This document provides guidance for post-approval changes to NDAs and ANDAs in accordance with section 506A of the Federal Food, Drug, and Cosmetic Act. It supersedes previous guidance from 1999. Recommendations are provided for post-approval changes in components and composition, manufacturing sites, manufacturing processes, specifications, container closure systems, and labeling. Changes are categorized as major, moderate, or minor based on their potential effect on a drug's safety and effectiveness. Major changes requiring prior approval include formulation changes and changes to manufacturing sites without satisfactory CGMP inspections. Moderate changes may be submitted as a supplement either 30 days or immediately before distribution. Minor changes can be described in an annual report.
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.
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.
A brief presentation on the Code of Federal Regulations
Covers the following aspects -
- What is CFR?
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- CFR in modern times.
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It contains details rules and regulations /legislation of Pharmaceuticals, Cosmetics, Active Substance Masters File, Investigational Medicinal Product Dossier for European Union
A brief presentation on the Code of Federal Regulations
Covers the following aspects -
- What is CFR?
-History of CFR
- CFR Title 21
- CFR in modern times.
- Research tools in CFR
It contains details rules and regulations /legislation of Pharmaceuticals, Cosmetics, Active Substance Masters File, Investigational Medicinal Product Dossier for European Union
Accpac to QuickBooks Conversion Navigating the Transition with Online Account...PaulBryant58
This article provides a comprehensive guide on how to
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Explore our most comprehensive guide on lookback analysis at SafePaaS, covering access governance and how it can transform modern ERP audits. Browse now!
Memorandum Of Association Constitution of Company.pptseri bangash
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A Memorandum of Association (MOA) is a legal document that outlines the fundamental principles and objectives upon which a company operates. It serves as the company's charter or constitution and defines the scope of its activities. Here's a detailed note on the MOA:
Contents of Memorandum of Association:
Name Clause: This clause states the name of the company, which should end with words like "Limited" or "Ltd." for a public limited company and "Private Limited" or "Pvt. Ltd." for a private limited company.
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Registered Office Clause: It specifies the location where the company's registered office is situated. This office is where all official communications and notices are sent.
Objective Clause: This clause delineates the main objectives for which the company is formed. It's important to define these objectives clearly, as the company cannot undertake activities beyond those mentioned in this clause.
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Liability Clause: It outlines the extent of liability of the company's members. In the case of companies limited by shares, the liability of members is limited to the amount unpaid on their shares. For companies limited by guarantee, members' liability is limited to the amount they undertake to contribute if the company is wound up.
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Capital Clause: This clause specifies the authorized capital of the company, i.e., the maximum amount of share capital the company is authorized to issue. It also mentions the division of this capital into shares and their respective nominal value.
Association Clause: It simply states that the subscribers wish to form a company and agree to become members of it, in accordance with the terms of the MOA.
Importance of Memorandum of Association:
Legal Requirement: The MOA is a legal requirement for the formation of a company. It must be filed with the Registrar of Companies during the incorporation process.
Constitutional Document: It serves as the company's constitutional document, defining its scope, powers, and limitations.
Protection of Members: It protects the interests of the company's members by clearly defining the objectives and limiting their liability.
External Communication: It provides clarity to external parties, such as investors, creditors, and regulatory authorities, regarding the company's objectives and powers.
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Binding Authority: The company and its members are bound by the provisions of the MOA. Any action taken beyond its scope may be considered ultra vires (beyond the powers) of the company and therefore void.
Amendment of MOA:
While the MOA lays down the company's fundamental principles, it is not entirely immutable. It can be amended, but only under specific circumstances and in compliance with legal procedures. Amendments typically require shareholder
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Business Valuation Principles for EntrepreneursBen Wann
This insightful presentation is designed to equip entrepreneurs with the essential knowledge and tools needed to accurately value their businesses. Understanding business valuation is crucial for making informed decisions, whether you're seeking investment, planning to sell, or simply want to gauge your company's worth.
