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

Open Unit 1

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

Open Unit 2

Unit 3

Quality Control: 

Quality control test for containers, rubber closures and secondary packing material

Good Laboratory Practices: 

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

Open Unit 3

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

Open Unit 4

Unit 5

Calibration and Validation: 

Introduction, definition and general principles of calibration, qualification and validation, importance and scope of validation, types of validation, validation master plan. Calibration of pH meter, Qualification of UV-Visible spectrophotometer, General principles of Analytical method Validation.

 Warehousing: 

Good warehousing practice, materials management

Open Unit 5