The document outlines the key aspects of current good manufacturing practices (cGMPs) that pharmaceutical manufacturers must follow. cGMPs come from the Food, Drug and Cosmetic Act and are enforced by the FDA. They help ensure safety and quality by requiring strict control over facilities, equipment, components, packaging, labeling, and processes. Key parts of cGMP regulations address organization, buildings, equipment, materials control, production, packaging, holding, distribution, and records. Failure to comply can result in serious legal and business consequences like product recalls or plant shutdowns.
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that regulated firms use the most current Good Manufacturing Practices (I believe that some firms would actually use outdated versions of the GMP’s to manufacture regulated products.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.)
In Pharma and Biotech, Weightage of the Documentation is around 70 % because as per FDA "If you do not have Document, You dint have do it."
So Good Documentation Practice is of tremendous importance for the Industry to comply any regulation like FDA, GMP or ISO.
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.
Quality Management system in accordance to Vol. 4 EU Guidelines for GMP for Medicinal Products for Human and Veterinary Use Chapter 1 Pharmaceutical QS
ICH Q10/ Q7.
ISO 9001/2015
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.
Documentation is an integral part of good manufacturing practices. It defines a system of information and control so that risks so inherent in misinterpretation and/or error in oral communication are minimized.
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.)
In Pharma and Biotech, Weightage of the Documentation is around 70 % because as per FDA "If you do not have Document, You dint have do it."
So Good Documentation Practice is of tremendous importance for the Industry to comply any regulation like FDA, GMP or ISO.
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.
Quality Management system in accordance to Vol. 4 EU Guidelines for GMP for Medicinal Products for Human and Veterinary Use Chapter 1 Pharmaceutical QS
ICH Q10/ Q7.
ISO 9001/2015
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.
Documentation is an integral part of good manufacturing practices. It defines a system of information and control so that risks so inherent in misinterpretation and/or error in oral communication are minimized.
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.
Overview on the Toyota production system principles, techniques and theories.
The presentation include:
-Lean Manufacturing Principles
-Productivity Measurement, Analysis and Improvement
-Effect & Elimination of the Manufacturing 7-Wastes
-Lean Improvement Techniques
-Lean Management for Making Improvement & Gaining Sustainability
Quality management systems for medical, pharmaceutical,Khalizan Halid
This presentation provides an overview of the role that a computerized quality management system plays in a manufacturer practising Good Manufacturing Practices and compares it's complimentary functions against an Enterprise Resource Planning System
The 2nd Speaker, Tessa Cerbolles, of the Breakout Session C Health and Food of the 1st Philippine Environment Summit discussed the regulation/government policy on maintaining the safety of food in the country
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)
The GMP Operations Manager is responsible for overseeing the implementation and sustained operations of world-class technical cleaning and sanitization programs to include cGMP space, semi-conductor, clean rooms, laboratory, data and other critical environments.
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.
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.
Welcome to the Program Your Destiny course. In this course, we will be learning the technology of personal transformation, neuroassociative conditioning (NAC) as pioneered by Tony Robbins. NAC is used to deprogram negative neuroassociations that are causing approach avoidance and instead reprogram yourself with positive neuroassociations that lead to being approach automatic. In doing so, you change your destiny, moving towards unlocking the hypersocial self within, the true self free from fear and operating from a place of personal power and love.
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2. Objectives
1. To understand where the regulations
come from, who has enforcement
authority, and why you need to comply
2. To understand the “Fundamentals”,
“Benefits” and “Key Parts” of cGMPs
3. What are cGMPs?
Current Good Manufacturing Practices
Come from the Food Drug and Cosmetic
Act
Rules set up by the FDA that drug
manufacturers needs to follow in order to
ensure that a safe and effective product is
manufactured
4. Where Did the Food Drug and
Cosmetic Act Come From?
1906 book by Upton Sinclair
The Jungle exposed the
dangers involved in the meat
packing industry
Helped drive public opinion to
support a new law passed by
Congress
Food Drug and Cosmetic Act
5. Provisions of the Law
(FDC Act)
– Creation of Federal Government agency
to oversee food industry
– Scope expanded later to medical
industry
6. Who Interprets and Enforces
This Law?
