This document discusses various types of documentation required in the pharmaceutical industry. It begins by explaining that documentation provides necessary details to reduce mistakes and batch variations. There are three main types of documents - commitment documents between industry and regulators, directive documents between management and employees, and record documents between employees and their work. Key documents discussed include master formula records, drug master files, distribution records, and generic drug development requirements. The importance of documentation for regulatory compliance and quality assurance is emphasized.
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
I. INTRODUCTION
II. DEFINITIONS
III. TYPES OF DRUG MASTER FILES
IV. SUBMISSIONS TO DRUG MASTER FILES
V. AUTHORIZATION TO REFER TO A DRUG MASTER FILE
VI. PROCESSING AND REVIEWING POLICIES
VII. HOLDER OBLIGATIONS
IX. CLOSURE OF A DRUG MASTER FILE.
Objectives of CGMP
Layout of buildings, services, equipments & maintenance
Production organization
material management
handling and transportation
inventory management &control
Production and planning control
Sales forcasting
Budget and cost control
Industrial and personnel relationship
Total quality management
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
I. INTRODUCTION
II. DEFINITIONS
III. TYPES OF DRUG MASTER FILES
IV. SUBMISSIONS TO DRUG MASTER FILES
V. AUTHORIZATION TO REFER TO A DRUG MASTER FILE
VI. PROCESSING AND REVIEWING POLICIES
VII. HOLDER OBLIGATIONS
IX. CLOSURE OF A DRUG MASTER FILE.
Objectives of CGMP
Layout of buildings, services, equipments & maintenance
Production organization
material management
handling and transportation
inventory management &control
Production and planning control
Sales forcasting
Budget and cost control
Industrial and personnel relationship
Total quality management
Documentation in pharaceutical industryJayeshRajput7
documentation in pharmaceutical industry, master formula record (MFR), DMF (drug master file), distribution records, generic drugs product development, hatch waxman act, CFR (code of federal regulation), drug product performance, in vitro ANDA regulatory approval process, NDA approval process, BE and drug product assessment, in-vivo scale up process approval changes, post marketing surveillance, outsourcing BA and BE to CRO (contract research organisation), Regulatory requireents for product approval, API, Biologics, Novel therapies obtaining NDA, ANDA for generic drug ways and means of US registration for foreign drugs.
This presentation gives an overview of the Drug Master File, a document submitted by the company or pharmaceutical industry to the regulatory authorities. It indicates that the company's product meets the desired quality standards. A brief introduction followed by types of DMF, its reviewing procedure and applications may give you a better understanding about Drug Master File.
A Drug Master File (DMF) is a confidential submission to the FDA containing detailed information about the manufacturing, processing, packaging, and storing of a pharmaceutical product. It is submitted by a drug manufacturer to support a regulatory application, such as a New Drug Application (NDA) or an Abbreviated New Drug Application (ANDA), without disclosing the information to the applicant. The DMF system helps streamline the regulatory review process while protecting proprietary information.
It includes information about regulatory bodies, role of drug Regulatory professional, countries with their regulatory bodies, intellectual property rights, terminologies related to DRA, drug approval process, event regarding lack of Drug regulatory affairs
Biological screening of herbal drugs: Introduction and Need for
Phyto-Pharmacological Screening, New Strategies for evaluating
Natural Products, In vitro evaluation techniques for Antioxidants, Antimicrobial and Anticancer drugs. In vivo evaluation techniques
for Anti-inflammatory, Antiulcer, Anticancer, Wound healing, Antidiabetic, Hepatoprotective, Cardio protective, Diuretics and
Antifertility, Toxicity studies as per OECD guidelines
The French Revolution, which began in 1789, was a period of radical social and political upheaval in France. It marked the decline of absolute monarchies, the rise of secular and democratic republics, and the eventual rise of Napoleon Bonaparte. This revolutionary period is crucial in understanding the transition from feudalism to modernity in Europe.
For more information, visit-www.vavaclasses.com
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.
Acetabularia Information For Class 9 .docxvaibhavrinwa19
Acetabularia acetabulum is a single-celled green alga that in its vegetative state is morphologically differentiated into a basal rhizoid and an axially elongated stalk, which bears whorls of branching hairs. The single diploid nucleus resides in the rhizoid.
Palestine last event orientationfvgnh .pptxRaedMohamed3
An EFL lesson about the current events in Palestine. It is intended to be for intermediate students who wish to increase their listening skills through a short lesson in power point.
The Roman Empire A Historical Colossus.pdfkaushalkr1407
The Roman Empire, a vast and enduring power, stands as one of history's most remarkable civilizations, leaving an indelible imprint on the world. It emerged from the Roman Republic, transitioning into an imperial powerhouse under the leadership of Augustus Caesar in 27 BCE. This transformation marked the beginning of an era defined by unprecedented territorial expansion, architectural marvels, and profound cultural influence.
