digi – Pharma GMP

The Role of GMP in IMP Supply Chain Traceability

digi — Tue, 25 Mar 2025 03:33:00 +0000

The Role of GMP in IMP Supply Chain Traceability The Role of GMP in IMP Supply Chain Traceability Introduction: The Importance of Traceability in IMP Supply Chains Investigational Medicinal Products (IMPs) play a critical role in clinical trials, serving as the therapeutic agents used to assess the safety, efficacy, and optimal dosing of new treatments....

How GMP Assures the Integrity and Quality of Drug Development Data

digi — Mon, 24 Mar 2025 20:43:00 +0000

How GMP Assures the Integrity and Quality of Drug Development Data How GMP Assures the Integrity and Quality of Drug Development Data Introduction: The Importance of Data Integrity in Drug Development Good Manufacturing Practice (GMP) is a fundamental set of guidelines that governs the production of pharmaceutical products to ensure they meet the highest standards...

GMP and the Manufacturing of IMPs for Advanced Therapeutic Medicinal Products

digi — Mon, 24 Mar 2025 14:36:00 +0000

GMP and the Manufacturing of IMPs for Advanced Therapeutic Medicinal Products GMP and the Manufacturing of IMPs for Advanced Therapeutic Medicinal Products Introduction: The Complexity of Advanced Therapeutic Medicinal Products (ATMPs) Advanced Therapeutic Medicinal Products (ATMPs) are a class of innovative medicines that include gene therapies, somatic cell therapies, and tissue-engineered products. These therapies have...

How to Address Auditing and Inspection Findings in Clinical Trials

digi — Mon, 24 Mar 2025 08:42:00 +0000

How to Address Auditing and Inspection Findings in Clinical Trials How to Address Auditing and Inspection Findings in Clinical Trials Introduction: The Importance of Addressing Auditing and Inspection Findings In clinical trials, maintaining compliance with Good Manufacturing Practice (GMP) and regulatory guidelines is crucial to ensure product quality, patient safety, and reliable data. Audits and...

The Role of GMP in Regulatory Filings for Clinical Trial and Drug Development

digi — Mon, 24 Mar 2025 07:23:00 +0000

The Role of GMP in Regulatory Filings for Clinical Trial and Drug Development The Role of GMP in Regulatory Filings for Clinical Trial and Drug Development Introduction: The Critical Role of GMP in Drug Development Regulatory Filings Good Manufacturing Practice (GMP) is an essential element of regulatory filings for clinical trial and drug development. Regulatory...

How to Overcome Challenges in GMP Compliance for IMPs in Emerging Markets

digi — Mon, 24 Mar 2025 01:39:00 +0000

How to Overcome Challenges in GMP Compliance for IMPs in Emerging Markets How to Overcome Challenges in GMP Compliance for IMPs in Emerging Markets Introduction: GMP Compliance in Emerging Markets As pharmaceutical companies expand clinical trials into emerging markets, ensuring Good Manufacturing Practice (GMP) compliance for Investigational Medicinal Products (IMPs) becomes increasingly important. Emerging markets...

The Relationship Between Clinical Trial Protocols and GMP Compliance

digi — Sun, 23 Mar 2025 22:12:00 +0000

The Relationship Between Clinical Trial Protocols and GMP Compliance The Relationship Between Clinical Trial Protocols and GMP Compliance Introduction: How GMP Compliance Shapes Clinical Trial Protocols Clinical trial protocols serve as the roadmap for the conduct of clinical trials, outlining key aspects such as the study design, participant selection, dosing procedures, and data collection methods....

How GMP Influences the Process of Filing for New Drug Applications (NDAs)

digi — Sun, 23 Mar 2025 18:03:00 +0000

How GMP Influences the Process of Filing for New Drug Applications (NDAs) How GMP Influences the Process of Filing for New Drug Applications (NDAs) Introduction: The Role of GMP in New Drug Applications (NDAs) Good Manufacturing Practice (GMP) plays a critical role in the approval process for new drugs, particularly when it comes to filing...

How to Overcome Challenges in GMP Compliance for IMPs in Emerging Markets

digi — Sun, 23 Mar 2025 12:42:00 +0000

GMP Guidelines for Clinical Trial Investigators and Site Managers

digi — Sun, 23 Mar 2025 11:42:00 +0000

GMP Guidelines for Clinical Trial Investigators and Site Managers GMP Guidelines for Clinical Trial Investigators and Site Managers Introduction: The Role of GMP in Clinical Trial Management Good Manufacturing Practice (GMP) guidelines are essential for ensuring the safety, quality, and consistency of investigational products in clinical trials. Clinical trial investigators and site managers play a...