Good Manufacturing Practices (GMPs) establish minimum standards for methods, facilities, and controls used in manufacturing drugs to ensure they are safe, have the appropriate identity and strength, and meet quality and purity standards. GMP violations can result in severe consequences for drug manufacturers such as product seizures, recalls, shutdown of facilities, and large financial penalties. Current trends in GMPs include a risk-based approach, international harmonization of quality standards, and proposed amendments regarding validation and cross-contamination prevention.
This presentation contain introduction to Good Distribution Practices Guideline. and Legal GDP requirements put worldwide.
Good distribution practice (GDP) describes the minimum standards that a wholesale distributor must meet to ensure that the quality and integrity of medicines is maintained throughout the supply chain
Each participant in the distribution chain must agree by the relevant requirements in order to retain the original quality of pharmaceutical products.
Each activity in the distribution of pharmaceutical products shall be carried out according to the principles of Good Distribution Practices (GDP) as applicable.
The risks involved are likely to be of a nature comparable to those that are present in the industrial environment, such as mix-ups, adulteration, contamination, cross-contamination, and spurious.
The guideline addresses
Personnel
Quality System
Premises Warehousing and Storage
Documentation
Traceability
Complaints and Returns
Transportation
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.
WHO has recently issued draft document titled "Guidelines on Validation". These guidelines (i.e., the main text included in this working document) cover the general principles of validation and qualification.
These guidelines focus mainly on the overall concept of validation and are not intended to be prescriptive in specific validation requirements. This document serves as general guidance only and the principles may be considered useful in its application in the manufacture and control of starting materials and finished pharmaceutical products (FPPs), as well as other areas. Validation of specific processes and systems, for example, in sterile product manufacture, requires much more consideration and a detailed approach that is beyond the scope of this document. The general text in this document may be applicable to validation and qualification of premises, equipment, utilities, systems, processes, and procedures.
The draft on the specific topics, the appendices to this main text, will follow. The following is an overview on the appendices that are intended to complement the text of this working document:
Appendix 1: Validation of heating, ventilation and air-conditioning systems - will be replaced by cross reference to WHO Guidelines on GMP for HVAC systems for considerations in qualification of HVAC systems (update - working document QAS/15.639/Rev. 1)
Appendix 2: Validation of water systems for pharmaceutical use - will be replaced by cross-reference to WHO Guidelines on water for pharmaceutical use for consideration in qualification of water purification systems
Appendix 3: Cleaning validation - consensus to retain
Appendix 4: Analytical method validation - update in process
Appendix 5: Validation of computerized systems - update in process
Appendix 6: Qualification of systems and equipment - update in process
Appendix 7: Non-sterile process validation - update already published as Annex 3, WHO Technical Report Series, No. 992, 2015
Comments on this draft document are due by July 12, 2016.
A presentation on this guidance is given below:
Presentation on New WHO Guidance on Validations
This presentation contain introduction to Good Distribution Practices Guideline. and Legal GDP requirements put worldwide.
Good distribution practice (GDP) describes the minimum standards that a wholesale distributor must meet to ensure that the quality and integrity of medicines is maintained throughout the supply chain
Each participant in the distribution chain must agree by the relevant requirements in order to retain the original quality of pharmaceutical products.
Each activity in the distribution of pharmaceutical products shall be carried out according to the principles of Good Distribution Practices (GDP) as applicable.
The risks involved are likely to be of a nature comparable to those that are present in the industrial environment, such as mix-ups, adulteration, contamination, cross-contamination, and spurious.
The guideline addresses
Personnel
Quality System
Premises Warehousing and Storage
Documentation
Traceability
Complaints and Returns
Transportation
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.
WHO has recently issued draft document titled "Guidelines on Validation". These guidelines (i.e., the main text included in this working document) cover the general principles of validation and qualification.
These guidelines focus mainly on the overall concept of validation and are not intended to be prescriptive in specific validation requirements. This document serves as general guidance only and the principles may be considered useful in its application in the manufacture and control of starting materials and finished pharmaceutical products (FPPs), as well as other areas. Validation of specific processes and systems, for example, in sterile product manufacture, requires much more consideration and a detailed approach that is beyond the scope of this document. The general text in this document may be applicable to validation and qualification of premises, equipment, utilities, systems, processes, and procedures.
