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…
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…
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 –…
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…
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 • Initial draft of the QM Guidance • Key Features of the QM Revised Draft Guidance • Phased-In Approach and Benefits to Participants • How FDA Intends to Use Metrics Data Pharmaceutical Quality for 21st Century Initiative Vision “A maximally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,…
Types of Glass used in Pharmaceutical Industries Parenteral Use Type I Glass: Highly Resistant Borosilicate. Used for Buffered and Unbuffered aqueous solution.Type II Glas: Highly Resistant Sodalime glass. The buffered aqueous solution below pH 7.0Type III Glass: Moderately Resistant Sodalime glass. Used for dry powder and oily solution.Non-Parenteral Use Type IV Glass: General Purpose Sodalime…
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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…
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…
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…
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…
PHARMACOVIGILANCE PLAN AS PER ICH Pharmacovigilance plan especially in preparation for the early postmarketing period of a new drug . Pharmacovigilance Plan that might be submitted at the time of licence application. Pharmacovigilance plan can be used by sponsors to develop a stand-alone document for regions that prefer this approach Pharmacovigilance Plan into the Common…
PROCEDURE FOR MICROBIOLOGICAL MONITORING OF WATER OBJECTIVE:To lay down a procedure for microbiological monitoring of raw water and purified water. SCOPE:This SOP shall provide the procedure for sampling and testing of raw water and purified water from all the user points and all the points across the critical functions in the water purification process. RESPONSIBILITY…
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IN-PROCESS CONTROL OF PACKING LINE of TABLETS OBJECTIVE: To ensure quality of Finished Products during strip packing and final packing operation of tablets. SCOPE: This SOP shall be applicable in-process controls during strip packing and final packing operation of tablets. RESPONSIBILITY: In process Quality Assurance Officer / Executive. ACCOUNTABILITY: Head Quality Assurance PROCEDURE: START UP Inspect the following…
INPROCESS CONTROL DURING TABLET MANUFACTURING OBJECTIVE: To lay down the procedure for In process Controls during Tablet Manufacturing. SCOPE: This SOP shall be applicable for in process controls during tablets manufacturing. RESPONSIBILITY: In process Quality Assurance Executive/Officer. ACCOUNTABILITY: Head Quality Assurance. PROCEDURE: Carry out line clearance at each stage of operation prior to…
Flow Chart and Manufacturing Procedure of Dextromethorphan Hydrobromide, Chlorphenamine Maleate & Phenylephrine Hydrochloride Flavoured Dispersible Tablets Bill of Material Ingredient Quantity in kg Dextromethorphan Hydrobromide and Chlorphenamine Maleate complex 12.12*# Phenylephrine Hydrochloride complex 8.08**# Mannitol (Pearlitol SD200, Roquette) 42.80 Silica, Colloidal Anhydrous 2.00 Indion 294 3.00 Talc 0.50 Magnesium Stearate 0.75 Croscarmellose Sodium 3.00…
