INDUSTRIAL PHARMACY

ELIGIBILITY

B. Pharm/ M Pharm/ Ph D Pharmacy students; researchers, Pharmacy faculty members/ Pharma Industry Personnel; the students of B Sc/ M Sc Chemistry/ Pharm. Chemistry/ biotechnology and other allied disciplines who aspire for the jobs in Pharma Industry or research.


Duration

12 weeks

COURSE LAYOUT

  • Preformulation I
  •   Preformulation I: Physical form (crystal & amorphous), 
  •   Preformulation I: polymorphism, particle size, shape  
  •    Preformulation I:, solubility profile (pKa, pH)
  •    Preformulation I: Partition coefficient, flow properties
  • Preformulation II
  •  Preformulation II: Hydrolysis, oxidation, reduction
  •  Preformulation II: Racemisation, 
  •  Preformulation II: Dissolution, permeability & BCS classification
  •    Preformulation II: Polymerization
  • Tablets
  •  Tablets: Introduction, classification of tablets. Formulation/preparing of tablets, granulation methods.
  •  Tablets: Compression and processing problems. Equipment and tablet tooling, Tablet defects.
  •  Tablets: Tablet coating: Types, coating materials, formulation of coating composition, methods of coating, equipments employed and defects in coating
  •    Tablets: QC of tablets: apparatus, methods, graphical presentations, official and unofficial tests.
  • Liquid Orals
  •  Liquid orals: Formulation and manufacturing of solution, syrups and elixirs, Filling and packaging
  •  Liquid orals: Emulsions: I
  •  Liquid orals: Emulsion II
  •    Liquid orals: Suspensions: Formulation, evaluation
  • Parenterals I
  •  Parenterals I: Introduction, Preformulation of parenterals
  •  Parenterals I: Formulation of Parenterals
  • Parenterals I
  •  Parenterals I: Types of Parenteral preparation
  •  Parenterals I: Lay out and Production facilities
  • Parenterals II
  •  Parenterals II: Pyrogens and pyrogenisity
  •  Parenterals II: Quality control of parenterals
  • Capsules
  •  Capsules: Introduction, Advantages, Disadvantages, Capsule Production, hard Gelatin capsules
  •  Capsules: Methods of filling capsules, Soft Gelatin Capsules
  •  Capsules: Formulation Consideration, Production of soft gelatin capsules, Non-gelatin soft capsules
  •   Capsules: Evaluation of commercial capsules 
  • Pellets and Ophthalmic Preparations
  •   Pellets: Introduction, formulation, pelletization process, equipment needed
  •  Ophthalmic Preparations: Introduction, absorption through eye, formulation considerations
  •  Ophthalmic Preparations:  formulation of eye drops, lotion, ointments
  •    Ophthalmic Preparations:  Methods of preparation; labeling, containers Evaluation
  • Pharmaceutical Aerosols
  •  Pharmaceutical Aerosols: Definitions, Advantages, Limitation, Uses
  •  Pharmaceutical Aerosols: Components of aerosols
  •  Pharmaceutical Aerosols: Components and systems of aerosols
  •    Pharmaceutical Aerosols: inhalers and  Evaluation of Aerosols
  • Cosmetics
  •  Cosmetics: Introduction, absorption through skin, types of cosmetic preparations, Formulation of tooth pastes Cosmetics: Formulation of lipsticks, shampoos, hair dyes  
  •  Cosmetics: Formulation of cold cream and vanishing cream, sunscreens
  • Packaging Materials Science
  •  Packaging Materials Science: Materials used for packaging of pharmaceutical products, 
  •  Packaging Materials Science: Factors influencing choice of containers Legal and official requirements, Stability aspects,
  •  Packaging Materials Science: Quality control tests of packaging materials

