SlideShare a Scribd company logo
1 of 24
www.ngsmips.nitte.edu.in
CGMP
Current Good Manufacturing Practices
Department of Regulatory Affairs
NGSMIPS, Nitte University
Mangalore
- Swapnil Dylan Fernandes
1
What is CGMP ?
• Current Good Manufacturing Practice regulations enforced by the US Food and
Drug Administration (FDA).
• Provides for systems that assure proper design, monitoring, and control of
manufacturing processes and facilities.
• Assures the identity, strength, quality, and purity of drug products.
• The "C" in CGMP stands for "current," requiring companies to use technologies
and systems that are up-to-date in order to comply with the regulations.
2
Importance of CGMP
• To assure that quality is built into the design and
manufacturing process at every step.
3
21 CFR Part 210
CURRENT GOOD MANUFACTURING PRACTICE IN
MANUFACTURING, PROCESSING, PACKING, OR HOLDING
OF DRUGS
• § 210.1 - Status of current good manufacturing practice regulations.
• § 210.2 - Applicability of current good manufacturing practice
regulations.
• § 210.3 - Definitions.
4
21 CFR Part 210
210.1 Status of the regulations
• Regulations set forth are “minimum” requirements!!!!
• Covers manufacturing, facilities and controls for Manufacturing,
processing, packaging or holding of a drug product
• Failure to comply will render the drug to be adulterated
• The person who is responsible for the failure to comply shall be
subject to regulatory action
5
21 CFR Part 210
210.2 Applicability of current good manufacturing practice
regulations.
• Applies to drug products for human use.
• If a person engages in only some operations subject to the
regulations in this part, and not in others, that person need only
comply with those regulations applicable to the operations in which
he or she is engaged.
6
21 CFR Part 210
210.3 Definitions
Act
-means the Federal Food, Drug, and Cosmetic Act.
Batch
-A specific quantity of drug/material intended to have uniform character and
quality produced under a single manufacturing order form during the same
cycle of manufacture.
Component
-Any ingredient intended for use INCLUDING those that may not appear in
such drug product.
Drug Product
- Finished dosage form
Fiber
- Any particulate with a length at least 3 times to its width
7
• Nonfibre releasing filter, will not release fibres into the component or
drug product that is being filtered.
• Active ingredient, Any component intended to furnish pharmacological
activity
• Drug is defined by the Act as any compound that has effect in the diagnosis,
cure, mitigation, treatment or prevention of disease or to affect the structure
or function of the body of man or animals
• In-process material, Any material fabricated, compounded, blended or
derived for use in the drug product.
• Lot means a batch, or a specific identified portion of a batch, having uniform
character and quality within specified limits
• Lot number, control number, or batch number means any
distinctive, from which the complete history of drug product or other material
can be determined.
8
• Acceptance criteria
• Representative sample
• Strength
• Gang-printed labelling means labelling derived from a sheet of
material on which more than one item of labelling is printed.
9
21 CFR Part 211
CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED
PHARMACEUTICALS
There are 11 subchapters
Identified by letters from A through K
Covers all sections of operations
Designed to be all encompassing (general) – DON’T
expect too many specific.
10
211.1 Scope
• Minimum requirements
• Applies to drugs for human use
211.3 Definitions
• Those set forth in 210.3 are applicable
SUBPART A – GENERAL PROVISIONS
11
SUBPART B – ORGANISATION & PERSONNEL
 211.22 - Responsibilities of quality control unit
211.25 - Personnel qualifications
 211.28 - Personnel responsibilities
 211.34 - Consultants.
12
SUBPART C – BUILDINGS AND FACILITIES
 211.42 - Design and construction features
 211.44 - Lighting
 211.46 - Ventilation, air filtration, air heating and cooling
 211.48 - Plumbing
 211.50 - Sewage and refuse
 211.52 - Washing and toilet facilities
 211.56 - Sanitation
 211.58 - Maintenance
13
SUBPART D – EQUIPMENT
 211.63 - Equipment design, size, and
location
 211.65 - Equipment construction
 211.67 - Equipment cleaning and
maintenance
 211.68 - Automatic, mechanical, and
electronic equipment
 211.72 - Filters
14
SUBPART E – CONTROL OF COMPONENTS AND DRUG PRODUCT
CONTAINERS AND CLOSURES
 211.80 - General requirements
 211.82 - Receipt and storage of untested
components, drug product containers, and
closures
 211.84 - Testing and approval or rejection of
components, drug product containers, and
closures
 211.86 - Use of approved components, drug product
containers, and closures
 211.87 - Retesting of approved components, drug
product containers, and closures
 211.89 - Rejected components, drug product
containers, and closures
 211.94 - Drug product containers and closures.
15
SUBPART F – PRODUCTION & PROCESS CONTROLS
 211.100 - Written procedures; deviations
 211.103 - Calculation of yield
 211.105 - Equipment identification
 211.110 - Sampling and testing of in-process
materials and drug products
 211.111 - Time limitations on production
 211.113 - Control of microbiological
contamination
 211.115 - Reprocessing
16
SUBPART G – PACKAGING AND LABELING CONTROL
 211.122 Materials examination and usage criteria
 211.125 Labeling issuance
 211.130 Packaging and labeling operations
 211.132 Tamper-resistant packaging
requirements for OTC human drug products
 211.134 Drug product inspection
 211.137 Expiration dating
17
SUBPART H – HOLDING AND DISTRIBUTION
 211.142 - Warehousing procedures
 211.150 - Distribution procedures
18
SUBPART I – LABORATORY CONTROLS
 211.160 - General requirements
 211.165 - Testing and release for distribution
 211.166 - Stability testing
 211.167 - Special testing requirements
 211.170 - Reserve samples
 211.173 - Laboratory animals
 211.176 - Penicillin contamination.
19
SUBPART J – RECORDS AND REPORTS
 211.180 - General requirements
 211.182 - Equipment cleaning and use log
 211.184 - Component, drug product container,
closure, and labeling records
 211.186 - Master production and control
records
 211.188 - Batch production and control records
 211.192 - Production record review
 211.194 - Laboratory records
 211.196 - Distribution records
 211.198 - Complaint files
20
 211.204 - Returned drug products
 211.208 - Drug product salvaging
SUBPART K – RETURNED AND SALVAGED DRUG PRODUCTS
21
CONCLUSION
CGMP compliance is not an option.
Quality should be built into the product right from the initial stage.
GMP's are very similar and are really Good Common Sense.
Good Practices cover all aspects of manufacturing activities prior to
supply.
The role and involvement of senior management is crucial.
The goal is to tell you
WHAT TO DO, NOT HOW TO DO it!
22
References
• https://www.fda.gov/drugs/developmentapprovalprocess/manufactu
ring/ucm090016.html, Current Good Manufacturing Practice
(CGMP) Regulations (Accessed on 13th September 2017)
• https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.
cfm?CFRPart=210 , 21 CFR Part 210 Guidelines (Accessed on 13th
September 2017)
• https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.
cfm?CFRPart=211 , 21 CFR Part 211 Guidelines (Accessed on 13th
September 2017)
• P.P. Sharma, How to Practice GMPs, 7th ed, New Delhi, Vallabh
Publishers; 2015
23
24

