An introductory overview of drug regulation in the biotch industry. Provides and intro to cGMP, FDA Inspections and Logistics and Drug Regulation History in the U.S.
This is a presentation that I developed and gave to the GMP constituency of a medium-sized biopharmaceutical company to satisfy one of the requirements for ongoing cGMP training. I feel that it very well epitomizes one of my central philosophies surrounding GXP and regulatory topic training -- STORYTELLING.
This is a presentation that I developed and gave to the GMP constituency of a medium-sized biopharmaceutical company to satisfy one of the requirements for ongoing cGMP training. I feel that it very well epitomizes one of my central philosophies surrounding GXP and regulatory topic training -- STORYTELLING.
Good Manufacturing Practice (GMP) | Arrelic InsightsArrelic
Good manufacturing practice (GMP) is that part of quality assurance which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing authorization. GMP is aimed primarily at diminishing the risks inherent in any pharmaceutical production, which may broadly be categorized in two groups: cross contamination/mix-ups and false labeling. Above all, manufacturers must not place patients at risk due to inadequate safety, quality or efficacy; for this reason, risk assessment has come to play an important role in WHO quality assurance guidelines.
CGMP guidelines, CFR, CDER and CBER, PIC/S, Environment control in pharma industry, plant layout, maintenance of sterile area, Clean room classification, Environmental monitoring, Types of contaminants in pharma industry & Good Warehousing Practices.
Pharmaceutical manufacturing has become a significant industry in India. It has been estimated that has the third largest pharmaceutical industry by volume We will examine how well they comply with Good Manufacturing Practices (GMP).
Good Manufacturing Practice (GMP) 2day course Jo Havemann
The following topics were presented to the participants through lectures, group discussions and exercises during 16 hours:
- Core values and guidelines of Good Laboratory Practice (GLP)
- Factors that might lead to questionable research & manufacturing practices and their impact
- GMP compliance, national & international regulations, guidelines and authorities
- Quality Management and Assessment
- Digital GMP Solutions
Introduction to manufacturing operations, Sanitation, Cross-contamination, Packaging, IPQC, time limitation, Expiration,Calculation of Yield, Production record review, process deviation
The European Commission Health and Consumers Directorate – General has published a draft “GUIDELINES ON THE PRINCIPLES OF GOOD DISTRIBUTION PRACTICES FOR ACTIVE SUBSTANCES FOR MEDICINAL PRODUCTS FOR HUMAN USE”.
The guideline addresses Quality systems, Personnel, Documentation, Order, Procedures, Records, Premises and Equipment, Receipts, Storage , Deliveries to Customers, Transfer of Information and Returns.
Following presentation is prepared by “ Drug Regulations” a non profit organization which provides free online resource to the Pharmaceutical Professional.
Good manufacturing practices, GMP, pharmaceutical quality assurance, 6th sem , b pharam
Introduction
Why GMP?
Evolution of GMP
Main risks without GMP
Principles of GMP
Design and construct the facilities and equipment properly
Follow written procedures and Instructions
Document work
Validate work
Monitor facilities and equipment
Write step by step operating procedures and work on instructions
Design ,develop and demonstrate job competence
Protect against contamination
Control components and product related processes
Conduct planned and periodic audits
GMP categories
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
Good Manufacturing Practices in Ayurveda Pharmaceutics (Past, Present & Future)Mohd Ehsan
Hello,
Dear friends, this ppt has been created by keeping in mind about GMP in Ayurveda pharmaceutics. This presentation help you all to understand how GMP works in Ayurveda Industries and how much quality is concerned with Ayurveda Drugs. You all get lots of ppts on slideshare regarding GMP but only few of them is related to Ayurveda.
Good Manufacturing Practice (GMP) | Arrelic InsightsArrelic
Good manufacturing practice (GMP) is that part of quality assurance which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing authorization. GMP is aimed primarily at diminishing the risks inherent in any pharmaceutical production, which may broadly be categorized in two groups: cross contamination/mix-ups and false labeling. Above all, manufacturers must not place patients at risk due to inadequate safety, quality or efficacy; for this reason, risk assessment has come to play an important role in WHO quality assurance guidelines.
