Quality imperatives in oral solid dosage manufacturing: an overview

July 26, 2024

Remove from favorites

Add to favorites

The article "Quality Imperatives in Oral Solid Dosage Manufacturing: An Overview" discusses the critical aspects of ensuring quality in the manufacturing of oral solid dosage forms, such as tablets and capsules. Key points covered in the article include:

*Quality Control: Emphasis on stringent quality control measures throughout the manufacturing process to ensure the safety, efficacy, and consistency of the final product.

*Good Manufacturing Practices (GMP): The importance of adhering to GMP standards to maintain high-quality production. This includes proper documentation, validation, and regular audits.

*Regulatory Compliance: Compliance with regulatory guidelines from agencies such as the FDA and EMA is crucial. This involves meeting specifications for purity, potency, and stability.

*Risk Management: Identifying and mitigating risks associated with the manufacturing process to prevent contamination, cross-contamination, and other quality issues.

*Technological Advancements: Leveraging new technologies and automation to improve precision, efficiency, and quality in manufacturing processes.

*Process Optimization: Continuous improvement and optimization of manufacturing processes to enhance product quality and reduce costs.

*Quality by Design (QbD): Implementing QbD principles to design robust manufacturing processes that consistently produce high-quality products.

*Supply Chain Management: Ensuring quality in the supply chain by carefully selecting and auditing suppliers, and managing the sourcing of raw materials.

*Training and Education: Providing ongoing training and education to personnel to maintain high standards of quality and stay updated with the latest industry practices.

*Case Studies and Examples: The article may include case studies or examples highlighting successful implementation of quality practices in oral solid dosage manufacturing.

Overall, the article underscores the multifaceted approach required to maintain high quality in the manufacturing of oral solid dosage forms, focusing on rigorous quality control, regulatory compliance, risk management, and continuous improvement.