More Related Content

What's hot

WHO GMP Requirements
WHO GMP  RequirementsWHO GMP  Requirements
WHO GMP RequirementsDeekshitha HS
 
batch formula record and master formula record
batch formula record and master formula recordbatch formula record and master formula record
batch formula record and master formula recordRashmitaPoojary1
 
Good Automated Laboratory Practices
Good Automated Laboratory PracticesGood Automated Laboratory Practices
Good Automated Laboratory PracticesSwapnil Fernandes
 
Purchase specifications & Maintenance of stores For Raw materials
Purchase specifications & Maintenance of stores For Raw materialsPurchase specifications & Maintenance of stores For Raw materials
Purchase specifications & Maintenance of stores For Raw materialsYash Menghani
 
Pharmaceutical inspection convention
Pharmaceutical inspection conventionPharmaceutical inspection convention
Pharmaceutical inspection conventionRAGHAV DOGRA
 
Pharmaceutical documentation
Pharmaceutical documentationPharmaceutical documentation
Pharmaceutical documentationK V NANDA KUMAR
 
Process validation and its types
Process validation and its typesProcess validation and its types
Process validation and its typesAnjali9410
 
c gmp (current good manufacturing practices)
c gmp (current good manufacturing practices)c gmp (current good manufacturing practices)
c gmp (current good manufacturing practices)Rohit K.
 
Product Registration Guidlines
Product Registration GuidlinesProduct Registration Guidlines
Product Registration GuidlinesSagar Bagul
 
Glp 112070804004
Glp  112070804004Glp  112070804004
Glp 112070804004Patel Parth
 
CHAPTER-1 DEFICIENCIES.pdf
CHAPTER-1 DEFICIENCIES.pdfCHAPTER-1 DEFICIENCIES.pdf
CHAPTER-1 DEFICIENCIES.pdfDr. Dinesh Mehta
 
Pharmaceutical validation ppt Rahul Dalvi
Pharmaceutical validation ppt Rahul DalviPharmaceutical validation ppt Rahul Dalvi
Pharmaceutical validation ppt Rahul DalviRahul Dalvi
 
GOOD AUTOMATED LABORATORY PRACTICE
GOOD AUTOMATED LABORATORY PRACTICEGOOD AUTOMATED LABORATORY PRACTICE
GOOD AUTOMATED LABORATORY PRACTICEjagrutivasava
 
USFDA guidelines of glp for non clinical testing laboratories
USFDA guidelines of glp for non clinical testing laboratoriesUSFDA guidelines of glp for non clinical testing laboratories
USFDA guidelines of glp for non clinical testing laboratoriesswrk
 