The draft on the specific topics, the appendices to this main text, will follow. The following is an overview on the appendices that are intended to complement the text of this working document:
Appendix 1: Validation of heating, ventilation and air-conditioning systems - will be replaced by cross reference to WHO Guidelines on GMP for HVAC systems for considerations in qualification of HVAC systems (update - working document QAS/15.639/Rev. 1)
Appendix 2: Validation of water systems for pharmaceutical use - will be replaced by cross-reference to WHO Guidelines on water for pharmaceutical use for consideration in qualification of water purification systems
Appendix 3: Cleaning validation - consensus to retain
Appendix 4: Analytical method validation - update in process
Appendix 5: Validation of computerized systems - update in process
Appendix 6: Qualification of systems and equipment - update in process
Appendix 7: Non-sterile process validation - update already published as Annex 3, WHO Technical Report Series, No. 992, 2015
Comments on this draft document are due by July 12, 2016.
A presentation on this guidance is given below:
Presentation on New WHO Guidance on Validations
Master of Good Manufacturing Practice - Course Detailsutspharmacy
Staff who hold postgraduate degrees in Good Manufacturing Practice (GMP) are essential for many pharmaceutical, biologic, medical device and food manufacturing companies.
This presentation provides an overview of the Master of Good Manufacturing Practice offered at the University of Technology, Sydney (UTS) in Australia. For more information visit www.gmp.uts.edu.au
Role of quality systems and audits in pharmaceutical manufacturing environmentMalay Pandya
By regulation, appropriate practice, and common sense, quality assurance (QA) is a critical function in the pharmaceutical manufacturing environment. The need for an independent unit to audit and comment on the appropriate application of standard operating procedures, master batch records, procedures approved in product applications, and the proper functioning of the quality control (QC) unit is paramount.
This helps assure that products are manufactured reliably, with adherence to approved specifications, and that current good manufacturing practices (cGMP) are maintained in conformance to regulation, both in the facility in general and the microenvironment of each product ’s manufacturing sequence.
Quality Audit in pharmaceutical industryHari Haran
It deals with the understanding and process for auditing
pharmaceutical industries. This covers the methodology involved in auditing process of different in pharmaceutical industries.
Aseptic / sterile- “ A state of control attained by using an aseptic work area and performing activities in a manner that precludes microbiological contamination of the exposed sterile product”
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.
Master of Good Manufacturing Practice - Course Detailsutspharmacy
Staff who hold postgraduate degrees in Good Manufacturing Practice (GMP) are essential for many pharmaceutical, biologic, medical device and food manufacturing companies.
This presentation provides an overview of the Master of Good Manufacturing Practice offered at the University of Technology, Sydney (UTS) in Australia. For more information visit www.gmp.uts.edu.au
Role of quality systems and audits in pharmaceutical manufacturing environmentMalay Pandya
By regulation, appropriate practice, and common sense, quality assurance (QA) is a critical function in the pharmaceutical manufacturing environment. The need for an independent unit to audit and comment on the appropriate application of standard operating procedures, master batch records, procedures approved in product applications, and the proper functioning of the quality control (QC) unit is paramount.
This helps assure that products are manufactured reliably, with adherence to approved specifications, and that current good manufacturing practices (cGMP) are maintained in conformance to regulation, both in the facility in general and the microenvironment of each product ’s manufacturing sequence.
Quality Audit in pharmaceutical industryHari Haran
It deals with the understanding and process for auditing
pharmaceutical industries. This covers the methodology involved in auditing process of different in pharmaceutical industries.
Aseptic / sterile- “ A state of control attained by using an aseptic work area and performing activities in a manner that precludes microbiological contamination of the exposed sterile product”
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.
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.
Process validation and validation requirementRavish Yadav
The all the content in this profile is completed by the teachers, students as well as other health care peoples.
thank you, all the respected peoples, for giving the information to complete this presentation.
this information is free to use by anyone.
Safalta Digital marketing institute in Noida, provide complete applications that encompass a huge range of virtual advertising and marketing additives, which includes search engine optimization, virtual communication advertising, pay-per-click on marketing, content material advertising, internet analytics, and greater. These university courses are designed for students who possess a comprehensive understanding of virtual marketing strategies and attributes.Safalta Digital Marketing Institute in Noida is a first choice for young individuals or students who are looking to start their careers in the field of digital advertising. The institute gives specialized courses designed and certification.
for beginners, providing thorough training in areas such as SEO, digital communication marketing, and PPC training in Noida. After finishing the program, students receive the certifications recognised by top different universitie, setting a strong foundation for a successful career in digital marketing.