BOOKS AND REFERENCES

  • IP/USP/BP
  • Semalty et al. Essentials of Pharmaceutical Technology, II edn 2018, reprint 2019, Pharma med Press, Hyderabad
  • Niazi SK, Handbook of Preformulation, Informa Health Care, 2007
  • Aulton ME (ED), Pharmaceutics: The science of Dosage form design, II edn, Churchill Livingstone, London, 2002.
  • Banker GS & Rhodes T, Modern Pharmaceutics, CRC Press.
  • Lachman L/Lieberman HA, Kanig JL, The Theory and Practice of Industrial Pharmacy,4E (2013).
  • Qiu Y, Chang Y and Zhang GZ (Exe. Eds), Developing solid oral dosage forms: Pharmaceutical theory and practice, Elsevier, 2009.
  • Gibson M. (Ed), Pharmaceutical Preformulation and formulation: a practical guide from candidate drug selection to commercial dosage form, II edn, Informa Healthcare.
  • Qiu Y, Chang Y and Zhang GZ (Exe. Eds), Developing solid oral dosage forms: Pharmaceutical theory and practice, Elsevier, 2009
  • Dressman JB, Karmer J, Pharmaceutical Dissolution Testing, 2005, Taylor & Francis, NY.
  • Ansel’s Pharmaceutical Dosage Forms and Drug Delivery Systems. Philadelphia: Lipincott Williams and Wilkins.
  • Augsburger LL, Hoag SW (Eds), Pharmaceutical Dosage Forms: Tablets, Volume 1, III Edn, Informa healthcare, 2008

CERTIFICATE IN QC AND PHARMACEUTICAL PRODUCTION

ELIGIBILITY

Graduates (B.Sc. / B. Pharm.) to Post Graduates (M.Sc. / M. Pharm.) in the field of Life Sciences and Pharmacy.


Duration

Five weeks


FEES

16,000/-

  • Orientation and overview of the Pharmaceuticals industry
  • Managing Environmental Health and Safety Compliance 
  • Application of Chemistry, Quality and Engineering Concepts in Manufacturing of Drugs
  • cGMP for Production Personnel
  • Standard Operating procedure - Preparation to Implementation
  • Fundamentals of Clean Room Behaviour
  • Manufacturing Process of Non-Sterile API and Drug Product (Including WPU and Packaging)
  • Manufacturing Batch Record Review
  • Developing CAPA Strategy in Pharma Manufacturing
  • Manufacturing Quality Management
  • GDP and Data Integrity (DI) for Production Personnel
  • Change Control Process
  • Process Validation for Production Personnel (including cleaning validation)
  • Managing waste Disposal
  • Audit Preparation for Production Personnel
  • Professional Skills for Production Personnel
DELIVERY MODE
  • The Program will be delivered online.
  • Students will be provided with unique login and password details to access “Daksh” portal
  • The Program will be delivered in a Hybrid Mode.
    • Self-learning Material for Students
    • Assessment towards end of each Chapter/Unit
    • 5 Days a Week Webinars with Industry experts for every module
    • Practical Demonstration on Video based learning for key manufacturing processes
    • Weekend Assignment
    • Assessment towards the end of Program
    • Certification to each successful participant

CERTIFICATION PROGRAM IN QUALITY ANALYTICS

ELIGIBILITY

Graduates (B.Sc. / B. Pharm./B.Tech) to Post Graduates (M.Sc. / M. Pharm./ M.Tech.) in the field of Life Sciences and Pharmacy.


Duration

This five-week online training.


FEES

16,000/-


PROGRAM MODULES
  • Orientation and overview of the Pharmaceuticals industry
  • Managing Environmental Health and Safety Compliance 
  • Application of Chemistry, Quality and Engineering Concepts in Quality Analysis of Samples
  • cGMP for Quality Control Personnel
  • cGLP and cGDP for Quality Control Personnel
  • Standard Operating procedure - Preparation to Implementation
  • Glassware used in Analysis
  • Volumetric Measurement
  • Weighing & Measurement
  • Sample Management
  • Method Validation
  • Process Validation for QC Personnel (including cleaning validation)
  • Equipment Qualification
  • Sample Results Analysis
  • Lab Management Information System
  • Managing waste Disposal
  • Audit Preparation for Quality Control Personnel
  • Professional Skills for Quality Control Personnel
DELIVERY MODE
  • The Program will be delivered online.
  • Students will be provided with unique login and password details to access “Daksh” portal
  • The Program will be delivered in a Hybrid Mode.
    • Self-learning Material for Students
    • Practical Demonstration on Video based learning for key quality control processes
    • Assessment towards end of each Chapter/Unit
    • Weekend Webinars (Saturday & Sunday) with Industry experts
    • Weekend Assignment
    • Assessment towards the end of Program
    • Certification to each successful participant

Course, Duration & Fee Structure


S.No Course Duration Course Fee (Rupees) Course Fee (Rupees)1st Installment Course Fee(Rupees) 2nd Installment
1 Certificate Programe in Quality Analytics 3 Month 36,000 12,000 24,000
2 Certificate in QC and Pharmaceutical Production 3 Month 36,000 12,000 24,000
3 Certificate in Industrial Pharmacy 3 Month 36,000 12,000 24,000
4 Executive MBA in Pharma Management 1 Year 50,000 25,000 25,000