Good Manufacturing Practice is a part of quality assurance which ensure that the products are consistently produced and controlled according to quality standards appropriate to their intended use.
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.
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.
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.
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.
GMP is important to ensure that businesses produce safe food to the public. Businesses in the food industry have a legal and moral responsibility to prepare food that is safe for the consumer. By not implementing adequate good manufacturing practices (GMP), a food business can risk several negative consequences.
The implemented of GMP on food and medicine industry's.
Most of the time it has been seen that the GMP content of the food industry related is very low so we have make a little effort. This makes will content available to students easily.
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 vendor audit is a vehicle used by pharmaceutical companies, and other large companies as well, to inspect and evaluate a vendor’s quality management system, as well as its practices, products, and documentation.
The need to conduct vendor audits stems from a higher need for quality control in an industry that needs to be more regulated than any other industry in the world.
Reason why organizations use audits is to reduce cost and improve quality control
The objective of vendor audit is to develop an audit function comprising of qualified resources to effectively perform compliance audits to ensure that the contracts are being executed in accordance with the intent and address the net benefit to include cost recoveries, process improvement savings, fraud improvement and identification of hidden risks.
In order to reduce the cost pharmaceutical companies have increasingly become dependent on their supplier/ out sourcing partners for customer success. Though it has drastically reduced the production cost for companies, there is a heightened supplier risk and lack of visibility into supplier processes.
To gain an insight into supplier process and eliminate the risks, FDA encourages companies to conduct GMP supplier audit at the manufacturing premises of the supplier.
According to GMP code, it is sole responsibility of pharmaceutical industry to ensure that the suppliers manufacturing process, analytical tests and examinations are carried out reliably by the supplier and are in compliances with the applicable standards and regulations.
After the audit supplier must provide an appropriate corrective action plan with measures that that will be implemented by the supplier within a defined time frame to the manufacturer.
Role of quality systems and audits in pharmaceutical manufacturing environmentMalay Pandya
By regulation, appropriate practice, and common sense, quality assurance (QA) is a critical function in the pharmaceutical manufacturing environment. The need for an independent unit to audit and comment on the appropriate application of standard operating procedures, master batch records, procedures approved in product applications, and the proper functioning of the quality control (QC) unit is paramount.
This helps assure that products are manufactured reliably, with adherence to approved specifications, and that current good manufacturing practices (cGMP) are maintained in conformance to regulation, both in the facility in general and the microenvironment of each product ’s manufacturing sequence.
Manufacturing Control Systems. J R Controls provides control systems for the manufacturing industry. A typical control system will monitor the progress of parts through the manufacturing and finishing process.
pratik ghive cGMP According to schedule Mpratikghive82
Pratik Ghive Current Good Manufacturing Practices (cGMP) Guidelines According to schedule M Cover all guidelines as per Drug and cosmetic act 1940 and ICH guidelines
GMP is important to ensure that businesses produce safe food to the public. Businesses in the food industry have a legal and moral responsibility to prepare food that is safe for the consumer. By not implementing adequate good manufacturing practices (GMP), a food business can risk several negative consequences.
The implemented of GMP on food and medicine industry's.
Most of the time it has been seen that the GMP content of the food industry related is very low so we have make a little effort. This makes will content available to students easily.
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 vendor audit is a vehicle used by pharmaceutical companies, and other large companies as well, to inspect and evaluate a vendor’s quality management system, as well as its practices, products, and documentation.
The need to conduct vendor audits stems from a higher need for quality control in an industry that needs to be more regulated than any other industry in the world.
Reason why organizations use audits is to reduce cost and improve quality control
The objective of vendor audit is to develop an audit function comprising of qualified resources to effectively perform compliance audits to ensure that the contracts are being executed in accordance with the intent and address the net benefit to include cost recoveries, process improvement savings, fraud improvement and identification of hidden risks.
In order to reduce the cost pharmaceutical companies have increasingly become dependent on their supplier/ out sourcing partners for customer success. Though it has drastically reduced the production cost for companies, there is a heightened supplier risk and lack of visibility into supplier processes.