Documentation in pharmaceutical industry
Documentation in pharmaceutical industryDocumentation in pharmaceutical industry
Documentation in pharmaceutical industryGayatriTiwaskar
 

What's hot (20)

WHO GMP Requirements
WHO GMP  RequirementsWHO GMP  Requirements
WHO GMP Requirements
 
BACPAC
BACPACBACPAC
BACPAC
 
batch formula record and master formula record
batch formula record and master formula recordbatch formula record and master formula record
batch formula record and master formula record
 
Good Automated Laboratory Practices
Good Automated Laboratory PracticesGood Automated Laboratory Practices
Good Automated Laboratory Practices
 
Purchase specifications & Maintenance of stores For Raw materials
Purchase specifications & Maintenance of stores For Raw materialsPurchase specifications & Maintenance of stores For Raw materials
Purchase specifications & Maintenance of stores For Raw materials
 
Pharmaceutical inspection convention
Pharmaceutical inspection conventionPharmaceutical inspection convention
Pharmaceutical inspection convention
 
cGMP.
cGMP.cGMP.
cGMP.
 
cGMP AS PER USFDA
cGMP AS PER USFDAcGMP AS PER USFDA
cGMP AS PER USFDA
 
Pharmaceutical documentation
Pharmaceutical documentationPharmaceutical documentation
Pharmaceutical documentation
 
Process validation and its types
Process validation and its typesProcess validation and its types
Process validation and its types
 
c gmp (current good manufacturing practices)
c gmp (current good manufacturing practices)c gmp (current good manufacturing practices)
c gmp (current good manufacturing practices)
 
Product Registration Guidlines
Product Registration GuidlinesProduct Registration Guidlines
Product Registration Guidlines
 
DOCUMENTATION -- CoA & SPECIFICATIONS
DOCUMENTATION -- CoA & SPECIFICATIONSDOCUMENTATION -- CoA & SPECIFICATIONS
DOCUMENTATION -- CoA & SPECIFICATIONS
 
Glp 112070804004
Glp  112070804004Glp  112070804004
Glp 112070804004
 
CHAPTER-1 DEFICIENCIES.pdf
CHAPTER-1 DEFICIENCIES.pdfCHAPTER-1 DEFICIENCIES.pdf
CHAPTER-1 DEFICIENCIES.pdf
 
Pharmaceutical validation ppt Rahul Dalvi
Pharmaceutical validation ppt Rahul DalviPharmaceutical validation ppt Rahul Dalvi
Pharmaceutical validation ppt Rahul Dalvi
 
ICH QSEM Guidelines
ICH QSEM GuidelinesICH QSEM Guidelines
ICH QSEM Guidelines
 
GOOD AUTOMATED LABORATORY PRACTICE
GOOD AUTOMATED LABORATORY PRACTICEGOOD AUTOMATED LABORATORY PRACTICE
GOOD AUTOMATED LABORATORY PRACTICE
 
USFDA guidelines of glp for non clinical testing laboratories
USFDA guidelines of glp for non clinical testing laboratoriesUSFDA guidelines of glp for non clinical testing laboratories
USFDA guidelines of glp for non clinical testing laboratories
 
Documentation in pharmaceutical industry
Documentation in pharmaceutical industryDocumentation in pharmaceutical industry
Documentation in pharmaceutical industry
 

Similar to Current Good Manufacturing Practices

21 CFR Part 211.pptx
21 CFR Part 211.pptx21 CFR Part 211.pptx
21 CFR Part 211.pptxrautrahul8080
 
GMP in Pharmaceutical Industry by Dr.A S Charan
GMP in Pharmaceutical Industry by Dr.A S CharanGMP in Pharmaceutical Industry by Dr.A S Charan
GMP in Pharmaceutical Industry by Dr.A S CharanCharan Archakam
 
Current good manufacturing practice
Current good manufacturing practiceCurrent good manufacturing practice
Current good manufacturing practiceDr Subodh Satheesh
 
Current good manufacturing practices and current good compounding
Current good manufacturing practices and current good compounding Current good manufacturing practices and current good compounding
Current good manufacturing practices and current good compounding Areej Abu Hanieh
 
Current Good Manufacturing Practices (cgmp)
Current Good Manufacturing Practices (cgmp)Current Good Manufacturing Practices (cgmp)
Current Good Manufacturing Practices (cgmp)surajkumar1499
 
Six System Inspection Model.pptx
Six System Inspection Model.pptxSix System Inspection Model.pptx
Six System Inspection Model.pptxVIJAYAVICHARE
 
Six system inspection model
Six system inspection modelSix system inspection model
Six system inspection modelVaishali Dandge
 
Objectives , policies and principles of cGMP guidelines in pharmaceutical ind...
Objectives , policies and principles of cGMP guidelines in pharmaceutical ind...Objectives , policies and principles of cGMP guidelines in pharmaceutical ind...
Objectives , policies and principles of cGMP guidelines in pharmaceutical ind...JaskiranKaur72
 