2024.06.01 Introducing a competency framework for languag learning materials ...Sandy Millin
http://sandymillin.wordpress.com/iateflwebinar2024
Published classroom materials form the basis of syllabuses, drive teacher professional development, and have a potentially huge influence on learners, teachers and education systems. All teachers also create their own materials, whether a few sentences on a blackboard, a highly-structured fully-realised online course, or anything in between. Despite this, the knowledge and skills needed to create effective language learning materials are rarely part of teacher training, and are mostly learnt by trial and error.
Knowledge and skills frameworks, generally called competency frameworks, for ELT teachers, trainers and managers have existed for a few years now. However, until I created one for my MA dissertation, there wasn’t one drawing together what we need to know and do to be able to effectively produce language learning materials.
This webinar will introduce you to my framework, highlighting the key competencies I identified from my research. It will also show how anybody involved in language teaching (any language, not just English!), teacher training, managing schools or developing language learning materials can benefit from using the framework.
Unit 8 - Information and Communication Technology (Paper I).pdfThiyagu K
This slides describes the basic concepts of ICT, basics of Email, Emerging Technology and Digital Initiatives in Education. This presentations aligns with the UGC Paper I syllabus.
The French Revolution, which began in 1789, was a period of radical social and political upheaval in France. It marked the decline of absolute monarchies, the rise of secular and democratic republics, and the eventual rise of Napoleon Bonaparte. This revolutionary period is crucial in understanding the transition from feudalism to modernity in Europe.
For more information, visit-www.vavaclasses.com
Read| The latest issue of The Challenger is here! We are thrilled to announce that our school paper has qualified for the NATIONAL SCHOOLS PRESS CONFERENCE (NSPC) 2024. Thank you for your unwavering support and trust. Dive into the stories that made us stand out!
Normal Labour/ Stages of Labour/ Mechanism of LabourWasim Ak
Normal labor is also termed spontaneous labor, defined as the natural physiological process through which the fetus, placenta, and membranes are expelled from the uterus through the birth canal at term (37 to 42 weeks
2. Good Manufacturing PracticeGood Manufacturing Practice
RegulationsRegulations
Establishes minimum GMP for methodsEstablishes minimum GMP for methods
to be used, and the facilities or controls toto be used, and the facilities or controls to
be used for, the manufacture, processing,be used for, the manufacture, processing,
packing or holding of a drug to assurepacking or holding of a drug to assure
that the drug is:that the drug is:
SafeSafe
Has the appropriate identity and strengthHas the appropriate identity and strength
Meets quality and purity characteristicsMeets quality and purity characteristics
21 C.F.R. 210 and 21121 C.F.R. 210 and 21103/22/15 www.PharmInfopedia.com
3. cGMP Violations --cGMP Violations --
Severe ConsequencesSevere Consequences
Product is “adulterated”Product is “adulterated”
