This document discusses documentation practices in the pharmaceutical industry. It provides definitions of key terms like documentation and good documentation practices. It also describes important pharmaceutical documents like those related to drug substance, drug product, and exploratory product development briefs. These documents provide information on development, manufacturing, testing, and controls of drugs to ensure their quality, safety and efficacy. Adherence to documentation standards like ALCOA and ALCOA+ helps ensure the integrity and reliability of data in the pharmaceutical industry.
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.
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.
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.
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.
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
A brief presentation on the current good manufacturing practices employed in the manufacture of pharmaceuticals in the US.
Comprises of all aspects of good manufacturing practices
This presentation contain introduction to Good Distribution Practices Guideline. and Legal GDP requirements put worldwide.
Good distribution practice (GDP) describes the minimum standards that a wholesale distributor must meet to ensure that the quality and integrity of medicines is maintained throughout the supply chain
Each participant in the distribution chain must agree by the relevant requirements in order to retain the original quality of pharmaceutical products.
Each activity in the distribution of pharmaceutical products shall be carried out according to the principles of Good Distribution Practices (GDP) as applicable.
The risks involved are likely to be of a nature comparable to those that are present in the industrial environment, such as mix-ups, adulteration, contamination, cross-contamination, and spurious.
The guideline addresses
Personnel
Quality System
Premises Warehousing and Storage
Documentation
Traceability
Complaints and Returns
Transportation
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
A brief presentation on the current good manufacturing practices employed in the manufacture of pharmaceuticals in the US.
Comprises of all aspects of good manufacturing practices
This presentation contain introduction to Good Distribution Practices Guideline. and Legal GDP requirements put worldwide.
Good distribution practice (GDP) describes the minimum standards that a wholesale distributor must meet to ensure that the quality and integrity of medicines is maintained throughout the supply chain
Each participant in the distribution chain must agree by the relevant requirements in order to retain the original quality of pharmaceutical products.
Each activity in the distribution of pharmaceutical products shall be carried out according to the principles of Good Distribution Practices (GDP) as applicable.
The risks involved are likely to be of a nature comparable to those that are present in the industrial environment, such as mix-ups, adulteration, contamination, cross-contamination, and spurious.
The guideline addresses
Personnel
Quality System
Premises Warehousing and Storage
Documentation
Traceability
Complaints and Returns
Transportation
Current Good Manufacturing Practices (cGMP) are followed by pharmaceutical and biotechnology companies
Items are manufactured to specific requirements including identity, strength, quality, and purity. Good Manufacturing Practices are regulated by the Food and Drug Administration (FDA)
Part of the MaRS Best Practices Series - Pre-Clinical development workshop
http://www.marsdd.com/bestpractices/
Speaker: James Ault, VP Regulatory Affairs, Ricerca BioSciences
Regulatory Compliance in Pharmaceutical DevelopmentGL.docxsodhi3
Regulatory Compliance in Pharmaceutical Development:
GLP & GMP
Jeffrey G. Sarver, Ph.D.
MBC 3100
March 8, 2016
email questions to:
[email protected]
*
Food and Drug Administration (FDA)Agency of U.S. Department of Health and Human Services (HHS)Protect public health and provide essential public servicesOther HHS agencies include: CDC, NIH, Medicare/MedicaidFDA responsible for assuring safety and efficacy of: Human Drugs - Center for Drug Evaluation and Research (CDER)Veterinary Drugs - Center for Veterinary Medicine (CVM)Biological Agents - Center for Biologic Evaluation and Research (CBER)Medical Devices - Center for Devices and Radiological Health (CDRH)Food/Supplements/Cosmetics - Center for Food Safety and Applied Nutrition (CFSAN)
Manufacture
Market Drug
NDA
FDA Review
Clinical
Trials
I, II, III
IND
FDA Review
Preclinical
Testing
Drug
Discovery
Drug Development/Approval ProcessIND – Investigational New Drug application (3-6 yr, $5M-$10M)FDA Approval → Proceed into Clinical Trials (~30% from preclinical tests)Clinical Hold → Collect More data or End DevelopmentNDA – New Drug Application (9-12 yr, $500M-$1B)FDA Approval → Drug Enters Market (~8% from preclinical tests)Not Approved → More Data or Adjust Application or End Development
Basic
Research
+
Target
Discovery
