Good manufacturing practice (GMP) is that part of quality assurance which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing authorization. GMP is aimed primarily at diminishing the risks inherent in any pharmaceutical production, which may broadly be categorized in two groups: cross contamination/mix-ups and false labeling. Above all, manufacturers must not place patients at risk due to inadequate safety, quality or efficacy; for this reason, risk assessment has come to play an important role in WHO quality assurance guidelines.
Lean what 21 CFR Parts 210 and 211 are and how you an implement these regulations in your organization. For more information and tips on compliance go to http://compliance-insight.com/fda-gcp-and-gmp-training/21-cfr-210-211/
CFR 21 is the basic for pharmaceutical professionals who are working in regulatory market. Here I have presented part 211 as it is described in the guidance.
Good Manufacturing Practice, or GMP, is a set of practices and systems that are aimed at making sure that pharmaceutical products are manufactured in conformance with set requirements and standards. The aim of GMP also referred to sometimes as cGMP or Current Good Manufacturing Practice, is to ensure that there is control and consistency in the pharmaceutical products, so that the processes used for controlling quality and consistency of the product can be traced back in the event of a problem.
Lean what 21 CFR Parts 210 and 211 are and how you an implement these regulations in your organization. For more information and tips on compliance go to http://compliance-insight.com/fda-gcp-and-gmp-training/21-cfr-210-211/
CFR 21 is the basic for pharmaceutical professionals who are working in regulatory market. Here I have presented part 211 as it is described in the guidance.
Good Manufacturing Practice, or GMP, is a set of practices and systems that are aimed at making sure that pharmaceutical products are manufactured in conformance with set requirements and standards. The aim of GMP also referred to sometimes as cGMP or Current Good Manufacturing Practice, is to ensure that there is control and consistency in the pharmaceutical products, so that the processes used for controlling quality and consistency of the product can be traced back in the event of a problem.
I am uploading this GMP presentation to make aware who are working in pharma and help to maintain high standards in products manufacturing .
GMP Vs cGMP: It is my understanding that , Ultimately GMP & cGMP both the aim is same, means to prevention of the product from bad quality entering the market to endover peoples's life.
GMP applies to pharmaceutical and healthcare products and help to maintain high standards in these products.
cGMP is to remind accepting countries that all guidelines must be followed with latest and current production processes i.e employ technologies and systems which are up-to-date in order to comply with the regulation.
FDA (Food and Drug Administration) included the word “current” to ensure that regulated firms use the most current Good Manufacturing Practices (I believe that some firms would actually use outdated versions of the GMP’s to manufacture regulated products.
(the FDA have made their standards immediately identifiable i.e cGMP; Other international bodies such as the ICH, WHO use the term GMP, as do Canada, Japan and the EMEA (European authority). In FDA view cGMP means following 21 CFR 210 and 211 and no other.)
History of GMP and Various GMP Regulations.
Introduction to cGMP
Why GMP is so important?
Schedule M and 21 CFR Part 211
Principles of Quality
Golden Rules of cGMP
How to sustain GMP compliance?
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
Good Manufacturing Practice (GMP) is a system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product.
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
Data integrity is a Fundamental in a pharmaceutical quality system. It ensures that medicines are of required quality. This presentation is based on MHRA Guidance and provides MHRA expectations. Guidance complements existing EU GMP relating to active substances and dosage forms. This guidance should be d in conjunction with national medicines legislation and the GMP standards published in Eudralex volume 4.
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.
I am uploading this GMP presentation to make aware who are working in pharma and help to maintain high standards in products manufacturing .
GMP Vs cGMP: It is my understanding that , Ultimately GMP & cGMP both the aim is same, means to prevention of the product from bad quality entering the market to endover peoples's life.
GMP applies to pharmaceutical and healthcare products and help to maintain high standards in these products.
cGMP is to remind accepting countries that all guidelines must be followed with latest and current production processes i.e employ technologies and systems which are up-to-date in order to comply with the regulation.
