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QUALITY CONTROL 2 LEC


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Unique harmonization initiative for regulators and pharmaceutical industry ; Founded in 1990 Reformed as a non profit legal entity under Swiss Law on October 23, 2015 An international nonprofit association that brings regulatory authorities and pharmaceutical industry together to HARMONIZE scientific and technical aspects of drug registration. Global platform for harmonization
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ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use)

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QUALITY CONTROL 2 LEC - Detalles

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REGULATORY HARMONIZATION BENEFITS AND REASONS
BENEFITS - Ensuring favorable marketing conditions to support early access to medicinal products - Promoting competition and efficiency - Reducing unnecessary duplication of clinical testing REASONS - Rising costs of healthcare - Escalation of the cost of R&D - Need to meet the public expectation
Initiation of ICH
1980s = European Commission, Europe Discussions between Europe, Japan, US
Initiation of ICH: PLANS FOR ACTION BEGAN
WHO conference of Drug Regulatory Authorities (ICDRA), Paris (1989)
Initiation of ICH: Joint regulatory-industry initiative on international harmonization
International Federation of Pharmaceutical Manufacturers and Associations (IFPMA)
Birth of ICH took place
April 1990, Brussels (European Federation of Pharmaceutical Industries and Associations (EFPIA)
ICH Logo explanation
I, C, H = speaks for benefits of harmonisation for better global health ABSTRACT HUMAN FORM Blue Color = Health Care Purple = Complementary to Blue
ICH Slogan
Harmonisation for Better Health
PURPOSE OF ICH
1 REDUCTION OF UNNECESSARY ANIMAL TESTING without compromising safety and effectiveness accomplished through technical guidelines implemented by the regulatory authorities 2 Prevention of unnecessary duplication of clinical trials and post-market clinical evaluations 3 Development and manufacturing of new medicines 4 Registration and supervision of new medicines 5 Post-authorisation safety reporting and pharmacovigilance Accomplished through Technical Guidelines that are implemented by the regulatory authorities
ICH MEMBERS AND OBSERVERS
1 Founding / Standing Member 2 Member 3 Observer 4 Standing Observer
ICH SUCCESSES
1 GCP (Good Clinical Practice) 2 CTD / eCTD (Common Technical Document) 3 MedDRA (Medical Dictionary for Regulatory Activities)
ICH PRODUCTS: 70 Guidelines on technical Requirements
Safety - 15 Guidelines Quality - 24 Guidelines Efficacy - 22 Guidelines Multidisciplinary - 9 Guidelines
DECISION MAKING IN ICH Management Committee provides:
RECOMMENDATION and SELECTION of new topics for harmonisation as well as on the adoption, withdrawal or amendments of ICH Guidelines
DECISION MAKING IN ICH Assembly takes decisions:
1 By consensus 2 If consensus is absent, vote in accordance with Articles of Association, where only REGULATORY MEMBERS have the right to vote
ICH Observers (Eligibility Criteria)
1 Limited eligibility criteria for new observers 2 No duties Imposed 3 Right of Observers: - Attend ICH Meetings, but no right to vote or appoint experts in WG - Standing Observers maintain right to appoint experts in Wgs
Steps in the ICH Process for Guideline Development
Step 1 - Consensus Building Step 2 - a. ICH Parties consensus on Technical Document b. Draft guideline adoption by regulators - Endorsement by A. assembly, B. regulators Step 3 - Regulatory consultation and discussion - Sign-off by regulatory topic leaders Step 4 - Adoption of an ICH Harmonised Guideline - Adoption by regulators Step 5 - Implementation
FOUR ICH GUIDELINES:
1 Quality Guidelines 2 Safety Guidelines 3 Efficacy Guidelines 4 Multidisciplinary Guidelines
Engagement in the ICH Process (ELIGIBILITY CRITERIA FOR REGULATORS& INDUSTRY)
1 Past regular attendance in ICH meetings 2 Past appointments of experts in WG
Application of ICH Guidelines
Tier 1 Q1: Stability Testing Guidelines G7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients E6: Good Clinical Practice Guideline
ELIGIBILITY CRITERIA FOR REGULATORS
1 Engagement in the ICH Process 2 Application of ICH Guidelines
ELIGIBILITY CRITERIA FOR INDUSTRY
1 Type of Organisation 2 Engagement in the ICH process 3 Impact of ICH Guidelines
Type of Organization (ELIGIBILITY CRITERIA FOR INDUSTRY)
International Pharmaceutical Industry Organisation IPIO
Impact of ICH Guidelines
The organisation & members must be regulated or affected by ICH guidelines
FDA has issued a primary regulation to the industry entitled current __
Good Manufacturing Practice (cGMP or GMP)- AO # 220 , s. 1974
In environmental monitoring:
Class 100 1.Airborne Particulate Cleanliness Classes in Cleanrooms and Clean Zones 2. are maintained in areas where parenteral products are filled into clean, sterile container 3. an area that can be controlled to contain fewer than 100 particles, 0.5 µm and larger per cubic foot of air
1 ISO's name 2 In French
1 "International Organization for Standardization" 2 "OIN" (Organisation internationale de normalisation)
ISO standards:
1 make the development, manufacturing and supply of products and services more efficient, safer and cleaner 2 facilitate trade between countries and provide governments with a technical base for health, safety and environmental legislation, and conformity assessment 3 share technological advances and good management practice 4 disseminate innovation 5 safeguard consumers, and users in general, of products and services