Shutdown of manufacturing facilityShutdown of manufacturing facility
Seizure of productSeizure of product
Recall productRecall product
Front page press coverageFront page press coverage
Competitive disadvantageCompetitive disadvantage
03/22/15 www.PharmInfopedia.com
4. Severe ConsequencesSevere Consequences (cont.)(cont.)
GMP Hold on product applicationsGMP Hold on product applications
International sitesInternational sites
Injunction / Consent decreeInjunction / Consent decree
Schering Plough ($500 Million)Schering Plough ($500 Million)
Abbott Laboratories ($100 Million)Abbott Laboratories ($100 Million)
Wyeth–Ayerst Laboratories ($30 Million)Wyeth–Ayerst Laboratories ($30 Million)
Individual DefendantsIndividual Defendants
Criminal Investigations and IndictmentsCriminal Investigations and Indictments
LawsuitsLawsuits
United States ex rel. KingUnited States ex rel. King03/22/15 www.PharmInfopedia.com
5. cGMP: Current TrendscGMP: Current Trends
21st Century: Risk-Based Approach21st Century: Risk-Based Approach
Risk-based assessmentRisk-based assessment
Up-to-date Science-based policies and standardsUp-to-date Science-based policies and standards
• Part 11Part 11
Integrated Systems approachIntegrated Systems approach
• Quality / Facilities and Equipment / Materials /Quality / Facilities and Equipment / Materials /
Production / Packaging and Labeling / LaboratoryProduction / Packaging and Labeling / Laboratory
ControlControl
International cooperationInternational cooperation
• ICH: International Conference on HarmonisationICH: International Conference on Harmonisation
Proposed amendments regarding validationProposed amendments regarding validation
and cross-contaminationand cross-contamination
03/22/15 www.PharmInfopedia.com
6. cGMP: The BasicscGMP: The Basics
Quality ControlQuality Control
Product meets specificationsProduct meets specifications
Quality AssuranceQuality Assurance
Systems ensure control and consistencySystems ensure control and consistency
Validation, validation, validationValidation, validation, validation
DocumentationDocumentation
If it is not documented, it did not happenIf it is not documented, it did not happen
03/22/15 www.PharmInfopedia.com
7. cGMP: Raw MaterialscGMP: Raw Materials
Active ingredientsActive ingredients
ExcipientsExcipients
Audit suppliers on regular basisAudit suppliers on regular basis
Before entering into contract, review regulatoryBefore entering into contract, review regulatory
historyhistory
Monitor regulatory complianceMonitor regulatory compliance
Test incoming raw materialTest incoming raw material
03/22/15 www.PharmInfopedia.com
8. cGMP: Buildings and FacilitiescGMP: Buildings and Facilities
Separate or defined areas as are necessarySeparate or defined areas as are necessary
to prevent contamination or mixupsto prevent contamination or mixups
Air filtration systems (HVAC) inAir filtration systems (HVAC) in
production areasproduction areas
SanitationSanitation
21 C.F.R. 211.42-5821 C.F.R. 211.42-58
03/22/15 www.PharmInfopedia.com
9. cGMP: Production and ProcesscGMP: Production and Process
ControlsControls (“SOPs”)(“SOPs”)
Written production and process controlWritten production and process control
procedures shall be followed in manufacturing andprocedures shall be followed in manufacturing and
shall be documented at the time of performance.shall be documented at the time of performance.
Any deviation from these procedures shall beAny deviation from these procedures shall be
recorded and explained or justified.recorded and explained or justified.
21 C.F.R. 211.10021 C.F.R. 211.100
03/22/15 www.PharmInfopedia.com
10. cGMP: In Process TestingcGMP: In Process Testing
Must have written procedures and testing of productMust have written procedures and testing of product
while being manufactured to assure batch uniformitywhile being manufactured to assure batch uniformity
and integrityand integrity
Control procedures shall be established to monitorControl procedures shall be established to monitor
output and to validate manufacturing processes thatoutput and to validate manufacturing processes that
could cause variabilitycould cause variability
21 C.F.R. 211.11021 C.F.R. 211.110
03/22/15 www.PharmInfopedia.com
11. cGMP: Expiration DatingcGMP: Expiration Dating
To assure that a drugTo assure that a drug
product meets applicableproduct meets applicable
standards of identity,standards of identity,
strength, quality andstrength, quality and
purity at the time of use, itpurity at the time of use, it
shall bear an expirationshall bear an expiration
date determined bydate determined by
appropriate stabilityappropriate stability
testing described intesting described in
Section 211.166.Section 211.166.
21 C.F.R. 211.137 (a)21 C.F.R. 211.137 (a)
Expiration dates shall beExpiration dates shall be
related to any storagerelated to any storage
conditions stated on theconditions stated on the
labeling, as determined bylabeling, as determined by
stability studies describedstability studies described
in Section 211.166.in Section 211.166.
21 C.F.R. 211.137 (b)21 C.F.R. 211.137 (b)
03/22/15 www.PharmInfopedia.com
12. cGMP: Packaging and LabelingcGMP: Packaging and Labeling
OperationsOperations
Company must have written proceduresCompany must have written procedures
designed to assure that correct labels, labelingdesigned to assure that correct labels, labeling
and packaging materials are used for drugand packaging materials are used for drug
products; such written procedures shall beproducts; such written procedures shall be
followed.followed.
Label mix ups have been a major reason forLabel mix ups have been a major reason for
drug product recalls.drug product recalls.
21 C.F.R. 211.13021 C.F.R. 211.130
03/22/15 www.PharmInfopedia.com
13. cGMP: Laboratory ControlscGMP: Laboratory Controls
Testing and release for distributionTesting and release for distribution
For each batch of drug product, there shall beFor each batch of drug product, there shall be
laboratory determination of satisfactorylaboratory determination of satisfactory
conformance to final specifications for the drugconformance to final specifications for the drug
product, including the identity and strength of eachproduct, including the identity and strength of each
active ingredient prior to release.active ingredient prior to release.
