BITS F 467: Bioethics and Biosafety Lecture Notes PDF

BITS F 467: Bioethics and Biosafety Shrikant Charde Scope and Objective to create an awareness on the basic concepts of biosafety and bioethics governing the experimentations on transgenic organisms and plants prenatal diagnosis and related social issues handl...

BITS F 467: Bioethics and Biosafety Shrikant Charde Scope and Objective to create an awareness on the basic concepts of biosafety and bioethics governing the experimentations on transgenic organisms and plants prenatal diagnosis and related social issues handling and disposal of hazardous materials environmental pollution concerns ethics in need based experimentation on animals and plants Lecture Schedule Learning objectives Contents Ref Mat Lec. No. Introduction Definitions, need and importance TB:1 1-2 RB-2:1 Biosafety and Bioethics Research and development, operational and TB:1 3-4 Considerations manufacturing stages involving safety and ethics concerns Global Regulations and Importance and need of harmonization TB:1 5 Harmonization RB-2:1 Guidelines for experiments on Global and country specific regulations TB:4.3, 5.1- 6-9 Animals 5.2 RB-2:13-15 Guidelines for experiments on Global and country specific regulations Class Notes 10-13 Humans Legal, ethical and social implications AI, IVF, ET, Surrogate Motherhood and Womb TB:2,3 14-16 including issues related to human Leasing RB-2:2,5,8 reproduction, gene manipulation, genetic testing Lecture Schedule Learning objectives Contents Ref Mat Lec. No. Guidelines for research in transgenic Therapeutic procedures for Sustaining Life, Ethical TB:2,3 17-21 organisms and plants such as implications in handling Stem cells and somatic and RB-2:3 cloning, stem cell research, gene Germ-line Gene Therapy therapy, etc. Ethics in stem cell research Ethical issues in Prospects and Techniques in Stem TB:3 22-24 cell research Animal cloning and organ Ethical consideration in Cloning TB:3,4 25-28 transplants RB-2: 26 Biosafety guidelines, regulations, International Agreements and regulations in TB: 4.2, 5.1, 29-30 public participation Biosafety, Efforts to preserve biodiversity 5.3 RB-2:12,27 Environmental pollution- hazards Environmental Problems and Protection TB:5.3 31-34 and control RB-2:9,10 Socio-economic impacts of Methodologies for the assessment of Biotechnology RB-2:8 35-37 biotechnological experiments Applications and its impact and Case study Good Manufacturing Practices Quality System of Management Controls for RB-2:11 38-42 guidelines Research Laboratories and Organizations Good Laboratory Practices Quality System of Management Controls for RB-2:11 43-45 guidelines Research Laboratories and Organizations Evaluation Components EC No. Evaluation Components Duration Weightage Date & Time 1 Quiz 30 minutes 15% 04/10/2024 (F1) 2 Mid Sem Test (Closed book) 50 minutes 30% 22/10/2024 (AN) 3 Assignment Take home 15% TBA 4 Comprehensive Exam (Closed and Open 3 hours. 40% 08/01/2025 (AN) book) Bioethics and Biosafety Law: Binding Ethics: Moral principles Bioethics: Moral principles in field of biology Safety: Act of protection from danger or risk Biosafety: Safe working practices associated with handling biological materials Bioethics and Biosafety Fritz Jahr published an article is 1927, Bioethics: A review of ethical relationships of humans to animals and plants and proposed bioethical imperative Joseph Fletcher wrote Morals and Medicines in 1954 Charak Samhita and Sushrut Samhita in Atharvaveda (600 BC) World War II testing was done on human subjects on military camps in Germany In 1945, Doctors Trial was conducted in Nuremberg Nuremberg Code (10 principles): Set of ethical principles for studies on humans Bioethics and Biosafety Van Rensselaer Potter, American Scientist introduced the idea of bioethics with his book “Bioethics: A bridge to future” He proposed a link between science of life and useable knowledge Asilomar Conference in Recombinant DNA in 1975 to debate ethical implications of genetic engineering Self regulation by scientists and they proposed appropriate safeguards Nuffield Council on