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Pharmaceutical Quality Assurance Unit 1 (BP606T)

is a branch of pharmacy that focuses on maintaining the quality, safety, and efficacy of pharmaceutical products. It involves implementing Good Manufacturing Practices (GMP), quality control tests, documentation, and regulatory compliance to ensure medicines meet required standards.

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Quality • It can be defined as the product with zero defect or product that meets Customer satisfaction Concepts of Quality control (QC)  Quality control • Quality Control (QC) is the process of checking and testing products to ensure they meet required quality standards before being released to the market. • The testing of pharmaceutical products involves chemical, physical, and microbiological evaluation or tests. • "Acc to ISO 9000“ A part of the Quality Management System (QMS) focused on fulfilling quality requirements. • It ensures that necessary tests are performed on the products, and the product is used only after verify its quality.
 Objectives of Quality Control: • To establish the desired quality standards, which are acceptable to the customers. • To discover or find flaws and variations in raw materials and manufacturing processes. • To improve quality. • To increase employee motivation and teamwork in the group.  Responsibilities of Quality Control: • QC is responsible for the day-to-day control of quality within the company • QC is responsible for analytical testing of incoming raw material and inspection of packaging components. • Selection of qualified vendors from whom raw materials are purchased. • QC also inspects environmental areas for manufacturing dosage forms. • QC also tests finished products.
Concepts of Quality Assurance (QA)  Quality Assurance: • Quality Assurance (QA) is the system of planned and systematic activities carried out to ensure that a product is consistently manufactured and controlled according to required quality standards. • It is the process to assure the quality of any manufactured product. • The quality must be safe, effective, and acceptable. • In this process, we compare the quality of the finished product with its pre-design sample. • It is an important step regarding the satisfaction of quality. • According to ISO 9000: QA is a part of the Quality Management System (QMS) focused on providing confidence that quality requirements will be fulfilled.
 Objectives of Q.A • Enhance the efficiency of product • Assuring the quality of raw material • Assuring the quality of finished product • Evaluating plant environment (premises) • Managing Good Laboratory Practices (GLP) • Managing Good Manufacturing Practices (GMP)  Responsibilities of Q.A. • Ensuring proper warehousing practices • Ensuring manufacturing process and process audit • Batch record review • QA is responsible for making the master plan for entire process • QA is responsible for stability testing and shelf-life evaluation • Deviation are reported, investigated, and recorded • Arrangements are made for the manufacture, supply and use of correct starting and packaging material
 Difference between Quality Assurance (QA) and Quality Control (QC) Quality Assurance (QA) Quality Control (QC) QA ensures quality by controlling the process. QC ensures quality by testing the product. Focuses on improving and controlling the manufacturing process. Focuses on checking and verifying the finished product. Quality Assurance is to prevent defects before they occur. Quality Control is to detect defects after production. Quality Assurance is a proactive approach to quality management. Quality Control is a reactive approach to quality management. Quality Assurance includes SOP preparation, audits, documentation, and training. Quality Control includes sampling, testing, inspection, and analysis. Quality Assurance is carried out throughout the production process. Quality Control is carried out during and after the production process. Quality Assurance is the responsibility of the entire organization. Quality Control is mainly the responsibility of the QC department.
Good Manufacturing Practices (GMP) • It is the part of QA which ensure that the product are consistently produced and controlled according to quality standard for their intended use • It is a set of principles and procedures which, when followed by the manufacturer for the therapeutic goods, it helps to ensure that the product manufactured will have the required quality. • It is designed to minimize the risks involved in any pharmaceutical production that can't be eliminated through testing the final product.  Objectives of GMP: • To consistently produce high-quality products which fulfill the standard quality. • To ensure safety and quality of products. • To minimize contamination and eliminate errors.
 Principles: • All manufacturing processes are clearly defined, systematically reviewed, that it gives consistently manufacturing of required quality with company specification. • Qualification and validation specification.  Resources: • Sufficient and appropriately qualified & trained personnel. • Space, suitable equipment, appropriate materials, containers, labels, approved procedures and instructions. • Suitable storage • Transport • Laboratory and equipment
 Process: • Instructions and procedures are written in clear and neat language. • Records are made. • Deviation during process is also recorded and then investigated. • The proper (storage) and distribution of product minimize any risk to their quality. • A system is available to recall any batch of product from sale/supply. • Also, complaints about marketed product are examined and cause of quality defect is investigated and appropriate measures are taken to overcome this.
TQM - Total Quality Management • A management approach where everyone in an organization works together to continuously improve quality in order to satisfy customers. • It is a concept created by W. Edward Deming. • It was originally introduced in Japan after World War II. • It originated in the 1950s and became popular since the early 1980s. • TQM is the art of handling the whole to achieve perfection.  Objective • The main focus of TQM is continuous quality improvement in the area of product/service, employee-employer relations, and customer-business relations. • TQM is a method by which management and employees can become involved in continuous improvement of product goods & services and increase the business.
