FDA Warning Letter – Major CGMP deficiencies

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FDA Warning Letter An FDA warning letter is a serious regulatory communication that identifies significant violations of FDA requirements and allows a pharmaceutical manufacturer to take corrective action. In this case, the FDA warning letter identifies three major CGMP deficiencies related to finished-product testing, incoming material controls, and cleaning validation. These findings demonstrate the importance … Read more

Quality Risk Assessment New Product Introduction: Non-Sterile Ointment / Semi-Solid Product

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Quality Risk Assessment – New Product Introduction: Non-Sterile Ointment / Semi-Solid Product Objective: Identify, assess, and control quality risks associated with the development and manufacture of a new non-sterile ointment/semi-solid pharmaceutical product. 1️⃣ Formulation Risks API–excipient incompatibility API solubility & dispersion Particle size / agglomeration Homogeneity of formulation Physical/chemical instability Preservative effectiveness, where applicable 2️⃣ Manufacturing … Read more

Quality Risk Assessment New Product Introduction: Non-Sterile Soft Gelatin Capsules

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Quality Risk Assessment – New Product Introduction: Non-Sterile Soft Gelatin Capsules Objective: Identify, assess, and control quality risks before commercial manufacture of a new soft gelatin capsule product. 1. Formulation Risks API–excipient incompatibility API degradation / oxidation / hydrolysis Fill viscosity and uniformity Solubility and precipitation Over/under-fill risk 2. Gelatin Shell Risks Gelatin–fill interaction Shell thickness … Read more

Quality Risk Evaluation for New Product Introduction Non-Sterile Oral Liquid Dosage Forms

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Quality Risk Assessment for Solid Oral Dosage Forms for New Product Introduction OBJECTIVEEvaluate and control quality risks before introducing a new oral liquid product to ensure patient safety, product quality, process robustness, and GMP compliance. KEY RISK AREAS 1️⃣ Product & Formulation API–excipient compatibility Solubility / suspension characteristics CQAs: assay, pH, viscosity, microbial limits Preservative … Read more

Quality Risk Evaluation for New Product Introduction Non-Sterile Solid Oral Dosage Forms

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Quality Risk Assessment for Solid Oral Dosage Forms Non-Sterile Solid Oral Dosage Forms 🎯 OBJECTIVEEvaluate and control quality risks before introducing a new solid oral dosage product to ensure patient safety, product quality, GMP compliance, and process robustness. 🔍 KEY RISK AREAS 1️⃣ Product & Formulation API/excipient compatibility CQAs: assay, dissolution, content uniformity, impurities API … Read more

Quality Risk Evaluation for New Product Introduction in a Sterile Facility

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Quality Risk Assessment for New Sterile Product Introduction Objective: Evaluate and control risks before introducing a new sterile product to ensure patient safety, sterility assurance, product quality, and GMP compliance. Key Risk Areas Product & Process Formulation compatibility Critical Quality Attributes (CQAs) Critical Process Parameters (CPPs) Aseptic processing requirements Terminal sterilization feasibility Facility & Utilities … Read more

HVAC Validation in Pharma

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HVAC Validation in Pharma HVAC Validation = Control + Evidence + Compliance 1. DQ – Design QualificationVerify HVAC design meets GMP, process, room classification & user requirements. 2. IQ – Installation QualificationConfirm equipment, ducts, filters, sensors, controls and utilities are installed as per approved specifications. 3. OQ – Operational QualificationChallenge and verify HVAC operation under … Read more

AHU / CLEANROOM REQUALIFICATION

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AHU / CLEANROOM REQUALIFICATION Reference: ISO 14644-3:2019 + ISO 14644-2:2015 Objective: To verify that the AHU/cleanroom continues to maintain the required air cleanliness and environmental conditions during operation. ISO 14644-3 provides the applicable cleanroom test methods, while ISO 14644-2 establishes the monitoring/periodic-testing framework. KEY REQUALIFICATION TESTS Airflow Volume / Velocity→ Verify supply airflow and required … Read more

Sticky Notes for Pharmaceutical QMS (Quality Management System)

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Sticky Notes for Pharmaceutical QMS (Quality Management System) Practical sticky notes for a pharmaceutical Quality Assurance (QA) department. You can print them or display them near workstations, laboratories, production areas, and document-control desks. 1. Daily QMS Reminders NOTE 1 — GMP Compliance “DO IT RIGHT. DOCUMENT IT RIGHT.” Follow approved SOPs. Never bypass an approved … Read more

QUALITY ASSURANCE & GMP REGULATORY SUPPORT

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QUALITY ASSURANCE & GMP REGULATORY SUPPORT “Strengthen Your Quality System. Be Audit-Ready. Stay GMP Compliant” AASP Lifesciences Pvt. Ltd. offers professional part-time Quality Assurance and GMP regulatory support to pharmaceutical and healthcare manufacturing organizations seeking experienced QA assistance without the need for a full-time resource. 🔹 OUR QA & GMP SUPPORT SERVICES ✅ GMP Audit … Read more