To gain an insight into supplier process and eliminate the risks, FDA encourages companies to conduct GMP supplier audit at the manufacturing premises of the supplier.
According to GMP code, it is sole responsibility of pharmaceutical industry to ensure that the suppliers manufacturing process, analytical tests and examinations are carried out reliably by the supplier and are in compliances with the applicable standards and regulations.
After the audit supplier must provide an appropriate corrective action plan with measures that that will be implemented by the supplier within a defined time frame to the manufacturer.
Role of quality systems and audits in pharmaceutical manufacturing environmentMalay Pandya
By regulation, appropriate practice, and common sense, quality assurance (QA) is a critical function in the pharmaceutical manufacturing environment. The need for an independent unit to audit and comment on the appropriate application of standard operating procedures, master batch records, procedures approved in product applications, and the proper functioning of the quality control (QC) unit is paramount.
This helps assure that products are manufactured reliably, with adherence to approved specifications, and that current good manufacturing practices (cGMP) are maintained in conformance to regulation, both in the facility in general and the microenvironment of each product ’s manufacturing sequence.
Manufacturing Control Systems. J R Controls provides control systems for the manufacturing industry. A typical control system will monitor the progress of parts through the manufacturing and finishing process.
pratik ghive cGMP According to schedule Mpratikghive82
Pratik Ghive Current Good Manufacturing Practices (cGMP) Guidelines According to schedule M Cover all guidelines as per Drug and cosmetic act 1940 and ICH guidelines
Tony seruga yolanda seruga business expert. Tony Seruga Yolanda Seruga hates scam and fraud and any kinds of ripoff. Tony Seruga a business i con knows pros and cons and has got very good reviews as he got the best review of internet marketer.In the early years, Tony Seruga started a professional lawn service, employing college kids to do the actual work when he was only 14 years old building revenues to over $12,000 per year by the time he was 17. Tony built his first computer from a kit in 1976 and started his first “online” business in the early 1980s, using AOL and Compuserve.
Tony is a serial entrepreneur, having personally started over 240 businesses and over 600 with business partners. Tony has mentored thousands upon thousands of business owners.
Tony has been an early stage investor and entrepreneur since 1987. Tony has over two decades of experience in the venture capital, technology and entertainment industries in a multitude of investing, operational and engineering roles acting as a key adviser. In addition to his investing efforts, Tony has been active with several non-profit organizations. Tony holds a Juris Doctorate, although he never chose to practice law, opting for buying and selling businesses and investing in those projects he felt had the best chance of success.
Tony was co-owner of half a dozen early search engines including three pay-per-click search engines and was an early angel investor and adviser to four different businesses that went on to become multi-billion dollar companies. As a business adviser, Tony’s past client roster included a number of household names and celebrities.
And while Tony enjoyed speaking at business and marketing events all over the world, his real passion is to empower entrepreneurs and business owners to create massive success. Tony loves to help people to understand specifically what it takes to build a successful business. He has a very successful background in venture capital, investing and marketing. He has spent two decades working with start-ups to major global brands increasing sales, productivity and overall success and is an innovator with a remarkable ability to determine and dictate success strategies that enable companies to seize global market opportunities.
For everyone that either wishes to start their own business, currently owns a business or would like to capitalize the entrepreneurial dream, Tony’s message will enlighten them with knowledge and actionable principles to turn that passion into success. Tony has an extensive background in starting businesses, commercial real estate development and building companies around the world. Over the past two decades, he has specialized in helping companies launch, grow and create exponential valuation in the marketplace.
For more info about Tony Seruga visit http://tonyserugatonyserugatonyseruga.blogspot.com/
Current good manufacturing practice .pptxOsamaTauseef2
Current good manufacturing practice according to Leon Lachman
Helpful contains for al pharmacy students like diploma, degree and also masters of pharmacy students
So use the contains and build your knowledge.