 Elements of TQM: 1. Foundation: • Ethics • Integrity • Trust 2. Building Bricks: • Training • Teamwork • Leadership 3. Binding Mortar: • Communication 4. Roof: • Recognition
1. Foundation a) Ethics 1) Organizational Ethics: • Establish a business code of ethics that set up guidelines that all employees are to adhere to in the performance of their work. 2) Individual Ethics: • It refers to the personal wrongs or rights. b) Integrity: • It implies honesty, morals, values, fairness, and sincerity. c) Trust: • It is important for any work without trust, a framework of teamwork (TQM) cannot be built. • It is essential to ensure customer satisfaction.
2. Building Bridges 1) Training • Training is important for employees that give highly productive functions within the team, which helps in solving problems, making decisions, technical skills, and improvements. 2) Teamwork • A key element of TQM to become successful in business. 3) Leadership • To provide inspirational vision and make strategic directions that guide subordinates. 3. Binding Mortal 1) Communication • It is a common understanding of ideas by sender and receiver. So, communication binds everything together to form a foundation which is the root of TQM. 4. Roof 1) Recognition • It is the last and final element of TQM which provides suggestions and achievements for the team as well as individuals.
INTERNATIONAL COUNCIL FOR HARMONIZATION (ICH) • It’s a global organization that brings together pharmaceutical industry and regulatory bodies • ICH is an international organization that makes common rules for testing, approving, and ensuring the quality, safety, and effectiveness of medicines across different countries. • Equal partners in scientific and technical discussion of testing procedures which are required to ensure the quality, safety, and efficacy of medicine. • It started in 1990. • It is a non-profit organization.  Objectives • The main aim was to make common guidelines for drug quality, safety, and effectiveness so that the same medicine does not need to be tested again in different countries. • To improve efficiency of new drug development and registration processes.
• To prevent duplication of trials in humans, and minimize the use of animal testing without compromising with safety, quality, and effectiveness  Purpose 1. There was a rapid increase in laws and guidelines for evaluating the data on quality, safety, efficacy of new medicinal products. 2. Global consistency - ensuring uniform regulation worldwide 3. Innovation promotion- new drug development 4. Access of medicine - simplify market entry for essential drugs 5. Continuous improvement - address new challenges
 Participants A. Regulatory Members: (i) European Union (EU) (ii) Food & Drug Administration (FDA) (iii) MHLW of Japan (Ministry of Health, Labor & Welfare) (iv) MFDS of Korea (Ministry of Food & Drug Safety) B. Industry Members: (i) WSMI - World Self-Medication Industry (ii) Biotechnology Innovation Organization (BIO) (iii) Pharmaceutical Research & Manufacturers of America (PRMA) (iv) Japan Pharmaceutical Manufacturers Association (JPMA) (v) Others: WHO, EFTA (European Free Trade Association).
 Process of Harmonization 1. Formal ICH Procedure:- its deals with new Topic for harmonization 2. Q.A. Procedure (Question & Answer Procedure) :- Clarification for an existing ICH guideline. 3. Revision Procedure :- When ICH guideline is invalid or when a new data is to be added. 4. Maintenance Procedure :- Changes to be made to maintained a guideline (for maintain procedures).
 Brief Overview of QSEM Q: Quality (Q1- Q11) • These guidelines cover the areas of quality of drug products such as impurity testing and stability studies and GMP risk management. S: Safety (S1-S10) • They help to detect potential risks such as genotoxicity, carcinogenicity. E: Efficacy (E1-E16) • These guidelines provide guidance about designing, conducting, safety aspects, and reporting of clinical trials for pharmaceutical products. • Novel drug products derived from biotechnology techniques for targeted drug delivery are also covered. M: Multidisciplinary (M1-M8) • terminology, standard , common documents. • If QSE not fit then follow M guideline • Topics in the pharmaceutical field that do not fit into any of the above categories are covered under this area.
