schedule M and WHO GMP

August 11, 2023March 12, 2024 digi

Comparative Table: Schedule M v/s WHO GMP Aspect Schedule M WHO GMP Application Specific to Indian pharmaceutical industry International guidelines for pharmaceutical manufacturing Scope Regulatory framework for pharmaceutical manufacturing in India Global standards for pharmaceutical manufacturing Quality Control Emphasizes quality control measures and testing procedures Focuses on quality assurance, including quality control and risk management…

GMP Blog

US – FDA

August 10, 2023 digi No Comments

When it comes to safeguarding public health and ensuring the safety and effectiveness of pharmaceuticals, one name stands out prominently – the Food and Drug Administration (FDA). As a pivotal regulatory authority in the United States, the FDA plays an indispensable role in overseeing the nation’s pharmaceutical industry. A Brief History The roots of the…

Role of GMP in preventing contamination

August 10, 2023August 10, 2023 digi

As a pharmaceutical expert deeply immersed in the world of pharmaceutical manufacturing, I can attest to the vital role that Good Manufacturing Practice (GMP) plays in safeguarding product quality and patient safety. GMP is the cornerstone of our industry, setting the standard for the meticulous processes and protocols that ensure contamination and cross-contamination are effectively…

GMP Blog

Mastering GMP : Five Pillars of Pharmaceutical Quality

August 10, 2023August 10, 2023 digi

Core Principles of Pharmaceutical Manufacturing Today, we’re diving into the core principles of Good Manufacturing Practice (GMP). GMP is the cornerstone of pharmaceutical manufacturing, ensuring safety, quality, and compliance. Let’s explore the five key principles in detail: 1. Quality Management System (QMS) The first principle is all about having a robust Quality Management System. Our…

GMP Blog

GMP v/s cGMP

August 10, 2023August 10, 2023 digi

GMP (Good Manufacturing Practice) Good Manufacturing Practice (GMP) is a set of quality management principles and guidelines that ensure the consistent production of safe, effective, and high-quality pharmaceutical products. GMP regulations are designed to ensure that pharmaceutical manufacturing processes are controlled, monitored, and documented to minimize risks to patient safety and product quality. GMP covers…

Can you provide an overview of your quality management system (QMS) and how it ensures compliance with FDA regulations?

August 10, 2023August 10, 2023 digi

Auditee: Our Quality Management System (QMS) is a comprehensive framework that governs every aspect of our pharmaceutical operations to ensure compliance with FDA regulations and maintain product quality. Our QMS encompasses various processes, procedures, and documentation that align with FDA guidelines and industry best practices. At its core, our QMS is designed to establish a…

US FDA Mock Audits

How are employees trained on FDA regulations and guidelines relevant to their roles?

August 10, 2023August 10, 2023 digi

Auditee: Our approach to training employees on FDA regulations and guidelines is comprehensive and tailored to individual roles and responsibilities within the organization. We recognize the critical importance of ensuring that every employee understands their role in maintaining compliance and upholding the highest quality standards. Training Program Structure: Our training program is structured to cover…

US FDA Mock Audits

Can you demonstrate how your documentation practices ensure accuracy, traceability, and completeness?

August 10, 2023August 10, 2023 digi

Auditee: Our documentation practices are meticulously designed to ensure accuracy, traceability, and completeness throughout our operations. Accurate and well-maintained documentation is not only essential for meeting FDA regulations but also plays a crucial role in maintaining product quality and integrity. Here’s how we ensure these key aspects: Document Control System: We maintain a robust document…

US FDA Mock Audits

How do you maintain and calibrate critical equipment used in your manufacturing process?

August 10, 2023August 10, 2023 digi

Auditee: The maintenance and calibration of critical equipment within our manufacturing process are integral components of our quality assurance efforts. These practices ensure that our equipment functions accurately, consistently, and within the specified parameters, thereby contributing to the production of safe and high-quality pharmaceutical products. Maintenance Program: Our equipment maintenance program is designed to prevent…

US FDA Mock Audits