Tag: Pharmaceutical equipment qualification

How to Establish an Effective Change Control System Under GMP

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How to Establish an Effective Change Control System Under GMP Establishing an Effective Change Control System Under GMP Compliance Introduction: The Need for an Effective Change Control System in GMP In the pharmaceutical industry, the introduction of changes to any part of the manufacturing process—be it equipment, materials, procedures, or suppliers—can have significant implications for…

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Good Manufacturing Practices (GMP)

QA Guidelines for Handling Deviations in Pharmaceutical Manufacturing

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QA Guidelines for Handling Deviations in Pharmaceutical Manufacturing Practical Tips for QA Teams in Managing Deviations in Pharmaceutical Manufacturing Introduction Deviations in pharmaceutical manufacturing can occur at any stage of production and can have serious consequences if not addressed promptly. From issues in raw material quality to inconsistencies in equipment performance, deviations can impact product…

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Quality Assurance and Control

How to Create Robust Batch Manufacturing Records (BMRs) for Schedule M

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How to Create Robust Batch Manufacturing Records (BMRs) for Schedule M Creating Robust Batch Manufacturing Records for Schedule M Compliance Introduction Batch Manufacturing Records (BMRs) are essential documents in pharmaceutical manufacturing, providing detailed information on each batch of product produced. They serve as a critical tool for ensuring that manufacturing processes are conducted in compliance…

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How-To-Implement

Sanitation and Hygiene: A Pillar of GMP Compliance in Revised Schedule M

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Sanitation and Hygiene: A Pillar of GMP Compliance in Revised Schedule M Ensuring Sanitation and Hygiene in GMP Compliance under Revised Schedule M Introduction: The Role of Sanitation and Hygiene in GMP Compliance In pharmaceutical manufacturing, maintaining sanitation and hygiene is not just about cleanliness—it’s a critical factor that ensures the safety, efficacy, and quality…

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Good Manufacturing Practices (GMP)

How to Implement Sustainable Practices in Compliance with Revised Schedule M

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How to Implement Sustainable Practices in Compliance with Revised Schedule M Implementing Sustainable Practices for Schedule M Compliance Introduction As the pharmaceutical industry continues to grow, the need for sustainable practices in manufacturing processes has become increasingly important. Sustainable manufacturing not only helps protect the environment but also aligns with regulatory standards, such as the…

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How-To-Implement

QC Guidelines for Raw Material and API Testing

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QC Guidelines for Raw Material and API Testing Best Practices for QC Testing of Raw Materials and Active Pharmaceutical Ingredients (APIs) Introduction In pharmaceutical manufacturing, ensuring that raw materials and active pharmaceutical ingredients (APIs) meet predefined quality standards is essential for producing safe and effective products. Quality Control (QC) testing plays a pivotal role in…

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Quality Assurance and Control

Step-by-Step Guide to Managing Toxic Waste as per Schedule M Amendments

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Step-by-Step Guide to Managing Toxic Waste as per Schedule M Amendments Managing Toxic Waste in Compliance with Schedule M Amendments Introduction Proper waste management is a critical aspect of Good Manufacturing Practice (GMP) in pharmaceutical manufacturing, especially for toxic waste, which poses significant risks to both human health and the environment. The revised Schedule M…

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How-To-Implement

The Role of Documentation in GMP Compliance as per Schedule M

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The Role of Documentation in GMP Compliance as per Schedule M Understanding the Role of Documentation in GMP Compliance under Schedule M Introduction: The Importance of Documentation in GMP Compliance In the pharmaceutical industry, ensuring product safety, quality, and regulatory compliance is essential. One of the key pillars of Good Manufacturing Practices (GMP) is proper…

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Good Manufacturing Practices (GMP)

How to Upgrade Security Systems for GMP Facilities to Meet Schedule M

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How to Upgrade Security Systems for GMP Facilities to Meet Schedule M Upgrading Security Systems for GMP Compliance under Schedule M Introduction Security systems are essential in Good Manufacturing Practice (GMP) facilities to ensure that pharmaceutical products are manufactured, stored, and distributed in compliance with safety and regulatory standards. The revised Schedule M guidelines emphasize…

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How-To-Implement

QA Standards for Multi-Product Manufacturing Facilities

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QA Standards for Multi-Product Manufacturing Facilities How QA Standards Ensure Compliance in Multi-Product Manufacturing Facilities Introduction In pharmaceutical manufacturing, maintaining consistent product quality across multiple product lines is a challenging but critical task. Multi-product manufacturing facilities, which produce various products using shared equipment and processes, face unique challenges in ensuring that each product meets the…

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Quality Assurance and Control