 Q series Guideline (Quality Q1 - Q11) 1. Q1 Stability 2. Q2 Analytical validation 3. Q3 Impurities 4. Q4 Pharmacopoeia 5. Q5 Quality of biotechnological product 6. Q6 Specification 7. Q7 Good Manufacturing practice (GMP) 8. Q8 Pharmaceutical development 9. Q9 Quality Risk management 10. Q10 Pharmaceutical quality system 11. Q11 Development of manufacturing of drug substances
 ICH STABILITY TESTING GUIDELINES (Q1 STABILITY) 1. Q1A Stability testing of new drug in different environments. 2. Q1B Stability testing (photo stability) of new drug (when drug in light). 3. Q1C Stability testing of new dosage form. 4. Q1D Bracketing and matrixing design for stability testing of drug substance (kit of the new drug substance for every combination of all drug factors) 5. Q1E Evaluation of data after analysis of drug for stability testing of drug 6. Q1F Stability data package for registration applications in climate zone
 ICH Guidelines For Stability • These guidelines were first adopted in 1993. • The ICH guidelines for stability testing define what information must be provided at the time of applying to register a new drug molecule. • This guideline harmonizes the drug registration process for all drugs in the USA, Japan, and the EU. • This means a drug registered in one of these regions will not require repeated stability testing when to be sold in any of the other two regions.  Types of Stability Testing 1. Real-time testing: • This involves testing drug product for a longer duration to find out what is the maximum product degradation when stored as recommended.
2. Accelerated stability testing: • Here, product is subjected to stress in the form of higher temperatures, moisture, agitation, light, pH, and packaging conditions to study its degradation 3. Sample stability testing: • This is testing of samples retained from each batch that has been sent into the market. 4. Cyclic temperature stress testing: • Not routinely used. It involves subjecting the products to temperature stresses in a way to mimic likely market storage conditions.
 Stability Testing Protocol This is the written document that describes all major requirements of a well-controlled stability study • Batch selection - how many batches to be tested • Containers and closures that must be used for the testing • Different positions in which product containers must be kept during testing • Frequency of drawing samples for analysis • Overall sampling plan - when and how much to sample and from where • Test storage conditions based on climatic zone where drug will be used • Methods to be used for testing, and their validation • Acceptance criteria for result values, and for degradation products
• It is a systemic approach that develops product design and process understanding and process control based on quality risk management (QRM). • QbD concept first outlined by Dr. Joseph M. Juran. • Dr. Joseph M. Juran explained that most of quality crises and issues in product is only due to lack of importance of product during product planning. • QbD is described in ICH Guideline Q8, Q9, and Q10. • Quality by Design is a scientific method that builds quality into a drug product from the initial design stage.  Elements of QbD program: 1. QTPP - Quality Target Product Profile 2. CQAs - Critical Quality Attributes 3. CMA - Critical Material Attributes 4. DS - Design Space 5. PP - Process Parameters
(i) Quality Target Product Profile (QTPP) • According to ICH Q8 guideline, it is the quality profile of drug product that ideally will be achieved to ensure the desired quality. (Drug Properties) • Quality, Safety, and Efficacy of the Drug Product • It is a quality characteristic that a drug product should possess in order to give therapeutic benefits. • It should include identity, dosage forms, delivery system, purity, and stability. (ii) Critical Quality Attributes (CQA): • It is a physical, chemical, biological, or microbiological property of a drug that should be within an appropriate limit range or distribution to ensure the desired quality. E.g. Assay, hardness, DT, Dissolution, content uniformity, etc.
(iii) Critical Material Attributes (CMA): • It is defined as the physical, chemical, biological, and microbiological property of raw material that needs to be monitored or controlled to ensure desired drug product quality. (iv) Design Space: • It is designed for single and multiple unit operations or also for the whole system. (v) Process Parameters (PP): • This is any input (Data) operational parameter of a system or unit operation to achieve the desired product quality. • Process parameters are the settings of a process that must be monitored to maintain quality.
 Objectives of QbD: • To achieve the quality product. • To achieve positive performance testing. • Ensure combination of product and process, knowledge gained during development.  Benefits of QbD: • Cost and time saving • Better design of product with fewer problems. • Eliminated batch failure. • Minimize deviation. • Continuous improvement. • Insure consistence information.
 Overview of QbD: Target Design Implementation
 Tools of QbD: 1. Screening 2. Optimization a) Screening • Designs are made to screen a large number of factors by using fewer experiments to identify the significant ones. • Main purpose of these designs is to identify the main effect. b) Optimization • These designs are only applied at once to a selected factor in formulation process. • Main purpose of these designs is to identify the main effect.
• ISO certify Quality Management System (QMS). • It is designed to help the company to satisfy its customers about the quality and achieve constant improvement. • Originally published in 1987 by the ISO • Its main aim is to increase productivity, reducing unnecessary costs and ensuring the quality of process and product.  Benefits of ISO 9000: • Quality is maintained. • More time spent on customer focus. • Opportunity to compete with large companies. • Compliance with GMP • Can increase customer confidence and satisfaction. • May facilitate trade and increased market opportunities.