FDA (Food and Drug Administration) included the word “current” to ensure that regulated firms use the most current Good Manufacturing Practices (I believe that some firms would actually use outdated versions of the GMP’s to manufacture regulated products.
(the FDA have made their standards immediately identifiable i.e cGMP; Other international bodies such as the ICH, WHO use the term GMP, as do Canada, Japan and the EMEA (European authority). In FDA view cGMP means following 21 CFR 210 and 211 and no other.)
History of GMP and Various GMP Regulations.
Introduction to cGMP
Why GMP is so important?
Schedule M and 21 CFR Part 211
Principles of Quality
Golden Rules of cGMP
How to sustain GMP compliance?
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
Good Manufacturing Practice (GMP) is a system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product.
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
Data integrity is a Fundamental in a pharmaceutical quality system. It ensures that medicines are of required quality. This presentation is based on MHRA Guidance and provides MHRA expectations. Guidance complements existing EU GMP relating to active substances and dosage forms. This guidance should be d in conjunction with national medicines legislation and the GMP standards published in Eudralex volume 4.
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.
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
Maintcon 2018 - Deepak Sahoo, CEO - Arrelic PresentationArrelic
How Machine Learning, AI and IIOT is going to change the fate of O&M practices in Manufacturing Industry?
Deepak Kumar Sahoo, CMRP, CRL
Founder & CEO, ARRELIC
www.arrelic.com
isk-Based Inspection (RBI) is a systematic approach that enables users to make informed business decisions regarding inspection and maintenance expenditure. It identifies, assesses and maps industrial risks (due to corrosion and stress cracking), which can compromise equipment integrity in both pressurized equipment and structural elements.
RBI combines the principles of risk with operational experience to obtain a safe and cost effective inspection program targeting inspection where and when it is needed. Also addresses risks that can be controlled through proper inspections and analysis.
Arrelic is a fast-growing deep technology firm aiming to bring the next level of IoT based sensor technology to transform the mode of manufacturing operation and maintenance practice of various industries with extensive expertise in Reliability Engineering, Predictive Maintenance, Industrial Internet of Things (IIoT) Sensors, Machine Learning and Artificial Intelligence.
We provide a single ecosystem for catering all industry needs from Consulting to IoT and Analytics as well as providing Training and Development courses for different stakeholders.
We aim to help manufacturing industries to improve their overall plant productivity, reliability and minimize total production cost by 25-30% by eliminating machine downtime, lightening management decisions by analyzing the machine data with right mind and expertise; for a worry free operation.
Expert and well informed in Ferro-alloys industry Building a program that is most financial viable and long term sustainable
Single point contact for building strategy and providing solutions
Over 15+ years of combined experience Bringing the best practices from 16 industries and 5 continents
ARLYTIC™ is a big data based multi-connected IoT analytics platform offers unprecedented advantages for machine manufactures as well as the plant managers who are end-users of the machines to avoid machine downtime through analysing the sensors data.
ARLYTIC™ relies on collecting data on the edge to uncover actionable insights, using the right tools and techniques, at the right time, to help a organization achieve its most desired business outcomes.
APM is a holistic approach used to ensure that the business of caring for corporation’s maintainable assets is done in the most cost-effective manner to promote asset longevity, performance and capability.
It cultivates a partnership between operations and maintenance, whose common goal is equipment uptime.
APM optimize the equipment performance and reliability on daily basis.
It will help to identify the current asset health and able to provide a long term view to drive capital planning.
Visibility into complete lifecycle of asset – Understanding the Economic Value Add
Aligning asset performance to corporate performance
An effective APM process involves the development and implementation of reliability programs for operational assets coupled with application of ongoing performance monitoring and improvement to drive program optimization overtime.
Preventive Maintenance (PM) Optimization increases equipment reliability by uniquely identifying potential gaps in PM performance and frequencies. The process lowers overall facility maintenance costs by comparing site PMs to industry best practices.
Arrelic end-to-end Reliability Management allows you to;
Identify and rectify equipment problems before they happen, Reduce maintenance costs and unplanned downtime.