The empire's roots lie in the city of Rome, founded, according to legend, by Romulus in 753 BCE. Over centuries, Rome evolved from a small settlement to a formidable republic, characterized by a complex political system with elected officials and checks on power. However, internal strife, class conflicts, and military ambitions paved the way for the end of the Republic. Julius Caesar’s dictatorship and subsequent assassination in 44 BCE created a power vacuum, leading to a civil war. Octavian, later Augustus, emerged victorious, heralding the Roman Empire’s birth.
Under Augustus, the empire experienced the Pax Romana, a 200-year period of relative peace and stability. Augustus reformed the military, established efficient administrative systems, and initiated grand construction projects. The empire's borders expanded, encompassing territories from Britain to Egypt and from Spain to the Euphrates. Roman legions, renowned for their discipline and engineering prowess, secured and maintained these vast territories, building roads, fortifications, and cities that facilitated control and integration.
The Roman Empire’s society was hierarchical, with a rigid class system. At the top were the patricians, wealthy elites who held significant political power. Below them were the plebeians, free citizens with limited political influence, and the vast numbers of slaves who formed the backbone of the economy. The family unit was central, governed by the paterfamilias, the male head who held absolute authority.
Culturally, the Romans were eclectic, absorbing and adapting elements from the civilizations they encountered, particularly the Greeks. Roman art, literature, and philosophy reflected this synthesis, creating a rich cultural tapestry. Latin, the Roman language, became the lingua franca of the Western world, influencing numerous modern languages.
Roman architecture and engineering achievements were monumental. They perfected the arch, vault, and dome, constructing enduring structures like the Colosseum, Pantheon, and aqueducts. These engineering marvels not only showcased Roman ingenuity but also served practical purposes, from public entertainment to water supply.
How libraries can support authors with open access requirements for UKRI fund...
Documentation in pharmaceutical industry, by dr. umesh kumar sharma and anu mathew
1. Documentation in
Pharmaceutical
Industry
Documentation in Pharmaceutical Industry , By : Dr. Umesh Kumar Sharma and Anu Mathew
By : Dr. Umesh Kumar Sharma
And Anu Mathew,
Department of Pharmaceutics,
Mar Dioscorus College of Pharmacy,
Thiruvananthapuram, Kerala, India
2. Documentation in pharmaceutical industry
Method of preparing a written material, which describes the process in
terms of specifications, instructions etc.
The D & C Act under conditions of granting license and schedule M
require manufacturer of drugs to maintain various records.
Importance of documentation
Provides necessary working details,
Reduces the risk of mistake,
Helps in decreasing batch to batch variation,
Considered as the history of batch operations,
3. Types of documents
Commitment document: Relationship between industry and the
regulatory authorities.
Directive document : Relationship between management and employee.
Record document : Relationship between the employee and the work
they perform.
5. Master Formula Records (MFR):
Written procedure that give the complete description of all aspects of manufacture, packing
and control with an inspection to ensure purity, identity, quality and strength of each dosage
unit through its shelf life.
Includes all the materials used in any batch manufacturing and step by step process of
manufacturing.
The master formula must include:
a) The name of the product together with product reference code relating to its
specifications.
b) The patent or proprietary name of the product along with the generic name, a
description of dosage form, strength, composition of the product and batch size.
6. c) A statement of the processing location and the principal equipment to be used.
d) Name , quantity and reference number of all starting materials to be used.
e) A statement of expected final yield with the acceptable limits and of relevant
intermediate yields, where applicable.
f) The methods or reference of the methods to be used for preparing the critical
equipment including cleaning, assembling, calibrating, sterilizing.
g) Detailed stepwise processing instructions and the time taken for each step.
Master Formula Records (MFR): cont…
7. Types of Master Formula Records (MFR):
The master formula records gives proportion of ingredients in the
formulation.
Master batch formula records which specify absolute amounts of specific
potent ingredients and excipients in a batch.
8. Master production and control records:
Detailed written instructions including all operations starting from dispensing
of raw materials till finishing of bulk products and packaging operation of the
particular product.
It includes batch size, date of manufacture and full signature by 1st person and
further independently checked, dated and signed by 2nd person.
9. Preparation of master formula :
Master formula can be prepared by competent technical
staff.
It should be reviewed by the head of production, QC
department and R & D department.
10. Drug Master File (DMF):
Document prepared by a pharmaceutical manufacturer and submitted solely
at its description to the appropriate regulatory authority in the intended drug
market.
There is no regulatory requirement to file a DMF.
The DMF provides confidential, detailed information about facilities, process
or articles used in the manufacturing, packaging, storing etc. to the regulatory
authority.