 Elements of ISO 9000: 1. Customer Focus • The main goal is to meet and exceed customer expectation • Satisfied customers ensure long term success and trust in organization 2. Leadership • Strong leadership establishes a clear vision and direction • It help align people and process toward achieving quality objective 3. Engagement of people • Involving all employees increases motivation and responsibility • Everyone contribute to process improvement and product quality 4. Process approach • Managing activities as interrelated process improve efficiency and consistency • It ensures predictable and desired outcome
5. Improvement • continuous improvement is essential for maintaining performance and competiveness • It exchange innovation and adaptation to changes 6. Evidence based decision making • Decision should be based on data and analysis, not assumption • The reduces error and improves effectiveness of actions. 7. Relation management • Good relationship with supplies customer and stakeholder enhance cooperation • It support sustained success and value creation 8. Resource Management 9. Inspection, Measuring, and Test Equipment 10. Handling, Storage, Packing, and Delivery 11. Quality Records (audit, training )
Set the registration objective Select the appropriate standard. Develop and implement a Quality System. Select a third-party registrar and apply. Perform a self-analysis audit. Submit the quality manual for approval. Pre-assessment by registrar. Take corrective actions. Final assessment by registrar. Registration  Steps for ISO 9000 Registration:
• ISO 14000 focuses on Environmental management standards, thus encouraging a cleaner, safer, healthier world. • It is a process for managing company activities that impact the environment. • The environment's impact effects everywhere and leads to problems all over the world. So, the International Organization for Standardization developed an internal standard organization for environmental management systems  Benefits of ISO 14000: • Improved environmental performance • Improved market access • Improved cost control • Credibility with stockholders • Competitive market advantage • Adopting a process of continuous improvement • Increased level of safety • High-quality goods and services
 Elements of ISO 14000: 1. Environment Policy: • It is the written statement describing the objectives and targets of a business with respect to this policy. • It includes the Environmental Management System (EMS). 2. Planning: • Analysis of all environmental aspects of the organization, including processes, products, goods, and services used by the organization. 3. Implementation and Operation: • Implementation of all developed plans. • Plans also include emergency response planning and awareness 4. Checking and Corrective Action: • This action is done by monitoring the plan's performance
5. Management Review: • The review is done by the organization's top management to ensure its continuing suitability, adequacy, and effectiveness. 6. Continual Improvement: • This is a key component of the environmental management system. • It completes the cycle process of plan, implement, check, review, and continually improve.
 Steps for ISO 14000 Registration: Selecting a Certification Body (Choose the type of certification) Complete Questionnaire and Establish Contract (Determine nature, scale, and cost of certification) Document Review (Review of the Environmental Management System (EMS) documentation.) First Stage Assessment (Audit site tour and system overview.) Certification Assessment (After the audit a follow-up after one month). Certificate awarded Certificates issued valid for 3 yr. Surveillance visit (every 6 month or annually) Renewal assessment (every 3 yr.)
• NABL was establish in 1988 under the department of science and technology (DST) government of India, later it become constituent board of the quality council of India. • It is an organization whose work is to check laboratories and provide them an international certificate related to quality. • It provides accreditation as a certificate to laboratories. • NABL accredited laboratories are linked with international bodies like Asia Pacific Laboratory Accreditation Co-operation (APLAC) and International Laboratory Accreditation Co-operation (ILAC), and thus got international recognition. • Accreditation by NABL signifies that laboratory is technically competent follows validated methods, and produce accurate, reliable and traceable result
 Benefits: • To ensure data integrity and traceability in laboratory result. • Provides better control over the laboratory operations. • Saves money by getting it right the first time. • Provides global equivalence. • Improves staff motivation • International recognition • Continues improvement
 NABL Accreditation Procedure 1. Application by CAB (Conformity assessment body) to NABL. • Submit application for NABL accreditation. • Include quality manual and fee. 2. Acknowledgement: • Acknowledgement of application. • Assignment of a unique ID number. 3. Review by Lead Assessor: • Application evaluation by the lead assessor. 4. Pre-Assessment: • Lead assessor visits the laboratory for evaluation. 5. Assessment: • NABL assessment team reviews documents (management system, work instructions, test methods, etc.). • Submission of the assessment report to NABL.
6. Scrutiny of Assessment Report: • Examination of the assessment report. • Corrective actions implemented if necessary. 7. Accreditation Committee: • Review of corrective reports by the accreditation committee. • Recommendation made by the committee. 8. Issue of Accreditation Certification by chairman of NABL • Granting of accreditation to the laboratory. • Issuance of the accreditation certificate (including accreditation number, NABL hologram, discipline, and date of validity).

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Pharmaceutical Quality Assurance Unit 1 (BP606T)

  • 3.