RCM is used to develop scheduled maintenance plans in an efficient and cost-effective manner that will provide an acceptable level of operability and risk. It focuses on processes and systems to reduce the overall cost to maintain and operate assets. Arrelic Consulting assists industries in integrating assets and increasing return on investment by enhanced asset performance and reliability.
Maintenance strategy development and optimisation through Critical Asset Ranking, RCM Approach and cost benefit analysis ensures you the best maintenance plan.
rrelic has developed a highly effective Total Reliability Framework for the implementation of reliability methods, tools and services in order to achieve your desired end results.
Total reliability Framework (TRF) Provides a management system for all reliability and Maintenance activities; focus on improving the performance of both the personnel and the plant equipment.
The word Lean comes from the ability to achieve more with less resource, by continuous elimination of waste. The lean manufacturing process is a comprehensive way to reduce waste of all types. It could be a waste of time or material, it is still waste.
Lean manufacturing is a manufacturing strategy that seeks to produce a high level of throughput with a minimum of inventory e.g. suppliers deliver small lots on a daily basis, and machines are not necessarily run at full capacity. One of the primary focuses of lean manufacturing is to eliminate waste; that is, anything that does not add value to the final product gets eliminated. A second major focus is to empower workers, and make production decisions at the lowest level possible.
Benchmarking is the process of measuring products, services, and processes against those of organizations known to be leaders in one or more aspects of their operations.
It is a way of discovering what is the best performance being achieved – whether in a particular company, by a competitor or by an entirely different industry. This information can then be used to identify gaps in an organization’s processes in order to achieve a competitive advantage.
Benchmarking can help you identify areas, systems, or processes for improvements—either incremental improvements or dramatic improvements.
Total Quality Management (TQM) | Arrelic InsightsArrelic
Total quality management is a management system for a customer focused organization that involves all employee in continual improvement of all aspects of the organization. TQM uses strategy, data, and effective communication to integrate the quality principles into the culture and activities of the organization.
Motor Current Signature Analysis (MCSA) | Arrelic InsightsArrelic
Motor Current Signature Analysis (MCSA) are diagnostic technique that are being used to analyze motors, transformers, generators, alternators, distribution and other electric equipment.
This technology has the ability to test on line and off line electrical equipment and identify a variety of mechanical and electrical problems. These techniques can be used to analyze the driver, the driven load and the power supply. As a preventative maintenance tool, MCSA can be used to perform a one-time test or periodic testing to track and trend motor performance. MCSA allows for remote, non-intrusive testing of the equipment being monitored. The test analyzes the current waveform using complex mathematics. They are non-intrusive, invisible to the equipment being monitored and can be performed from remote connections such as Motor Control Centers (MCC).The information is captured and thereafter analyzed for the following possible defects:
Phase imbalance
Rotor bar faults
Winding lamination defects
Stator faults
Field studies have shown that up to 20% of all induction motors in use suffer from problems such as high resistance joints, cracked or broken rotor bars or air-gap eccentricities. Typically, starting a motor can induce five to six times the starting current in the rotor and stator windings. This can result in a number of problems upon start-up.
Effective techniques can be employed to detect and analyze critical electrical machinery to prevent failure and loss of production.
Read| The latest issue of The Challenger is here! We are thrilled to announce that our school paper has qualified for the NATIONAL SCHOOLS PRESS CONFERENCE (NSPC) 2024. Thank you for your unwavering support and trust. Dive into the stories that made us stand out!
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.
Model Attribute Check Company Auto PropertyCeline George
In Odoo, the multi-company feature allows you to manage multiple companies within a single Odoo database instance. Each company can have its own configurations while still sharing common resources such as products, customers, and suppliers.
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.
June 3, 2024 Anti-Semitism Letter Sent to MIT President Kornbluth and MIT Cor...Levi Shapiro
Letter from the Congress of the United States regarding Anti-Semitism sent June 3rd to MIT President Sally Kornbluth, MIT Corp Chair, Mark Gorenberg
Dear Dr. Kornbluth and Mr. Gorenberg,
The US House of Representatives is deeply concerned by ongoing and pervasive acts of antisemitic
harassment and intimidation at the Massachusetts Institute of Technology (MIT). Failing to act decisively to ensure a safe learning environment for all students would be a grave dereliction of your responsibilities as President of MIT and Chair of the MIT Corporation.