Preclinical Testing RequirementsMechanism of Action (in vitro) and Efficacy (in vivo)General Toxicology: Single and Repeated Dose (in vivo)Genotoxicity/Mutagenicity (in vitro/in vivo)Carcinogenicity (in vivo)Reproductive Toxicology/Teratology (in vivo)ADME (in vitro)/Pharmacokinetics (in vivo)Additional Safety TestingCore: Cardiovascular (hERG), Respiratory, CNSOther tests as needed based on structure, mechanism, general tox
Additional Information for INDChemistry, Manufacturing, and Controls (CMC)Structure, physical propertiesSynthetic method and scale-upPurity, identification of impuritiesDosage form/route, formulation, preparation, packagingClinical Study ProtocolsPrevious Human Experience (if available)
FDA Guidance Documents
Information on suggested: testing methods, analyzing and summarizing data
Can be found at: http://www.fda.gov/RegulatoryInformation/Guidances/Searching can be difficult/tedious, use appropriate filters:Product → Drugs (or Biologics)FDA Organization → CDER (or CBER)Document Type → Guidance DocumentsExample Guidance Documents available on Blackboard:Genotoxicity TestingCardiotoxicity (hERG) TestingChemistry, Manufacturing, and Controls (CMC) for Phase I DrugMaximum Safe Starting Dose for Clinical Testing
International Council on Harmonization (ICH)Harmonize procedures for evaluating/reporting safety, efficacy, CMC in multiple regions/countriesRegulators and industry representatives from participating regions collaborate to generate internationally acceptable guidelinesImprove efficiency of drug testing/reporting requirements for approval in multiple countriesOriginally Europe, Japan, U.S.Other countries adopting IC ...
Welcome to TechSoup New Member Orientation and Q&A (May 2024).pdfTechSoup
In this webinar you will learn how your organization can access TechSoup's wide variety of product discount and donation programs. From hardware to software, we'll give you a tour of the tools available to help your nonprofit with productivity, collaboration, financial management, donor tracking, security, and more.
Instructions for Submissions thorugh G- Classroom.pptxJheel Barad
This presentation provides a briefing on how to upload submissions and documents in Google Classroom. It was prepared as part of an orientation for new Sainik School in-service teacher trainees. As a training officer, my goal is to ensure that you are comfortable and proficient with this essential tool for managing assignments and fostering student engagement.
Ethnobotany and Ethnopharmacology:
Ethnobotany in herbal drug evaluation,
Impact of Ethnobotany in traditional medicine,
New development in herbals,
Bio-prospecting tools for drug discovery,
Role of Ethnopharmacology in drug evaluation,
Reverse Pharmacology.
Students, digital devices and success - Andreas Schleicher - 27 May 2024..pptxEduSkills OECD
Andreas Schleicher presents at the OECD webinar ‘Digital devices in schools: detrimental distraction or secret to success?’ on 27 May 2024. The presentation was based on findings from PISA 2022 results and the webinar helped launch the PISA in Focus ‘Managing screen time: How to protect and equip students against distraction’ https://www.oecd-ilibrary.org/education/managing-screen-time_7c225af4-en and the OECD Education Policy Perspective ‘Students, digital devices and success’ can be found here - https://oe.cd/il/5yV
How to Create Map Views in the Odoo 17 ERPCeline George
The map views are useful for providing a geographical representation of data. They allow users to visualize and analyze the data in a more intuitive manner.
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.
Operation “Blue Star” is the only event in the history of Independent India where the state went into war with its own people. Even after about 40 years it is not clear if it was culmination of states anger over people of the region, a political game of power or start of dictatorial chapter in the democratic setup.
The people of Punjab felt alienated from main stream due to denial of their just demands during a long democratic struggle since independence. As it happen all over the word, it led to militant struggle with great loss of lives of military, police and civilian personnel. Killing of Indira Gandhi and massacre of innocent Sikhs in Delhi and other India cities was also associated with this movement.
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.
2. CONTENTS
INTRODUCTION
DOCUMENTATION
PHARMACEUTICAL DOCUMENTS
ALCOA & ALCOA+
DRUG SUBSTANCE
DRUG PRODUCT
EXPLORATORY PRODUCT DEVELOPMENT BRIEF
(EPDB) FOR DRUG SUBSTANCE AND DRUG PRODUCT
3. INTRODUCTION
A DOCUMENT is a piece of written, printed, or electronic
matter that provides information or evidence or that serves as
an official record.
Documents should be designed, prepared, reviewed, and
distributed for use per established procedures.
Good Documentation Practice (GDP or GDocP), a term
use in the pharmaceutical industry, is essential for the
integrity of data collection and reporting for supporting
development, registrations, commercialization, and life-cycle
management of pharmaceutical products.
4. DOCUMENTATION
“ Documentation is any communicable material that is used to
describe, explain or instruct regarding some attributes of an
object, system or procedure, such as its parts, assembly,
installation, maintenance and use.”
