Pharmaceutical Quality Control and Analysis Overview

PHARMACEUTICAL ANALYSIS PHARMACEUTICAL ANALYSIS AND AND https://upload.wikimedia.org/wikipedia/commons/thumb/a/a2/Rx_symbol_border.svg/120px-Rx_symbol_border.svg.png DRUG QUALITY CONTROL DRUG QUALITY CONTROL PH483 Lecture PH483 Lecture # 1 2021 # 1 18 18- -01 01- -2021 https://upload.wikimedia.org/wikipedia/commons/thumb/a/a7/PharmacistsMortar.svg/120px-PharmacistsMortar.svg.png https://upload.wikimedia.org/wikipedia/commons/thumb/7/7b/Bowl_Of_Hygieia_by_David.svg/91px-Bowl_Of_Hygieia_by_David.svg.png https://upload.wikimedia.org/wikipedia/commons/thumb/1/19/Asclepius_staff.svg/62px-Asclepius_staff.svg.png DR. Badr M. Al DR. Badr M. Al- -Hadiya Hadiya

COURSE CONTENT COURSE CONTENT - - General Introduction & Definitions General Introduction & Definitions - - Principles of Pharmaceutical Quality Control Principles of Pharmaceutical Quality Control - - Analytical Criteria for Drug Quality Assessment Analytical Criteria for Drug Quality Assessment - - Statistical Methods for Analysis Statistical Methods for Analysis - - Quality Control Methods Validation Quality Control Methods Validation - - Chemical Purity and its Control Chemical Purity and its Control - - Assay of Bulk and Pharmaceutical Preparation Assay of Bulk and Pharmaceutical Preparation - - Analytical Problems Analytical Problems - - Stability Indicating Method of Analysis Stability Indicating Method of Analysis - - Others Others

General Introduction & Definitions General Introduction & Definitions Pharmaceutical Pharmaceutical analysis series series of of processes processes that and and structure structure of of pharmaceutical pharmaceutical products. analysis is is a a broader that are are used elucidation elucidation broader term used for for identification, identification, determination, of of the the given given term which which can can be determination, separation, compound compound used used be defined defined in in many many ways separation, purification, purification, in in the the ways. . It It is is the the formulation formulation What What is is Pharmaceutical Pharmaceutical Quality Quality Control? Control? The term quality identity and purity of a particular pharmaceutical quality control control refers to the sum of all procedures undertaken to ensure the pharmaceutical. What What is is the the role role of of quality quality control control in in pharmaceutical pharmaceutical industry? industry? The The main main function predefined predefined standards the the batches batches manufactured, manufactured, at function of standards. . ... Quality of quality quality control Quality Control at every control is is to Control department department functions every stage stage of of manufacturing manufacturing / /processing to test test and and verify verify the functions for the product product quality for assuring assuring the processing Drug quality against the quality quality of Drug Products Products. . against the the of all all

What What is quality control analysis? is quality control analysis? Quality control Quality control involves testing of units and determining if they are within the specifications for the final product. involves testing of units and determining if they are within the specifications for the final product. The purpose of the testing is to determine any needs for corrective actions in the manufacturing process. The purpose of the testing is to determine any needs for corrective actions in the manufacturing process. Good Good quality control quality control helps companies meet consumer demands for better helps companies meet consumer demands for better products. products. What is quality control analysis? What is quality control analysis? Quality control Quality control involves testing of units and determining if they are within the specifications for the final product. involves testing of units and determining if they are within the specifications for the final product. The purpose of the testing is to determine any needs for corrective actions in the manufacturing process. The purpose of the testing is to determine any needs for corrective actions in the manufacturing process. Good Good quality control quality control helps companies meet consumer demands for better products. helps companies meet consumer demands for better products. Which Which comes first QA or QC? comes first QA or QC? Quality assurance Quality assurance is a proactive process which starts even is a proactive process which starts even before before the work on the deliverable has started, the work on the deliverable has started, while while quality control quality control is a reactive process and its activity starts as soon as you start working on the is a reactive process and its activity starts as soon as you start working on the deliverable. deliverable.

QUALITY CONTROL AND QUALITY CONTROL AND QUALITY ASSURANCE QUALITY ASSURANCE MEASURES IN PHARMACY MEASURES IN PHARMACY

In In order order to to maintain maintain or or enhance enhance the the quality quality of of the the offerings, offerings, manufacturers manufacturers use use Two Two Techniques Techniques: : Quality Quality Control Control (QC) (QC) and and Quality Quality Assurance Assurance (QA) (QA). . These These two two practices practices make make sure sure that that the the end end products products meets meets the the quality quality requirements requirements and and standards standards defined defined for for the the product product. . Somebody Somebody may may ask ask: : Are Are QA QA and and QC QC same same Terms? Terms? The The Answer Answer is is Big Big No No. . This This both both terms terms are are effectively effectively different different. . Most Most of of the the time time we we use use both both terms terms randomly, randomly, hence hence to to study study and and understand understand the the difference difference between between them them is is important important. .

