This presentation is aimed at providing information on automation in the GLP practices in the pharmaceutical industry.
-Standard Operating Procedures.
-Documentation in GALP.
-Logs and Related Forms.
MARKETING AUTHORISATION, LICENSING AND QUALITY ASSESSMENT OF VACCINES IN INDI...Swapnil Fernandes
- European pharmaceutical legislation provides a comprehensive framework for the marketing authorisation of vaccines.
- In contrast to the European scenario, the Indian scenario for vaccines is relatively less regulated and follows the same process of approval as other biologics in spite of having a National Handbook for Vaccine Policy.
- Vaccine authorisation in the US, as is the case in EU, is a more straightforward process than in most other markets as the USFDA has provided vaccines with a distinct set of regulations in concerned areas of safety and quality.
What is a Variation…?
Variation regulations and guidelines
Types of variations
Type-IA
Type-IB
Type-II
Extension
Unforeseen variations (Z category)
Grouping of variations
Work sharing of variations
Fee
eAF
Renewals
This presentation is aimed at providing information on automation in the GLP practices in the pharmaceutical industry.
-Standard Operating Procedures.
-Documentation in GALP.
-Logs and Related Forms.
MARKETING AUTHORISATION, LICENSING AND QUALITY ASSESSMENT OF VACCINES IN INDI...Swapnil Fernandes
- European pharmaceutical legislation provides a comprehensive framework for the marketing authorisation of vaccines.
- In contrast to the European scenario, the Indian scenario for vaccines is relatively less regulated and follows the same process of approval as other biologics in spite of having a National Handbook for Vaccine Policy.
- Vaccine authorisation in the US, as is the case in EU, is a more straightforward process than in most other markets as the USFDA has provided vaccines with a distinct set of regulations in concerned areas of safety and quality.
What is a Variation…?
Variation regulations and guidelines
Types of variations
Type-IA
Type-IB
Type-II
Extension
Unforeseen variations (Z category)
Grouping of variations
Work sharing of variations
Fee
eAF
Renewals
It contains details rules and regulations /legislation of Pharmaceuticals, Cosmetics, Active Substance Masters File, Investigational Medicinal Product Dossier for European Union
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Herbal medicines are popular because of experience and the abundant
availability of plants in India due to its varied climatic zones. India has
around 45,000 species of plants, out of which 15,000–20,000 plants have
proven medicinal value.
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this ppt is about all the rules and regulations of drugs in Japan.this ppt contains the PMDA structure, DMF data, IND and NDA procedure, cosmetic regulations, post marketing survelliance etc.
It contains details rules and regulations /legislation of Pharmaceuticals, Cosmetics, Active Substance Masters File, Investigational Medicinal Product Dossier for European Union
Medical Devices registration in Japan , quality system requirements and evaluation and investigation of medical devices in regulated countries ASEAN, China JAPAN and WHO regulations. quality and ethical considerations regulatory and documentation requirements for marketing medical devices and IVDs in regulated countries.
Herbal medicines are popular because of experience and the abundant
availability of plants in India due to its varied climatic zones. India has
around 45,000 species of plants, out of which 15,000–20,000 plants have
proven medicinal value.
FDA WARNING LETTER IS A OFFICIAL LETTER FROM USFDA TO A MANUFACTURING FIRM TO NOTICE THE SERIOUS VIOLATION FOUND AT THE FDA INSPECTION AT FIRM AND THE CORRECTIVE ACTION SHOULD TO TAKEN BY FIRM TO OVERCOME THE VIOLATION FOR FDA APPROVAL
plasma master file in European countries and requirements in letter of intent...Sanjay batra
it includes that what is plasma master file, principles, procedure to file PMF, strategy involved, administration information, certification procedure & inspection
Regulatory requirnment and approval procedure of drugs in japan pptsandeep bansal
this ppt is about all the rules and regulations of drugs in Japan.this ppt contains the PMDA structure, DMF data, IND and NDA procedure, cosmetic regulations, post marketing survelliance etc.
