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 | ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use) |
| A process where regulatory authorities align technical requirements for the development and marketing of pharmaceutical products | REGULATORY HARMONIZATION |
| 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 Founding Member Countries | Europe, Japan, US |
| Basis for approving and authorizing new medicinal products | SAFETY, QUALITY, EFFICACY |
| 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) |
| Clinical Trials conducted in one ICH region can be used in other ICH regions by setting common standards on science and ethics | GCP (Good Clinical Practice) |
| ICH PRODUCTS: 70 Guidelines on technical Requirements | Safety - 15 Guidelines Quality - 24 Guidelines Efficacy - 22 Guidelines Multidisciplinary - 9 Guidelines |
| The BODY THAT OVERSEES OPERATIONAL ASPECTS of the association on behalf of all members, including administrative and financial matters and oversight of the WG | Management Committee |
| 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 |
| Develop and follows standard operating procedures directed toward assuring the quality, safety, purity and effectiveness of drug products | Quality Assurance and Quality Control |
| 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 |
| An undesirable characteristics of a product and therefore its failure to conform to specifications | DEFECTS |
| 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 |
| Can be measured directly by instruments (length, weight, height, thickness, concentration, pH, etc.) | Variable defect |
| Cannot be measured directly by instruments (odor, color, clarity, cleanliness, taste, etc.) | 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 |
| Visible; ex. Foreign particulate contamination | Ocular defect |
| Not seen but present; ex. Subpotent drug product | Internal defect |
| Defect in function; Ex. Suppository that does not melt at body temp. | Performance defect |
| Sample and examine materials while they are being processed Environmental monitoring | Monitor Functions: |
| Carefully reviewing the batch record for the lot and assuring that all necessary records are present, complete. | Record Review and Release Functions: |
| 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) |
| Suitable for use in analytical chemistry, products meet or exceed American Chemical Society (ACS) requirements where applicable. | Guaranteed Reagent (GR) |
| Long term & accelerated studies on the product as it is to be registered | Confirmatory studies |
| Long term & accelerated studies on the product as it is to be registered | Confirmatory studies |
| 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 |
| Long term & accelerated studies on the product as it is to be registered | Confirmatory studies |
| 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 |
| Long term & accelerated studies on the product as it is to be registered | Confirmatory studies |
| TYPES OF STABILITY | 1 Microbiological Stability 2 Physical Stability 3 Toxicologic Stability 4 Chemical Stability 5 Therapeutical Stability |
| Each active ingredient retains its chemical integrity and labeled potency within the specified limit | Chemical Stability |
| Stability properties includes appearance, palatability, uniformity, dissolution, and suspendability are retained | Physical Stability |
| Sterility or resistance to microbial growth is retained according to specified requirement | Microbiological Stability |