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Introduction to quality assurance 1c (Control and assurance of…
Introduction to quality assurance 1c
Definetion of PQA
Raw materials up to finished products
Assures tests passed
Q.A and Q.C =
Quality
Safety
Purity
Effectiveness
Reasons for the need of pharmaceutical quality assurance
Definetion of PQC
3.Goods Manufacturing Practices (GMP)
Personnel
Facilities
Packaging
Quality control
QA ,GMP and QC inter-relationships
QC and QA :
Qc:
Sampling
Specification
Testing
Within organization
Documentation
Release procedures
Ensures tedt carried out.
Laboratory techniques
Lab based
QA
Sum total of organized arrangements
Ensuring that products will be of quality required
Planned or systematic actions
Compony based
Principles of Q.C
Quality Controller
Organization chart
Organization of QA and Q.C
Responsibilities of Q.A and Q.C
Duties of Q.C officer incharge
Control and assurance of manufacturing practices
Personnel
2.equipment and buildings
Ontrol of records
4.master formula records
Batch production records
Control of productions procedures
7.manufacturing control
Packaging materials
Validation
Control assurance of finished products
Total quality management (TQM) in pharmaceutical industry
Documentation procedures in phàrmaceutical industry