Documentation provides Both;
1. Information on when, where, who, why & How to Complete
tasks
2. Evidence providing that the tasks have been completed as
they should be.
5. DOCUMENTATION should be as detail as possible. A list of some examples (but not limited
to) to be included in the document are:
D = Design, Development, deviations, dossiers and Drug Master Files for regulated
markets, Distribution Records etc.
O = Operational procedures/techniques/methods, Out of specifications (OOS), Out of trend
(OOT) etc.
C = Cleaning, calibration, controls, complaints, Certificate of Analysis (CoA) ,containers
and closures, contamination and change control etc.
U = User requirement specifications, utilities like water systems, HVAC, etc.
M = Man, materials, machines, methods, maintenance, MANUFACTURING operations and
controls, monitoring, master formula, manuals (quality, safety and environment), medical
records, Master Formula Record etc.
E = Engineering control and practices, Environment control, Equipment qualification
documents, Exploratory Product Development Brief (EPDB) for Drug substance and
Drug product etc.
N = Non-routine activities, New products and substances etc.
T = Technology transfer, training, testing, Trend analysis, Technical dossiers etc.
S = SOPs, safety practices, sanitation, storage, self-inspection, standardization, supplier
qualification, specifications and standard test procedures and SITE MASTER FILE.
6. PHARMACEUTICAL DOCUMENTS
Good documentation were first described by US-FDA in the form of ALCOA –
A = Attributable (Records and data linked to the individual or system
performing the action.)
L = Legible (All data recorded must be legible (readable) and permanent)
C = Contemporaneous ( Record the result, measurement or data at the
time the work is performed. )
O = Original (Source information accessible and preserved in its original form)
A = Accurate (Data are correct, truthful, complete, valid and reliable.)
NOTE - Proper verification of source documents to ensure data integrity,
validity, and subject safety among other aspects.
7. ALCOA+
Recently ALCOA has been updated to ALCOA+ which is widely been used
by the WHO and FDA.
Complete - All data is available, nothing has been deleted and evidence
must be available in an audit trail.
Consistent - Data is recorded chronologically with data and time evident
again in an audit trail.
Enduring - Data is accessible for an extended period of time.
Available - Data is accessible over the lifetime of the product.
8. DRUG SUBSTANCE
DRUG SUBSTANCE is an active ingredient that is intended to furnish
pharmacological activity or other direct effect in the diagnosis, cure, mitigation,
treatment, or prevention of disease or to affect the structure or any function of
the human body, but does not include intermediates used in the synthesis of
such ingredient.
Demonstration batch
Certificate of analysis for each batch
manufactured (final API and reference
standards)
BSE/TSE statements and GMP certificate
Process development (including
manufacture of demonstration batch) report
Process safety assessment report
cGMP campaign report
Master and executed batch records
Analytical test procedures, methods validation
protocols and reports
Reference standards and analytical markers
characterization report
Forced degradation study report
Specifications for API release
ICH stability protocol, interim and final reports
Biweekly updates on project progress
Documentation suitable for IMPD submission
9. DRUG PRODUCT
DRUG PRODUCT is a finished dosage form, e.g., tablet, capsule, or solution, that
contains a drug substance, generally, but not necessarily, in association with one or
more other ingredients.
Clinical batches supply
Certificate of analysis and statement of cGMP compliance (per batch manufactured)
TSE statements for excipients
Formulation development reports
Executed batch records for DP manufacturing
Analytical test procedures, methods validation protocols and reports
Specifications for DP release
ICH stability protocol, interim and final reports
Biweekly updates on project progress
Documentation suitable for IMPD submission
10. ExPDB DOCUMENTS
EXPLORATORY PRODUCT DEVELOPMENT BRIEF - Clarify
preclinical and clinical approaches, as well as chemistry,
manufacturing, and controls information, should be considered when
planning exploratory studies in humans, including studies of closely
related drugs or therapeutic biological products, under an
investigational new drug (IND) application.
Information on a clinical development plan .
Chemistry, manufacturing, and controls information .
Pharmacology and toxicology information .
Previous human experience with the investigational candidate or
related compounds.
Other.
11. CLINICAL INFORMATION
Introductory statement and general investigational plan
Types of studies
CHEMISTRY, MANUFACTURING, AND CONTROLS INFORMATION
General information for the candidate product
Analytical characterization of candidate product
SAFETY PROGRAM DESIGNS
Clinical studies of pharmacokinetics or imaging
Clinical trials to study pharmacologically relevant doses
Clinical studies of MOAs related to efficacy
GLP COMPLIANCE
CONCLUSION