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.
Data Integrity app Link: https://play.google.com/store/apps/details?id=com.innovativeapps.dataintegrity&hl=en
One Step Ahead in Pharma Compliance
Across the internet, there are millions of resources are available which provide information about Computer System Validation.
Refer above Data Integrity app which helps you to understand current regulatory agencies thinking on Data Integrity.
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.
Data Integrity app Link: https://play.google.com/store/apps/details?id=com.innovativeapps.dataintegrity&hl=en
One Step Ahead in Pharma Compliance
Across the internet, there are millions of resources are available which provide information about Computer System Validation.
Refer above Data Integrity app which helps you to understand current regulatory agencies thinking on Data Integrity.
Indian GMP Certification & WHO GMP CertificationVishal Shelke
Indian GMP Certification & WHO GMP Certification by Mr. Vishal Shelke
https://youtube.com/vishalshelke99
https://instagram.com/vishal_stagram
Sub :- Drug Regulatory Affairs
M.Pharm Sem II
Savitribai Phule Pune University
WHO Good Manufacturing Practice Requirements
Good Manufacturing Practice is the part of quality assurance that ensures that products are consistently manufactured and controlled to the quality standards appropriate to their intended use.
This presentation covered the defination of dmf , importance of dmf filing , procedure of it , time period , requirement of dmf , letter of authorization meaning ,content of dmf , types of dmf
Indian GMP Certification & WHO GMP CertificationVishal Shelke
Indian GMP Certification & WHO GMP Certification by Mr. Vishal Shelke
https://youtube.com/vishalshelke99
https://instagram.com/vishal_stagram
Sub :- Drug Regulatory Affairs
M.Pharm Sem II
Savitribai Phule Pune University
WHO Good Manufacturing Practice Requirements
Good Manufacturing Practice is the part of quality assurance that ensures that products are consistently manufactured and controlled to the quality standards appropriate to their intended use.
This presentation covered the defination of dmf , importance of dmf filing , procedure of it , time period , requirement of dmf , letter of authorization meaning ,content of dmf , types of dmf
Objectives , policies and principles of cGMP guidelines in pharmaceutical ind...JaskiranKaur72
The presentation contains detailed information about the current GMP in the pharmaceutical industry. It has objectives , policies and principles of cGMP guidelines.
Pdf file is being attached in the link below- https://drive.google.com/file/d/11al8n8AqrkUR_Vnm-z4Mp6O0elzyniEz/view?usp=drivesdk
RMD24 | Retail media: hoe zet je dit in als je geen AH of Unilever bent? Heid...BBPMedia1
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Memorandum Of Association Constitution of Company.pptseri bangash
www.seribangash.com
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.
https://seribangash.com/article-of-association-is-legal-doc-of-company/
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.
www.seribangash.com
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.
https://seribangash.com/promotors-is-person-conceived-formation-company/
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.
https://seribangash.com/difference-public-and-private-company-law/
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
Putting the SPARK into Virtual Training.pptxCynthia Clay
This 60-minute webinar, sponsored by Adobe, was delivered for the Training Mag Network. It explored the five elements of SPARK: Storytelling, Purpose, Action, Relationships, and Kudos. Knowing how to tell a well-structured story is key to building long-term memory. Stating a clear purpose that doesn't take away from the discovery learning process is critical. Ensuring that people move from theory to practical application is imperative. Creating strong social learning is the key to commitment and engagement. Validating and affirming participants' comments is the way to create a positive learning environment.
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.
Discover the innovative and creative projects that highlight my journey throu...dylandmeas
Discover the innovative and creative projects that highlight my journey through Full Sail University. Below, you’ll find a collection of my work showcasing my skills and expertise in digital marketing, event planning, and media production.
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.
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Kyiv PMDay 2024 Summer
Website – www.pmday.org
Youtube – https://www.youtube.com/startuplviv
FB – https://www.facebook.com/pmdayconference
Affordable Stationery Printing Services in Jaipur | Navpack n PrintNavpack & Print
Looking for professional printing services in Jaipur? Navpack n Print offers high-quality and affordable stationery printing for all your business needs. Stand out with custom stationery designs and fast turnaround times. Contact us today for a quote!
Personal Brand Statement:
As an Army veteran dedicated to lifelong learning, I bring a disciplined, strategic mindset to my pursuits. I am constantly expanding my knowledge to innovate and lead effectively. My journey is driven by a commitment to excellence, and to make a meaningful impact in the world.
GMP and cGMP Considerations Training by KLE University
1. GMP AND cGMP CONSIDERATIONS
By
Dr. Basavaraj K. Nanjwade M.Pharm., Ph.D.
Associate Professor
Department of Pharmaceutics
KLE University
BELGAUM - 590010
2. What is GMP ?
GMP is that part of Quality assurance
which ensures that the products are
consistently manufactured and controlled
to the Quality standards appropriate to
their intended use
"GMP" - A set of principles and procedures
which, when followed by manufacturers
for therapeutic goods, helps ensure that
the products manufactured will have the
required quality.