Six system management.pptx in pharmaceutical industry
Six system management.pptx in pharmaceutical industrySix system management.pptx in pharmaceutical industry
Six system management.pptx in pharmaceutical industryvinitnai
 
21 CFR-FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES...
21 CFR-FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES...21 CFR-FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES...
21 CFR-FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES...ICHAPPS
 
Biotech -validation.ppt
Biotech -validation.pptBiotech -validation.ppt
Biotech -validation.pptssusera7f12d
 
C gmp and industrial management
C gmp and industrial managementC gmp and industrial management
C gmp and industrial managementPradipkumarRathod1
 
cgmp presentation upld.pptx
cgmp presentation upld.pptxcgmp presentation upld.pptx
cgmp presentation upld.pptxDimple Marathe
 
Validation regulatory review
Validation regulatory reviewValidation regulatory review
Validation regulatory reviewArpitSuralkar
 

Similar to Current Good Manufacturing Practices (20)

cGMP AS PER USFDA
cGMP AS PER USFDAcGMP AS PER USFDA
cGMP AS PER USFDA
 
21 CFR Part 211.pptx
21 CFR Part 211.pptx21 CFR Part 211.pptx
21 CFR Part 211.pptx
 
21 CFR CGMP
21 CFR  CGMP21 CFR  CGMP
21 CFR CGMP
 
GMP in Pharmaceutical Industry by Dr.A S Charan
GMP in Pharmaceutical Industry by Dr.A S CharanGMP in Pharmaceutical Industry by Dr.A S Charan
GMP in Pharmaceutical Industry by Dr.A S Charan
 
Current good manufacturing practice
Current good manufacturing practiceCurrent good manufacturing practice
Current good manufacturing practice
 
Current good manufacturing practices and current good compounding
Current good manufacturing practices and current good compounding Current good manufacturing practices and current good compounding
Current good manufacturing practices and current good compounding
 
FDA Regulations
FDA RegulationsFDA Regulations
FDA Regulations
 
Current Good Manufacturing Practices (cgmp)
Current Good Manufacturing Practices (cgmp)Current Good Manufacturing Practices (cgmp)
Current Good Manufacturing Practices (cgmp)
 
Six System Inspection Model.pptx
Six System Inspection Model.pptxSix System Inspection Model.pptx
Six System Inspection Model.pptx
 
Six system inspection model
Six system inspection modelSix system inspection model
Six system inspection model
 
2 the regulations
2 the regulations2 the regulations
2 the regulations
 
Objectives , policies and principles of cGMP guidelines in pharmaceutical ind...
Objectives , policies and principles of cGMP guidelines in pharmaceutical ind...Objectives , policies and principles of cGMP guidelines in pharmaceutical ind...
Objectives , policies and principles of cGMP guidelines in pharmaceutical ind...
 
cGMP.pptx
cGMP.pptxcGMP.pptx
cGMP.pptx
 
cGMP in the USA Training by CDER FDA
cGMP in the USA Training by CDER FDAcGMP in the USA Training by CDER FDA
cGMP in the USA Training by CDER FDA
 
Six system management.pptx in pharmaceutical industry
Six system management.pptx in pharmaceutical industrySix system management.pptx in pharmaceutical industry
Six system management.pptx in pharmaceutical industry
 
21 CFR-FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES...
21 CFR-FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES...21 CFR-FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES...
21 CFR-FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES...
 
Biotech -validation.ppt
Biotech -validation.pptBiotech -validation.ppt
Biotech -validation.ppt
 
C gmp and industrial management
C gmp and industrial managementC gmp and industrial management
C gmp and industrial management
 
cgmp presentation upld.pptx
cgmp presentation upld.pptxcgmp presentation upld.pptx
cgmp presentation upld.pptx
 
Validation regulatory review
Validation regulatory reviewValidation regulatory review
Validation regulatory review
 

More from Swapnil Fernandes

MARKETING AUTHORISATION, LICENSING AND QUALITY ASSESSMENT OF VACCINES IN INDI...
MARKETING AUTHORISATION, LICENSING AND QUALITY ASSESSMENT OF VACCINES IN INDI...MARKETING AUTHORISATION, LICENSING AND QUALITY ASSESSMENT OF VACCINES IN INDI...
MARKETING AUTHORISATION, LICENSING AND QUALITY ASSESSMENT OF VACCINES IN INDI...Swapnil Fernandes
 
Common Technical Document (CTD)
Common Technical Document (CTD)Common Technical Document (CTD)
Common Technical Document (CTD)Swapnil Fernandes
 
FSSAI REGULATIONS FOR THE IMPORT, MANUFACTURE AND SALE OF NUTRACEUTICALS IN I...
FSSAI REGULATIONS FOR THE IMPORT, MANUFACTURE AND SALE OF NUTRACEUTICALS IN I...FSSAI REGULATIONS FOR THE IMPORT, MANUFACTURE AND SALE OF NUTRACEUTICALS IN I...
FSSAI REGULATIONS FOR THE IMPORT, MANUFACTURE AND SALE OF NUTRACEUTICALS IN I...Swapnil Fernandes
 