India Orthopedic Devices Market: Unlocking Growth Secrets, Trends and Develop...Kumar Satyam
According to TechSci Research report, “India Orthopedic Devices Market -Industry Size, Share, Trends, Competition Forecast & Opportunities, 2030”, the India Orthopedic Devices Market stood at USD 1,280.54 Million in 2024 and is anticipated to grow with a CAGR of 7.84% in the forecast period, 2026-2030F. The India Orthopedic Devices Market is being driven by several factors. The most prominent ones include an increase in the elderly population, who are more prone to orthopedic conditions such as osteoporosis and arthritis. Moreover, the rise in sports injuries and road accidents are also contributing to the demand for orthopedic devices. Advances in technology and the introduction of innovative implants and prosthetics have further propelled the market growth. Additionally, government initiatives aimed at improving healthcare infrastructure and the increasing prevalence of lifestyle diseases have led to an upward trend in orthopedic surgeries, thereby fueling the market demand for these devices.
Enterprise Excellence is Inclusive Excellence.pdfKaiNexus
Enterprise excellence and inclusive excellence are closely linked, and real-world challenges have shown that both are essential to the success of any organization. To achieve enterprise excellence, organizations must focus on improving their operations and processes while creating an inclusive environment that engages everyone. In this interactive session, the facilitator will highlight commonly established business practices and how they limit our ability to engage everyone every day. More importantly, though, participants will likely gain increased awareness of what we can do differently to maximize enterprise excellence through deliberate inclusion.
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Enterprise Excellence is a holistic approach that's aimed at achieving world-class performance across all aspects of the organization.
What might I learn?
A way to engage all in creating Inclusive Excellence. Lessons from the US military and their parallels to the story of Harry Potter. How belt systems and CI teams can destroy inclusive practices. How leadership language invites people to the party. There are three things leaders can do to engage everyone every day: maximizing psychological safety to create environments where folks learn, contribute, and challenge the status quo.
Who might benefit? Anyone and everyone leading folks from the shop floor to top floor.
Dr. William Harvey is a seasoned Operations Leader with extensive experience in chemical processing, manufacturing, and operations management. At Michelman, he currently oversees multiple sites, leading teams in strategic planning and coaching/practicing continuous improvement. William is set to start his eighth year of teaching at the University of Cincinnati where he teaches marketing, finance, and management. William holds various certifications in change management, quality, leadership, operational excellence, team building, and DiSC, among others.
The world of search engine optimization (SEO) is buzzing with discussions after Google confirmed that around 2,500 leaked internal documents related to its Search feature are indeed authentic. The revelation has sparked significant concerns within the SEO community. The leaked documents were initially reported by SEO experts Rand Fishkin and Mike King, igniting widespread analysis and discourse. For More Info:- https://news.arihantwebtech.com/search-disrupted-googles-leaked-documents-rock-the-seo-world/
3.0 Project 2_ Developing My Brand Identity Kit.pptxtanyjahb
A personal brand exploration presentation summarizes an individual's unique qualities and goals, covering strengths, values, passions, and target audience. It helps individuals understand what makes them stand out, their desired image, and how they aim to achieve it.
What is the TDS Return Filing Due Date for FY 2024-25.pdfseoforlegalpillers
It is crucial for the taxpayers to understand about the TDS Return Filing Due Date, so that they can fulfill your TDS obligations efficiently. Taxpayers can avoid penalties by sticking to the deadlines and by accurate filing of TDS. Timely filing of TDS will make sure about the availability of tax credits. You can also seek the professional guidance of experts like Legal Pillers for timely filing of the TDS Return.
Unveiling the Secrets How Does Generative AI Work.pdfSam H
At its core, generative artificial intelligence relies on the concept of generative models, which serve as engines that churn out entirely new data resembling their training data. It is like a sculptor who has studied so many forms found in nature and then uses this knowledge to create sculptures from his imagination that have never been seen before anywhere else. If taken to cyberspace, gans work almost the same way.
