Aberdeenshire

 SOP for Quality Assurance Policy Quality assurance policies are to ensure that routine and continuous quality improvement is an essential, and fundamental part of our organization. Controlling change will aim for continuous improvement in the quality of all aspects of its work as part of its determination to help to get achieve the highest possible … Read more

RISK MANAGEMENT METHODOLOGY – ICH Q9 Quality risk management (QRM) – a scientific and practical approach to decision-making. QRM provides documented, transparent and reproducible methods to accomplish steps of the quality risk management process based on current knowledge about assessing the probability, severity, and detectability of the risk. Quality risk management (QRM) In general, risks … Read more

TABLE OF CONTENTS – QUALITY RISK MANAGEMENT -ICH Q9 TABLE OF CONTENTS 1. INTRODUCTION…………………………………………………………………………………………………1 2. SCOPE………………………………………………………………………………………………………………..2 3. PRINCIPLES OF QUALITY RISK MANAGEMENT…………………………………………………2 4. GENERAL QUALITY RISK MANAGEMENT PROCESS…………………………………………..2 4.1 Responsibilities ………………………………………………………………………………………………… 3 4.2 Initiating a Quality Risk Management Process ……………………………………………………. 3 4.3 Risk Assessment……………………………………………………………………………………………….. 3 4.4 Risk Control……………………………………………………………………………………………………… 4 4.5 Risk Communication…………………………………………………………………………………………. 5 4.6 Risk … Read more

SECTIONS OF THE DRUGS AND COSMETICS ACT, 1940 FOR MEDICINE ARRANGEMENT OF SECTIONS CHAPTER I INTRODUCTORY SECTIONS 1. Short title, extent and commencement. 2. Application of other laws is not barred. 3. Definitions. 3A. Construction of references to any law not in force or any functionary not in existence in the State of Jammu and … Read more

Market complaints and product recall DEFINITION: A ‘Complaint’ simply designates, that something is wrong or not good enough. Generally in the pharmaceutical industry, complaints are regarding the quality of drug products. A complaint shows customer dissatisfaction about a product and consequently, about a company. Principle: All complaints and other information concerning potentially defective products should … Read more

Qualified Persons A qualified person shall be in possession of a diploma, certificate, or other evidence of formal qualifications awarded on completion of a university course of study, or a course recognized as equivalent by the Member State concerned, extending over a period of at least four years of theoretical and practical study in one … Read more

DRUG DESIGN (AN OVERVIEW) DRUG DESIGN DRUG DESIGN Approaches to drug discovery: Serendipity (luck) Chemical Modification Screening Rational Irrational, based on serendipity & Intuition Trial & error approach in DRUG DESIGN Time consuming with low through output No de novo design, mostly  “Me Too Approach” First generation Rational approach in Drug design In 1970s the … Read more

CHANGE CONTROL Change Control is “A formal system by which qualified representatives of appropriate disciplines review proposed or actual changes that might affect the validated status of facilities, systems, equipment or processes. The intent is to determine the need for action that would ensure and document that the system is maintained in a validated state.” … Read more

Quality Management System Definition: A Quality Management System is a collection of policies, procedures, plans, resources, processes, practices, and the specification of responsibilities and authority of an organization designed to achieve product and service quality levels, customer satisfaction, and company objectives. Documentation: Quality Policy – describes the organization’s approach to quality Quality Manual – Addresses … Read more

HAZARD ANALYSIS OF CRITICAL CONTROL POINT (HACCP) TABLE OF CONTENTS HAZARD ANALYSIS OF CRITICAL CONTROL POINT 1. Declaration. Quality Policy Quality Objectives Company Profile Layout of Plant Organization Chart HACCP Introduction HACCP Prerequisite Programs Seven Principles of HACCP Hazards HACCP Scope HACCP Team Responsibility Hazard Analysis Introduction Hazard Analysis for processing steps Hazard Analysis Worksheet … Read more

Interview Questions & Answers (Quality Assurance) 1.What is Quality Assurance : Quality Assurance is a deep concept covering all matters that individually or collectively influence the quality of a product. It is the complete & whole of the arrangements made with the object of ensuring that the manufactured products are of the quality required for their … Read more