The potential benefits derived from a quality control system are as follows:
1. The system minimizes or eliminates the risk of marketing unsafe products 2. It guarantees conformance to regulatory requirements 3. It guarantees product efficacy 4. It reduces operating costs 5. It reduces operating losses 6. It produces higher employee morale 7. It motivates the pharmaceutical/ medical professions to sell or prescribe the product
Quality Control Manager
- Materials Inspection Section - Analytical Laboratory - Biological Testing Laboratory - Specifications and Analytical development - Quality Coordinating Office
Quality Control Manager (COMPONENTS)
- Materials Inspection Section - Analytical Laboratory - Biological Testing Laboratory - Specifications and Analytical development - Quality Coordinating Office
Quality Coordination Office:
1 Documentation is its main responsibility 2 Maintain and store records that represent the history of the batch from start to finish. ( batch and master formula records, raw mat, analytical record, printed and packaging material inspection reports and retention files)
Materials Inspection Section:
1 To sample and examine all raw materials received 2 Conduct physical tests on: a. all shipments of packaging materials b. all manufacturing, filling and packaging operations 3. Maintain periodic examination on the quality of inventories throughout all phases of storage, shipping and distribution 4 Perform audit which is independent of the work done by product personnel Note: inspection stations are placed in the area of operation, warehouse, manufacturing and packaging areas
Analytical laboratory:
1 For testing and approving raw materials, work in-process and finished product 2 To perform chemical and physical analysis / tests and specifications maybe found in several sources as USP, NF, BP and Merck Index
Biological Testing Laboratory:
1 Staff must be well trained and experience in both simple and complex microbiogical procedures 2 To perform and evaluate microbiological and pharmacological assays, sterility, pyrogen and bacteriological tests, irritation, safety or acute toxicity tests 3 Conduct environmental monitoring
Specifications and Analytical Development:
1 Coordinate w/ research, product development, production, sales and management towards improvements of product 2 Establish specifications for raw and packaging materials 3 Validate existing and tentative procedures of testing 4 Establish specifications based on validation procedures 5 Develop new assay methods for in-house use 6 Develop and improve specifications for quality characteristics of the final product being manufactured
Quality Coordination Office:
1 Documentation is its main responsibility 2 Maintain and store records that represent the history of the batch from start to finish. ( batch and master formula records, raw mat, analytical record, printed and packaging material inspection reports and retention files) 3 To furnish data that will aid in analyzing product performance in the market ( documents are: stability studies and returned goods reports) 4. Investigate customer complaints 5. Maintain and develop SOP’s
Sources of Quality Variations
1 MATERIALS 2 MACHINES 3 METHODS 4 MEN
DEFECTS can be classified as
1 According to MEASURABILITY 2 According to SERIOUSNESS OR GRAVITY 3 According to NATURE MSN
Defect according to measurability
1 Variable defect 2 Attribute defect
Defect according to seriousness or gravity
1 Critical defect 2 Major defect 3 Minor defect
Defect according to nature
1 Ocular defect 2 Internal defect 3 Performance defect
SOP must be followed
Audit Function:
Success as an analyst:
1 Manipulative skill acquired by experience 2 Ability to follow directions under supervision of skilled analyst 3 Has fundamental knowledge of theory 4 Practical ability in the application of analytical methods 5 Skill of technique, patience, neatness and accuracy 6 Must not only use common sense in the laboratory but think throughout each step of the procedure
Accuracy and honesty
All quantitative work be performed without even a slight loss of material or gain of extraneous matter At least 2 determinations of any analytical value are required (trials and replicates)
Economy of Time:
1 Keep the working area clean 2 Clean all apparatus immediately after using 3 Label all solutions 4 Keep 2 or more operations going at one time 5 Utilize all time between operations in making calculations and writing up experiments
Grades of Chemicals:
1 Reagent ACS 2 Guaranteed Reagent (GR)
Objective of Stability Testing
To provide evidence on how the quality of a drug substance or drug product VARIES WITH TIME under the influence of a variety of environmental factors such as TEMEPRATURE, HUMIDITY AND LIGHT, & enables recommended STORAGE CONDITIONS, RE-TEST PERIODS & SHELF LIVES to be established
Variable affecting stability
1 Formulation 2 Packaging 3 Site and method of manufacture - API - Finished product 4 Batch size 5 Batch to batch variability - Process validation - Quality risk management 6 Container labelling 7 Changes to product
Adverse effects of instability of drugs
1 Loss of active drug 2 Loss of vehicle 3 Loss of content uniformity 4 Loss of elegance 5 Reduction of bioavailability 6 Production of Potential toxic materials
TYPES OF STABILITY
1 Microbiological Stability 2 Physical Stability 3 Toxicologic Stability 4 Chemical Stability 5 Therapeutical Stability