Pharmacovigilance Pharmacovigilance: Pharmacovigilance WHO defines pharmacovigilance as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects of marketed medicines or those under trial. The drug regulatory agencies have the responsibility of having a well-established pharmacovigilance system to monitor adverse reactions of drugs, during the …
Read More »EU and US GMP/GDP: Similarities and Differences
EU and US GMP/GDP: Similarities and Differences [embeddoc url=”https://pharmaguidances.com/wp-content/uploads/2019/02/eu-and-us-gmp-gdp-similarities-and-differences.pdf” download=”all”] Reference: McGee Pharma International-Nov. 2016 Thank you for visit and for more pharma updates click here – https://pharmaguidances.com
Read More »USFDA Generic Drugs: Questions & Answers
USFDA Generic Drugs: Questions & Answers What are generic drugs? A generic drug is a medication created to be the same as an already marketed brand-name drug in dosage form, safety, strength, route of administration, quality, performance characteristics, and intended use. These similarities help to demonstrate bioequivalence, which means that a …
Read More »USFDA – INTRODUCTION TO DRUG REGULATION
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 …
Read More »USFDA Foreign Priorities, Inspections and Compliance
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 …
Read More »USFDA Regulatory Inspection Do’s and Dont’s
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 …
Read More »DATA INTEGRITY: ALCOA AND ALCOA PLUS
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 …
Read More »Data Integrity: TGA Expectations
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 …
Read More »Quality Metrics
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 …
Read More »CLINICAL TRAILS
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 …
Read More »Definitions and Glossary as per TRS 986 Annex 2
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 …
Read More »Drug stability in Pharmaceutical products
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 …
Read More »General Terminology used for good Hand hygiene practices as per USFDA
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 …
Read More »Good Manufacturing Practice (GMP) Inspection Checklist as per USFDA
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 …
Read More »COMPRESSED MEDICAL GASES AS PER USFDA GUIDELINE
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 …
Read More »Data Integrity In Pharmaceuticals
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 …
Read More »PROCEDURE FOR VIABLE AIR MONITORING
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 …
Read More »PHARMACOVIGILANCE PLAN AS PER ICH
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 …
Read More »INPROCESS CONTROL DURING TABLET MANUFACTURING
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 …
Read More »RAW MATERIAL PRE-SAMPLING INSPECTION CHECKLIST BY QUALITY CONTROL ANALYST
RAW MATERIAL PRE-SAMPLING INSPECTION CHECKLIST BY QUALITY CONTROL ANALYST Material Name: AR No./MRR No./ Date: SNo. Description Check Point 1 Environmental Conditions Temperature RH 2 Under test label Affixed / Not affixed 3 Packing Packed in carboys / drums Packed in fiber/plastic drums with polybag inside Packed in PP woven …
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