Quality System Requirements 21 CFR Part 820 and Labelling Requirements for Me...
Quality System Requirements 21 CFR Part 820 and Labelling Requirements for Me...Quality System Requirements 21 CFR Part 820 and Labelling Requirements for Me...
Quality System Requirements 21 CFR Part 820 and Labelling Requirements for Me...Swapnil Fernandes
 

More from Swapnil Fernandes (6)

MARKETING AUTHORISATION, LICENSING AND QUALITY ASSESSMENT OF VACCINES IN INDI...
MARKETING AUTHORISATION, LICENSING AND QUALITY ASSESSMENT OF VACCINES IN INDI...MARKETING AUTHORISATION, LICENSING AND QUALITY ASSESSMENT OF VACCINES IN INDI...
MARKETING AUTHORISATION, LICENSING AND QUALITY ASSESSMENT OF VACCINES IN INDI...
 
Common Technical Document (CTD)
Common Technical Document (CTD)Common Technical Document (CTD)
Common Technical Document (CTD)
 
FSSAI REGULATIONS FOR THE IMPORT, MANUFACTURE AND SALE OF NUTRACEUTICALS IN I...
FSSAI REGULATIONS FOR THE IMPORT, MANUFACTURE AND SALE OF NUTRACEUTICALS IN I...FSSAI REGULATIONS FOR THE IMPORT, MANUFACTURE AND SALE OF NUTRACEUTICALS IN I...
FSSAI REGULATIONS FOR THE IMPORT, MANUFACTURE AND SALE OF NUTRACEUTICALS IN I...
 
Quality System Requirements 21 CFR Part 820 and Labelling Requirements for Me...
Quality System Requirements 21 CFR Part 820 and Labelling Requirements for Me...Quality System Requirements 21 CFR Part 820 and Labelling Requirements for Me...
Quality System Requirements 21 CFR Part 820 and Labelling Requirements for Me...
 
Code of Federal Regulations
Code of Federal RegulationsCode of Federal Regulations
Code of Federal Regulations
 
The Pharmacy act, 1948
The Pharmacy act, 1948The Pharmacy act, 1948
The Pharmacy act, 1948
 

Recently uploaded

Medisep insurance policy , new kerala government insurance policy for govrnm...
Medisep insurance policy , new  kerala government insurance policy for govrnm...Medisep insurance policy , new  kerala government insurance policy for govrnm...
Medisep insurance policy , new kerala government insurance policy for govrnm...LinshaLichu1
 
EHR Market Growth is The Boom Over - Jasper Colin
EHR Market Growth is The Boom Over - Jasper ColinEHR Market Growth is The Boom Over - Jasper Colin
EHR Market Growth is The Boom Over - Jasper ColinJasper Colin
 
Immediate care of newborn, midwifery and obstetrical nursing
Immediate care of newborn, midwifery and obstetrical nursingImmediate care of newborn, midwifery and obstetrical nursing
Immediate care of newborn, midwifery and obstetrical nursingNursing education
 
ANTIGEN- SECTION IMMUNOLOGY DEPARTMENT OF MICROBIOLOGY
ANTIGEN- SECTION IMMUNOLOGY  DEPARTMENT OF MICROBIOLOGYANTIGEN- SECTION IMMUNOLOGY  DEPARTMENT OF MICROBIOLOGY
ANTIGEN- SECTION IMMUNOLOGY DEPARTMENT OF MICROBIOLOGYDrmayuribhise
 
TEENAGE PREGNANCY PREVENTION AND AWARENESS
TEENAGE PREGNANCY PREVENTION AND AWARENESSTEENAGE PREGNANCY PREVENTION AND AWARENESS
TEENAGE PREGNANCY PREVENTION AND AWARENESSPeterJamesVitug
 
Learn Tips for Managing Chemobrain or Mental Fogginess
Learn Tips for Managing Chemobrain or Mental FogginessLearn Tips for Managing Chemobrain or Mental Fogginess
Learn Tips for Managing Chemobrain or Mental Fogginessbkling
 
Artificial Intelligence Robotics & Computational Fluid Dynamics
Artificial Intelligence Robotics & Computational Fluid DynamicsArtificial Intelligence Robotics & Computational Fluid Dynamics
Artificial Intelligence Robotics & Computational Fluid DynamicsParag Kothawade
 
Innovations in Nephrology by Dr. David Greene Stem Cell Potential and Progres...
Innovations in Nephrology by Dr. David Greene Stem Cell Potential and Progres...Innovations in Nephrology by Dr. David Greene Stem Cell Potential and Progres...
Innovations in Nephrology by Dr. David Greene Stem Cell Potential and Progres...Dr. David Greene Arizona
 