    Quality • It canbe defined as the product with zero defect or product that meets Customer satisfaction Concepts of Quality control (QC)  Quality control • Quality Control (QC) is the process of checking and testing products to ensure they meet required quality standards before being released to the market. • The testing of pharmaceutical products involves chemical, physical, and microbiological evaluation or tests. • "Acc to ISO 9000“ A part of the Quality Management System (QMS) focused on fulfilling quality requirements. • It ensures that necessary tests are performed on the products, and the product is used only after verify its quality.
  • 4.
     Objectives ofQuality Control: • To establish the desired quality standards, which are acceptable to the customers. • To discover or find flaws and variations in raw materials and manufacturing processes. • To improve quality. • To increase employee motivation and teamwork in the group.  Responsibilities of Quality Control: • QC is responsible for the day-to-day control of quality within the company • QC is responsible for analytical testing of incoming raw material and inspection of packaging components. • Selection of qualified vendors from whom raw materials are purchased. • QC also inspects environmental areas for manufacturing dosage forms. • QC also tests finished products.
  • 5.
    Concepts of QualityAssurance (QA)  Quality Assurance: • Quality Assurance (QA) is the system of planned and systematic activities carried out to ensure that a product is consistently manufactured and controlled according to required quality standards. • It is the process to assure the quality of any manufactured product. • The quality must be safe, effective, and acceptable. • In this process, we compare the quality of the finished product with its pre-design sample. • It is an important step regarding the satisfaction of quality. • According to ISO 9000: QA is a part of the Quality Management System (QMS) focused on providing confidence that quality requirements will be fulfilled.
  • 6.
     Objectives ofQ.A • Enhance the efficiency of product • Assuring the quality of raw material • Assuring the quality of finished product • Evaluating plant environment (premises) • Managing Good Laboratory Practices (GLP) • Managing Good Manufacturing Practices (GMP)  Responsibilities of Q.A. • Ensuring proper warehousing practices • Ensuring manufacturing process and process audit • Batch record review • QA is responsible for making the master plan for entire process • QA is responsible for stability testing and shelf-life evaluation • Deviation are reported, investigated, and recorded • Arrangements are made for the manufacture, supply and use of correct starting and packaging material
  • 7.
     Difference betweenQuality Assurance (QA) and Quality Control (QC) Quality Assurance (QA) Quality Control (QC) QA ensures quality by controlling the process. QC ensures quality by testing the product. Focuses on improving and controlling the manufacturing process. Focuses on checking and verifying the finished product. Quality Assurance is to prevent defects before they occur. Quality Control is to detect defects after production. Quality Assurance is a proactive approach to quality management. Quality Control is a reactive approach to quality management. Quality Assurance includes SOP preparation, audits, documentation, and training. Quality Control includes sampling, testing, inspection, and analysis. Quality Assurance is carried out throughout the production process. Quality Control is carried out during and after the production process. Quality Assurance is the responsibility of the entire organization. Quality Control is mainly the responsibility of the QC department.
  • 8.
    Good Manufacturing Practices(GMP) • It is the part of QA which ensure that the product are consistently produced and controlled according to quality standard for their intended use • It is a set of principles and procedures which, when followed by the manufacturer for the therapeutic goods, it helps to ensure that the product manufactured will have the required quality. • It is designed to minimize the risks involved in any pharmaceutical production that can't be eliminated through testing the final product.  Objectives of GMP: • To consistently produce high-quality products which fulfill the standard quality. • To ensure safety and quality of products. • To minimize contamination and eliminate errors.
  • 9.
     Principles: • Allmanufacturing processes are clearly defined, systematically reviewed, that it gives consistently manufacturing of required quality with company specification. • Qualification and validation specification.  Resources: • Sufficient and appropriately qualified & trained personnel. • Space, suitable equipment, appropriate materials, containers, labels, approved procedures and instructions. • Suitable storage • Transport • Laboratory and equipment
  • 10.
     Process: • Instructionsand procedures are written in clear and neat language. • Records are made. • Deviation during process is also recorded and then investigated. • The proper (storage) and distribution of product minimize any risk to their quality. • A system is available to recall any batch of product from sale/supply. • Also, complaints about marketed product are examined and cause of quality defect is investigated and appropriate measures are taken to overcome this.
  • 12.
    TQM - TotalQuality Management • A management approach where everyone in an organization works together to continuously improve quality in order to satisfy customers. • It is a concept created by W. Edward Deming. • It was originally introduced in Japan after World War II. • It originated in the 1950s and became popular since the early 1980s. • TQM is the art of handling the whole to achieve perfection.  Objective • The main focus of TQM is continuous quality improvement in the area of product/service, employee-employer relations, and customer-business relations. • TQM is a method by which management and employees can become involved in continuous improvement of product goods & services and increase the business.
  • 13.
