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US FDA Data Integrity

Data Integrity : The increasingly complex regulatory environments have forced laboratories to adopt a new mindset to compliance and auditing… moving away from traditional instrument validation approaches and consolidating both the instrument data as well as the instrument support across the full spectrum of their lab assets. Contents What is …

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Process Validation Guidances: FDA and Global

Process Validation Guidances: FDA and Global   OUTLINE Process Validation Lifecycle Approach Overview History and development Is the lifecycle approach really new? FDA commentary Lifecycle Approach Stages 1 — Process Understanding (Process Design) 2 — Process Demonstration (Process Qualification) 3 — Maintaining Validation (Continued Process Verification) Fundamental Concepts The “process …

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Concept of URS,Design Qualification,Installation Qualification,Operational Qualification,Performance Qualification

Concept of URS,Design Qualification,Installation Qualification,Operational Qualification,Performance Qualification Introduction  Validation User Requirement Specification.(URS) Phase of validation Design qualification (DQ) Installation Qualification (IQ) Operation Qualification (OQ) Performance Qualification (PQ) Maintenance Qualification (MQ) Component Qualification (CQ) Instrument Re-Qualification According to the Food and Drug Administration (FDA), the goal of validation is to: “Establish …

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Good storage practices for pharmaceuticals as per regulatory Guideline

Good storage practices for pharmaceuticals as per regulatory Guideline 1. Introduction 2. Glossary 3. Personnel 4. Premises and facilities 5. Storage requirements 6. Returned goods 7. Dispatch and transport 8. Product recall 1. Introduction The storage, transportation and distribution of pharmaceuticals. The stability testing of pharmaceutical products containing well-established drug …

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stability tests for pharmaceutical products

  Stability Definition These studies provide information about the packaging in that it is not reactive, additive, or absorptive so that the identity, strength, quality and purity of the drug product is not affected, also to provide clearance on stability process flow. To assessment of the stability characteristics of all …

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Phases of clinical trials

Phases of clinical trials Contents • Introduction:Clinical research • Drug development phases • Pre-Phase 1 activities • Phases of Clinical trial • Regulatory approvals: IND & NDA • Summary of Clinical trial phases INTRODUCTION • Clinical trial is a systematic investigation in human subjects for evaluating the safety & efficacy …

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Determining Whether to Submit an ANDA or a 505(b)(2) Application in USFDA

Determining Whether to Submit an ANDA or a 505(b)(2) Application in USFDA This guidance is intended to serve as a foundational guidance to assist applicants in determining which one of the abbreviated approval pathways under the Federal Food, Drug, and Cosmetic Act (FD&C Act) is appropriate for the submission of …

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Sampling of starting and packaging materials: Glycerol as per EU GMP

Sampling of starting and packaging materials: Glycerol as per EU GMP EU GMP guide annexes: Supplementary requirements: Annex 8: Sampling of starting and packaging materials: Glycerol 1. What is the background regarding international incidents of glycerol contamination? H+V December 2007 There is a history of sporadic reports from around the world of supplies …

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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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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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