Biology class 12 assignment neet level practise chapter wise
Biology class 12 assignment neet level practise chapter wiseBiology class 12 assignment neet level practise chapter wise
Biology class 12 assignment neet level practise chapter wiseNAGKINGRAPELLY
 
arpita 1-1.pptx management of nursing service and education
arpita 1-1.pptx management of nursing service and educationarpita 1-1.pptx management of nursing service and education
arpita 1-1.pptx management of nursing service and educationNursing education
 
Importance of Assessing Level of Consciousness in Medical Care | The Lifescie...
Importance of Assessing Level of Consciousness in Medical Care | The Lifescie...Importance of Assessing Level of Consciousness in Medical Care | The Lifescie...
Importance of Assessing Level of Consciousness in Medical Care | The Lifescie...The Lifesciences Magazine
 
Champions of Health Spotlight On Leaders Shaping Denmark's Healthcare.pdf
Champions of Health Spotlight On Leaders Shaping Denmark's Healthcare.pdfChampions of Health Spotlight On Leaders Shaping Denmark's Healthcare.pdf
Champions of Health Spotlight On Leaders Shaping Denmark's Healthcare.pdfeurohealthleaders
 
Back care and back massage. powerpoint presentation
Back care and back massage. powerpoint presentationBack care and back massage. powerpoint presentation
Back care and back massage. powerpoint presentationpratiksha ghimire
 
Low Vision Case (Nisreen mokhanawala).pptx
Low Vision Case (Nisreen mokhanawala).pptxLow Vision Case (Nisreen mokhanawala).pptx
Low Vision Case (Nisreen mokhanawala).pptxShubham
 
Critical Advancements in Healthcare Software Development | smartData Enterpri...
Critical Advancements in Healthcare Software Development | smartData Enterpri...Critical Advancements in Healthcare Software Development | smartData Enterpri...
Critical Advancements in Healthcare Software Development | smartData Enterpri...amynickle2106
 
Text Neck Syndrome and its probable way out.pptx
Text Neck Syndrome and its probable way out.pptxText Neck Syndrome and its probable way out.pptx
Text Neck Syndrome and its probable way out.pptxProf. Satyen Bhattacharyya
 
Information about acne, detail description of their treatment by topical and ...
Information about acne, detail description of their treatment by topical and ...Information about acne, detail description of their treatment by topical and ...
Information about acne, detail description of their treatment by topical and ...mauryashreya478
 
Globalny raport: „Prawdziwe piękno 2024" od Dove
Globalny raport: „Prawdziwe piękno 2024" od DoveGlobalny raport: „Prawdziwe piękno 2024" od Dove
Globalny raport: „Prawdziwe piękno 2024" od Doveagatadrynko
 

Recently uploaded (20)

Kidney Transplant At Hiranandani Hospital
Kidney Transplant At Hiranandani HospitalKidney Transplant At Hiranandani Hospital
Kidney Transplant At Hiranandani Hospital
 
DELIRIUM psychiatric delirium is a organic mental disorder
DELIRIUM  psychiatric  delirium is a organic mental disorderDELIRIUM  psychiatric  delirium is a organic mental disorder
DELIRIUM psychiatric delirium is a organic mental disorder
 
Medisep insurance policy , new kerala government insurance policy for govrnm...
Medisep insurance policy , new  kerala government insurance policy for govrnm...Medisep insurance policy , new  kerala government insurance policy for govrnm...
Medisep insurance policy , new kerala government insurance policy for govrnm...
 
EHR Market Growth is The Boom Over - Jasper Colin
EHR Market Growth is The Boom Over - Jasper ColinEHR Market Growth is The Boom Over - Jasper Colin
EHR Market Growth is The Boom Over - Jasper Colin
 
Immediate care of newborn, midwifery and obstetrical nursing
Immediate care of newborn, midwifery and obstetrical nursingImmediate care of newborn, midwifery and obstetrical nursing
Immediate care of newborn, midwifery and obstetrical nursing
 
ANTIGEN- SECTION IMMUNOLOGY DEPARTMENT OF MICROBIOLOGY
ANTIGEN- SECTION IMMUNOLOGY  DEPARTMENT OF MICROBIOLOGYANTIGEN- SECTION IMMUNOLOGY  DEPARTMENT OF MICROBIOLOGY
ANTIGEN- SECTION IMMUNOLOGY DEPARTMENT OF MICROBIOLOGY
 
TEENAGE PREGNANCY PREVENTION AND AWARENESS
TEENAGE PREGNANCY PREVENTION AND AWARENESSTEENAGE PREGNANCY PREVENTION AND AWARENESS
TEENAGE PREGNANCY PREVENTION AND AWARENESS
 
Learn Tips for Managing Chemobrain or Mental Fogginess
Learn Tips for Managing Chemobrain or Mental FogginessLearn Tips for Managing Chemobrain or Mental Fogginess
Learn Tips for Managing Chemobrain or Mental Fogginess
 
Artificial Intelligence Robotics & Computational Fluid Dynamics
Artificial Intelligence Robotics & Computational Fluid DynamicsArtificial Intelligence Robotics & Computational Fluid Dynamics
Artificial Intelligence Robotics & Computational Fluid Dynamics
 
Innovations in Nephrology by Dr. David Greene Stem Cell Potential and Progres...
Innovations in Nephrology by Dr. David Greene Stem Cell Potential and Progres...Innovations in Nephrology by Dr. David Greene Stem Cell Potential and Progres...
Innovations in Nephrology by Dr. David Greene Stem Cell Potential and Progres...
 
