Tag: FDA

Top OSD GMP Deficiencies Identified in FDA and EU Inspections

November 26, 2025November 25, 2025 digi

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….

OSD GMP Checklist

Common Sampling Plan Deficiencies Noted by FDA Inspectors

November 26, 2025November 25, 2025 digi

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…

In-Process Sampling

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

November 25, 2025November 25, 2025 digi

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…

OOS & OOT

Regulatory Expectations on Quality Metrics Submissions and Transparency

November 25, 2025November 25, 2025 digi

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…

Quality Metrics, Risk & Management Review

Inspection Findings on Poor Documentation Practices in Pharma Sites

November 25, 2025November 25, 2025 digi

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…

SOP & Documentation Control

Common BMR Deficiencies Found in FDA and EU GMP Inspections

November 25, 2025November 25, 2025 digi

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…

Batch Manufacturing Records

Top QC Laboratory Findings in FDA and EU Inspections

November 25, 2025November 25, 2025 digi

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…

QC Lab Audits

Top Warehouse GMP Deficiencies Identified in FDA and EU Inspections

November 25, 2025November 25, 2025 digi

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,…

Warehouse Audit

Top OSD GMP Deficiencies Identified in FDA and EU Inspections

November 24, 2025November 24, 2025 digi

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),…

GMP checklist for oral solid dosage manufacturing

Common Sampling Plan Deficiencies Noted by FDA Inspectors

November 24, 2025November 24, 2025 digi

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,…

In Process sampling plan for tablets