This Congress will not stand idly by and allow an environment hostile to Jewish students to persist. The House believes that your institution is in violation of Title VI of the Civil Rights Act, and the inability or
unwillingness to rectify this violation through action requires accountability.
Postsecondary education is a unique opportunity for students to learn and have their ideas and beliefs challenged. However, universities receiving hundreds of millions of federal funds annually have denied
students that opportunity and have been hijacked to become venues for the promotion of terrorism, antisemitic harassment and intimidation, unlawful encampments, and in some cases, assaults and riots.
The House of Representatives will not countenance the use of federal funds to indoctrinate students into hateful, antisemitic, anti-American supporters of terrorism. Investigations into campus antisemitism by the Committee on Education and the Workforce and the Committee on Ways and Means have been expanded into a Congress-wide probe across all relevant jurisdictions to address this national crisis. The undersigned Committees will conduct oversight into the use of federal funds at MIT and its learning environment under authorities granted to each Committee.
• The Committee on Education and the Workforce has been investigating your institution since December 7, 2023. The Committee has broad jurisdiction over postsecondary education, including its compliance with Title VI of the Civil Rights Act, campus safety concerns over disruptions to the learning environment, and the awarding of federal student aid under the Higher Education Act.
• The Committee on Oversight and Accountability is investigating the sources of funding and other support flowing to groups espousing pro-Hamas propaganda and engaged in antisemitic harassment and intimidation of students. The Committee on Oversight and Accountability is the principal oversight committee of the US House of Representatives and has broad authority to investigate “any matter” at “any time” under House Rule X.
• The Committee on Ways and Means has been investigating several universities since November 15, 2023, when the Committee held a hearing entitled From Ivory Towers to Dark Corners: Investigating the Nexus Between Antisemitism, Tax-Exempt Universities, and Terror Financing. The Committee followed the hearing with letters to those institutions on January 10, 202
Good Manufacturing Practice (GMP) | Arrelic Insights
1. GOOD
M A N UFA C TURIN G
PRACTICES
(GMP)
Ar r e l i c
I NSI GHTSwww. arrelic. com
2. INTRODUCTION
Good Manufacturing Practices (GMP) are the practices
required in order to conform to the guidelines
recommended by agencies that control authorization
and licensing for manufacture and sale of food, drug
products and active pharmaceutical products. These
guidelines provide minimum requirements that a
pharmaceutical or a food product manufacturer must
meet to assure that the products are of high quality and
do not pose any risk to the consumer or public. Good
manufacturing practices along with good agricultural
practices, good laboratory practices and good clinical
practices are overseen by regulatory agencies in the
United States, Canada, Europe, China, India and other
countries. Good Manufacturing Practice guidelines
provide guidance for manufacturing, testing and quality
assurance in order to ensure that a food or drug
product is safe for human consumption. Many countries
have legislated that food, pharmaceutical and medical
device manufacturers follow GMP procedures and
create their own GMP guidelines that correspond with
their legislation. All guidelines follow a few basic
principles. Manufacturing facilities must maintain a
clean and hygienic manufacturing area controlled
environmental conditions in order to prevent cross-
contamination of food or drug product from adulterants
that may render the product unsafe for human
consumption.
3. THE PROCESSES
Manufacturing processes are clearly defined and
controlled. All critical processes are validated to
ensure consistency and compliance with specifications.
Manufacturing processes are controlled and any
changes to the process are evaluated. Changes that
affect the quality of the drug are validated as necessary
instructions and procedures are written in clear and
unambiguous language and in good documentation.
Practice operators are trained to carry out and
document procedures. Cross contamination with
unlabeled major allergens is prevented. Records are
made manually or by instruments during manufacture.