Regulatory aspect of pharmaceutical change control systemDeveshDRA
CHANGE CONTROL,BENEFITS OF CHANGE CONTROL SYSTEM,MANAGEMENT OF CHANGE AND CONTINUOUS IMPROVEMENT(Prepare a Change Proposal,Classify & Approve Proposed Changes,Develop an Implementation Plan, Install the Change,Verify Installation,Close out the change
) FLOW CHART OF CHANGE MANAGEMENT,HANDLING AND CONTROLLING CHANGES,SOP ON CHANGE CONTROL SYSTEM,
CATEGORY OF CHANGES(Major Changes,Moderate changes,Minor changes),ENSURING TRAINING & PROCEDURES IN A MANAGEMENT OF CHANGE PROGRAM,LEVEL OF APPROVAL,REGULATOR PROSPECTIVE OF CHANGE CONTROL(21 CFR Part 211: Sec. 211.100,21 CFR Part 211.194 (Laboratory Records),ICH Q7A,USFDA Guidance for Industry: Change to an approved NDA or ANDA ( April 2004- Revison-1)),CONCLUSION
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ATUL CHAUDHARY (STUDENTS)
DEPARTMENT OF PHARMACEUTICS
ISF COLLEGE OF PHARMACY, GHALKALAN, MOGA , PUNJAB
THIS SLIDE IS THE BEST SLIDE FOR PREPARING THE TOPIC SUPAC OF REGULATORY AFFAIRS SUBJECT
SLIDE ARE SPECIALLY DESIGN FOR MASTER STUDENTS AS WELL AS GRADUATION STUDENTS
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Synthetic Fiber Construction in lab .pptxPavel ( NSTU)
Synthetic fiber production is a fascinating and complex field that blends chemistry, engineering, and environmental science. By understanding these aspects, students can gain a comprehensive view of synthetic fiber production, its impact on society and the environment, and the potential for future innovations. Synthetic fibers play a crucial role in modern society, impacting various aspects of daily life, industry, and the environment. ynthetic fibers are integral to modern life, offering a range of benefits from cost-effectiveness and versatility to innovative applications and performance characteristics. While they pose environmental challenges, ongoing research and development aim to create more sustainable and eco-friendly alternatives. Understanding the importance of synthetic fibers helps in appreciating their role in the economy, industry, and daily life, while also emphasizing the need for sustainable practices and innovation.
2024.06.01 Introducing a competency framework for languag learning materials ...Sandy Millin
http://sandymillin.wordpress.com/iateflwebinar2024
Published classroom materials form the basis of syllabuses, drive teacher professional development, and have a potentially huge influence on learners, teachers and education systems. All teachers also create their own materials, whether a few sentences on a blackboard, a highly-structured fully-realised online course, or anything in between. Despite this, the knowledge and skills needed to create effective language learning materials are rarely part of teacher training, and are mostly learnt by trial and error.
Knowledge and skills frameworks, generally called competency frameworks, for ELT teachers, trainers and managers have existed for a few years now. However, until I created one for my MA dissertation, there wasn’t one drawing together what we need to know and do to be able to effectively produce language learning materials.
This webinar will introduce you to my framework, highlighting the key competencies I identified from my research. It will also show how anybody involved in language teaching (any language, not just English!), teacher training, managing schools or developing language learning materials can benefit from using the framework.
How to Split Bills in the Odoo 17 POS ModuleCeline George
Bills have a main role in point of sale procedure. It will help to track sales, handling payments and giving receipts to customers. Bill splitting also has an important role in POS. For example, If some friends come together for dinner and if they want to divide the bill then it is possible by POS bill splitting. This slide will show how to split bills in odoo 17 POS.
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Unit 8 - Information and Communication Technology (Paper I).pdfThiyagu K
This slides describes the basic concepts of ICT, basics of Email, Emerging Technology and Digital Initiatives in Education. This presentations aligns with the UGC Paper I syllabus.
4. Types Of Prior Approval
Supplements
Standard
PASs
• Within 6 months of
submission date if
preapproval inspection
not required.
• Within 10 months of
submission date if
preapproval
inspection required.
Priority PASs
• Within 4 months of
submission date if
preapproval inspection
not required.
• Within 8 months,
provided the applicant,
not later than 60 days
prior to the submission
of an application
• Within 10 months of
submission date if FDA
determines it does not
appear to meet the
prioritization criteria.
General information contained in the
supplement:
A detailed description of the proposed
change
The drug product(s) involved
The manufacturing site(s) or area(s)
affected
A description of the methods used and studies
performed to assess the effects of the change
and the data derived from such studies
Relevant validation protocols and S.O.P. for
Herbals and Biologics
Relevant validation protocols and S.O.P. for
sterilization process and test methodologies
related to it.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
15.
16.
17.
18. To facilitate processing, FDA recommends that the applicant provide the following
information on the first page of the submission:
A
statement
indicating
whether
the PAS is
for a new-
strength
product
A
statement
indicating
whether
the PAS is
for a
request for
proprietary
name
review.
A statement
indicating
whether the
PAS is for a
Risk
Evaluation
and
Mitigation
Strategy
(REMS) or a
REMS
modification.
A statement
indicating
whether the
submission is
an
amendment
to a PAS, and
whether it is a
major or
minor
amendment
A statement
indicating
whether the
PAS contains
any
manufacturin
g or facilities
changes
A list of the
specific review
disciplines to
review the PAS
(Chemistry,
Biopharmaceutics,
Labeling, DMF,
Bioequivalence,
Microbiology, or
Clinical)
If expedited
review is
requested, the
label Expedited
Review Request
should be placed
prominently at
the top of the
submission. The
submission
should include a
basis for the
expedited review
Any PAS to an approved ANDA should identify on the first page of the submission
that it is a PAS.
19. Fees For PAS
GDUFA I established application fees (for ANDAs, PASs to ANDAs, and certain DMFs), annual facility
fees, and a one-time fee for ANDAs that were pending on October 1, 2012.
As explained in the GDUFA II Commitment Letter, however, the Agency and industry agreed to the
elimination of PAS fees. As of October 1, 2017, ANDA applicants are no longer required to pay
application fees when they submit a PAS.