CGMP guidelines, CFR, CDER and CBER, PIC/S, Environment control in pharma industry, plant layout, maintenance of sterile area, Clean room classification, Environmental monitoring, Types of contaminants in pharma industry & Good Warehousing Practices.
Pharmaceutical manufacturing has become a significant industry in India. It has been estimated that has the third largest pharmaceutical industry by volume We will examine how well they comply with Good Manufacturing Practices (GMP).
Good Manufacturing Practice (GMP) 2day course Jo Havemann
The following topics were presented to the participants through lectures, group discussions and exercises during 16 hours:
- Core values and guidelines of Good Laboratory Practice (GLP)
- Factors that might lead to questionable research & manufacturing practices and their impact
- GMP compliance, national & international regulations, guidelines and authorities
- Quality Management and Assessment
- Digital GMP Solutions
Introduction to manufacturing operations, Sanitation, Cross-contamination, Packaging, IPQC, time limitation, Expiration,Calculation of Yield, Production record review, process deviation
The European Commission Health and Consumers Directorate – General has published a draft “GUIDELINES ON THE PRINCIPLES OF GOOD DISTRIBUTION PRACTICES FOR ACTIVE SUBSTANCES FOR MEDICINAL PRODUCTS FOR HUMAN USE”.
The guideline addresses Quality systems, Personnel, Documentation, Order, Procedures, Records, Premises and Equipment, Receipts, Storage , Deliveries to Customers, Transfer of Information and Returns.
Following presentation is prepared by “ Drug Regulations” a non profit organization which provides free online resource to the Pharmaceutical Professional.
Good manufacturing practices, GMP, pharmaceutical quality assurance, 6th sem , b pharam
Introduction
Why GMP?
Evolution of GMP
Main risks without GMP
Principles of GMP
Design and construct the facilities and equipment properly
Follow written procedures and Instructions
Document work
Validate work
Monitor facilities and equipment
Write step by step operating procedures and work on instructions
Design ,develop and demonstrate job competence
Protect against contamination
Control components and product related processes
Conduct planned and periodic audits
GMP categories
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
Good Manufacturing Practices in Ayurveda Pharmaceutics (Past, Present & Future)Mohd Ehsan
Hello,
Dear friends, this ppt has been created by keeping in mind about GMP in Ayurveda pharmaceutics. This presentation help you all to understand how GMP works in Ayurveda Industries and how much quality is concerned with Ayurveda Drugs. You all get lots of ppts on slideshare regarding GMP but only few of them is related to Ayurveda.
FDA 2013 Clinical Investigator Training Course: CMC and Investigator Brochure...MedicReS
FDA 2013 Clinical Investigator Training Course: CMC and Investigator Brochure (Drugs): Ensuring the Quality of a Drug Used in Clinical Trial
Dorota Matecka, Ph.D., Office of New Drug Quality Assessment, CDER
Bionext Pharma Pvt. Ltd., a dedicated manufacturing facility for Liquid Orals is pledged to Ethics for manufacturing of quality drug products that consistently meet the standards by adhering to current Good Manufacturing Practices (cGMP) in its facility, it also endeavors to delight the customers through its unique and cost effective formulations and timely quality services? .
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.
A phase 1 clinical trial includes the initial introduction of an investigational new drug product, including biological drug products, into humans. Such studies are conducted to establish the basic safety of the drug, and are designed to determine the metabolism and pharmacologic actions of the drug in humans. The total number of subjects in a phase 1 clinical trial is limited generally to no more than 80 subjects.
This presentation covers the CGMP’s for Investigation New Drugs for Phase I. The presentation has been compiled from publicly available material on the world wide web by “ Drug Regulations” a not for profit organization.
Gino Martini, EIPG President
Presentation at Malta Qualified Persons Association-European Industrial Pharmacists Group-University of Malta joint seminar “The Successes And Challenges Of Today’s Pharmaceutical Industry”, Malta 2008.