DMF is filed when two or more firms work in a partnership or developing or
manufacturing a drug product.
11. Drug Master File (DMF) Includes:
A) General information
1. General properties.
2. Structure.
3. Nomenclature.
B) Manufacture
1. Manufactures.
2. Description of manufacturing process and process control.
a) Flow chart of manufacturing process,
b) Synthetic route of manufacturing process,
c) Manufacturing method,
12. 3. Control of Material
1. List of materials
2. Specification and routine test of the raw material
4.Control of critical steps and intermediates
1. Critical steps,
2. Process validation,
5.Specifications and test method for the intermediates,
6.Manufacturing process development
Drug Master File (DMF) Includes: Cont …..
13. C) Characterization
1.Elucidation of structure and other characteristics-
a) Elemental analysis
b) IR spectrum of drug substance
c) NMR spectrum of drug substance
d) Mass spectrum of drug substance
e) UV spectrum of drug substance
f) X-ray diffraction
g) Thermal analysis
h) Comprehensive illustration
Drug Master File (DMF) Includes: Cont …..
14. 2) Impurities
a) Sources of potential impurities
b) Types of impurities
c) Test procedure for determining impurities
D) Control of drug substances
a) Specifications
b) Analytical procedure
c) Validation of analytical procedure
d) Batch analysis
e) Justification of specification
Drug Master File (DMF) Includes: Cont …..
15. E) Reference standards of material
F) Container closure system
G) Stability
H) Material data safety sheet
APPENDICES
1. Facilities and Equipment’s.
2. Equipment’s design and location.
3. Adventitious agents safety evaluations statement of comment.
Drug Master File (DMF) Includes: cont …..
16. Types of Drug Master File (DMF) :
Type 1: Manufacturing site, facilities, operating procedures and personnel.
Type 2: Drug substance, drug substance intermediate and material used in
their production or drug product.
Type 3: Packaging material.
Type 4: Excipient ,colorant, flavor.
Type 5: FDA accepted reference information.
17. Types of Drug Master File (DMF) : Cont…
Type 1:
Manufacturing site, facilities ,operating procedures and personnel
No longer used, once used to describe facilities.
Recommended for a person outside of the United states to assist FDA in
conducting on site inspections of their manufacturing facilities.
Should describe manufacturing site, operational layout, equipment
capabilities, processing layout.
18. Types of Drug Master File (DMF) : Cont…
Type 2:
Drug substance ,drug substance intermediate and material used in their preparation or
drug product required for drug substance – active ingredient.
A separate DMF is filed for each active ingredient.
Brief description of the manufacturing facilities, the address, a contact, phone number
and fax number.
Manufacturing procedures and control for finished dosage forms submitted in an IND,
NDA , ANDA or export application.
19. Types of Drug Master File (DMF) : Cont…
Type 3:
Packaging material,
Its components and composition,
Packaging material intended for use,
Name of the suppliers or fabrications of the components used in preparing the packaging
material.
Acceptance specifications,
Eg: - Products that would be classified as type 3 DMFs include bottles, seals, dispensers
etc.
20. Types of Drug Master File (DMF) : Cont…
Type 4:
Excipient, colorant, flavor, essence used in their preparation.
Each additive should be identified by this method of manufacture, release
specification and testing methods.
Toxicological data would be included.
The official compendia and FDA regulation for color additives, direct food additives
and food substances may be used as sources for release tests and safety.
21. Types of Drug Master File (DMF) : Cont…
Type 5:
FDA accepted reference information.
FDA discourages the use of type 5 DMFs for miscellaneous information, duplicate
information.
To submit the data which is not covered in type 1 to type 4 DMF.
A holder must first submit a letter of intent to the drug master file staff.
FDA will contact the holder to discuss the proposed submission.
22. Distribution records
Written procedures shall be established and followed, describing the
distribution of drug products
Include:
1. A procedure where by the oldest approved stock of a drug product is
distributed first
2. A system by which the distribution of each lot of drug product can be
readily determined to facilitate its recall if necessary.
23. Distribution records
• Distribution records must be constructed and procedures established to
facilitate recall of defective product.
• All records should be indexed by either the manufacturing batch-lot number
of the packaging control number as a means of accountability.
It shall contains:
Name and strength of the product-
Description of dosage form-
Name and address of the consigner-
Date and qty shipped-
Lot and control number of the drug-
24.
25. WHO guidelines for distribution records:
Written instruments and records should be available.
Procedure should be established and maintained.
The title, name and purpose of each document should be clearly stated.
All documents should be completed, approved ,signed ad dated by an appropriate
authorized persons.
In the case of temperature-sensitivity pharmaceutical products, records of
investigations and actions should be retained for at least one year after the expiry
date of the product.
