Quality assurance and Quality Control in Biotechnology detailed syllabus for Biotechnology (BioTech) for 2021 regulation curriculum has been taken from the Anna Universities official website and presented for the BioTech students. For course code, course name, number of credits for a course and other scheme related information, do visit full semester subjects post given below.
For Biotechnology 6th Sem scheme and its subjects, do visit BioTech 6th Sem 2021 regulation scheme. For Professional Elective-VII scheme and its subjects refer to BioTech Professional Elective-VII syllabus scheme. The detailed syllabus of quality assurance and quality control in biotechnology is as follows.
Course Objectives:
Download the iStudy App for all syllabus and other updates.
Unit I
INTRODUCTION 9
Quality Assurance , Quality Control , Role of Quality Assurance, QA testing, Role of Quality Control, Test for quality control, Quality assurance – Quality control – Practice of cGMP- Overview of ICH Guidelines – QSEM, with special emphasis on Q-series guidelines. Good Laboratory Practices: Scope of GLP, Definitions, Quality assurance unit, protocol for conduct of non clinical testing, control on animal house, , scope of quality certifications – responsibilities of QA & QC departments, Analysis of raw materials, finished products, packaging materials, in process quality control (IPQC), Developing specification (ICH Q6 and Q3)
Unit II
QUALITY ASSURANCE AND QUALITY CONTROL IN CLINICAL TRIALS 9
Audit criteria, Audit process, Responsibilities of stakeholders in audit process, Audit follow-up and documentation, Audit resolution and Preparing for FDA inspections, Fraud and misconduct management – Clinical Trial Data Management- Standard Operating Procedures, Data management plan, CRF & Data base design considerations, Study set-up, Data entry, CRF tracking and corrections, Central lab, IVRS, source data. Data cleaning, managing laboratory and ADR data, Data transfer and database lock, Quality Control and Quality Assurance in CDM, Data mining and warehousing
Unit III
Download the iStudy App for all syllabus and other updates.
Unit IV
QUALITY SYSTEM REGULATIONS AND QUALITY CONTROL OF MEDICAL
DEVICES 9
Quality System Requirements 21 CFR Part 820, Labeling requirements 21 CFR Part 801, Post marketing surveillance of MD and Unique Device Identification (UDI), Quality System requirements and clinical evaluation and investigation. IMDRF study groups and guidance documents, ISO 13485, Quality Risk Management of Medical Devices: ISO 1497-
Unit V
QUALITY IN FOOD, NUTRACEUTICALS, BIOLOGICAL AND COSMETIC
PRODUCTS 9
WHO guidelines on nutrition. NSF International: Its Role in the Dietary Supplements and Nutraceuticals Industries, NSF Certification, NSF Standards for Food And Dietary Supplements. Good Manufacturing Practices for Nutraceuticals, Quality, safety and legislation for herbal products in India, USA and European Union, Analysis of Cosmetics, Toxicity screening and test methods: Quality control and toxicity studies as per Drug and Cosmetics Act, Analysis of Food additives- milk constituents and milk products- Pesticide analysis
Course Outcomes:
- This course deals with the various aspects of quality control and quality assurance aspects of various biotechnological industries.
- It covers the important aspects like cGMP, QC tests, documentation, quality certifications, GLP and regulatory affairs.
Text Books:
Download the iStudy App for all syllabus and other updates.
Reference Books:
- Mindy J. Allport-Settle, Current Good Manufacturing Practices: Pharmaceutical, Biologics, and Medical Device Regulations and Guidance Documents Concise Reference, Pharmalogika Inc., USA, 2009.
For detailed syllabus of all the other subjects of Biotechnology 6th Sem, visit BioTech 6th Sem subject syllabuses for 2021 regulation.
For all Biotechnology results, visit Anna University BioTech all semester results direct link.