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that regulated firms use the most current Good Manufacturing Practices (I believe that some firms would actually use outdated versions of the GMP’s to manufacture regulated products.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.)
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.
Pharmaceutical Good Manufacturing PracticesPharmaceutical
When you are in healthcare, Then GMP is must. Regulatory philosophy for product Quality have been changed from "Quality by Testing QbT" to "Quality by Design QbD". Quality is to be built in product and that only can be done by GMP.
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, 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.)
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.
Pharmaceutical Good Manufacturing PracticesPharmaceutical
When you are in healthcare, Then GMP is must. Regulatory philosophy for product Quality have been changed from "Quality by Testing QbT" to "Quality by Design QbD". Quality is to be built in product and that only can be done by GMP.
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.
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Quality control
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Components of quality control
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Quality assurance
Total quality management
Characteristics of tqm
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GMP Requirements & Drug & Cosmetic Act Provision.pptxEasy Concept
Good Manufacturing Practices (GMP) is that part of quality assurance, which ensures that products are regularly produced and controlled according to the quality standards suitable for their use.
(GMP) comes in Schedule M in D & C Act 1940 and Rules 1945.
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Quality Assurance and Quality Management System, QUALITY CONTROL
cGMP (GOOD MANUFACTURING PRACTICES
ELEMENTS OF QUALITY MANAGEMENT SYSTEM
PURPOSES OF QUALITY MANAGEMENT SYSTEMS
CONCEPT OF QUALITY ASSURANCE
RESPONSIBILITIES OF QA
GMP COVERS
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June 20, 2024, Prix Galien International and Jerusalem Ethics Forum in ROME. Detailed agenda including panels:
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Good Manufacturing Practices (GMP)- Purpose and Principles
1.
2. Good Manufacturing Practices
Purpose and Principles of GMP
DIPSAR
MD. IMRAN MALIK
(D.pharm, B.pharm- DIPSAR)
Persuing M.Pharm (Pharm. Management)
New Delhi, 14 Aug, 2015
2
3. GOOD MANUFACTURING PRACTICES
QUALITY OF DRUGS IS ESSENTIALLY THE RESPONSIBILITY OF
MANUFACTURERS.
GMP GUIDELINES ARE A MEANS TO ASSURE THIS VERY QUALITY OF
DRUGS.
GMP REGULATIONS WERE INTRODUCED IN THE FORM OF AMENDED
SCHEDULE ‘M’ IN 1988.
4. PRINCIPLES OF GMP
1. General Requirements
Location and surrounding
Buildings and premises
Water system
Disposal of waste
2. Quality assurance (QA)
3. Sanitation and hygiene
4. Qualification and validation
5. 5. Warehousing area
6. Production area
7. Ancillary areas
8. Quality control area
9. Personnel
10. Quality control area
11. Manufacturing operations and control
6. 12. Raw materials
13. Documentation and records
14. Self inspection and quality audit
15. Specifications
16. Master formula records
17. Standard Operating Procedures (SOP)
7. GMP is actually Good Common Sense
Quality Management
Quality Assurance
GMP
Production and Quality Control
8. Quality Management:
What is Quality Management?
The aspect of management function that determines and
implements the “quality policy”
The overall intention and direction regarding quality, as
formally expressed and authorized by top management
9. Intermezzo: the five P's
Premises
Primary materials
People
Procedures
Processes defined and recorded
10. Quality Assurance
QUALITY ASSURANCE IS COMPANY BASED.
Quality assurance is a management tool
In contractual situations, it also serves to generate confidence in
a supplier
QA, GMP and Quality Control are interrelated aspects of Quality
Management
11. The position of QA
DirectorDirector
QAQA
ProductionProduction QC labQC lab Other DeptsOther Depts
12. Quality Assurance includes:
Responsibility of the Manufacturer for the quality of the product
Fit for intended use
Comply with marketing authorization
Safety, efficacy and quality
Commitment of senior management and involvement of all staff
Comprehensively designed and well implemented quality system
Full documentation and monitoring of effectiveness
Competent personnel, sufficient premises, equipment and facilities
13. AIM OF Good Manufacturing Practices
That part of QA that ensures that products are consistently
produced and controlled
Quality standards
Marketing authorization
Aim: Diminishing risks that cannot be controlled by testing of
product
Contamination and cross-contamination
Mix-ups (confusion)
14. Basic requirements for GMP:
Clearly defined and systematically reviewed processes
Qualification and validation is performed
Appropriate resources are provided:
Qualified and trained personnel
Premises, space, equipment and services
Materials, containers, labels
Procedures, storage, transport
Laboratories and in-process control
15. Clear, written instructions and procedures
Trained operators
Records of actions, deviations and investigations
Records for manufacture and distribution
Proper storage and distribution
Systems for complaints and recalls
16. GMP = continuous urge for improvement
Involvement of the management
Annual Product Quality Review
Complaints handling
Self-inspection
17. Annual Product Quality Review
Objectives to do an Annual Product Quality Review:
To review and verify the consistency and appropriateness of the
existing process
To identify and highlight any trends in the process, e.g. in analytical
results, yields etc.
To identify any possible product or process improvements
18. Complaints handling
“All complaints and other information concerning
potentially defective products must be carefully
reviewed according to written procedures and
corrective action should be taken.”
Investigation and evaluation should result in
appropriate follow-up actions
All decisions and measures taken should be recorded
Referenced in batch records
Records reviewed - trends and recurring problems
19. Self-Inspection
Purpose is to evaluate whether a company’s operations
remain compliant with GMP
The programme should
cover all aspects of production and quality control
be designed to detect shortcomings in the implementation of GMP
recommend corrective actions
set a timetable for corrective action to be completed
Be performed routinely
Also on special occasions such as
Recalls
Repeated rejections
When a GMP inspection is announced by the national drug
regulatory authority
20. Summary and conclusions:
GMP is mandatory in countries with a regulated pharmaceutical
market, and in the WHO Prequalification Programme too.
GMP's are very similar, they are nothing but Good Common Sense
Good Practices cover all aspects of company's activities prior to sales
GMP is not a reward, nor an external assignment, it should be built
into the company
Just like quality, which should be built into the product
The role and involvement of senior management is crucial
GMP means an urge for continuous improvement, 3 of the tools to do
so are:
Annual Product Quality Reviews
Complaint handling and trending
Self-inspection
The product complaint principle is defined in the WHO GMP.
The manufacturer must assume responsibility for the quality of the pharmaceutical products to ensure that they are fit for their intended use, comply with the requirements of the marketing authorization, and do not place the patient at risk because of inadequate safety, quality or efficacy.
Complaints must be handled positively and carefully reviewed, and corrective actions must be taken as necessary. This can mean amending a manufacturing process as well as implementing a recall of a defective product from all markets where it has been distributed.
The purpose of self-inspection is to evaluate the manufacturer’s compliance with GMP in all aspects of production and quality control.
It also assists in ensuring quality improvement. There should be a programme that covers all aspects of production and quality control. It should be designed to detect shortcomings in the implementation of GMP and recommend corrective actions. The company should set a timetable for corrective action to be completed. You can verify this during your assessment.