Virginia Llera - Cómo optimizar la investigación en Enfermedades RarasFundación Ramón Areces
La Doctora Virginia Llera, Virginia A. Llera ofreció una conferencia el 17/09/2014 en la Fundación Ramón Areces. Llera es la Fundadora de la primera organización de Enfermedades Raras y drogas huérfanas en Latino América y Caribe, GEISER, y Presidenta del Foro Internacional, ICORD (International Conference on Rare Diseases & Orphan Drugs). Su conferencia, titulada 'Optimizando los procesos de investigación en enfermedades raras y medicamentos huérfanos', tuvo lugar dentro del ciclo sobre patologías poco frecuentes organizado por Fundación Ramón Areces en colaboración con Vall d'Hebron Institute of Research, Barcelona.
Speaker: Peter Pekos, Dalton Pharma Services. Part of the MaRS Best Practices Series.This session, led by seasoned industry experts, will explore how to effectively set up your pre-clinical POC studies, address pre-clinical safety requirements and issues, and give you an overview of the manufacturing standards required for Phase I studies
More information: http://www.marsdd.com/Events/Event-Calendar/Best-Practices-Series/ind-05132008.html
2. A cGMP Primer
Agenda
What is cGMP?
Basic Principles
Implications
Drug Regulation History
The FDA
Inspectional Methodology
cGMP Subparts
Summary
A cGMP Primer Chet French Oct 2011
3. Regulated Industries
Nuclear Power Banking
Construction
Utilities
Airlines Minerals & Mining
Pharmaceuticals
Regulations; properly applied confer benefits and protections
A cGMP Primer Chet French Oct 2011
3
4. Drug Regulations
How Do We Know the Rules?
cGMP Regulations
21CFR 210 & 211
Proposed Regulations
FDA Guidelines
Inspectional Findings
Best Practices – feasible and valuable
Changing Technology/Tragedies
Articles and Presentations by FDA personnel
ICH Documents
A cGMP Primer Chet French Oct 2011
4
5. The cGMPs
21CFR Parts 210 & 211
What are the cGMPs?
A: General Provisions Federal laws
Often ambiguous
B: Organization & Personnel
Establish minimum requirements
C: Buildings and Facilities
D: Equipment
E: Control of Components
F: Production and Process Controls
G: Packaging & Labeling
H: Holding & Distribution
I: Laboratory Controls
J: Records & Reports
K: Returned & Salvaged Drug Products
A cGMP Primer Chet French Oct 2011
7. Drug Regulation History
Food & Drug Act 1906
“The Jungle”
by Upton Sinclair
The Food and Drug Act (1906)
Establishment of the FDA
Prohibited interstate commerce in misbranded
and adulterated foods, drinks, and drugs
A cGMP Primer Chet French Oct 2011
9. Drug Regulation History
Elixir of Sulfanilamide Tragedy 1937
Sulfa drugs were a commodity
Introduction of a liquid syrup to differentiate product
Used diethylene glycol as solvent
240 gallons produced and sold
107 Deaths; Suicide of chemist
A cGMP Primer Chet French Oct 2011
10. Drug Regulation History
Federal Food Drug and Cosmetics Act of 1938
Must demonstrate scientific proof that new products could be
safely used before putting them on the market.
Proof of fraud no longer required to stop false claims for
drugs.
Addition of poisonous substances to foods was prohibited
except where unavoidable in production.
Specific authority conferred for
conducting inspections.
Federal court injunctions against
violations were added to the previous
legal remedies of product seizures and
criminal prosecutions.
