Quality
Assurance Systems: Basic concept of quality control & quality
assurance, functions, sources of variation, quality assurance for raw
materials, APIs, packing materials &
finished products (specifications, receipt, testing, sampling and certificate
of analysis), production (change control, aseptic process control, temperature,
pressure & humidity control tests, tests for air flow pattern,
microbiological monitoring) buildings & facilities (design and construction
features, construction materials, lighting, air handling systems, sanitation
& maintenance) equipments (construction, cleaning and maintenance,
calibration & handling).
In-process
quality control: Importance, inspection, IPQC tests for
tablets (weight variation, hardness, thickness, friability, disintegration
tests and content uniformity), suspensions and emulsions (appearance and feel, volume check,
viscosity, particle size distribution, electrical conductivity and content
uniformity) and parenterals (pH, volume check, clarity, content uniformity,
integrity of seals and particulate matter). Problems encountered and trouble
shooting.
Thermal
Methods of Analysis: Principles,
instrumentation and applications of thermogravimetric analysis (TGA),
differential thermal analysis (DTA), differential scanning calorimetry (DSC),
and thermo mechanical analysis (TMA).
X-Ray
Diffraction Methods: Origin of
X-rays, basic aspects of crystals, X-ray
crystallography, miller indices, rotating crystal technique, single
crystal diffraction, powder diffraction, structural elucidation and
applications.
Good
Laboratory Practices: Scope, organization, personnel – desirable qualities
of analyst, responsibilities of key personnel in the QC lab. Validation of analysis methods. Facilities,
equipments, testing facilities operation – systems and procedures in QC lab,
analytical worksheet, test methods, evaluation of test results. Test and control articles – incoming samples,
retention samples, reference materials, reagents, specification reportory. Safety guidelines in QC lab.
Statistical Quality Control: Scope, sampling – importance, sampling plans, sample size, statistical consideration - probability, frequency distribution. Sampling procedures, handling, labeling & preservation. Analysis of data, Control charts – X charts, R charts, applications.