Differentiation Between QA and QC Differentiation Between QA and QC Let s us Differentiate according to below points: Let s us Differentiate according to below points: - - Definition Definition - - Focus on Focus on - - Goal Goal - - How to Achieve How to Achieve - - Example Example - - Responsibility Responsibility

DEFINITION: QUALITY CONTROL (QC) DEFINITION: QUALITY CONTROL (QC) QC is is a a set activities activities focus produced produced. . Quality Quality is is the patient patient. . It It refers dimension, dimension, composition, The The Quality Quality Control variables variables encountered the the excellence excellence of of the Also, Also, Quality Quality Control of of industrial industrial management uniform uniform acceptable acceptable quality QC set of of activities activities for focus on for ensuring ensuring quality on identifying identifying defects quality in in products defects in in the the actual products. . The actual products products The the fitness fitness of of a a product refers to to its its features composition, strength, Control is is the encountered in in manufacturing the end end product Control is is that that technique management by quality are product for features and strength, finish the systematic systematic control manufacturing process product. . technique or or group by means means of of which are manufactured manufactured. . for purpose purpose or or use and characteristics characteristics like finish and and color control of of these process which use by like shape, shape, by color. . these affect which affect group of of techniques techniques products of of which products

DEFINITION: QUALITY ASSURANCE (QA) DEFINITION: QUALITY ASSURANCE (QA) QA QA is a set of activities for ensuring quality in the process by which products is a set of activities for ensuring quality in the process by which products are developed. are developed. QA QA ensures that products are consistently produced and controlled to the ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use. quality standards appropriate to their intended use. QA QA can be defined as "part of can be defined as "part of quality confidence that confidence that quality quality requirements will be fulfilled. The confidence requirements will be fulfilled. The confidence provided by provided by quality assurance quality assurance is twofold is twofold internally to management and externally to customers, government agencies, regulators, certifiers, and externally to customers, government agencies, regulators, certifiers, and third parties. third parties. quality management focused on providing management focused on providing internally to management and QA QA is a way of preventing mistakes and defects in manufactured products is a way of preventing mistakes and defects in manufactured products and avoiding problems when delivering products or services to customers; and avoiding problems when delivering products or services to customers; which ISO 9000 defines as "part of which ISO 9000 defines as "part of quality quality management focused on providing confidence that providing confidence that quality quality requirements will be fulfilled". requirements will be fulfilled". management focused on

FOCUS ON QA and QC FOCUS ON QA and QC QA focuses on: QA focuses on: - - It aims to prevent defects with a focus on the process It aims to prevent defects with a focus on the process used to make the product used to make the product - - It is a proactive quality process It is a proactive quality process - - It identifies weakness in processes to improve them. It identifies weakness in processes to improve them. QC focuses on: QC focuses on: - - It aims to identify and correct defects in the finished It aims to identify and correct defects in the finished product product - - It is a reactive process. It is a reactive process. - -

GOALS OF QA AND QC GOALS OF QA AND QC QA Goal: QA Goal: It is to improve development and test It is to improve development and test so that defects do not arise so that defects do not arise developed. developed. - processes processes when the product is being when the product is being QC Goal: QC Goal: It is to identify defects after a product is It is to identify defects after a product is developed and before it is released. and before it is released. - developed

How to achieve QA and QC Goals How to achieve QA and QC Goals QA Goals: QA Goals: - - Establish a good quality management system and the Establish a good quality management system and the assessment of its adequacy. assessment of its adequacy. - - Periodic conformance audits of the operations of the system. Periodic conformance audits of the operations of the system. - - Prevention of quality problems through planned and Prevention of quality problems through planned and systematic activities including documentation. systematic activities including documentation. QC Goals: QC Goals: - - Finding and eliminating sources of quality problems through tools Finding and eliminating sources of quality problems through tools and equipment so that customer and equipment so that customer s requirements are continually s requirements are continually met. met. - - The activities or techniques used to achieve and maintain the The activities or techniques used to achieve and maintain the product quality, process and service. product quality, process and service.

Quality Assurance of Pharmaceuticals Quality Assurance of Pharmaceuticals Quality Assurance Assurance may may be be defined defined as as the the sum sum of of all all Pharmaceutical Pharmaceutical Quality activities activities and and responsibilities responsibilities required required to to ensure ensure that that the the medicine medicine that that reaches reaches the the patient patient is is safe, safe, effective, effective, and and acceptable acceptable to to the the patient patient. . In In the the Pharmaceutical Pharmaceutical Industry Industry, Quality Quality Assurance Assurance (QA) (QA) is is essential essential for for ensuring ensuring that that Pharmaceutical Pharmaceutical products products are are manufactured manufactured to to a a safe safe and and consistent consistent standard standard. . ... QA QA professionals professionals are are responsible responsible for for instituting instituting a a range range of of practices practices that that help help guarantee guarantee a a drug's drug'sQuality Quality.

Pharmaceutical Quality Assurance Pharmaceutical Quality Assurance in Pharmacy in Pharmacy A A Quality Quality Assurance Assurance Specialist Specialist should should ensure ensure that that the the final final product product observes observes the the company's company's quality quality standards standards. . In In general, general, these these detail detail- - oriented oriented professionals professionals are are responsible responsible for for the the development development and and implementation implementation of of inspection inspection activities, activities, the the detection detection and and resolution resolution of of problems, problems, and and the the delivery delivery of of satisfactory satisfactory outcomes outcomes. .

QA EXAMPLES QA EXAMPLES and Responsibilities and Responsibilities QA QA Example: Example: A QA Audit A QA Audit Process Documentation Process Documentation Establishing Standards Establishing Standards Developing Checklist Developing Checklist Conducting Internal Audit Conducting Internal Audit - - - - - - - - - - RESPONSIBLE FOR QA : RESPONSIBLE FOR QA : Everyone in the team involved in developing the product is responsible for Quality Assurance product is responsible for Quality Assurance Everyone in the team involved in developing the

QC EXAMPLE QC EXAMPLE and Responsibilities and Responsibilities QC QC - - EXAMPLE: EXAMPLE: - - - - - - A QC review A QC review Performing Inspections Performing Inspections Performing Testing. Performing Testing. Responsible For QC: Responsible For QC: QC is usually the responsibility of a specific team that tests the product defects.