     Elements ofTQM: 1. Foundation: • Ethics • Integrity • Trust 2. Building Bricks: • Training • Teamwork • Leadership 3. Binding Mortar: • Communication 4. Roof: • Recognition
  • 14.
    1. Foundation a) Ethics 1)Organizational Ethics: • Establish a business code of ethics that set up guidelines that all employees are to adhere to in the performance of their work. 2) Individual Ethics: • It refers to the personal wrongs or rights. b) Integrity: • It implies honesty, morals, values, fairness, and sincerity. c) Trust: • It is important for any work without trust, a framework of teamwork (TQM) cannot be built. • It is essential to ensure customer satisfaction.
  • 15.
    2. Building Bridges 1)Training • Training is important for employees that give highly productive functions within the team, which helps in solving problems, making decisions, technical skills, and improvements. 2) Teamwork • A key element of TQM to become successful in business. 3) Leadership • To provide inspirational vision and make strategic directions that guide subordinates. 3. Binding Mortal 1) Communication • It is a common understanding of ideas by sender and receiver. So, communication binds everything together to form a foundation which is the root of TQM. 4. Roof 1) Recognition • It is the last and final element of TQM which provides suggestions and achievements for the team as well as individuals.
  • 17.
    INTERNATIONAL COUNCIL FORHARMONIZATION (ICH) • It’s a global organization that brings together pharmaceutical industry and regulatory bodies • ICH is an international organization that makes common rules for testing, approving, and ensuring the quality, safety, and effectiveness of medicines across different countries. • Equal partners in scientific and technical discussion of testing procedures which are required to ensure the quality, safety, and efficacy of medicine. • It started in 1990. • It is a non-profit organization.  Objectives • The main aim was to make common guidelines for drug quality, safety, and effectiveness so that the same medicine does not need to be tested again in different countries. • To improve efficiency of new drug development and registration processes.
  • 18.
    • To preventduplication of trials in humans, and minimize the use of animal testing without compromising with safety, quality, and effectiveness  Purpose 1. There was a rapid increase in laws and guidelines for evaluating the data on quality, safety, efficacy of new medicinal products. 2. Global consistency - ensuring uniform regulation worldwide 3. Innovation promotion- new drug development 4. Access of medicine - simplify market entry for essential drugs 5. Continuous improvement - address new challenges
  • 19.
     Participants A. RegulatoryMembers: (i) European Union (EU) (ii) Food & Drug Administration (FDA) (iii) MHLW of Japan (Ministry of Health, Labor & Welfare) (iv) MFDS of Korea (Ministry of Food & Drug Safety) B. Industry Members: (i) WSMI - World Self-Medication Industry (ii) Biotechnology Innovation Organization (BIO) (iii) Pharmaceutical Research & Manufacturers of America (PRMA) (iv) Japan Pharmaceutical Manufacturers Association (JPMA) (v) Others: WHO, EFTA (European Free Trade Association).
  • 20.
     Process ofHarmonization 1. Formal ICH Procedure:- its deals with new Topic for harmonization 2. Q.A. Procedure (Question & Answer Procedure) :- Clarification for an existing ICH guideline. 3. Revision Procedure :- When ICH guideline is invalid or when a new data is to be added. 4. Maintenance Procedure :- Changes to be made to maintained a guideline (for maintain procedures).
  • 21.
     Brief Overviewof QSEM Q: Quality (Q1- Q11) • These guidelines cover the areas of quality of drug products such as impurity testing and stability studies and GMP risk management. S: Safety (S1-S10) • They help to detect potential risks such as genotoxicity, carcinogenicity. E: Efficacy (E1-E16) • These guidelines provide guidance about designing, conducting, safety aspects, and reporting of clinical trials for pharmaceutical products. • Novel drug products derived from biotechnology techniques for targeted drug delivery are also covered. M: Multidisciplinary (M1-M8) • terminology, standard , common documents. • If QSE not fit then follow M guideline • Topics in the pharmaceutical field that do not fit into any of the above categories are covered under this area.
  • 22.
     Q seriesGuideline (Quality Q1 - Q11) 1. Q1 Stability 2. Q2 Analytical validation 3. Q3 Impurities 4. Q4 Pharmacopoeia 5. Q5 Quality of biotechnological product 6. Q6 Specification 7. Q7 Good Manufacturing practice (GMP) 8. Q8 Pharmaceutical development 9. Q9 Quality Risk management 10. Q10 Pharmaceutical quality system 11. Q11 Development of manufacturing of drug substances
  • 23.
