Hello friends, in this post I have shared an overview and download links of notes on Pharmaceutical Quality Assurance (BP606T) according to the PCI syllabus for B Pharm 6th Semester 2023.
Overview
In the notes of Pharmaceutical Quality Assurance, we have given two types of notes namely Handwritten notes and Standard notes.
Pharmaceutical Quality Assurance notes cover various aspects of quality control and quality assurance for the pharmaceutical industry. It covers crucial issues like CGMP, QC test documents, documents, quality certifications, and various other regulatory issues.
Friends In the Pharmaceutical Quality Assurance as per the syllabus copy of PCI B Pharm 6th semester, there are a total of 5 units in this subject.
Read this: B Pharma 6th Semester all Study Material PDF Free
Download Pharmaceutical Quality Assurance All Units Notes PDFs FREE
Click on the following download buttons below the names of the units to download Pharmaceutical Quality Assurance both Handwritten and Standard Notes.
In the Pharmaceutical Quality Assurance Notes Pdfs, the following chapters are explained in detail.
UNIT-1
Quality Assurance and Quality Management concepts: Definition and the notion of Quality control, Quality assurance, and GMP
Total Quality Management (TQM): The concept, its elements, and concepts
ICH Guidelines: for Objectives and participants, and Harmonization process brief description of the QSEM guidelines and ICH Guidelines, with a special focus on Q-series guidelines, ICH recommendations for testing stability
QbD means Quality by Design (QbD): Overview and definition, the components of QbD’s program, as well as tools
ISO 9000 & ISO14000: Overview, Benefits and elements and ways to sign up
Accreditation of NABL: NABL Principles and Methods
UNIT-2
Organization and personnel: Personal obligations Training hygiene, and other personal papers.
Premises: The planning, construction as well as maintenance of the facility of environmental controls, sanitation utilities, the management of sterile zones, and the elimination of contamination.
Equipment and raw materials: The selection of the equipment and maintenance specifications, purchasing of specifications for purchase, and the maintenance of facilities for storage of raw materials.
UNIT-3
Quality Control: Test for Quality Control container closures made from rubber and different packing material.
Good Laboratory Practices: General Guidelines for Organization and Personnel, Facilities, Equipment, Testing Facilities Operating Testing, and Control Articles, Procedure for Conducting the Nonclinical Labor Study Record and reports, disqualification of testing Facilities.
UNIT-4
Complaints: Complaints, analysis of complaints, processing of returned goods recalling, as well as disposal of garbage.
Documents maintained that are used in the pharmaceutical industry: include The Batch Formula Record, Master Formula Record SOP Quality Audit Quality Review, and Quality documentation Documents, reports, and distributive records.
UNIT-5
Qualification and calibration: Introduction to the concept and general rules of calibration, as well as the validation process and qualifications. The importance and nature of validation, types of validation Master plans to validate. The calibration of pH meters. Qualification of UV-visible spectrophotometers as well as the fundamental principles in Analytical Method Qualification and Validation.
Warehousing: The best method of warehousing materials management.
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