Hello friends, in this post, I have shared an overview and download links of notes of Industrial Pharmacy 2 (BP702T) according to the PCI syllabus for B Pharm 7th Semester 2023.
In the notes of Industrial Pharmacy 2 (BP702T), we have given two types of notes namely Handwritten notes and Standard notes.
Industrial Pharmacy 2 notes are designed to help students understand the fundamentals regarding the process of developing pharmaceutical products and their transfer from the lab to the market.
Friends Industrial Pharmacy 2 is the subject of the 7th semester of the B Pharm course, and as per the syllabus copy of PCI B Pharm 7th semester, there are a total of 5 units in this subject.
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Click on the following download buttons below the names of the units to download Industrial Pharmacy 2 both Handwritten and Standard Notes.
In the Industrial Pharmacy 2 Notes Pdfs, the following chapters are explained in detail.
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
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
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.
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.
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.
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