22/10/2008
Department of Pharmaceutics
2
3. What is cGMP ?
Usually
see “cGMP” – where c =
current, to emphasize that the
expectations are dynamic
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4. Quality Definition
Quality
of a medicinal product is
measured by it’s fitness for purpose .
Safety and efficacy are not separable
from Quality but part of it
Quality
Safety
Efficacy
Quality
Safety Efficacy
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X
6. Good Manufacturing Practices
A basic tenet of GMP is that quality cannot
be tested into a batch of product but must
be built into each batch of product during
all stages of the manufacturing process.
It is designed to minimize the risks
involved in any pharmaceutical production
that cannot be eliminated through testing
the final product.
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7. Some of the main risks are
– unexpected contamination of products, causing
damage to health or even death.
– incorrect labels on containers, which could
mean that patients receive the wrong
medicine.
– insufficient or too much active ingredient,
resulting in ineffective treatment or adverse
effects.
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Department of Pharmaceutics
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8. Why GMP is important
– A poor quality medicine may contain
toxic substances that have been
unintentionally added.
– A medicine that contains little or none of
the claimed ingredient will not have the
intended therapeutic effect.
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Department of Pharmaceutics
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9. GMP helps boost pharmaceutical
export opportunities
Most
countries will only accept import
and sale of medicines that have been
manufactured to internationally
recognized GMP.
Governments
seeking to promote their
countries export of pharmaceuticals
can do so by making GMP mandatory
for all pharmaceutical production and
by training their inspectors in GMP
requirements.
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Department of Pharmaceutics
9
10. GMP Covers…
ALL aspects of production; from the starting
materials, premises and equipment to the
training and personal hygiene of staff.
Detailed, written procedures are essential for
each process that could affect the quality of the
finished product.
There must be systems to provide documented
proof that correct procedures are consistently
followed at each step in the manufacturing
process - every time a product is made.
22/10/2008
Department of Pharmaceutics
10
11. GMP
The
Quality of a formulation or a
bulk drug depends on the Quality of
those
producing it
GMP is the magic key that opens the
door of the Quality
In matter of GMP, swim with the
current and in matter of Quality
stand like a rock!
22/10/2008
Department of Pharmaceutics
11
12. QA, GMP & QC inter-relationship
QA
GMP
QC
22/10/2008
Department of Pharmaceutics
12
13. QA, GMP & QC inter-relationship
QA
It is the sum total of the
organized arrangements
with the objective of
ensuring that products
will be of the quality
required for their
intended use
22/10/2008
Department of Pharmaceutics
13
14. QA, GMP & QC inter-relationship
GMP
Is that part of Quality
Assurance aimed at
ensuring that products
are consistently
manufactured to a
quality appropriate to
their intended use
22/10/2008
Department of Pharmaceutics
14
15. QA, GMP & QC inter-relationship
QC
Is that part of GMP concerned
with sampling, specification
& testing, documentation &
release procedures which
ensure that the necessary &
relevant tests are performed
& the product is released for
use only after ascertaining
it’s quality
22/10/2008
Department of Pharmaceutics
15
16. QC and QA
QC is that part of GMP QA is the sum total
which is concerned with
of organized
sampling,
arrangements
specifications, testing
made with the
and with in the
object of ensuring
organization,
that product will be
documentation,and
of the Quality
release procedures
which ensure that the
required by their
necessary and relevant
intended use.
tests are carried out
22/10/2008
Department of Pharmaceutics
16
17. QC and QA
Operational
laboratory
techniques and
activities used to
fulfill the
requirement of
Quality
22/10/2008
All those planned
or systematic
actions necessary
to provide
adequate
confidence that a
product will satisfy
the requirements
for quality
Department of Pharmaceutics
17
18. QC and QA
QC is lab based
22/10/2008
QA is company
based
Department of Pharmaceutics
18
19. GMP guidelines
GMP as per Schedule “M”
www.cdsco.nic.in
GMP as per WHO
www.who.int
GMP as per MCA now known as MHRA
www.mca.gov.uk
GMP as per TGA
www.tga.gov.au
GMP as per US FDA
www.fda.gov
GMP as per ICH guidelines
www.ich.org
22/10/2008
Department of Pharmaceutics
19
20. GMP
GMP
GMP
GMP
GMP
GMP
GMP
GMP
GMP
22/10/2008
in solid dosage forms
in semisolid dosage forms
in Liquid orals
in Parenterals Production
in Ayurvedic medicines
in Bio technological products
in Nutraceuticals and cosmeceuticals
in Homeopathic medicines
Department of Pharmaceutics
20
21. GMP
Good
Manufacturing Practice
Good Management Practice
Get More Profit
Give more Production
GMP Training with out tears
22/10/2008
Department of Pharmaceutics
21
22. GMP
All
past GMPs are history….It is
looking like in rear view mirror and
driving
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Department of Pharmaceutics
22
23. Ten Principles of GMP
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
Design and construct the facilities and
equipments properly
Follow written procedures and Instructions