Bioethics (https://www.nuffieldbioethics.org/ ) Bioethics and Biosafety Bioethics and Biosafety WHO 1995 Cognitive Goals Sensitivity, Critical reflection, Ethical Reasoning Behavioral Goals Practicing cognitive goals Attitudinal Goals Imbibing the goals Current Good Manufacturing Practices (GMP) Total Quality Management Guidance for Pharmaceuticals and Biotechnology Based Products 21 CFR Guidance ( https://www.fda.gov/drugs/pharmaceutical-quality-resou rces/current-good-manufacturing-practice-cgmp-regulati ons ) Concept of Quality Quality Control Quality Assurance Total Quality Management Quality by Design cGMP Guidelines Personnel Building and Facilities Equipment Raw Materials (Components, Closures and Containers) Process Control Packaging and Labelling Laboratory Controls Storage and Distribution Returned and Salvaged Products Documentation and Records Personnel Orientation Induction Training Retraining Building and Facilities Facility Design Box within a Box Design (Duplex structure) Material of construction (cement blocks impermeable) Areas of different levels of cleanliness (Class 10, 100, 1000) and control Floor and Ceiling Doors Double doors (sensor controlled) Windows Building and Facilities Heating Ventilation Air Conditioning System Proper temperature and humidity Prevents cross contamination Differential pressure Building Monitoring System Prevents entry of micro-organisms and dust Laminar air flow Air changes Building and Facilities Utilities Air/ Gas (compressed, gases) Water SS316 Standard Operating Procedures Logs Cleaning Climate control Air Changes Fumigation Equipment Equipment Design Contacts part of SS 316 Special design changes Ease of cleaning and maintenance Calibration and Validation Protocol Calibration deals with accuracy of outcome/ result Validation is a holistic approach which ensures that the equipment will produce consistent quality product Equipment Labels Equipment Validation Design Qualification Installation Qualification Operation Qualification Performance Qualification Safety Qualification Maintenance Qualification Tunnel Sterilizer Loading Zone Washing Zone Drying Zone Sterilization Zone Filling Area Sealing Area Checking and Labeling Tunnel Sterilizer Design Qualification Installation Qualification Operation Qualification: Heat Distribution Studies (Cold Spot) Heat Penetration Studies Performance Qualification Heat Distribution Studies Heat Penetration Studies (Bacilus atrophaeus) Safety Qualification Maintenance Qualification Equipment Validation Identify critical parameters for proper output Parameters are measured using standard devices Radiation Sterilization Equipment Validation Maintenance of logs for each equipment Standard Operating Procedure Operation Cleaning Maintenance Control of Components, Closures and Containers Raw Material Specification sheet Approved Vendor List (Drug Master File Holders) Purchase order: Packing and Labelling Details Receipt of Material Checking and Quarantine Testing (Certificate of Analysis) Release Issuance Control of Components, Closures and Containers Control of Components, Closures and Containers Temperature and Humidity Control FIFO Concept Retesting Schedule Areas of Stores (Quarantine, Under Test, Approved, Rejected/ Expired) Process Validation Ensures a given process gives consistent quality output when carried out in substantial the same way Forms basis for design of Batch Manufacturing Record/ MMR/ MFD/ BPR Process Qualification Equipment need to be qualified Process Validation Prospective Validation Retrospective Validation Concurrent Validation Revalidation Fish Bone Diagram/Ishikawa Diagram Identifying the variable Impact on output Sampling Method Testing Method Labelling and Packaging Room labels Area Labels Equipment Label In process Material Labels Finished Good Product Laboratory Control Storage and Distribution Standard Test Procedure FIFO Concept Analytical Report Environmental Condition Certificate of Analysis Approved, Under Test and Rejected Material traced to shelf of consumer Returned and Salvaged Products Batch reconciliation sheet Reworked Tracked properly