Tag: Pharmaceutical standards

Ensuring Batch-to-Batch Consistency in Hardness Testing for Coated Tablets

March 6, 2025 Admin

Ensuring Batch-to-Batch Consistency in Hardness Testing for Coated Tablets Ensuring Batch-to-Batch Consistency in Hardness Testing for Coated Tablets Introduction: In the pharmaceutical industry, ensuring the quality and efficacy of tablet formulations is paramount. Among various quality parameters, hardness testing plays a crucial role in assessing the mechanical integrity of coated tablets. The consistency of tablet…

Solid Dosage form, Tablets

Ensuring Robustness in Purified Water Flow Rates for Cleaning Validation

March 4, 2025 Admin

Ensuring Robustness in Purified Water Flow Rates for Cleaning Validation Ensuring Robustness in Purified Water Flow Rates for Cleaning Validation Introduction: In the pharmaceutical industry, maintaining high standards of cleanliness and sanitation is paramount. One critical component of this process is the use of purified water for cleaning validation. The flow rate of purified water…

Solid Dosage form, Tablets

Ensuring Robustness in Thickness Testing for Extended Release Tablets

March 4, 2025 Admin

Ensuring Robustness in Thickness Testing for Extended Release Tablets Ensuring Robustness in Thickness Testing for Extended Release Tablets Introduction: In the pharmaceutical industry, maintaining the robustness and consistency of extended release tablets is paramount for both efficacy and safety. Thickness testing of these tablets plays a crucial role in ensuring their quality and performance. Variability…

Solid Dosage form, Tablets

Troubleshooting Failures in Compressed Air Distribution for Coated Tablets

March 4, 2025 Admin

Troubleshooting Failures in Compressed Air Distribution for Coated Tablets Troubleshooting Failures in Compressed Air Distribution for Coated Tablets Introduction: In the pharmaceutical industry, the production of coated tablets is a sophisticated process that requires precision and adherence to strict quality standards. Compressed air plays a vital role in various stages of tablet manufacturing, including coating,…

Solid Dosage form, Tablets

Troubleshooting Brittleness in Multi-Layer Tablets During Quality Testing

March 4, 2025 Admin

Troubleshooting Brittleness in Multi-Layer Tablets During Quality Testing Troubleshooting Brittleness in Multi-Layer Tablets During Quality Testing Introduction: Multi-layer tablets have emerged as a significant innovation in the pharmaceutical industry, offering the advantage of delivering multiple drugs or the same drug at different release rates within a single dosage form. However, one of the critical challenges…

Solid Dosage form, Tablets

Addressing Color Fading in Sugar-Coated Tablets During Accelerated Testing

March 2, 2025 Admin

Addressing Color Fading in Sugar-Coated Tablets During Accelerated Testing Addressing Color Fading in Sugar-Coated Tablets During Accelerated Testing Introduction: In the pharmaceutical industry, the aesthetic and functional integrity of sugar-coated tablets is paramount. The coating not only enhances the appearance but also affects consumer perception and compliance. However, during accelerated stability testing, a crucial phase…

Solid Dosage form, Tablets

Ensuring Compliance with GMP Standards in Utility Validation Documentation

March 1, 2025 Admin

Ensuring Compliance with GMP Standards in Utility Validation Documentation Ensuring Compliance with GMP Standards in Utility Validation Documentation Introduction: The pharmaceutical industry operates under strict regulations to ensure the safety, quality, and efficacy of products. Good Manufacturing Practice (GMP) standards are integral to these regulations, guiding the production, testing, and quality assurance of pharmaceutical products….

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

What are the objectives of Schedule M?

July 27, 2023July 27, 2023 Admin

Unveiling the Objectives of Schedule M: Ensuring Quality and Safety in Pharmaceuticals Schedule M is a crucial part of the regulatory framework under the Drugs and Cosmetics Act, 1940, in India. Its objectives are designed to ensure the production of high-quality drugs and pharmaceuticals that meet strict standards of safety, efficacy, and quality control. Let’s…

Schedule M