Industrial pharmacy 2 7th sem – Notes, syllabus, books, mcqs

Industrial pharmacy 2 7th sem – Notes, syllabus, books, mcqs Here are the seventh semester b pharmacy of Industrial Pharmacy notes. So friends we are going to discuss this topics in this article they are – syllabus, notes pdf, university question paper, Industrial pharmacy 2 pv book pdf free download etc.

Industrial pharmacy 2

Industrial pharmacy 2 syllabus

Syllabus of IP- II is given below:

There are total five units :

• UNIT 1
• UNIT 2
• UNIT 3
• UNIT 4
• UNIT 5

UNIT 1

Unit 1 is basically based on the pilot plant scale up techniques. Important topics are as follows :

• General considerations
• Personnel requirements
• Space requirements
• Raw material requirements.
• Pilot plant scale up Consideration for solid, liquid, orals, semisolids and relevant documentation.

UNIT 2

Unit 2 is basically based on the Technology transfer(TT). Important topics are given below :

• WHO guidelines
• Terminology Technology transfer protocols
• Quality management
• Transfer from R and D to Production place.
• Finished product packaging
• Qualification and validation
• Quality control
• Write Analytics method for transfer
• Regulatory bodies and their agencies
• TT agencies in india
• Licensing
• Legal issues

UNIT 3

Unit 3 is based on Regulatory affairs and its requirements for drug approval. Important topics of these unit are as follows :

• Introduction
• Historical overview
• Authorities for regulations
• Role and responsibilities of regulatory affairs departments For drug approval Drug approval teams
• Nonclinical drug development
• Pharmacological studies
• Drug metabolism study
• And toxic effect of drugs
• Considerations of Investigational new drug application
• Detail in investigator’s brochure(IB)
• About newly drugs application
• Clinical researches for drug
• and its protocols
• Write a note on Biostatistics in PPD
• Give a introduction on Data presentation to the FDA submissions
• Management of clinical studies

UNIT 4

Unit 4 is for Quality Management. Important topics are:

• Quality management and its certification
• Concepts of quality
• Define quality
• Total quality management
• Quality by design (QbD)
• Six sigma conceptOut of specifications (OOS)
• Change control
• Write in detail about the ISO 9000 series of quality systems standards
• And also in detail about ISO 14000 series
• Good laboratory practices (GLP)

UNIT 5

Unit 5 is the Indian regulatory requirements. The important topics are given as follows :

• About central drug standard control organizations (CDSCO)
• state Licensing Authority its organization,
• Responsibilities of bodies
• Proper Certificate of pharmaceutical product development ( COPP).
• Write down in detail about the Regulatory requirements and approval procedures for New Drugs.

Industrial pharmacy 2 notes pdf

Download here all unites of Industrial Pharmacy – 2 Click on the below units

UNIT 1

UNIT 2

UNIT 3

UNIT 4

UNIT 5

Industrial pharmacy 2 question paper

Previous years question papers give you an idea about the questions usually asked in exams. If for industrial pharmacy then mostly questions are asked are repeated questions. Do refer your university question paper. Previous questions of various universities.

AKTU University

DBATU University

GONDWANA UNIVERSITY

RTMNU University

SGBAU University

Industrial pharmacy 2 pv book pdf free download

CLICK HERE to get all publications books you want link download here

As you are in seventh semester for an industrial pharmacy subject you refer to the publications books that will cover all the important topics.

This ttelegram group specially made for final year students to get help in their studies. In this group we daily updates about 7th semester what ever material needs we uploads so join as soon as possible and be a part of our family thank you if you have already joined.

Also read:

NDDS Question Bank – Novel Drug Delivery system 7th ssemester link

Conclusion

So friends this was all about industrial pharmacy I hope you get a clear understanding of the units and its important topics you need to prepare for. This was my article if you like do share and subscribe us for more thank you. Please visit next time.

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