Document work
Validate work
Monitor facilities and equipment
Write step by step operating procedures and
work on instructions
Design ,develop and demonstrate job
competence
Protect against contamination
Control components and product related
processes
Conduct planned and periodic audits
22/10/2008
Department of Pharmaceutics
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24. Beyond GMP
Reduce
pollution - Zero discharge
Adaptation of environment friendly
methods
Consideration for better and
healthier life tomorrow
Consideration of ethics in life
One should begin with end in mind
otherwise it will be the beginning of
the end
22/10/2008
Department of Pharmaceutics
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25. Cost of effective GMP
In fact Cost benefits – positive cost
benefits of GMP/QA
Good plant lay out, Smooth work flows,
Efficient documentation systems, well
controlled process, good stores lay outs
and stores records- These are Good
manufacturing practices
Reduction in work in process and
inventory holding costs
Avoidance of cost of Quality failure ( cost
of waste, of rework, of recall, of consumer
compensation and of loss of company
reputation)
22/10/2008
Department of Pharmaceutics
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26. List of important documents in GMP
Policies
SOP
Specifications
MFR (Master Formula Record)
BMR
Manuals
Master plans/ files
Validation protocols
Forms and Formats
Records
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Department of Pharmaceutics
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27. 10 attributes of a good document
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
Accurate
Clear
Complete
Consistent
Indelible
Legible
Timely
Direct
Authentic
Authorized
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Department of Pharmaceutics
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28. Certifying agencies
ICH. www.ich.org
WHO. www.who.int
US
FDA. www.fda.gov
EU/EMEA. www.emea.europa.eu
22/10/2008
Department of Pharmaceutics
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29. How do GMPs of different countries
compare?
At a high level, GMPs of various nations are very
similar; most require things like:
Equipment and facilities being properly
designed, maintained, and cleaned
Standard Operating Procedures (SOPs) be
written and approved
An independent Quality unit (like Quality
Control and/or Quality Assurance)
Well trained personnel and management
22/10/2008
Department of Pharmaceutics
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30. cGMP For Finished Pharmaceuticals
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
General Provision
Organization & Personnel
Building & Facilities
Equipment
Control of Components & Drug
Product Containers & Closures
Production & Process Control
Packaging & Labeling Control
Handling & Distribution
Laboratory Control
Records & Reports
Returned & Salvaged Drugs
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Department of Pharmaceutics
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32. Organization & Personnel
1.
Responsibilities of quality control
unit.
2.
Personnel qualifications.
3.
Personnel responsibilities.
4.
Consultants.
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Department of Pharmaceutics
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33. Building & Facilities
1.
2.
3.
4.
5.
6.
7.
8.
Design and construction features.
Lighting.
Ventilation, air filtration, air heating
and cooling.
Plumbing.
Sewage and refuse.
Washing and toilet facilities.
Sanitation.
Maintenance.
22/10/2008
Department of Pharmaceutics
33
34. Equipment
1.
2.
3.
4.
5.
Equipment design, size, and
location.
Equipment construction.
Equipment cleaning and
maintenance.
Automatic, mechanical, and
electronic equipment.
Filters.
22/10/2008
Department of Pharmaceutics
34
35. Control of Components & Drug
Product Containers & Closures
1.
2.
3.
4.
5.
6.
7.
General requirements.
Receipt & storage of untested components,
drug product containers, and closures.
Testing and approval or rejection of
components, drug product containers, and
closures.
Use of approved components, drug product
containers, and closures.
Retesting of approved components, drug
product containers, and closures.
Rejected components, drug product containers,
and closures.
Drug product containers and closures.
22/10/2008
Department of Pharmaceutics
35
36. Production & Process Control
1.
2.
3.
4.
5.
6.
7.
8.
Written procedures; deviations.
Charge-in of components.
Calculation of yield.
Equipment identification.
Sampling and testing of in-process
materials and drug products.
Time limitations on production.
Control of microbiological contamination.
Reprocessing.
22/10/2008
Department of Pharmaceutics
36
37. Packaging & Labeling Control
1.
2.
3.
4.
5.
6.
Materials examination and usage
criteria.
Labeling issuance.
Packaging and labeling operations.
Tamper-evident packaging
requirements for over-the-counter
(OTC) human drug products.
Drug product inspection.
Expiration dating.
22/10/2008
Department of Pharmaceutics
37
40. Records & Reports
1.
2.
3.
4.
5.
6.
7.
8.
9.
General requirements.
Equipment cleaning and use log.
Component, drug product container, closure,
and labeling records.
Master production and control records.
Batch production and control records.
Production record review.
Laboratory records.
Distribution records.
Complaint files.
22/10/2008
Department of Pharmaceutics
40
41. Returned & Salvaged Drug
Products
1.
2.
Returned drug products.
Drug product salvaging.
22/10/2008
Department of Pharmaceutics
41