A cGMP Primer Chet French Oct 2011
11. Drug Regulation History
Thalidomide Tragedy 1961
Thalidomide
Severe Teratogenic Properties
5,000 Pregnant women ~3,000 affected children
A cGMP Primer Chet French Oct 2011
12. Drug Regulation History
Kefauver Hearings 1960 - 1962
Regulation Amendments
Tightened control over
prescription drugs
Safe and effective
Adverse reaction reporting
Benefits and risks
Label changes
Ernst Kefauver
A cGMP Primer Chet French Oct 2011
14. Drug Regulation History
Barr Laboratories 1993
Supreme Court Decision 1993
Failure Investigations
Process Validation
Quality must be built into the product/process
A cGMP Primer Chet French Oct 2011
15. Drug Regulation History
PDUFA 1997
Prescription Drug User Fee Act (1997)
Reduced the legal standard for new drug reviews
Reauthorized user fees
Fee for Application
Fee for Establishments
Renewal Fee for Products
Promotion of drugs for “off label” use
A cGMP Primer Chet French Oct 2011
16. The Food & Drug Administration
Mission: “Protect the Public”
An enforcement agency
$39 BL
Enforces the Federal Food Drug
and Cosmetic Act of 1938
$350 BL
Determines the state of $487 BL
compliance by conducting site $102 BL
inspections
Under Fire for Unsafe Drug Approvals*
Inspections Behind Schedule Annual Commerce = $1,000,000,000,000+
Resource Constraints - High Staff Turnover
*Outlook: Likely much greater safety vigilance
A cGMP Primer *Source: Institute of Medicine Report 2006 French Oct 2011
Chet
17. The Regulatory Environment
Drug Safety Under Scrutiny
BEXTRA®
(Arthritis)
Heart Attack
Stroke
Stevens Johnson
Syndrome
TYSABRI®
(MS)
PML
AVANDIA® MERIDIA®
(Diabetes) (Obesity)
VIOXX® Heart Attack Heart Failure
(Acute Pain) Renal Failure
Heart Attack
Stroke
A cGMP Primer Chet French Oct 2011
18. Drug Regulation
Safety Data – Risks vs. Benefits
Do the Risks
Outweigh the
Benefits?
?
Safety Profile
Cumulative
Clinical Approval
Identified Risks
Safety Data Collected
A cGMP Primer Chet French Oct 2011
19. Drug Regulation
Patient Safety Takes “Center Stage”
What Clinical Trials Do Well
Determine with some certainty that the product is effective and
that the common serious adverse events are identified
Limitations of Clinical Trials
Seldom more than 3,000 patients
Patients with complicated medical conditions often excluded
Patients receiving certain concurrent meds are often excluded
Pediatric and elderly populations may be excluded
Trials often last only weeks to months; identification of reactions due
to long- term use or latent effects is difficult
A cGMP Primer Chet French Oct 2011
20. Drug Development and Commercialization
Stakeholders - Competing Interests
Thorough Reviews
Safe & Effective
Accessible Quick Review
Inexpensive Quick to Market
“Latest & Greatest”
Greatest” First-in-Class
Safe & Effective Profitable
Preserve Status Quo
Balance Competing Interests
Allocate Resources Judiciously
A cGMP Primer Chet French Oct 2011
21. FDA
Partial Organization Structure
U.S. Dept of Health & Human Services
FDA
CDER CBER ORA
Biennial
Preapproval
Inspections
Inspections
Team Biologics
A cGMP Primer Chet French Oct 2011
22. FDA Inspections
Types
Licensure/Surveillance Inspections (Planned)
Pre-Approval Inspection for Licensure (BLA)
Prior Approval Supplement (PAS)
GMP or Compliance Inspection (Biennial)
For-Cause Inspections (Unplanned):
Product Complaint
Adverse Event
Industry “Triggered” event
Market Withdrawal
Legal Authority for Inspections
Sec. 704 of the Federal Food, Drug and Cosmetic Act of 1938
Sec. 351(c) of the Public Health Service Act (licensed biologics)
21 CFR 600.22 (licensed biologics)
A cGMP Primer Chet French Oct 2011
23. The Inspection
Goals & Objectives
Goal of the Investigators:
1. Verify the integrity of information
supporting the application (PAS)
2. Determine conformance to
cGMPs at the facility used for
manufacturing, processing,
packaging, and holding of the
drug product.