Biology class 12 assignment neet level practise chapter wise
Biology class 12 assignment neet level practise chapter wiseBiology class 12 assignment neet level practise chapter wise
Biology class 12 assignment neet level practise chapter wise
 
arpita 1-1.pptx management of nursing service and education
arpita 1-1.pptx management of nursing service and educationarpita 1-1.pptx management of nursing service and education
arpita 1-1.pptx management of nursing service and education
 
Importance of Assessing Level of Consciousness in Medical Care | The Lifescie...
Importance of Assessing Level of Consciousness in Medical Care | The Lifescie...Importance of Assessing Level of Consciousness in Medical Care | The Lifescie...
Importance of Assessing Level of Consciousness in Medical Care | The Lifescie...
 
Champions of Health Spotlight On Leaders Shaping Denmark's Healthcare.pdf
Champions of Health Spotlight On Leaders Shaping Denmark's Healthcare.pdfChampions of Health Spotlight On Leaders Shaping Denmark's Healthcare.pdf
Champions of Health Spotlight On Leaders Shaping Denmark's Healthcare.pdf
 
Back care and back massage. powerpoint presentation
Back care and back massage. powerpoint presentationBack care and back massage. powerpoint presentation
Back care and back massage. powerpoint presentation
 
Low Vision Case (Nisreen mokhanawala).pptx
Low Vision Case (Nisreen mokhanawala).pptxLow Vision Case (Nisreen mokhanawala).pptx
Low Vision Case (Nisreen mokhanawala).pptx
 
Critical Advancements in Healthcare Software Development | smartData Enterpri...
Critical Advancements in Healthcare Software Development | smartData Enterpri...Critical Advancements in Healthcare Software Development | smartData Enterpri...
Critical Advancements in Healthcare Software Development | smartData Enterpri...
 
Text Neck Syndrome and its probable way out.pptx
Text Neck Syndrome and its probable way out.pptxText Neck Syndrome and its probable way out.pptx
Text Neck Syndrome and its probable way out.pptx
 
Information about acne, detail description of their treatment by topical and ...
Information about acne, detail description of their treatment by topical and ...Information about acne, detail description of their treatment by topical and ...
Information about acne, detail description of their treatment by topical and ...
 
Globalny raport: „Prawdziwe piękno 2024" od Dove
Globalny raport: „Prawdziwe piękno 2024" od DoveGlobalny raport: „Prawdziwe piękno 2024" od Dove
Globalny raport: „Prawdziwe piękno 2024" od Dove
 

