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B Pharm Pharmaceutical Quality Assurance PDF Notes


B-Pharmers, ensuring top-notch quality for every medicine is crucial, and that's where B Pharm Pharmaceutical Quality Assurance PDF Notes steps in! Think of it as the guardian of quality, making sure every drug, from production to distribution, meets strict standards. This unit dives into the essential principles and practices, like Good Manufacturing Practices (GMPs), the golden rules for safe and effective drug production. You'll also master quality control tests to ensure drugs meet specifications, learn record-keeping for transparency, and understand how regulations ensure safety. By the end, you'll be equipped to contribute to this vital field, safeguarding public health and building trust in the medications we all rely on. Remember, quality isn't just a label; it's a promise, and you'll have the knowledge and skills to uphold it!


B Pharm Pharmaceutical Quality Assurance Notes
B Pharm Pharmaceutical Quality Assurance Notes

Scope

This course deals with the various aspects of quality control and quality assurance aspects of pharmaceutical industries. It deals with the important aspects like cGMP, QC tests, documentation, quality certifications and regulatory affairs.


Objectives:-

Upon completion of the subject student shall be able to

  1. Understand the cGMP aspects in a pharmaceutical industry

  2. Appreciate the importance of documentation

  3. Understand the scope of quality certifications applicable to pharmaceutical industries

  4. Understand the responsibilities of QA & QC departments


B Pharm Pharmaceutical Quality Assurance PDF Notes


Unit 1


Quality Assurance and Quality Management concepts: Definition and concept of Qualitycontrol, Quality assurance and GMP Total Quality Management (TQM): Definition, elements, philosophies

ICH Guidelines: purpose, participants, process of harmonization, Brief overview of QSEM, with special emphasis on Q-series guidelines, ICH stability testing guidelines

Quality by design (QbD): Definition, overview, elements of QbD program, tools ISO 9000 & ISO14000: Overview, Benefits, Elements, steps for registration

NABL accreditation : Principles and procedures





Unit 2


Organization and personnel: Personnel responsibilities, training, hygiene and personal records.

Premises: Design, construction and plant layout, maintenance, sanitation, environmental control, utilities and maintenance of sterile areas, control of contamination

Equipments and raw materials: Equipment selection, purchase specifications, maintenance, purchase specifications and maintenance of stores for raw materials.





Unit 3


Quality Control: Quality control test for containers, rubber closures and secondary packing materials

Good Laboratory Practices: General Provisions, Organization and Personnel, Facilities, Equipment, Testing Facilities Operation, Test and Control Articles, Protocol for Conduct of a Nonclinical Laboratory Study, Records and Reports, Disqualification of Testing Facilities





Unit 4


Complaints: Complaints and evaluation of complaints, Handling of return good, recalling and waste disposal.

Document maintenance in pharmaceutical industry: Batch Formula Record, Master Formula Record, SOP, Quality audit, Quality Review and Quality documentation, Reports and documents, distribution records





Unit 5


Calibration and Validation: Introduction, definition and general principles of calibration, qualification and validation, importance and scope of validation, types of validation, validationmaster plan. Calibration of pH meter, Qualification of UV-Visible spectrophotometer, General principles of Analytical method Validation. Warehousing: Good warehousing practice, materials management


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