26. Generic drug product development:
Product development is the set of activities beginning with the perception of
a market opportunity and ending in production, sale and delivery of a
product.
The 1st generic drug product filed and approved by FDA has several
financial incentives.
As per Hatch-Waxman Act, a 180 day exclusively is awarded to generic
manufacturer who first files.
During this 6 month period the FDA does not approve any second product
of the same generic version.
27. The following general aspects are considered:-
Selection of a drug product for manufacture.
Patents and exclusivity.
Resources for ANDA submission.
Selection of a drug product for generic version
Previous experience in the selected areas become an advantage to the manufacturer to
introduce generic products.
The manufacturer may be already making a variety of dosage forms, including the
immediate and modified release products.
The products such as transdermal drug product may be difficult to make and also
riskier but have a greater financial reward due to less competition from generic drug
forms.
28. Generic drug product development: Cont……
The market research data and technological advantages influences the
selection of generic drug product.
Estimated current sales volume of the innovator product.
Estimated market share for the generic product, if introduced into the
market.
The cost of acquiring the technology is important to manufacture the
product.
Lead time required to make the product and submission of ANDA to
the FDA for the approval.
29. Patents and exclusivity:
The patent holder may obtain the exclusivity, which prevents the approval
of ANDAs.
When period of patent or exclusivity expires other manufactures apply to
FDA to get permission for the manufacture and sale of generic versions.
Orange book is a register in which all the approved products of innovator
and generic products are maintained.
Orange book updated monthly is made available in the website.
30. Patents and exclusivity: Cont….
Patents that claim the active ingredients or other ingredients.
Drug product patents including formulation.
Approved polymorphic form , particle size of API.
Drugs qualified for Orphan drugs exclusivity.
Exclusivity information for other categories with their expiry periods.
31. Hatch –Waxman act:
• The amendment to federal, food, D&C act which established the
modern system of approval of generics through abbreviated new drug
applications (ANDA).
• The Drug Price Competition and Patent Term Restoration Act
informally known as the Hatch-Waxman Act is a 1984 United States
federal law which encourages the manufacture of generic drugs by
pharmaceutical industry and established the modern system of
government generic drug regulation in the US.
32. Significant results due to Hatch-Waxman act
Prior to the Hatch and Waxman act, the generic drug manufacturer had to
do the entire clinical trials. After the passage of this act, the generic drug
manufacturer had to only prove bioequivalence of generic drug to the
innovator by showing that the generic drug is 80-125% bioequivalent to
the innovator drug.
The time and cost involved for getting the generic drug into the market was
significantly reduced.
Low cost quality, safe and effective generic drugs were available to the
patients.
Billions of dollars in health care costs are being saved annually.
33. Patent certifications:
As per Hatch and Waxman act, generic drug and 505(b) applicants include
certifications in their applications for each patent listed in the orange book for
innovator drug.
The certification must state one of the following:
That the required patent information relating to such patent has not been
filled (para I certification).
That such patent has expired (para II certification).
That the patent will expire on a particular date(para III certification).
34. Patent certifications: Cont….
That such patent is invalid or will not be infringed by the drug for which
approval is being sought (para IV certification).
The certification under paragraph 1 or II permits the ANDA to be approved
immediately, if it is otherwise eligible. A certification under paragraph III
indicates that the ANDA may be approved when the patents expires.
35. 180 day exclusivity:
The Hatch Waxman Amendments provide an incentive of 180 days of
market exclusivity to the 1st generic applicant who challenges a listed
patent by filing a paragraph IV certification and thereby runs the risk of
having to defend a patent infringement suit.
The statue provides that the first applicant to file a substantially complete
ANDA containing a paragraph IV certification to a listed patent will be
eligible for a 180-day period of exclusivity beginning either from the date
it begins commercial marketing to the generic drug product.
180 day exclusivity could be granted to more than one applicant.
Eg.: 180 day exclusivity was granted to Ranbaxy and Watson Laboratories for
marketing generic version of Lipitor.
36. Hatch-Waxman bill:
The Hatch-Waxman bill officially as the drug price competition and patent
term restoration act , brought about the following changes:
Generic medicine no longer need to prove their safety and efficacy. Under
the bill, generic drug manufactures need only submit an ANDA to prove their
product’s bioequivalence to the original branded drug.
Generic drug are granted a 180 day period of exclusivity.
Manufacturers filling ANDAs can only do so for drugs that have not been
patented.
ANDAs can only be filled when a branded drug’s patent has expired.
Generic drugs cannot go on to market until the branded patent has expired.
37. References:
Generic drug product development, solid oral dosage forms, Leon
Shargel and Isaderkaufer, vol.143
FDA regulatory affairs: A guide prescription drugs and biologics by
Douglas J pisano, David Mantus.
Wikipedia.com