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Risk-based approach as per EU Good Manufacturing Practice specific to Advanced Therapy Medicinal Products

Risk-based approach as per EU Good Manufacturing Practice specific to Advanced Therapy Medicinal Products Introduction ATMPs are complex products and risks may differ according to the type of product,nature/characteristics of the starting materials and level of complexity of the manufacturing process. It is also acknowledged that the finished product may entail …

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Premises and Equipment as per EU GMP EudraLex

Premises and Equipment as per EU GMP EudraLex PRINCIPLE Premises and equipment must be located, designed, constructed, adapted and maintained to suit the operations to be carried out. Their layout and design must aim to minimise the risk of errors and permit effective cleaning and maintenance in order to avoid …

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Pharmacovigilance

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 …

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Levels of Cleaning in cleaning Validation

Levels of Cleaning in cleaning Validation Introduction The manufacturing process of an Active Pharmaceutical Ingredient (API) typically consists of various chemical reaction and purification steps followed by physical changes. In general, early steps undergo further processing and purification and so potential carryover of the previous product would be removed. The level of cleaning …

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EU and US GMP/GDP: Similarities and Differences

EU and US GMP/GDP: Similarities and Differences   Reference: McGee Pharma International-Nov. 2016   Thank you for visit and for more pharma updates click here – http://pharmaguidances.com

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Procedure for operation of Autotitrator (METTLER TOLEDO). Quality assurance

Procedure for operation of Autotitrator (METTLER TOLEDO). Quality assurance OBJECTIVE To lay down the procedure for operation of AUTO TITRATOR (METTLER TOLEDO DL50) SCOPE This procedure is applicable to Autotitrator (METTLER TOLEDO DL50). RESPONSIBILITY Quality Control Executive/Officer. ACCOUNTABILITY Head Quality Control. PROCEDURE FOR CLEANING Check that the power supply to …

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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 …

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PROCEDURE FOR OPERATION OF HUMIDITY CONTROL OVEN (NEWTRONIC). Quality assurance

PROCEDURE FOR OPERATION OF HUMIDITY CONTROL OVEN (NEWTRONIC). Quality assurance OBJECTIVE To lay down the procedure for operation of Humidity control oven. Model  : NEC 228R 10S SCOPE This SOP shall be applicable for the operation of Newtronic make Humidity control oven (30°C/65%RH) &. (40°C/75%RH) RESPONSIBILITY QA Officer / Executive …

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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 …

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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 …

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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 …

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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 …

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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 …

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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 …

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Types of Glass used in Pharmaceutical Industries

Types of Glass used in Pharmaceutical Industries Parenteral Use Type I Glass: Highly Resistant Borosillicate. Used for Buffered and Unbuffered aqueous solution.Type II Glas: Highly Resistant Sodalime glass. 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 …

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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 …

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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 …

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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 condition. Stability studies should be based on the basis of pharmaceutical R&D and regulatory requirements. Degradation studies reveal the intrinsic chemical properties …

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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 …

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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 …

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