FDA – Pharma GMP

Top OSD GMP Deficiencies Identified in FDA and EU Inspections

digi — Wed, 26 Nov 2025 04:18:04 +0000

Top OSD GMP Deficiencies Identified in FDA and EU Inspections Comprehensive Step-by-Step Guide: GMP Checklist for Oral Solid Dosage Manufacturing Deficiencies Manufacturing oral solid dosage (OSD) forms under current Good Manufacturing Practices (cGMP) demands a rigorous and systematic approach to compliance. Even with well-established pharmaceutical quality systems, regulatory inspections by authorities such as the U.S....

Common Sampling Plan Deficiencies Noted by FDA Inspectors

digi — Wed, 26 Nov 2025 02:57:04 +0000

Common Sampling Plan Deficiencies Noted by FDA Inspectors Addressing Common Deficiencies in In Process Sampling Plans for Tablets In the pharmaceutical industry, ensuring the quality and compliance of tablet manufacturing depends heavily on robust in process sampling plans. Regulatory authorities such as the FDA consistently identify issues related to sampling during inspections, which can lead...

SOP for Handling Out-of-Specification (OOS) Results in QC Laboratory

digi — Tue, 25 Nov 2025 22:24:04 +0000

SOP for Handling Out-of-Specification (OOS) Results in QC Laboratory Comprehensive Step-by-Step Guide to SOP for Handling Out-of-Specification (OOS) Results in QC Laboratory An Out-of-Specification (OOS) result is a critical finding in Quality Control (QC) laboratories that demands immediate, methodical, and regulatory-aligned investigation. This article provides a detailed step-by-step tutorial guide to creating and executing an...

Regulatory Expectations on Quality Metrics Submissions and Transparency

digi — Tue, 25 Nov 2025 21:18:04 +0000

Regulatory Expectations on Quality Metrics Submissions and Transparency Understanding Regulatory Expectations on Quality Metrics in Pharmaceutical Manufacturing In the pharmaceutical industry, regulatory expectations on quality metrics pharma manufacturers have become increasingly rigorous, focusing on enhancing transparency, risk management, and continuous quality improvement. Quality metrics provide objective data to assess production processes, facilitate compliance with good...

Inspection Findings on Poor Documentation Practices in Pharma Sites

digi — Tue, 25 Nov 2025 18:57:04 +0000

Inspection Findings on Poor Documentation Practices in Pharma Sites Inspection Findings on Poor Documentation Practices in Pharmaceutical Manufacturing Sites Accurate and reliable documentation is the cornerstone of compliance in pharmaceutical manufacturing. Regulatory authorities such as the US Food and Drug Administration (FDA), the European Medicines Agency (EMA), and other global agencies consistently emphasize the criticality...

Common BMR Deficiencies Found in FDA and EU GMP Inspections

digi — Tue, 25 Nov 2025 14:51:04 +0000

Common BMR Deficiencies Found in FDA and EU GMP Inspections Step-by-Step Guide to Identifying and Addressing Common BMR Deficiencies in GMP Batch Manufacturing Records (BMRs) are the cornerstone of pharmaceutical manufacturing quality systems. They ensure complete traceability, facilitate compliance with regulatory standards, and support product quality and patient safety. However, observations and deficiencies associated with...

Top QC Laboratory Findings in FDA and EU Inspections

digi — Tue, 25 Nov 2025 14:33:04 +0000

Top QC Laboratory Findings in FDA and EU Inspections Comprehensive Step-by-Step Guide to QC Laboratory Findings and Remediation in FDA and EU Inspections Quality Control (QC) laboratories are critical to ensuring pharmaceutical product quality, safety, and compliance. Regulatory inspections by agencies such as the FDA, EMA, and MHRA identify specific common findings in QC labs...

Top Warehouse GMP Deficiencies Identified in FDA and EU Inspections

digi — Tue, 25 Nov 2025 09:33:04 +0000

Top Warehouse GMP Deficiencies Identified in FDA and EU Inspections Comprehensive Step-by-Step GMP Audit Checklist for Pharmaceutical Warehouse: Addressing Deficiencies from FDA and EU Reports Pharmaceutical warehouses are critical nodes in the supply chain ensuring the integrity, quality, and compliance of medicinal products stored prior to distribution or manufacturing. Regulatory bodies such as the FDA,...

Top OSD GMP Deficiencies Identified in FDA and EU Inspections

digi — Mon, 24 Nov 2025 23:09:42 +0000

Top OSD GMP Deficiencies Identified in FDA and EU Inspections Step-by-Step Guide to Addressing Top OSD GMP Deficiencies Identified by FDA and EU Inspectors Manufacturing oral solid dosage (OSD) forms such as tablets and capsules presents complex challenges under pharmaceutical Good Manufacturing Practice (GMP). Regulatory authorities including the United States Food and Drug Administration (FDA),...

Common Sampling Plan Deficiencies Noted by FDA Inspectors

digi — Mon, 24 Nov 2025 21:45:42 +0000

Common Sampling Plan Deficiencies Noted by FDA Inspectors Step-by-Step Guide to Identifying and Correcting Common Sampling Plan Deficiencies Noted by FDA Inspectors In pharmaceutical manufacturing, especially in the production of tablets, robust and compliant in-process sampling plans are essential for ensuring product quality and regulatory adherence. Across jurisdictions such as the US, UK, and EU,...