Tag: GMP

Managing Cross-Contamination Risks in Fluid Bed Granulators for Multi-Layer Tablets

March 4, 2025 Admin

Managing Cross-Contamination Risks in Fluid Bed Granulators for Multi-Layer Tablets Managing Cross-Contamination Risks in Fluid Bed Granulators for Multi-Layer Tablets Introduction: In the pharmaceutical industry, the production of multi-layer tablets requires meticulous attention to detail to ensure product safety and efficacy. One critical aspect of tablet production is the use of fluid bed granulators, which…

Solid Dosage form, Tablets

Challenges in validating equipment used for delayed-release capsule coating.

March 3, 2025 Admin

Challenges in validating equipment used for delayed-release capsule coating. Challenges in validating equipment used for delayed-release capsule coating. Introduction: In the pharmaceutical industry, delayed-release capsule coating is crucial for ensuring that active ingredients are released at the right time and location within the gastrointestinal tract. This technology enhances therapeutic efficacy, minimizes side effects, and improves…

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

Ensuring Robustness in Utility Validation for High-Speed Compression Equipment

March 2, 2025 Admin

Ensuring Robustness in Utility Validation for High-Speed Compression Equipment Ensuring Robustness in Utility Validation for High-Speed Compression Equipment Introduction: In the pharmaceutical industry, the production of solid dosage forms, particularly tablets, is a critical process that demands precision, efficiency, and compliance with stringent regulatory standards. High-speed compression equipment plays a pivotal role in this process,…

Solid Dosage form, Tablets

Validating Residual Solvent Control Measures in Coated Tablets

March 2, 2025 Admin

Validating Residual Solvent Control Measures in Coated Tablets Validating Residual Solvent Control Measures in Coated Tablets Introduction: Residual solvents are volatile chemicals used or produced in the manufacture of pharmaceutical substances, excipients, or in the preparation of drug products. Their presence in pharmaceuticals is a critical quality and safety concern, especially in coated tablets where…

Solid Dosage form, Tablets

Addressing Residual Solvent Issues in Compressed Air Lines for Enteric Tablets

March 2, 2025 Admin

Addressing Residual Solvent Issues in Compressed Air Lines for Enteric Tablets Addressing Residual Solvent Issues in Compressed Air Lines for Enteric Tablets Introduction: In the pharmaceutical industry, maintaining the purity and quality of solid dosage forms, particularly enteric tablets, is crucial. Enteric tablets, designed to withstand the acidic environment of the stomach and dissolve in…

Solid Dosage form, Tablets

Managing Over-Lubrication in Blending Processes for Compression

March 2, 2025 Admin

Managing Over-Lubrication in Blending Processes for Compression Managing Over-Lubrication in Blending Processes for Compression Introduction: In the realm of pharmaceutical manufacturing, ensuring the quality and efficacy of solid dosage forms like tablets is paramount. The blending process, a critical step in tablet production, often involves the use of lubricants to improve the flow of powder…

Solid Dosage form, Tablets

Common Causes of Cracking in Film Coatings During Quality Checks

March 1, 2025 Admin

Common Causes of Cracking in Film Coatings During Quality Checks Common Causes of Cracking in Film Coatings During Quality Checks Introduction: In pharmaceutical manufacturing, film coatings play a crucial role in ensuring tablet stability, controlling drug release, and enhancing the aesthetic appeal of the final product. However, one of the most common and challenging quality…

Solid Dosage form, Tablets

Developing Equipment Qualification Protocols for Tablet Compression Machines

March 1, 2025 Admin

Developing Equipment Qualification Protocols for Tablet Compression Machines Developing Equipment Qualification Protocols for Tablet Compression Machines Introduction: In the pharmaceutical industry, the production of tablets is a critical process that demands precision and adherence to stringent quality standards. Equipment qualification for tablet compression machines is a vital step to ensure that the machinery used in…

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 the documentation and record-keeping requirements in pharmaceutical quality control.

September 21, 2023September 11, 2023 Admin

Documentation and Record-Keeping Requirements in Pharmaceutical Quality Control Documentation and record-keeping are critical components of pharmaceutical quality control. They serve as essential tools for maintaining traceability, ensuring compliance with regulatory requirements, and supporting decision-making processes. The documentation and record-keeping requirements in pharmaceutical quality control include the following aspects: 1. Standard Operating Procedures (SOPs) Quality control…

Pharma Quality Control

What are the qualifications and responsibilities of personnel in pharmaceutical quality control?

September 20, 2023September 11, 2023 Admin

Qualifications and Responsibilities of Personnel in Pharmaceutical Quality Control 1. Qualifications Personnel working in pharmaceutical quality control must possess specific qualifications and skills to perform their duties effectively. The qualifications required for personnel in pharmaceutical quality control include: Bachelor’s or Master’s degree in a relevant scientific field, such as chemistry, pharmacy, microbiology, or a related…

Pharma Quality Control

How are critical processes validated in compliance with Schedule M?

September 20, 2023September 11, 2023 Admin

Validation of Critical Processes in Compliance with Schedule M Validation of critical processes is an essential aspect of pharmaceutical manufacturing to ensure that these processes consistently produce products of the desired quality and meet regulatory requirements. In compliance with Schedule M of the Drugs and Cosmetics Rules in India, pharmaceutical manufacturers must perform process validation…

Schedule M