Tag: Pennsylvania

Checklist in Quality control for Audit Preparation of FDA & USFDA Personnel Organogram of Quality control departments List of Employee and education details Individual Job Description Training Record of Individual employee as per   individual Job Responsibility  and Training Log and training assessments records Analyst Qualification records as per  individual Job Responsibility and  Organogram Specimen Signature log of…

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USFDA – INTRODUCTION TO DRUG REGULATION Basic Mission Safety Efficacy Drugs Medical Devices Truthful Labeling Adulteration Misbranding FDA’s Structure and Organization The Commissioner President Appoints,  Senate Confirms 4th Tier in HHS Not an Independent Agency Insulation From Politics (Old Days) Few Political Appointees Scientific Basis of Its Decisions Visibility Protects It From Presidential Pressure Does…

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USFDA Foreign Priorities, Inspections and Compliance Priorities Challenges of globalization cGMP deficiencies Comparison Post inspection regulatory actionsAdvance Regulatory Science:  the science of developing new tools, standards and approaches to assess the safety and effectiveness, quality and performance of FDA-regulated productsStrengthen the safety and integrity of the global supply chain A paradigm shift is required to…

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USFDA Regulatory Inspection Do’s and Dont’s FDA Audit – The Do and Don’t List Pre-inspection Do’s: • Have a Company Inspection Manual • Have a trained Company Inspection Team • Identify what FDA (or the state) may inspect • Be familiar with relevant sections of FDA’s Investigations Operations Manual. Company Inspection Manual should include policies…

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DATA INTEGRITY: ALCOA AND ALCOA PLUS The guidance has been written to apply to on-site inspections of those sites  performing manufacturing (GMP) and distribution (GDP) activities. The principles  within this guide are applicable for all stages throughout the product lifecycle. The  guide should be considered as a non-exhaustive list of areas to be considered during  inspection. ALCOA TERM –…

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Data Integrity: TGA Expectations Discussion Topics What is Data Integrity? • Global/Australian/US FDA Environments • Data Integrity General Examples • Basic Data Integrity Expectations • ALCOA Principles • TGA Licensed Manufacturers Expectations • Conclusions What is data integrity? • The extent to which all data are complete, consistent and accurate throughout the data lifecycle • From…

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Quality Metrics Objectives • Pharmaceutical Quality for the 21st Century • Why Quality Metrics (QM)? • Initial draft of the QM Guidance • Key Features of the QM Revised Draft Guidance • Phased-In Approach and Benefits to Participants • How FDA Intends to Use Metrics Data Pharmaceutical Quality for 21st Century Initiative Vision “A maximally efficient,…

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CLINICAL TRAILS To collect data on usual and unusual events, conditions, & population groups. To test hypotheses formulated from observations. To understand better one’s Three main types are there Observational Studies: Groups are studied & contrasts made between groups The observed data collected are analyzed Analytic Studies: Also called Experimental Study the impact of a…

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Definitions and Glossary as per TRS 986 Annex 2 The definitions given below apply to the terms used in this guide. They may have different meanings in other contexts Active pharmaceutical ingredient (API). Any substance or mixture of substances intended to be used in the manufacture of a pharmaceutical dosage form and that, when so used,…

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Drug stability in Pharmaceutical products Pharmaceutical products are assigned a shelf life which determines the time when a product is considered to be safe and effective under storage conditions. Stability studies should be based on pharmaceutical R&D and regulatory requirements. Degradation studies reveal the intrinsic chemical properties of the API while formal stability studies establish…

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General Terminology used for good Hand hygiene practices as per USFDA Hand hygiene practices Antiseptic handwashing Washing hands with soap and water,or other detergents containing an antiseptic agent. Antiseptic handrubbing (or handrubbing). Applying an antiseptic handrub to reduce or inhibit the growth of microorganisms without the need for an exogenous source of water and requiring no rinsing or…

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Good Manufacturing Practice (GMP) Guidelines/Inspection Checklist Building and Facilities. Check whether Buildings used in the manufacture or storage of cosmetics are of suitable size, design and construction to permit unobstructed placement of equipment, orderly storage of materials, sanitary operation, and proper cleaning and maintenance. Floors, walls and ceilings are constructed of smooth, easily cleanable surfaces and…

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COMPRESSED MEDICAL GASES AS PER USFDA GUIDELINE INTRODUCTION This guideline describes practices and procedures for compressed medical gas (CMG) fillers (including companies engaged in home respiratory services) that constitute acceptable means of complying with certain sections of the current good manufacturing practice (CGMP) regulations for drug products (21 CFR Parts 210 and 211). All sections…

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Data Integrity In Pharmaceuticals Data integrity: Data integrity is a fundamental component of information security. In its broadest use, “data integrity” refers to the accuracy, reliability and consistency of data stored over its entire life-cycle in a database, data warehouse, data mart or other construct. The term – Data Integrity – can be used to…

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PROCEDURE FOR VIABLE AIR MONITORING OBJECTIVE:To lay down a procedure for environmental monitoring of air. SCOPE:This SOP shall provide the procedure for monitoring the viable air borne count. RESPONSIBILITY :Quality Control Executive / Officer. ACCOUNTABILITY:Head Quality Assurance. PROCEDURE:The microbial environmental conditions of unit II shall be monitored by Settle plate method or air sampling at…

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