The FDA (Food and Drug Administration) is
an agency within the Department of Health
and Human Services and consists of eight
centers/offices.
7. FDA
The FDA consists of eight branches
Center for Biologics Evaluation Center for Devices and
and Research (CBER) Radiological Health (CDRH)
Center for Drug Evaluation Center for Food Safety and
and Research (CDER) Applied Nutrition (CFSAN)
Center for Veterinary Medicine National Center for Toxicological
(CVM) Research (NCTR)
Office of the Commissioner (OC) Office of Regulatory Affairs
(ORA)
8. Interpretations of the Law
The Code of Federal Regulations is a
government publication where Federal Agencies
post regulations
– Contain regulations enforced by the DOT, DEA,
FCC, FDA, and all other agencies
Found in Code of Federal Regulations (CFR)
– Drug (cGMP): Title 21, Part 210 & 211
– Device (QSR): Title 21, Part 820
– Combination Product: Title 21 CFR Part 3 Subpart
A (section 3.2e)
9. Interpretations of the
Regulations
Guidance documents published by FDA and
International Conference on Harmonization (ICH)
Draft guidance documents
Preamble documents published by government
FDA 483 inspectional observations documents
Warning letters from FDA to various companies
www.fda.gov
10. What Happens if cGMP’s are
not Followed?
– Adulteration: “A drug is deemed to be
adulterated if the methods used in or the facilities
or controls used for its manufacture, processing,
packing, or holding do not conform to or are not
operated or administered in conformity with
cGMP to assure that such drug meets the
requirements of this act as to Safety and has the
Identity and Strength, and meets the Quality
and Purity characteristics which it purports or is
represented to possess.”
11. Why Comply?
• Food drug and cosmetic act is the law
• When charged with a violation:
– Proof of criminal intent is not necessary. (Guilty
until proven innocent)
– Actual harm from contamination does not need
to be proven.
– (Passing product ≠ non-adulterated product)
• Consequences are numerous
12. Consequences of
Non-compliance
Legal Consequences
– FDA 483s
– FDA warning letters
– Consent decree
– Recall of product
– Product seizure
– Plant Injunction
– Company closure
– Debarment
13. Consequences of
Non-compliance
Business Consequences
– Expensive to do recalls
– Loss of sales
– Bad publicity
– Potential harm to customers
14. Fundamentals of cGMPs?
– Based on fundamental concepts of
Quality Assurance Principles
Control
Quality, safety, and effectiveness must be
designed and built into the product
Quality cannot be inspected or tested into a
finished product
Each step of manufacturing must be
controlled to maximize the chances that the
Finished Good will be acceptable
15. What are the Benefits of cGMPs?
– They outline a Quality System that reduces or
prevents errors
– Ensures products are safe for use in humans
– Prevent/control contamination and cross-
contamination
– Minimizes variations in potency of the drug
– Ensures reproducible physiological activity
– Prevent side effects and toxicity due to
variations in drug content and potency
– Prevents mislabeling and adulteration
16. Key Parts of cGMP’s
Subpart B: Organization and Personnel
Subpart C: Buildings and Facilities
Subpart D: Equipment
Supbart E: Control of Components and Drug
Product Containers and Closures
Subpart F: Production and Process Controls
17. Key Parts of cGMP’s
Subpart G: Packaging & Labeling Control
Subpart H: Holding & Distribution
Subpart I: Laboratory Controls
Subpart J: Records & Reports
Subpart K: Returned & Salvaged Drug
Product
18. Organization and Personnel
Management Responsibility
– Responsible for facility, quality system,
organizational structure, ensuring adequate
resources
– Responsible for actions of those reporting to them
– Responsible for reviewing products annually, and
procedures routinely
– Responsible for providing adequate resources to
perform operations
Facilities, personnel, training, equipment, etc
19. Quality Unit
Responsible for approval or rejection of
– all components, raw materials, containers, closures,
subassemblies, packaging, labeled finished
products, process validation reports, procedures
and product specifications
– Investigative reports for non-conformances and out-
of-specifications (OOS’s)
20. Quality Unit
Responsible for reviewing production records
and ensuring that no errors have occurred
(may include verification activities)
Responsible for releasing product for use
Must be independent of manufacturing
21. Buildings and Facilities
Buildings must be designed with adequate size and space
for operations (helps to eliminate mix-ups)
Facilities must be validated
There must be a good flow pattern for personnel,
materials, products and waste materials (flow from clean to
dirty)
The facility must be easy to clean and sanitize (surfaces,
equipment, exposed cords, floors, ceilings…)
Environmental controls must be in place (clean rooms)
Utilities must be validated (water systems, electrical, etc)
22. Buildings and Facilities
Must have engineering documents describing the layout of
the clean rooms – controlled documents
Changes to the layout of the room after it has been
validated must go through change control procedures and
may require revalidation of the room
Any changes that potentially impact the ventilation in the
room must be assessed for impact on the microbial levels
in the room
Microorganisms, particulates, and hazardous materials
must be controlled
23. Equipment
Equipment should be selected based on the
intended use and cleanability if it is to be in a
clean room
Equipment must be placed in an appropriate
location (temperature, humidity, etc.)
