Quality: Concept of quality, nature of product quality, study of various approaches for quality like Deming’, Juran, Crosby, Feigenbaum, Shikaw.
Quality income and cost. TQM awards and prizes.
Quality benchmarking, details of international standards (ISO, GMP, GLP, TGM, VAN and
ISI), its need and fact sheet evaluation (should include review or statistics of industries
implemented these standards with those which have not implemented these)
Role of quality audit and quality circle in quality assurance.
Quality assurance and GLP, implementing of GLP in non GLP analytical laboratory.
Process management, project management, strategic development and product development.
Measurement of quality, information and decision making or utilization of data.
Quality operations, its inspection and test used for it.
Human resource and training for quality.
Market survey, customer demand and marketing in addition to supplier and customer relationships.
Quality, society and national culture.
Computerized system- software development, computer applications and quality system.
Requirements of product registration, in India and other countries (USA, UK, Japan and
Europe etc)., GLP, ISO 9000, TQM, Quality review and Quality Documentation
Application of process analytical technology (PAT) in quality assurance
Qualification validation and calibration of equipment. Analytical and bioanalytical method validation
Regulatory requirement in pharmaceutical analysis – US-FDA, ICH, PAC-ALTS: Post
approval changes – analytical testing laboratory site etc.
Analysis of drug from biological fluids
Application of analytical methods to product obtained through genetic engineering,
Amino acid sequence analysis, tryptic mapping, ion exchange amino acid analysis,
isoelectric focusing etc.
Application of analytical methods to product obtained from natural sources (extracts,herbal formulations, isolated compounds, modern herbal formulations) (Compendial methods for evaluation of crude drug and herbal formulation) Dosage form impurity profile and its validation Organization & personnel, responsibilities, training and records. Equipment selection purchase specifications, maintenance, clean in place for analytical department Premises - location, design, plant layout, construction maintenance and utilities and services like gas, water for analytical department
Introduction to pharmaceutical validation: definition, manufacturing process model, scope of validation, advantage of validation, organization for validation, validation of master plan, types of process validation, design qualification, installation qualification, operational qualification and performance qualification of facilities.
Process validation: prospective, concurrent, retrospective and revalidation,
Process validation of formulations like tablets, capsules, ointment/creams, liquid orals, sterile dosage form which should include following aspects
Personnel and organization
1. Raw materials
2. Equipments (e.g. Dry powder mixers, fluid bed and tray dryers, tablet
3. compression machine, capsule filling machines etc)
4. Area, premises and environment including storage of raw materials to finished
6. Water (validation of pharmaceutical water system and pure steam),
7. Packaging and labeling controls and its validation
8. Cleaning validation: cleaning of equipment, cleaning of facilities
9. Validation of Integrated lines by media fill test.
10. Validation of HVAC system
Vendor Certification. Validation of compressed air, validation of water and air handling systems Validation of existing equipment and utilities validation
Computer system validation including installed softwares, Pharmaceutical development of drug substance and drug product, formulations, manufacture and supply of materials, labeling and presentation, stability and storage, purity, compatibility, disposal.
ii. Text Books:
1. K. Bansal, Chromatography, 1st Ed., Campus books, New Delhi, 2000.
2. K. Bansal, Analytical spectroscopy, 1st Ed., Campus books, New Delhi, 2000.
3. A. Kar, Pharmaceutical drug analysis, 1st Ed., Minerva books, New Delhi, 2001.
4. S. Usharani, Analytical chemistry, 1st Ed., McMillan, New Delhi, 2000.
5. D.H. Shah, SOP; Guidelines, 1st Ed., Business horizons, New Delhi, 1997.
6. D.H. Shah, QA manual, 1st Ed., Business horizons, New Delhi, 1997
7. A.H. Beckett, J.B.Stanlake, Practical Pharmaceutical chemistry-Vol- 1, 4th Ed., CBS, New Delhi, 2004.
8. G.R. Chatwaal, Analytical spectroscopy, 1st, Himalaya publishing house, Mumbai, 1996.
9. G.R. Chatwaal, Analytical chromatography, 1st, Himalaya publishing house, Mumbai, 1996.
10. M. Parkany, Quality assurance and TQM for analytical laboratory, Royal society of chemisty, New Delhi,1995