Tag: Equipment qualification

Do Not Use Laboratory Glassware with Faded or Unreadable Calibration Marks

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Do Not Use Laboratory Glassware with Faded or Unreadable Calibration Marks Discard Glassware with Illegible Calibrations in GMP Laboratories Remember: Laboratory glassware with unreadable volume markings must not be used—accurate measurements are essential for GMP analytical reliability. Why This Matters in GMP Accurate analytical testing relies heavily on the precision of volumetric instruments such as…

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GMP Tips

Use Only Validated Autoclaves for Sterile Component Preparation

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Use Only Validated Autoclaves for Sterile Component Preparation Only Use Validated Autoclaves for Sterile Manufacturing Processes Remember: Autoclaves must be validated before being used for sterilizing components in GMP sterile operations to ensure consistent and effective microbial inactivation. Why This Matters in GMP Autoclaves are critical equipment used to sterilize components such as glassware, garments,…

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GMP Tips

Never Use Damaged Sieves or Mesh During Granulation in GMP

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Never Use Damaged Sieves or Mesh During Granulation in GMP Damaged Sieves Must Not Be Used in Granulation Processes Remember: Inspect all sieves and meshes before use—damaged screens compromise granule size, uniformity, and product safety. Why This Matters in GMP Sieves are used during granulation to control particle size distribution and ensure blend uniformity. A…

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GMP Tips

Conduct Alarm Challenge Tests to Validate Critical GMP System Responses

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Conduct Alarm Challenge Tests to Validate Critical GMP System Responses Perform Regular Alarm Challenge Tests on Critical GMP Systems Remember: All critical alarms—HVAC, pressure, temperature—must be challenge-tested to confirm functionality and operator response protocols. Why This Matters in GMP Alarms serve as the first line of defense in detecting and correcting deviations in critical GMP…

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GMP Tips

How to Conduct Commissioning and Qualification of Pharmaceutical Facilities

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How to Conduct Commissioning and Qualification of Pharmaceutical Facilities Step-by-Step Guide to Conducting Commissioning and Qualification of Pharmaceutical Facilities Introduction: What is Commissioning and Qualification in Pharmaceutical Facilities? In the pharmaceutical industry, commissioning and qualification are vital processes that ensure pharmaceutical facilities, including manufacturing plants, laboratories, and packaging areas, meet required regulatory standards and function…

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Validation and Qualification Processes in GMP

Equipment Validation in Pharmaceutical Industry: Best Practices

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Equipment Validation in Pharmaceutical Industry: Best Practices Equipment Validation in Pharmaceutical Industry: Best Practices for Compliance and Quality Assurance Introduction: The Importance of Equipment Validation in Pharma Equipment validation is a fundamental process in the pharmaceutical industry that ensures all equipment used in drug manufacturing, testing, and packaging operates efficiently, safely, and in compliance with…

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Validation and Qualification Processes in GMP

Guide to Pharmaceutical Isolator Validation

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Guide to Pharmaceutical Isolator Validation Step-by-Step Guide to Pharmaceutical Isolator Validation Introduction: What is Pharmaceutical Isolator Validation? Pharmaceutical isolator validation refers to the process of verifying and documenting that isolators used in pharmaceutical manufacturing consistently provide a controlled, contaminant-free environment for the production of sterile products. Isolators are critical for maintaining the sterility of drug…

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Validation and Qualification Processes in GMP

The Importance of V-Model in Pharma Validation

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The Importance of V-Model in Pharma Validation Understanding the V-Model in Pharmaceutical Validation: A Comprehensive Guide Introduction: What is the V-Model in Pharmaceutical Validation? The V-Model is a structured approach to validation that ensures pharmaceutical processes, equipment, and systems are fit for their intended use. In pharmaceutical validation, the V-Model is a lifecycle model that…

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Validation and Qualification Processes in GMP

Process Validation and Its Role in Drug Manufacturing

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Process Validation and Its Role in Drug Manufacturing Process Validation and Its Critical Role in Drug Manufacturing Introduction: The Importance of Process Validation in Pharma Process validation is an essential component of pharmaceutical manufacturing that ensures the safety, quality, and consistency of drug products. It involves a series of tests, checks, and documentation to verify…

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Validation and Qualification Processes in GMP

The Impact of Clean Room Validation in Pharmaceutical Production

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The Impact of Clean Room Validation in Pharmaceutical Production The Impact of Clean Room Validation in Pharmaceutical Production Introduction: The Role of Clean Room Validation in Pharma Clean room validation is a critical component of pharmaceutical manufacturing that ensures the environment in which drugs are produced is free from contamination. Clean rooms are specially designed…

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Validation and Qualification Processes in GMP