     ICH STABILITYTESTING GUIDELINES (Q1 STABILITY) 1. Q1A Stability testing of new drug in different environments. 2. Q1B Stability testing (photo stability) of new drug (when drug in light). 3. Q1C Stability testing of new dosage form. 4. Q1D Bracketing and matrixing design for stability testing of drug substance (kit of the new drug substance for every combination of all drug factors) 5. Q1E Evaluation of data after analysis of drug for stability testing of drug 6. Q1F Stability data package for registration applications in climate zone
  • 24.
     ICH GuidelinesFor Stability • These guidelines were first adopted in 1993. • The ICH guidelines for stability testing define what information must be provided at the time of applying to register a new drug molecule. • This guideline harmonizes the drug registration process for all drugs in the USA, Japan, and the EU. • This means a drug registered in one of these regions will not require repeated stability testing when to be sold in any of the other two regions.  Types of Stability Testing 1. Real-time testing: • This involves testing drug product for a longer duration to find out what is the maximum product degradation when stored as recommended.
  • 25.
    2. Accelerated stabilitytesting: • Here, product is subjected to stress in the form of higher temperatures, moisture, agitation, light, pH, and packaging conditions to study its degradation 3. Sample stability testing: • This is testing of samples retained from each batch that has been sent into the market. 4. Cyclic temperature stress testing: • Not routinely used. It involves subjecting the products to temperature stresses in a way to mimic likely market storage conditions.
  • 26.
     Stability TestingProtocol This is the written document that describes all major requirements of a well-controlled stability study • Batch selection - how many batches to be tested • Containers and closures that must be used for the testing • Different positions in which product containers must be kept during testing • Frequency of drawing samples for analysis • Overall sampling plan - when and how much to sample and from where • Test storage conditions based on climatic zone where drug will be used • Methods to be used for testing, and their validation • Acceptance criteria for result values, and for degradation products
  • 28.
    • It isa systemic approach that develops product design and process understanding and process control based on quality risk management (QRM). • QbD concept first outlined by Dr. Joseph M. Juran. • Dr. Joseph M. Juran explained that most of quality crises and issues in product is only due to lack of importance of product during product planning. • QbD is described in ICH Guideline Q8, Q9, and Q10. • Quality by Design is a scientific method that builds quality into a drug product from the initial design stage.  Elements of QbD program: 1. QTPP - Quality Target Product Profile 2. CQAs - Critical Quality Attributes 3. CMA - Critical Material Attributes 4. DS - Design Space 5. PP - Process Parameters
  • 29.
    (i) Quality TargetProduct Profile (QTPP) • According to ICH Q8 guideline, it is the quality profile of drug product that ideally will be achieved to ensure the desired quality. (Drug Properties) • Quality, Safety, and Efficacy of the Drug Product • It is a quality characteristic that a drug product should possess in order to give therapeutic benefits. • It should include identity, dosage forms, delivery system, purity, and stability. (ii) Critical Quality Attributes (CQA): • It is a physical, chemical, biological, or microbiological property of a drug that should be within an appropriate limit range or distribution to ensure the desired quality. E.g. Assay, hardness, DT, Dissolution, content uniformity, etc.
  • 30.
    (iii) Critical MaterialAttributes (CMA): • It is defined as the physical, chemical, biological, and microbiological property of raw material that needs to be monitored or controlled to ensure desired drug product quality. (iv) Design Space: • It is designed for single and multiple unit operations or also for the whole system. (v) Process Parameters (PP): • This is any input (Data) operational parameter of a system or unit operation to achieve the desired product quality. • Process parameters are the settings of a process that must be monitored to maintain quality.
  • 31.
     Objectives ofQbD: • To achieve the quality product. • To achieve positive performance testing. • Ensure combination of product and process, knowledge gained during development.  Benefits of QbD: • Cost and time saving • Better design of product with fewer problems. • Eliminated batch failure. • Minimize deviation. • Continuous improvement. • Insure consistence information.
  • 32.
     Overview ofQbD: Target Design Implementation
  • 34.
     Tools ofQbD: 1. Screening 2. Optimization a) Screening • Designs are made to screen a large number of factors by using fewer experiments to identify the significant ones. • Main purpose of these designs is to identify the main effect. b) Optimization • These designs are only applied at once to a selected factor in formulation process. • Main purpose of these designs is to identify the main effect.
  • 35.
    • ISO certifyQuality Management System (QMS). • It is designed to help the company to satisfy its customers about the quality and achieve constant improvement. • Originally published in 1987 by the ISO • Its main aim is to increase productivity, reducing unnecessary costs and ensuring the quality of process and product.  Benefits of ISO 9000: • Quality is maintained. • More time spent on customer focus. • Opportunity to compete with large companies. • Compliance with GMP • Can increase customer confidence and satisfaction. • May facilitate trade and increased market opportunities.
  • 36.