Goal of the Inspected:
“A favorable outcome”
24. Facility and Product Licensure
The Stakes
Consequences of failure are extreme:
Loss of Revenue
Business Viability - Time
Jobs
Company’s Reputation
Credibility
More Rigorous Future Scrutiny
Drug-to-market costs: $800 million -$1.7 BBL*
*Source: Tufts Center for the Study of Drug Development 2001
25. Inspection Preparation
Relevant Documentation
Documents compiled for review:
Deviations/OOS/CAPAs
Validation/Revalidation Data/Trending
Logbooks
P&ID
Material Review Board Minutes
Critical Systems
Systems Review – (examples)
Cleaning Validations (Equipment and Facilities)
Change Management
Environmental Monitoring
Stability Program
HVAC/Water/Utilities
Shipping/Receiving/Warehousing
Raw Material In-Process Testing & Release
A cGMP Primer Interested in assessing capabilities Chet French Oct 2011
26. The FDA Investigators
Inspectional Experts
Civil Servants - Strong belief in purpose
Specialized training (frequent and recurring):
Human Psychology
Interview Techniques
Inspection Team
1-5 Investigators with Lead
CDER Office of Compliance
Office of Biotechnology Products
CDER District Office
Mix and Match
1- 3 weeks duration
No vested interest in organizations’ success…
Application for approval must stand on own merits!!
27. The FDA Inspection
Systems-Based Approach
Production
Facilities &
System
Equipment
System
Quality
Laboratory
System
Control
Materials
System
System
Packaging
and
Labeling
System
One System out of control = Noncompliance
28. FDA Inspections
Receiving the Investigators
Credentials – Agency represented
Visitor badge issued; seated in lobby
Contact list notified in order
Responsible Head is presented the Notice
of Inspection (FDA 482 Form)
Escorted and Sequestered in Room(s)
(Controlled Environment)
Ms.
Investigator
29. Inspection Logistics
Day One
Introductions
Review FDA 482
Establish & Negotiate Agenda
Inventory of Controlled Docs
Prepared Overview Presentations
(SMEs)
CAPAs, Deviations, Failure
Investigations, Prior Inspection
Corrective Actions
Alert: Conduct Walkthroughs of Potential Inspection Touring Areas
A cGMP Primer Chet French Oct 2011
30. Inspection Logistics
Inside the Inspection Room
Host SME
Scribe
Front Room
Manager
FDA
Investigators
Runners
SMEs
Scribe
Host
SME
A “well-choreographed dance”
31. The Inspection
Day-by-Day
What do they do?
Ask lots of questions
Review lots of documents
Make copies
Talk to lots of employees
Tour the facility (Start → End)
Observe processes/equipment &
people
Collect Samples
32. The Inspection
Day-by-Day
What do they find?
Recordkeeping Errors
Documentation Inconsistencies
Logsbooks, BRs, Validation Protocols
Logsbooks, BRs,
Procedures not followed
Timeliness
Responsibilities
Electronic Issues BATCH RECORD
Systems Issues
33. The Inspection
Day-by-Day
Daily Wrap-up Sessions FDA 483*
Chaired by Senior Quality Host
Convey trends and anticipate next areas of focus
Push for spot corrections
Annotated 483s
FDA 483 Final Day
Observation 1…….
Observation 2
FDA 483 Form – List of Observations
Observation 3**
Most significant listed first
Type important; not number
Final Wrap-up Session
A cGMP Primer Chet French Oct 2011
34. FDA 483 Observations Biologics 2010
by Category
108 (27%)
68 (17%)
55 (14%)
31 (8%)
Number of FDA 483 Observations
Source: BioQuality May 2010
A cGMP Primer Chet French Oct 2011
35. FDA Inspectional Outcomes
Preapproval Inspection (PAI)
Withold Approval
FDA 483 Form
Reinspection Inadequate
or Late
Corrective Actions
Adequate
Conditional Approval
Approval
A cGMP Primer Chet French Oct 2011
36. FDA Inspectional Outcomes
Compliance or Biennial Inspection
FDA 483 Form
Warning Letter
Establishment Official Action
Inspection Report Indicated (OAI)
NOIR
Action Indicated
Consent Decree
No Official
Corrective
Actions
Criminal Charges
Continued
Operation
A cGMP Primer Chet French Oct 2011
37. Regulatory Inspection Trends
Enforcement Statistics
Civil Money Penalties* 1 Trend is to focus on more
Seizures* 6 (-44%) serious violations
Injunctions* 12
Convictions 344
Warning Letters 471 (-39%)
Recalls* 5,585
FDA 483 Observations 5,100 (-1%)
Inspections* 15,581
Import Refusals 49,988
Fines/Restitutions* $1.92 BBL
(*)= Voluntary
Searchable Database at the FDA Website
www.fda.gov/ICECI/EnforcementActions/WarningLetters/default.htm
A cGMP Primer Chet French Oct 2011
Source: FDA PDUFA Goals Report 2008
38. Quality by Design
A Model for cGMP Compliance
FDA assigns quality oversight to the Quality division
211.22 The quality control unit shall have the
responsibility and authority to review production records
to assure that no errors have occurred or, if errors have
occurred, that they have been fully investigated.