Quality control measures in pharmaceutical industryChemOnTheGo
QUALITY CONTROL
ROLE OF QUALITY CONTROL IN PHARMACEUTICAL INDUSTRY
OBJECTIVES OF QUALITY CONTROL
STEPS IN QUALITY CONTROL
COST OF QUALITY CONTROL
TOTAL QUALITY MANAGEMENT
QUALITY CIRCLE
documentation in pharmaceutical industry ppt.pptxashokgorja8
To define specifications and procedures for all materials and method of manufactured and control.
To ensure that all personal concern with manufacture know what to do and when to do it.
documentation in pharmaceutical industry ppt.pptxashokgorja8
DOCUMENTATION IN PHARMACEUTICAL INDUSTRY :
WORKING INSTRUCTIONS AND RECORD FORMATS
To define specifications and procedures for all materials and method of manufactured and control.
To ensure that all personal concern with manufacture know what to do and when to do it.
To ensure that authorized persons have all the information necessary to decide whether or not realize a batch of drug for sale.
To ensure the existence of documented evidence , trace ability and adult trail that will permit investigation.
Role of wto wipo & epo in patent pre simpleShital Patil
Bretton Woods conference (1944)
To overcome recession after post world war 2nd group of 44 nations meet in Breetonwood , England.
To discuss about establishment of an organization , which will help restoring international trade.
General Agreement on Tarrifs and Trade (GATT)
GATT was established in 1948 in Geneva.
This organization deals with regulation of trade between participating countries.
Research in general refers to….
A search for knowledge.
A scientific and systematic search for relevant information on a specific topic.
Research is an art of scientific investigation.
Research is a careful investigation or inquiry especially through search for new facts in any branch of knowledge.
when you can measure what you are speaking about and express it in numbers, you know something about it but when you cannot measure, when you cannot express it in numbers, your knowledge is of meagre and unsatisfactory kind.”
A system of maintaining standards in manufactured products by testing a sample of the output against the specification.
ISO 9000 defines quality control as "A part of quality management focused on fulfilling quality requirements"
It is that part of GMP concerned with sampling, specification and testing, documentation and release procedures which ensure that the necessary and relevant tests are performed and the product is released for use only after ascertaining it’s quality.
1.5 international conference on harmonizationShital Patil
ICH is a joint initiative involving both regulators and research-based industry representatives of the EU, Japan and the US in scientific and technical discussions of the testing procedures required to assess and ensure the safety, quality and efficacy of medicines.
3. economy of multiple effect evaporatorShital Patil
A multiple-effect evaporator, as defined in chemical engineering, is an equipment for efficiently using the heat from steam to evaporate water.
Steam is mostly used as heating medium in Multiple effect evaporator.
Multiple Effect Evaporation remains one of the popular method for the concentration of aqueous solutions.
A multiple-effect evaporator, as defined in chemical engineering, is an equipment for efficiently using the heat from steam to evaporate water.
Steam is mostly used as heating medium in Multiple effect evaporator.
Multiple Effect Evaporation remains one of the popular method for the concentration of aqueous solutions.
Quality assurance is a wide ranging concept covering all matters that individually and collectively influence the quality of product.
It is the arrangements made with the object of ensuring that pharmaceutical products are of the quality required for the intended use.
Assurance of product quality is derived from careful attention of factors including selection of quality parts and materials, adequate product and process design, control of the process, and in-process and end-product testing.
Bryophytes are mostly terrestrial plants. They are found in moist shady places. But they need water for fertilization and completion of their life cycle. Hence they are called ‘amphibious plants’.
They include approximately 960 genera and about 25,000 species.
Life cycle of Bryophytes shows sporophytic and gametophytic stages..
Bryophytes have root-like structures called rhizoids. Rhizoids are unicellular in liverworts while multicellular in mosses.
Kingdom Plantae is further classified on the basis of characteristics like absence or presence of seeds, vascular tissues, differentiation of plant body, etc.
Unit 8 - Information and Communication Technology (Paper I).pdfThiyagu K
This slides describes the basic concepts of ICT, basics of Email, Emerging Technology and Digital Initiatives in Education. This presentations aligns with the UGC Paper I syllabus.