Attending a job Interview for B1 and B2 Englsih learnersErika906060
It is a sample of an interview for a business english class for pre-intermediate and intermediate english students with emphasis on the speking ability.
RMD24 | Debunking the non-endemic revenue myth Marvin Vacquier Droop | First ...BBPMedia1
Marvin neemt je in deze presentatie mee in de voordelen van non-endemic advertising op retail media netwerken. Hij brengt ook de uitdagingen in beeld die de markt op dit moment heeft op het gebied van retail media voor niet-leveranciers.
Retail media wordt gezien als het nieuwe advertising-medium en ook mediabureaus richten massaal retail media-afdelingen op. Merken die niet in de betreffende winkel liggen staan ook nog niet in de rij om op de retail media netwerken te adverteren. Marvin belicht de uitdagingen die er zijn om echt aansluiting te vinden op die markt van non-endemic advertising.
2. This guidance provides recommendations to holders of NDAs and ANDAs who intend
to make post approval changes in accordance with section 506A of the Federal Food,
Drug, and Cosmetic Act and 314.70 (21 CFR 314.70). It supersedes the guidance of the
same title published November 1999. Recommendations are provided for post approval
changes in
1. Components and composition
2. Manufacturing sites
3. Manufacturing process
4. Specifications
5. Container closure system, and
6. Labeling, as well as
7. Miscellaneous changes and
8. Multiple related changes. 2
3. 1. Guidance prepare: prepared by under the direction of the Chemistry,
Manufacturing and Controls Coordinating Committee in the Center for Drug
Evaluation and Research (CDER) at the FDA.
2. Modernization Act: On November 21, 1997, the President signed the FDA
Modernization Act of 1997.
3. Section 116 of the Modernization Act: amended the Act by adding section 506A,
which provides requirements for making and reporting manufacturing changes to an
approved application and for distributing a drug product made with such changes.
4. The FDA has revised its regulations: on supplements and other changes to an
approved application (21 CFR 314.70) to conform to section 506 A of the Act.
5/21/2019
DR G.K.SHARMA PHARMD, CPPM,
CGCPh, DCMS 3
4. To assess the effect of the change on the identity, strength (e.g., assay, content uniformity),
Quality (e.g., physical, chemical, and biological properties), Purity (e.g., impurities and
degradation products), or Potency (e.g., biological activity, bioavailability, bioequivalence) of
a drug product as these factors may relate to the safety or effectiveness of the drug product.
CDER has published guidance, including the SUPAC (scale-up and post approval changes)
guidance, that provide recommendations on reporting categories.
Reporting categories: This guidance does not provide for components and composition
changes. Section 506A of the Act and 314.70(c) provide for two types of changes-being
effected supplements while previously there was only one type.
A. Major change: is a change that has a substantial potential to have an adverse effect on the
identity, strength, quality, purity, or potency of a drug product as these factors may relate to the
safety or effectiveness of the drug product.
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DR G.K.SHARMA PHARMD, CPPM,
CGCPh, DCMS 4
5. Prior Approval Supplement: An applicant may ask FDA to expedite its review of a prior
approval supplement for public health reasons (e.g., drug shortage)
B. Moderate change: is a change that has a moderate potential to have an adverse effect on the
identity, strength, quality, purity, or potency of the drug product as these factors may relate to
the safety or effectiveness of the drug product. There are two types of moderate change. (
314.70(c)(6)).
Supplement - Changes Being Effected in 30 Days: requires the submission of a supplement
to FDA at least 30 days before the distribution of the drug product made using the change.
Supplement - Changes Being Effected: FDA may identify certain moderate changes for
which distribution can occur when FDA receives the supplement.
C. Minor change: minimal potential to have an adverse effect on the identity, strength, quality,
purity, or potency of the drug product as these factors may relate to the safety or effectiveness
of the drug product. The applicant must describe minor changes in its next Annual Report (
314.70(d)).