QA
Oversight
Product Mfg, Processing,
Holding, Testing,
Packaging, Labeling
A cGMP Primer Chet French Oct 2011
38
39. Records and Reports - Good Documentation
Subpart J
Logbooks
Re
co
ch rd
at sM
M atc
rds h
co
Re
Labels All cGMP records must be:
• Accurate
• Legible
• Complete
• Timely
• Truthful
and… reconcilable
Records Match Batch Records & Systems
A cGMP Primer Chet French Oct 2011
39
40. FDA’s View on Documentation/Recordkeeping
How data is entered into cGMP
documents is important because this is
the documented evidence of GMP
activities.
The drug regulatory program
depends on the reliability,
truthfulness, completeness and
accuracy of data and information
on record.
“If it wasn’t documented; then it wasn’t
performed”
A cGMP Primer Chet French Oct 2011
40
41. Organization & Personnel
Subpart B
… shall have the education, experience
and training or any combination thereof to
enable each individual to perform their
assigned function.
Training on cGMPs
Training ongoing and current
Be knowledgeable about:
cGMP Regulations
Policies, Procedures and Guidelines
Stay current on:
Regulatory inspectional activity
Changing technology
A cGMP Primer Chet French Oct 2011
41
42. Building and Facilities - Design Implications
Subpart C
Linear Facility: Parenterals and API Process Drives Design
Separation of Operations Essential
Reduced Heating and Cooling Costs Compact Facility
Shorter Pipe and Process Flows
Gravity Feed
Reduced Construction Costs
A cGMP Primer Chet French Oct 2011
42
43. Components of an HVAC System:
Building and Facilities
Subpart C Terminal Diffusers
Controlled Cleanroom Airflow
Appropriate for intended purpose
Adequate space & layout
HEPA Filter Ensure a state of control
A cGMP Primer Chet French Oct 2011
44. Equipment
Subpart D
HPLC - Analytical Scale
Equipment adequate and
appropriate for state of
control*
Chromatography Very Large Scale
Source: FDA Guidance for Industry cGMP for Phase 1 Investigational Drugs 2008
A cGMP Primer Chet French Oct 2011
45. Production & Process Controls
Subpart F
A Typical Biopharmaceutical Process:
Raw Material Storage/Handling
Weigh/Dispense
Media/Buffer/Component Preparation & Hold
Inoculum Preparation
Fermentation/Cell Culture
Recovery/Harvest
Purification
Bulk Filling
CIP/SIP
Biowaste Deactivation
A cGMP Primer Chet French Oct 2011
46. Production & Process Controls
Subpart F
Host Cells Personnel
Raw
Materials
Common Conduits of Contamination
Bacteria
MMV (Parvovirus) Saprolegnia Mold Mycoplasma
A cGMP Primer Chet French Oct 2011
47. Production & Process Controls - Cleaning Validation
Subpart F
Spore Dots
Riboflavin Surface Studies
Validation: Scientifically and statistical
verification of a state of control of
process and equipment
TOC Swabbing
A cGMP Primer Chet French Oct 2011
47
48. Packaging & Labeling
Subpart G
QA Line Clearance
Critical Step
100% Reconciliation of closures containers and labels
Labeling: #1 root cause for recalls
A cGMP Primer Chet French Oct 2011
49. Summary
The FDA regulates the drug industry
The FDA is required by law to periodically conduct site
inspections to assess our level of compliance with the
regulations.
GMP regulations are the intent of the law
GMP expectations are the spirit of the law
FDA focusing attention on quality systems approach to
inspections to assure a sustained state of control
Robust quality systems are the centerpiece to compliance
with the cGMPs
A cGMP Primer Chet French Oct 2011
50. Q&A
?
Questions/Comments
A cGMP Primer Chet French Oct 2011