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Industrial Pharmacy 2 B Pharm 7th Semester Notes PDF [2023]

Hello Dear Friends, How are you all, hope you are doing well, today in this article we are going to tell you how you can download Industrial Pharmacy 2 B.Pharma 7th Semester Notes Download Free PDFs for free. Friends, you will also get to see PDF and download links of B.Pharmacy 7th Semester Handwritten and Standard Notes in this article.

According to the syllabus of 2023 by PCI (Pharmacy Council of India), you will get the link to download all the handwritten and standard notes, you get the option to download all the notes semester wise or unit wise.

Industrial Pharmacy 2 B.Pharm 7th Semester Information:

Course NameB.Pharma
Semester Year7th Semester
Notes TypesHandwritten & Standard Notes
PCI Syllabus NotesLatest PCI 2023
Subject NameIndustrial Pharmacy 2
CategoryB Pharm
Telegram Group LinkJoin Us
Official Website PCIwww.pci.nic.in

Note:- Friends, on this website all types of information like – B.Pharma and D.Pharma All Subject PDF Free Notes, Semester Wise Note, Latest Syllabus 2023 and Exam Pattern 2023 Download, Previous Year Question Paper PDF Download etc.

Also Read : B Pharm 1st Semester Notes Free PDFs Download

Industrial Pharmacy 2 Syllabus 2023 Pdf Download

Let us see what is in the syllabus of Industrial Pharmacy 2.

Unit I

  • Methods to scale up Pilot plants: General considerations include the significance of personnel requirements and space requirements, the raw materials, Scale-up Pilot plants to solids, liquids semi-solids, and solids, as well as relevant documents, SUPAC guidelines, Introduction to the technology platform

Unit 2

  • Development and transfer in technology: WHO standards for Technology Transfer(TT) Terminology Protocol for Technology Transfer, Quality risk management, and transfer from R & D to production (Process packaging and cleaning) The degree of the Technology Transfer Process (API Excipients and packaging materials, as well as the final items) Documentation, facilities and equipment for validation and qualification quality control Transfer of analytical methods that are approved by regulatory bodies and organizations commercialization – the actual aspects and concerns (case research studies) along with TT institutions located in India (including APCTD, NRDC, TIFAC, BCIL, TBSE and SIDBI Documentation that pertains with TT such as confidentiality agreement, Mou’s, licensing agreements and legal concerns

Unit 3

  • An introduction to Regulatory Affairs: Historical review of the topic historical overview of the subject as well as Regulatory Authority, and the job of the department that is responsible for Regulatory Affairs.
  • The responsibilities of Regulatory Affairs Professionals, Regulatory conditions for approval of drugs to be approved for use: Drug Development Teams Non-clinical Drug Development Pharmaceutical and Pharmacology Drug Metabolism and Toxicology, General issues that are part of Investigational New Drug (IND) Application Investigator’s Brochure (IB) and New Drug Application (NDA) Clinical research/BE studies the Clinical Research Protocols Statistics in the field of Pharmaceutical Product Development and Data Presentations for FDA Submissions as well as Management for Clinical Studies.

Unit 4

  • Quality Management Systems: for Quality Management and certifications concepts of Quality are the idea of Quality Total Management (QLD) Q. by Design, Six Sigma concept and out of Specifications (OOS) in addition to along with Change Control introduction of the ISO 9000 series of quality standards for systems, ISO 14000, NABL, GLP.

Unit 5

  • Indian Regulatory Requirements: Central Drug Standard Control Organization (CDSCO) and State Licensing Authority: Organization Responsibilities, Certificate of Pharmaceutical Product (COPP) Regulations, and approval procedures for new drugs.
B.Pharma Syllabus 2023Download Link
B.Pharma A to Z Semester Syllabus PDFCLICK HERE

ALSO READ

B.PHARMA 1ST SEMESTER NOTES PDFDOWNLOAD LINK
Human Anatomy And Physiology-1CLICK HERE
Pharmaceutical AnalysisCLICK HERE
PharmaceuticsCLICK HERE
Pharmaceutical Inorganic ChemistryCLICK HERE
Communication SkillSCLICK HERE

Download free Pdf of notes of Industrial Pharmacy 2

You can download free Pdfs of Industrial Pharmacy 2 Standard Notes by clicking on the download links given below table.

Standard NotesDownload Link
UNIT-1CLICK HERE
UNIT-2CLICK HERE
UNIT-3CLICK HERE
UNIT-4CLICK HERE
UNIT-5CLICK HERE

You can download free Pdfs of Industrial Pharmacy 2 Handwritten Notes by clicking on the download links given below table.

Handwritten NotesDownload Link
UNIT-1CLICK HERE
UNIT-2CLICK HERE
UNIT-3CLICK HERE
UNIT-4CLICK HERE
UNIT-5CLICK HERE

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