Tag: Environmental monitoring

Addressing Humidity Control Failures in Utility Validation for Film-Coated Tablets

March 4, 2025 Admin

Addressing Humidity Control Failures in Utility Validation for Film-Coated Tablets Addressing Humidity Control Failures in Utility Validation for Film-Coated Tablets Introduction: In the realm of pharmaceutical manufacturing, maintaining optimal environmental conditions is crucial to ensuring product quality and efficacy. One significant aspect is humidity control, especially when it comes to the production of film-coated tablets….

Solid Dosage form, Tablets

Validating Temperature Mapping in Cleanrooms for Sustained Release Tablets

March 4, 2025 Admin

Validating Temperature Mapping in Cleanrooms for Sustained Release Tablets Validating Temperature Mapping in Cleanrooms for Sustained Release Tablets Introduction: In the pharmaceutical industry, maintaining the integrity of sustained release tablets during production is vital to ensure efficacy and safety. A critical step in this process is validating temperature mapping in cleanrooms, where these tablets are…

Solid Dosage form, Tablets

Poor reproducibility in validation results for air filtration systems.

March 3, 2025 Admin

Poor reproducibility in validation results for air filtration systems. Poor reproducibility in validation results for air filtration systems. Introduction: In the pharmaceutical industry, air filtration systems are crucial for maintaining cleanroom standards and ensuring the quality and safety of products, especially in the manufacturing of solid oral dosage forms like capsules. These systems are designed…

Capsules (Hard & Soft Gelatin), Solid Oral Dosage Forms

Validating Cleanroom Air Change Rates for Hygroscopic Tablet Areas

March 2, 2025 Admin

Validating Cleanroom Air Change Rates for Hygroscopic Tablet Areas Validating Cleanroom Air Change Rates for Hygroscopic Tablet Areas Introduction: In the pharmaceutical industry, maintaining the integrity of tablet production environments is crucial, especially when dealing with hygroscopic materials. Hygroscopic tablets, known for their tendency to absorb moisture from the air, require precisely controlled environments to…

Solid Dosage form, Tablets

Troubleshooting Non-Adherence to Cleanroom Validation Standards for Particle Monitoring

March 2, 2025 Admin

Troubleshooting Non-Adherence to Cleanroom Validation Standards for Particle Monitoring Troubleshooting Non-Adherence to Cleanroom Validation Standards for Particle Monitoring Introduction: In the pharmaceutical industry, maintaining a pristine environment is paramount to ensuring product quality and patient safety. Cleanrooms play a crucial role in this process, particularly in the manufacturing of solid dosage forms like tablets. A…

Solid Dosage form, Tablets

Troubleshooting Failures in Cleanroom Classification for Sugar-Coated Tablet Production

March 2, 2025 Admin

Troubleshooting Failures in Cleanroom Classification for Sugar-Coated Tablet Production Troubleshooting Failures in Cleanroom Classification for Sugar-Coated Tablet Production Introduction: In the pharmaceutical industry, the production of sugar-coated tablets necessitates strict adherence to cleanroom classifications to ensure product quality and patient safety. Cleanrooms are controlled environments where parameters like airborne particles, temperature, and humidity are meticulously…

Solid Dosage form, Tablets

Controlling Humidity Variations in Compression Stages

March 1, 2025 Admin

Controlling Humidity Variations in Compression Stages Controlling Humidity Variations in Compression Stages Introduction: In the realm of pharmaceutical manufacturing, maintaining the integrity and quality of solid dosage forms is paramount. Among the various stages of tablet production, the compression stage stands out as a critical phase where humidity control plays a decisive role. Humidity variations…

Solid Dosage form, Tablets

Validating Cleanroom Classification for Sustained Release Tablet Manufacturing Facilities

March 1, 2025 Admin

Validating Cleanroom Classification for Sustained Release Tablet Manufacturing Facilities Validating Cleanroom Classification for Sustained Release Tablet Manufacturing Facilities Introduction: The pharmaceutical industry is heavily reliant on maintaining controlled environments to ensure the safety and efficacy of its products. Cleanrooms play a critical role in the manufacturing of pharmaceutical products, particularly for sustained release tablets, where…

Solid Dosage form, Tablets

Explain Research and Development in Pharma.

August 7, 2023 Admin

Research and Development in Pharma Research and Development (R&D) plays a critical role in the pharmaceutical industry, driving innovation and the discovery of new drugs and therapies. It is a dynamic and complex process that involves various stages of scientific exploration, preclinical testing, and clinical trials. 1. Drug Discovery Drug discovery is the initial phase…

Pharma Research

What are the requirements for premises and equipment under Schedule M?

July 27, 2023July 27, 2023 Admin

Premises and Equipment Requirements in Pharmaceutical Manufacturing Let’s explore the specific requirements for premises and equipment under Schedule M: 1. Premises Requirements Under Schedule M, the manufacturing premises must meet specific criteria to ensure a controlled and suitable environment for drug production. The following are the key requirements for premises: Location: The manufacturing facility should…

Schedule M

How is compliance with Schedule M ensured during drug manufacturing?

July 27, 2023 Admin

Ensuring Compliance with Schedule M during Drug Manufacturing Schedule M lays down stringent guidelines and requirements to ensure the quality, safety, and efficacy of drugs produced in India. Manufacturers must adhere to these guidelines throughout the manufacturing process to maintain compliance. Let’s explore the key measures taken to ensure compliance with Schedule M during drug…

Schedule M

What types of drugs and pharmaceuticals does Schedule M apply to?

July 27, 2023 Admin

Types of Drugs and Pharmaceuticals Covered by Schedule M Schedule M, a crucial aspect of the regulatory framework under the Drugs and Cosmetics Act, 1940, applies to various types of drugs and pharmaceuticals. The following are the main categories of drugs and pharmaceuticals that fall under the purview of Schedule M: 1. Allopathic Medicines Schedule…

Schedule M