     Elements ofISO 9000: 1. Customer Focus • The main goal is to meet and exceed customer expectation • Satisfied customers ensure long term success and trust in organization 2. Leadership • Strong leadership establishes a clear vision and direction • It help align people and process toward achieving quality objective 3. Engagement of people • Involving all employees increases motivation and responsibility • Everyone contribute to process improvement and product quality 4. Process approach • Managing activities as interrelated process improve efficiency and consistency • It ensures predictable and desired outcome
  • 37.
    5. Improvement • continuousimprovement is essential for maintaining performance and competiveness • It exchange innovation and adaptation to changes 6. Evidence based decision making • Decision should be based on data and analysis, not assumption • The reduces error and improves effectiveness of actions. 7. Relation management • Good relationship with supplies customer and stakeholder enhance cooperation • It support sustained success and value creation 8. Resource Management 9. Inspection, Measuring, and Test Equipment 10. Handling, Storage, Packing, and Delivery 11. Quality Records (audit, training )
  • 38.
    Set the registrationobjective Select the appropriate standard. Develop and implement a Quality System. Select a third-party registrar and apply. Perform a self-analysis audit. Submit the quality manual for approval. Pre-assessment by registrar. Take corrective actions. Final assessment by registrar. Registration  Steps for ISO 9000 Registration:
  • 40.
    • ISO 14000focuses on Environmental management standards, thus encouraging a cleaner, safer, healthier world. • It is a process for managing company activities that impact the environment. • The environment's impact effects everywhere and leads to problems all over the world. So, the International Organization for Standardization developed an internal standard organization for environmental management systems  Benefits of ISO 14000: • Improved environmental performance • Improved market access • Improved cost control • Credibility with stockholders • Competitive market advantage • Adopting a process of continuous improvement • Increased level of safety • High-quality goods and services
  • 41.
     Elements ofISO 14000: 1. Environment Policy: • It is the written statement describing the objectives and targets of a business with respect to this policy. • It includes the Environmental Management System (EMS). 2. Planning: • Analysis of all environmental aspects of the organization, including processes, products, goods, and services used by the organization. 3. Implementation and Operation: • Implementation of all developed plans. • Plans also include emergency response planning and awareness 4. Checking and Corrective Action: • This action is done by monitoring the plan's performance
  • 42.
    5. Management Review: •The review is done by the organization's top management to ensure its continuing suitability, adequacy, and effectiveness. 6. Continual Improvement: • This is a key component of the environmental management system. • It completes the cycle process of plan, implement, check, review, and continually improve.
  • 43.
     Steps forISO 14000 Registration: Selecting a Certification Body (Choose the type of certification) Complete Questionnaire and Establish Contract (Determine nature, scale, and cost of certification) Document Review (Review of the Environmental Management System (EMS) documentation.) First Stage Assessment (Audit site tour and system overview.) Certification Assessment (After the audit a follow-up after one month). Certificate awarded Certificates issued valid for 3 yr. Surveillance visit (every 6 month or annually) Renewal assessment (every 3 yr.)
  • 45.
    • NABL wasestablish in 1988 under the department of science and technology (DST) government of India, later it become constituent board of the quality council of India. • It is an organization whose work is to check laboratories and provide them an international certificate related to quality. • It provides accreditation as a certificate to laboratories. • NABL accredited laboratories are linked with international bodies like Asia Pacific Laboratory Accreditation Co-operation (APLAC) and International Laboratory Accreditation Co-operation (ILAC), and thus got international recognition. • Accreditation by NABL signifies that laboratory is technically competent follows validated methods, and produce accurate, reliable and traceable result
  • 46.
     Benefits: • Toensure data integrity and traceability in laboratory result. • Provides better control over the laboratory operations. • Saves money by getting it right the first time. • Provides global equivalence. • Improves staff motivation • International recognition • Continues improvement
  • 47.
     NABL AccreditationProcedure 1. Application by CAB (Conformity assessment body) to NABL. • Submit application for NABL accreditation. • Include quality manual and fee. 2. Acknowledgement: • Acknowledgement of application. • Assignment of a unique ID number. 3. Review by Lead Assessor: • Application evaluation by the lead assessor. 4. Pre-Assessment: • Lead assessor visits the laboratory for evaluation. 5. Assessment: • NABL assessment team reviews documents (management system, work instructions, test methods, etc.). • Submission of the assessment report to NABL.
  • 48.
    6. Scrutiny ofAssessment Report: • Examination of the assessment report. • Corrective actions implemented if necessary. 7. Accreditation Committee: • Review of corrective reports by the accreditation committee. • Recommendation made by the committee. 8. Issue of Accreditation Certification by chairman of NABL • Granting of accreditation to the laboratory. • Issuance of the accreditation certificate (including accreditation number, NABL hologram, discipline, and date of validity).