Current Good Manufacturing Practices

  • 1. www.ngsmips.nitte.edu.in CGMP Current Good Manufacturing Practices Department of Regulatory Affairs NGSMIPS, Nitte University Mangalore - Swapnil Dylan Fernandes 1
  • 2. What is CGMP ? • Current Good Manufacturing Practice regulations enforced by the US Food and Drug Administration (FDA). • Provides for systems that assure proper design, monitoring, and control of manufacturing processes and facilities. • Assures the identity, strength, quality, and purity of drug products. • The "C" in CGMP stands for "current," requiring companies to use technologies and systems that are up-to-date in order to comply with the regulations. 2
  • 3. Importance of CGMP • To assure that quality is built into the design and manufacturing process at every step. 3
  • 4. 21 CFR Part 210 CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PROCESSING, PACKING, OR HOLDING OF DRUGS • § 210.1 - Status of current good manufacturing practice regulations. • § 210.2 - Applicability of current good manufacturing practice regulations. • § 210.3 - Definitions. 4
  • 5. 21 CFR Part 210 210.1 Status of the regulations • Regulations set forth are “minimum” requirements!!!! • Covers manufacturing, facilities and controls for Manufacturing, processing, packaging or holding of a drug product • Failure to comply will render the drug to be adulterated • The person who is responsible for the failure to comply shall be subject to regulatory action 5
  • 6. 21 CFR Part 210 210.2 Applicability of current good manufacturing practice regulations. • Applies to drug products for human use. • If a person engages in only some operations subject to the regulations in this part, and not in others, that person need only comply with those regulations applicable to the operations in which he or she is engaged. 6
  • 7. 21 CFR Part 210 210.3 Definitions Act -means the Federal Food, Drug, and Cosmetic Act. Batch -A specific quantity of drug/material intended to have uniform character and quality produced under a single manufacturing order form during the same cycle of manufacture. Component -Any ingredient intended for use INCLUDING those that may not appear in such drug product. Drug Product - Finished dosage form Fiber - Any particulate with a length at least 3 times to its width 7
  • 8. • Nonfibre releasing filter, will not release fibres into the component or drug product that is being filtered. • Active ingredient, Any component intended to furnish pharmacological activity • Drug is defined by the Act as any compound that has effect in the diagnosis, cure, mitigation, treatment or prevention of disease or to affect the structure or function of the body of man or animals • In-process material, Any material fabricated, compounded, blended or derived for use in the drug product. • Lot means a batch, or a specific identified portion of a batch, having uniform character and quality within specified limits • Lot number, control number, or batch number means any distinctive, from which the complete history of drug product or other material can be determined. 8
  • 9. • Acceptance criteria • Representative sample • Strength • Gang-printed labelling means labelling derived from a sheet of material on which more than one item of labelling is printed. 9
  • 10. 21 CFR Part 211 CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS There are 11 subchapters Identified by letters from A through K Covers all sections of operations Designed to be all encompassing (general) – DON’T expect too many specific. 10
  • 11. 211.1 Scope • Minimum requirements • Applies to drugs for human use 211.3 Definitions • Those set forth in 210.3 are applicable SUBPART A – GENERAL PROVISIONS 11
  • 12. SUBPART B – ORGANISATION & PERSONNEL  211.22 - Responsibilities of quality control unit 211.25 - Personnel qualifications  211.28 - Personnel responsibilities  211.34 - Consultants. 12
  • 13. SUBPART C – BUILDINGS AND FACILITIES  211.42 - Design and construction features  211.44 - Lighting  211.46 - Ventilation, air filtration, air heating and cooling  211.48 - Plumbing  211.50 - Sewage and refuse  211.52 - Washing and toilet facilities  211.56 - Sanitation  211.58 - Maintenance 13
  • 14. SUBPART D – EQUIPMENT  211.63 - Equipment design, size, and location  211.65 - Equipment construction  211.67 - Equipment cleaning and maintenance  211.68 - Automatic, mechanical, and electronic equipment  211.72 - Filters 14
  • 15. SUBPART E – CONTROL OF COMPONENTS AND DRUG PRODUCT CONTAINERS AND CLOSURES  211.80 - General requirements  211.82 - Receipt and storage of untested components, drug product containers, and closures  211.84 - Testing and approval or rejection of components, drug product containers, and closures  211.86 - Use of approved components, drug product containers, and closures  211.87 - Retesting of approved components, drug product containers, and closures  211.89 - Rejected components, drug product containers, and closures  211.94 - Drug product containers and closures. 15
  • 16. SUBPART F – PRODUCTION & PROCESS CONTROLS  211.100 - Written procedures; deviations  211.103 - Calculation of yield  211.105 - Equipment identification  211.110 - Sampling and testing of in-process materials and drug products  211.111 - Time limitations on production  211.113 - Control of microbiological contamination  211.115 - Reprocessing 16
  • 17. SUBPART G – PACKAGING AND LABELING CONTROL  211.122 Materials examination and usage criteria  211.125 Labeling issuance  211.130 Packaging and labeling operations  211.132 Tamper-resistant packaging requirements for OTC human drug products  211.134 Drug product inspection  211.137 Expiration dating 17
  • 18. SUBPART H – HOLDING AND DISTRIBUTION  211.142 - Warehousing procedures  211.150 - Distribution procedures 18
  • 19. SUBPART I – LABORATORY CONTROLS  211.160 - General requirements  211.165 - Testing and release for distribution  211.166 - Stability testing  211.167 - Special testing requirements  211.170 - Reserve samples  211.173 - Laboratory animals  211.176 - Penicillin contamination. 19
  • 20. SUBPART J – RECORDS AND REPORTS  211.180 - General requirements  211.182 - Equipment cleaning and use log  211.184 - Component, drug product container, closure, and labeling records  211.186 - Master production and control records  211.188 - Batch production and control records  211.192 - Production record review  211.194 - Laboratory records  211.196 - Distribution records  211.198 - Complaint files 20
  • 21.  211.204 - Returned drug products  211.208 - Drug product salvaging SUBPART K – RETURNED AND SALVAGED DRUG PRODUCTS 21
  • 22. CONCLUSION CGMP compliance is not an option. Quality should be built into the product right from the initial stage. GMP's are very similar and are really Good Common Sense. Good Practices cover all aspects of manufacturing activities prior to supply. The role and involvement of senior management is crucial. The goal is to tell you WHAT TO DO, NOT HOW TO DO it! 22
  • 23. References • https://www.fda.gov/drugs/developmentapprovalprocess/manufactu ring/ucm090016.html, Current Good Manufacturing Practice (CGMP) Regulations (Accessed on 13th September 2017) • https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch. cfm?CFRPart=210 , 21 CFR Part 210 Guidelines (Accessed on 13th September 2017) • https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch. cfm?CFRPart=211 , 21 CFR Part 211 Guidelines (Accessed on 13th September 2017) • P.P. Sharma, How to Practice GMPs, 7th ed, New Delhi, Vallabh Publishers; 2015 23
  • 24. 24