Equipment must be properly qualified (Design,
Installation, Operation, Performance)
24. Component/Materials Control
Suppliers must be evaluated and approved and
monitored for quality
Incoming Materials must be tested before they can be
accepted for use
Materials must be placed in stores or issued according
to FIFO (stock rotation)
Materials must be stored so that they are not mixed
up, damaged, or contaminated.
25. Production/Process Control
Have & Follow Procedures: A good
procedure is a written step-by-step
procedure that provides a roadmap for
Controlled and Consistent performance.
Examples:
– (Manufacturing) Work Instructions
– Operating Procedures
– Testing Procedures
– Quality Manual
Deviations must be recorded and justified
26. Procedures should address…
…verification of critical steps by a second
person
…line clearance
…monitoring of processes to make sure they
are in control
…time limits and yield calculations as
appropriate checks for critical processes
…gowning for controlled environments
(cleanrooms)
27. Packaging and Labeling Control
Label is a display of a written, printed or graphic
matter upon the immediate container of any article
Labeling is the label and any other packaging material
or container that is printed (ex. IFU, advertising
materials)
Procedures must exist that document receiving,
identity, storage, handling, sampling, and testing of
labels and ensure that integrity is maintained
throughout production and use of product
28. Packaging and Labeling Control
Labeling must be separated physically in storage to
avoid mix-ups
Wording of labels cannot be changed unless the
FDA is notified
Labeling must be inspected prior to issuing to
production
All labels must be reconciled (accounted for) if not
100% inspected.
Label control begins with the design
29. Holding and Distribution
Warehousing procedures should address…
…Quarantine of drug products
…storage of products under appropriate conditions
Distribution procedures should address…
…FEFO (First Expiring First Out)
…traceability of product lots/batches
30. Laboratory Controls
Written procedures must be established & followed
All actions must be documented at the time of
performance
Calculations need to be recorded
Second person must review records
Data must be directly recorded into appropriate records
Equipment, software, and methods must be validated
An Out-of-Specification (OOS) result must be investigated
and a root cause identified
Laboratory data is considered to be a quality record
31. Records and Reports
Quality Records are the proof that the
procedures were followed and they show
traceability of product.
Examples:
– Lot History Records
– Laboratory Notebooks
– Protocols
– Reports
– Logbooks
– Distribution Records
– Complaint Files
32. Quality Records
Records are legal documents and can be subpoenaed
in a court of law as evidence
Signatures on documentation have the same meaning
as on any kind of contract
Information must be recorded and signed for at the
time of performance on the original record
33. Website References
http://www.fda.gov (Food and Drug Administration)
http://www.fda.gov/foi/warning.htm (FDA Warning Letters)
http://www.access.gpo.gov/uscode/title21/chapter9_.html
(Food Drug and Cosmetic Act)
http://www.gpoaccess.gov/fr/index.html (Federal Register)
http://www.fda.gov/opacom/morechoices/industry/guidedc.
htm (Guidance Documents)
http://www.ich.org (International Conference on Harmonization)
http://www.pda.org (Parenteral Drug Association)