5/21/2019
DR G.K.SHARMA PHARMD, CPPM,
CGCPh, DCMS 5
6. a. Editorial changes: in previously submitted information (e.g., correction of spelling or
typographical errors, reformatting of batch records), (314.70(a)(1)).
b. Supplement or annual report: must include a list of all changes. list must be provided
in the cover letter (314.70(a)(6)). In annual reports, the list should be included in the
summary section (314.81(b)(2)(i)).
c. An applicant making a change: to an approved application under section 506A of the
Act must also conform to other applicable laws and regulations, including current good
manufacturing practice (CGMP) requirements of the Act (21 U.S.C. 351(a)(2)(B))
d. Code of Federal Regulations: (e.g., 21 CFR parts 210, 211, 314). labeling changes
under 314.70(c)(6)(iii) must include 12 copies of the final printed labeling
(314.70(c)(1)). In accordance with 314.70(a)(4), any labeling change implemented in
accordance with 314.70(b) or (c).
5/21/2019
DR G.K.SHARMA PHARMD, CPPM,
CGCPh, DCMS 6
7. A. Assessment of the Effects of the Change: The holder of an approved application under section 505 of
the Act manufacturing change.
1. Conformance to Specifications: A specification is a quality standard (i.e., tests, analytical procedures,
and acceptance criteria) provided in an approved application to confirm the quality of drug substances,
drug products, intermediates, raw materials, reagents, components, in-process materials, container
closure systems, and other materials used in the production of drug product. “Acceptance criteria are
numerical limits, ranges, or other criteria for the tests described.” Conformance to a specification means
that the 8 material, when tested according to the analytical procedures listed in the specification, will
meet the listed acceptance criteria.
2. Additional Testing: material affected by manufacturing changes that the applicant perform additional
testing, when appropriate, to assess whether the identity, strength, quality, purity, or potency of the drug
product as these factors may relate to the safety or effectiveness of the drug product have been or will be
affected.
5/21/2019
DR G.K.SHARMA PHARMD, CPPM,
CGCPh, DCMS 7
8. Evaluation of any changes in the chemical, physical, microbiological, biological,
bioavailability, or stability profiles. type of manufacturing change, the type of drug
substance and the effect of the change on the quality of the drug product. For example:
a. Evaluation of changes in the impurity: toxicology tests to qualify a new impurity.
b. Evaluation of the hardness or friability: tablet
B. Equivalence: When testing is performed, the applicant should usually assess the extent to
which the manufacturing change has affected the identity, strength, quality, purity, and potency
of the drug product. equivalent does not necessarily mean identical. Equivalence may also
relate to maintenance of a quality characteristic (e.g., stability) rather than a single
performance of a test.
C. Adverse Effect: Some manufacturing changes have an adverse effect on the identity, strength,
quality, purity, or potency of the drug product. If an assessment indicates that a change FDA
recommends that the change be submitted in a prior approval supplement regardless of the
recommended reporting category for the change. For example, a process change recommended
for a changes-being-effected-in-30days
5/21/2019
DR G.K.SHARMA PHARMD, CPPM,
CGCPh, DCMS 8
9. 1. Changes in the qualitative or quantitative formulation: including inactive
ingredients, as provided in the approved application, are considered major changes
requiring a prior approval supplement, unless exempted by regulation or guidance (
314.70(b)(2)(i)).
2. The deletion or reduction of an ingredient: intended to affect only the color of the
drug product may be reported in an annual report (314.70(d)(2)(ii)).
3. Guidance on changes in components and composition: that may be submitted in a
changes-being-effected supplement or annual report is not included in this document
because of the complexity of the recommendations, but may be covered in one or
more guidance documents describing post approval changes (e.g., SUPAC
documents).
