Pharmatipszone
Pharmatipszone: - The website deals with the Pharma related topics. It is a common platform for Industrial professionals, Pharmacy lecturers and students uniting them by sharing the views and subject related questionnaires, new thoughts and ideas. Students can share their Abstracts, Project related topics. New courses related to the pharmacy, Featured jobs are also can be updated in the blog.
This page gives you the information regarding Pharmaceutical Analysis, Pharmacopeia Methods, GMP, GLP , Data Integrity, Industrial training, Pharma News, PCI updates, Student forum.
Anyone can share their views and ideas to the page. The page will give you clear and complete solution their Queries.
The clear objective is to bring the Pharmacy Professionals to one thread there by sharing the knowledge.
Pharmatipszone
Question:
Can anyone Explain about GAMP 5 Guidelines of CSV systems?
Answer here
1 month ago | [YT] | 0
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Pharmatipszone
Question:
What is called CSV and what are the applications of CSV in the pharmaceutical industry?
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Pharmatipszone
Interview Question:
What is DMF and What are the types in Regulatory Affairs?
Answer:
DMF stands for Drug Master File in regulatory submissions of a Drug Substance or Drug Product and all other Drug related packaging and Intermediates, Excipients
It has the complete information about your submission
Drug Master File contains the confidential information about the Material's (Drug Substance or Drug Product or any Intermediate or Packaging Material) CMC that has Chemistry, Manufacturing and controls. that means how your product is Manufacturing and its Specifications.
It is submitted to the Regulatory agencies like FDA as a supporting document during IND, NDA and ANDA submissions
DMF as it contains Product and Manufacturing details, It is submitted as a confidential Document which protects the Intellectual Properties of the Submitters (manufacturers) during IND, NDA and ANDA submissions
DMFs are categorised as Type-I, Type-II, Type-III, Type-IV and Type-V
Type I has information about Manufacturing sites, Personnel, Operating Procedures
Type II has information of Drug substance, Drug Product, Intermediates and the Materials used in preparation of Drug product
Type-III has Packaging Material Information like Primary and secondary packing, How the Materials and Drug product Packed and the details of chemistry of Packaging Material, like HDPE containers.
Type IV has Excipients used in Manufacturing procedure like for a Tablets what and which colorants, Binders are used and it depends on Formulation like Lyophilised forms, for Injections and Injections and all kinds
Type V has FDA accepted reference information like Biocompatibility and Toxicology information combination product components, any specific procedures
DMF Type. Information included
Type-I. Manufacturing site, Personnel, Operating Procedures
Type-II. Drug substance, Intermediates and or Drug product
Type-III. Packing
Materials
Type-IV. Excipients
Type-V. FDA accepted reference Information ( Biocompatibility and Toxicology information)
For your comments and suggestions
Post in the link below
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1 month ago (edited) | [YT] | 0
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Pharmatipszone
KT (Knowledge Transfer) :
What is dwell volume and explain in the given link
www.pharmatipszone.com/analytical/what-is-dwell-vo…
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Pharmatipszone
The question is Why do we do Mass balance in Forced degradation
Answer this by opening the link
www.pharmatipszone.com/analytical/why-do-we-do-mas…
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Pharmatipszone
Interview Question:
What is the Acceptance criteria of Mass balance for Assay and Related substances in Forced Degradation
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Pharmatipszone
Which of the following drugs are Class-III category ( High soluble and Low Permeable)
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Pharmatipszone
Question:
What is the Biopharmaceutical classification, and what are they?
and
What is the Classification of Insulin?
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Pharmatipszone
Question:
India comes under which stability zone?
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Pharmatipszone
Question:
Which is the Class-III category based on Solubility and Permeability?
1 month ago | [YT] | 1
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