These records demonstrate that all the steps required
by the defined procedures and instructions were in fact
taken and that the quantity and quality of the food or
drug was as expected. Deviations are investigated and
documented. Records of manufacture including
distribution that enable the complete history of a batch
to be traced are retained in a comprehensible and
accessible form. The distribution of the food or drugs
minimizes any risk to their quality. A system is available
for recalling any batch from sale or supply. Complaints
about marketed products are examined. The causes of
quality defects are investigated and appropriate
measures are taken with respect to the defective
products. To prevent recurrence, practices are
recommended with the goal of safeguarding the health
of consumers and patients as well as producing good
quality food medicine. Medical devices or active
pharmaceutical products in the United States, a food or
a drug may be deemed adulterated if it has passed all o
4. THE PROCESSES
of the specifications tests but is found to be
manufactured in a facility or condition which violates
or does not comply with current good manufacturing
guideline. Therefore, complying with GMP is mandatory
in all pharmaceutical manufacturing. And most food
processing GMP guidelines are not just prescriptive
instructions on how to manufacture products but they
are a series of general principles that must be observed
during manufacturing where the company is setting up
its quality program and manufacturing process. There
may be many ways it can fulfil GMP requirements. It is
the company's responsibility to determine the most
effective and efficient quality process. The quality is
built into the product and GMP is the most essential
part of ensuring this product quality. GMPs in forests in
the United States by the US Food and Drug
Administration FDA under title 21 CFR.
WORLDWIDE
The regulations use the phrase ‘Current Good
Manufacturing Practices (cGMP)’. According to the
GMP guidelines, courts may theoretically hold that a
product is adulterated even if there is no specific
regulatory requirement that was violated, as long as
the process was not performed according to industry
standards. Since June 2010, a different set of cGMP
requirements have applied to all manufacturers of
dietary supplements. The World Health Organization
(WHO) version of GMP is used by pharmaceutical
regulators and the pharmaceutical industry in over
5. WORLDWIDE
100 countries worldwide. Primarily, in the developing
world, the European Union's GMP i.e., EU-GMP
enforces similar requirements to WHO-GMP as does
the FDA's version in the US. Similar GMP s are used in
other countries with Australia, Canada, Japan, Saudi
Arabia, Singapore, Philippines, Vietnam and others
having highly developed sophisticated GMP
requirements.
In the United Kingdom, the medicines act 1968 covers
most aspects of GMP. It is commonly referred to as the
orange guide and is named so because of the color of its
cover. It is officially known as Rules and Guidance for
Pharmaceutical Manufacturers and Distributors since
the 1999 publication of GMP s for active
pharmaceutical ingredients by the International
Conference on harmonization itch GMPs now apply in
those countries and trade groupings that are
signatories to it the EU Japan and the US and applies in
other countries for example Australia Canada
Singapore which had dropped its guidelines for the
manufacture and testing of active raw materials. GMP
is a part of Quality Assurance which ensures that
products are consistently produced and controlled to
the quality standards, appropriate to their intended use
and as required by marketing authorization or product
specification within the European Union.
6. REGULATORIES
GMP inspections are performed by national regulatory
agencies. For example, GMP inspections are performed
in the United Kingdom by the Medicines and Healthcare
Products Regulatory Agency, whereas in the Republic
of Korea i.e., South Korea by The Ministry of Food and
Drug Safety, in Australia by the Therapeutic Goods
Administration, in India by Central Drugs Standard
Control Organization (CDSCO), in Bangladesh by the
Director-general of Drug Administration, in South
Africa by the medicines Control Council MCC, in Brazil
by the National Health surveillance agency and by
CDSCO in India .GMP inspections are carried out by
state Food and Drugs administration's FDA and these
FDA report to the Central Drug Standard Control
Organization, in Pakistan by the Drug Regulatory
Authority of Pakistan, in Nigeria by NAVTEQ and by
similar national organizations worldwide. Each of the
inspectors carry out routine GMP inspections to ensure
that drug products are produced safely and correctly.
Additionally many countries perform pre-approval
inspections i.e., for GMP compliance prior to the
approval of a new drug for marketing.