5/21/2019
DR G.K.SHARMA PHARMD, CPPM,
CGCPh, DCMS 9
10. A. General Considerations: CDER must be notified when a manufacturer changes to a manufacturing site
that is different from those specified in the approved application (314.70(a)). Sites can include those
used by an applicant to
1. Manufacture or process drug products: in-process materials, drug substances, or drug substance
intermediates,
2. Package drug products,
3. Label drug products, and
4. Test components, drug product containers, closures, packaging materials, in-process materials, or drug
products.
a. Testing sites: include those performing physical, chemical, biological, and microbiological testing to
monitor, accept, or reject materials, as well as those performing stability testing.
b. FDA recommends: that a move to a different manufacturing site, when it is a type of site routinely
subject to FDA inspection, be submitted as a prior approval supplement if the site does not have a
satisfactory CGMP inspection for the type of operation being moved.
5/21/2019
DR G.K.SHARMA PHARMD, CPPM,
CGCPh, DCMS 10
11. A. Major Changes: following are examples of changes.
1. Changes that may affect the controlled (or modified) release,
2. Changes that may affect drug product sterility assurance including,
a. Changes in the sterilization method. These include changes from sterile filtered or aseptic processing to
terminal sterilization.
b. Addition to an aseptic processing line of new equipment made of different materials
c. Replacing a Class 100 aseptic fill area with a barrier system or isolator for aseptic filling.
d. Changes from bioburden-based terminal sterilization to the use of an overkill process,
e. Changes in materials or pore size rating of filters used in aseptic processing.
3. Manufacturing process or technology
Drug product: Dry to wet granulation
Drug substance: Filtration to centrifugation & Change in the route of synthesis of a drug substance.
Addition of an ink code imprint or in the ink used for an existing imprint code when the ink as changed is
not currently used on CDER-approved drug products
5/21/2019
DR G.K.SHARMA PHARMD, CPPM,
CGCPh, DCMS 11
12. Specifications (i.e., tests, analytical procedures, and acceptance criteria) are the quality
standards provided in an approved application to confirm the quality of drug
substances, drug products, intermediates, raw materials, reagents, components, in-
process materials, container closure systems, and other materials used in the
production of a drug substance or drug product. The recommendations in this section
also apply to specifications associated with sterility assurance that are included in
NDA and ANDA submissions.
5/21/2019
DR G.K.SHARMA PHARMD, CPPM,
CGCPh, DCMS 12
13. The potential for adverse effect on the identity, strength, quality, purity, or potency of a drug product as
these factors may relate to the safety or effectiveness of the drug product when making a change to or in
the container closure system is generally dependent on the route of administration of the drug product,
performance of the container closure system, and the likelihood of interaction between the packaging
component and the dosage form. In some cases there may be a substantial potential for adverse effect,
regardless of direct drug product testing for conformance with the approved specification.
A change to or in a packaging component will often result in a new or revised specification for the
packaging component. This situation does not have to be considered a multiple related change. Only the
reporting category for the packaging change needs to be considered.
5/21/2019
DR G.K.SHARMA PHARMD, CPPM,
CGCPh, DCMS 13
14. A change in a drug’s labeling includes changes in one of the following:
Package insert
Package labeling
Container label
All promotional labeling and advertising must be promptly revised to be consistent
with any labeling change(s) implemented. In addition, “all labeling changes for
ANDA drug products must be consistent with section 505(j) of the Act.”
5/21/2019
DR G.K.SHARMA PHARMD, CPPM,
CGCPh, DCMS 14
15. Multiple related changes involve various combinations of individual changes. If an
applicant has multiple related changes that fall into different recommended reporting
categories, “CDER recommends that the submission be in accordance with the
reporting category for the individual changes.”
As this is simply a summary of the guidance document, we only touched on the
“general considerations” that are provided. FDA also provides numerous examples of
each type of change that is considered to be major, moderate, and minor.
5/21/2019
DR G.K.SHARMA PHARMD, CPPM,
CGCPh, DCMS 15