The Art Pastor's Guide to Sabbath | Steve ThomasonSteve Thomason
What is the purpose of the Sabbath Law in the Torah. It is interesting to compare how the context of the law shifts from Exodus to Deuteronomy. Who gets to rest, and why?
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.
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.
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!
We all have good and bad thoughts from time to time and situation to situation. We are bombarded daily with spiraling thoughts(both negative and positive) creating all-consuming feel , making us difficult to manage with associated suffering. Good thoughts are like our Mob Signal (Positive thought) amidst noise(negative thought) in the atmosphere. Negative thoughts like noise outweigh positive thoughts. These thoughts often create unwanted confusion, trouble, stress and frustration in our mind as well as chaos in our physical world. Negative thoughts are also known as “distorted thinking”.
How to Make a Field invisible in Odoo 17Celine George
It is possible to hide or invisible some fields in odoo. Commonly using “invisible” attribute in the field definition to invisible the fields. This slide will show how to make a field invisible in odoo 17.
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.
2. Good Manufacturing Practice
• Good Manufacturing Practice is a part of
quality assurance which ensure that the
products are consistently produced and
controlled according to quality standards
appropriate to their intended use.
3. Good Manufacturing Practice
• GMP – A set of principles and procedures
which, when followed by manufacturers for
the therapeutic goods, helps ensure that the
products manufactured will have the required
quality.
4. Good Manufacturing Practice
• It is designed to minimize the risks involved in
any pharmaceutical production that cannot be
eliminated through testing the final product.
5. 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 documents
proof that correct procedures are consistently
followed at each step in the manufacturing
process every time a product is made.
6. WHO GOOD MANUFACTURING PRACTICES FOR PHARMACEUTICAL
PRODUCTS: MAIN PRINCIPLES
• GMP is that part of quality management which
ensures that products are consistently produced
and controlled according to the quality standards
appropriate to their intended use and as required
by the marketing authorization, clinical trial
authorization or product specification.
• GMP is concerned with both production and QC.
• GMP is aimed primarily at managing and
minimizing the risks inherent in pharmaceutical
manufacture to ensure the quality, safety and
efficacy of products.
7. Under GMP
• a)All manufacturing processes are clearly defined,
systematically reviewed for associated risks in the
light of scientific knowledge and experience, and
shown to be capable of consistently manufacturing
pharmaceutical products of the required quality
that comply with their specifications.
• b) Qualification and validation are Performed;
8. UNDER GMP
• c) All necessary resources are provided, including:
– sufficient and appropriately qualified and trained personnel,
– adequate premises and space,
– suitable equipment and services,
– appropriate materials, containers and labels,
– approved procedures and instructions,
– suitable storage and transport,
– adequate personnel, laboratories and equipment for in- process
controls;
9. UNDER GMP
• d) Instructions and procedures are written in clear and
unambiguous language, specifically applicable to the
facilities provided;
• e) Procedures are carried out correctly and personnel are
trained to do so;
• f) Records are made (manually and/or by recording
instruments) during manufacture to show that all the steps
required by the defined procedures and instructions have
in fact been taken and that the quantity and quality of the
product are as expected. Any significant deviations are fully
recorded and investigated with the objective of
determining the root cause and appropriate corrective and
preventive action is implemented;
10. UNDER GMP
• g) Records covering manufacture and distribution, which
enable the complete history of a batch to be traced, are
retained in a comprehensible and accessible form;
• h) The proper storage and distribution of the products
minimizes any risk to their quality and takes account of
good distribution practices (GDP);
• i) A system is available to recall any batch of product from
sale or supply;
• j) Complaints about marketed products are examined, the
causes of quality defects investigated and appropriate
measures taken in respect of the defective products to
prevent recurrence.
11. LISTS OF IMPORTANT DOCUMENTS IN
GMP
• Policies
• Standard operating procedures SOP
• Specifications
• Master formula records MFR
• Batch manufacturing record BMR
• Manuals
• Master plans/Files
• Validation protocols
• Forms and formats
• Records