There shall be appropriate laboratory testing, asThere shall be appropriate laboratory testing, as
necessary, of each batch required to be free ofnecessary, of each batch required to be free of
objectionable microorganisms.objectionable microorganisms.
21 C.F.R. 211.165 (a) & (b)21 C.F.R. 211.165 (a) & (b)
03/22/15 www.PharmInfopedia.com
14. cGMP: Stability TestingcGMP: Stability Testing
A written testing program designed toA written testing program designed to
assess stability characteristics isassess stability characteristics is
required. Stability testing results mustrequired. Stability testing results must
be used in determining storagebe used in determining storage
conditions and expiration dates.conditions and expiration dates.
21 C.F.R. 211.16621 C.F.R. 211.166
03/22/15 www.PharmInfopedia.com
15. cGMP: Production RecordcGMP: Production Record
ReviewReview
Production and control records shall be reviewedProduction and control records shall be reviewed
and approved by the quality control unit toand approved by the quality control unit to
determine compliance with all established,determine compliance with all established,
approved written procedures before a batch isapproved written procedures before a batch is
released or distributed.released or distributed.
Product Impact AssessmentProduct Impact Assessment
Trend AnalysisTrend Analysis
Distributed ProductDistributed Product
21 C.F.R. 211.19221 C.F.R. 211.19203/22/15 www.PharmInfopedia.com
16. cGMP: Deviation InvestigationscGMP: Deviation Investigations
Any unexplained discrepancy or the failure of a batchAny unexplained discrepancy or the failure of a batch
or any of its components to meet any of itsor any of its components to meet any of its
specifications must be investigated whether or not thespecifications must be investigated whether or not the
batch has already been distributed.batch has already been distributed.
Investigate other batches of same drug productInvestigate other batches of same drug product
Investigate other drug products thatInvestigate other drug products that
may have been associated with themay have been associated with the
specific failure or discrepancyspecific failure or discrepancy
Written record of investigationWritten record of investigation03/22/15 www.PharmInfopedia.com
17. cGMP: Deviation InvestigationscGMP: Deviation Investigations
(cont.)(cont.)
Documenting the Investigation is CriticalDocumenting the Investigation is Critical
Hypotheses should be scientifically basedHypotheses should be scientifically based
Subject matter experts should be consultedSubject matter experts should be consulted
throughout the investigation, including the initialthroughout the investigation, including the initial
identification of hypothesesidentification of hypotheses
Once a hypothesis is identified, it must beOnce a hypothesis is identified, it must be
investigatedinvestigated
All hypotheses should be validated or invalidatedAll hypotheses should be validated or invalidated
03/22/15 www.PharmInfopedia.com
18. cGMP: Deviation InvestigationscGMP: Deviation Investigations
(cont.)(cont.)
Corrective and Preventative Action ProgramCorrective and Preventative Action Program
As part of deviation investigations...As part of deviation investigations...
Root cause identification and definitive correctiveRoot cause identification and definitive corrective
actionsactions
• Company Program / System should audit:Company Program / System should audit:
– Timeliness of corrective / preventative actionsTimeliness of corrective / preventative actions
– Effectiveness of actionsEffectiveness of actions
– DocumentationDocumentation
• Example:Example:
– Environmental monitoring/CleaningEnvironmental monitoring/Cleaning
03/22/15 www.PharmInfopedia.com
19. cGMP: Deviation InvestigationscGMP: Deviation Investigations
(cont.)(cont.)
Corrective and Preventative Action ProgramCorrective and Preventative Action Program (cont.)(cont.)
After an FDA inspection...After an FDA inspection...
Establish scientifically sound corrective andEstablish scientifically sound corrective and
preventative actionspreventative actions
• Realistic timeframesRealistic timeframes
Ensure compliance with commitments to FDAEnsure compliance with commitments to FDA
• SystemsSystems
• Specific IssuesSpecific Issues
– E.g., Change Control / TrainingE.g., Change Control / Training
03/22/15 www.PharmInfopedia.com
20. cGMP: Responsibility andcGMP: Responsibility and
Authority of Quality ControlAuthority of Quality Control
Quality control unit “shall have the responsibility andQuality control unit “shall have the responsibility and
authority to approve or reject all components, drugauthority to approve or reject all components, drug
product containers, closures, in-process materials,product containers, closures, in-process materials,
packaging material, labeling, and drug products, andpackaging material, labeling, and drug products, and
the authority to review production records to assurethe authority to review production records to assure
that no errors have occurred or, if errors havethat no errors have occurred or, if errors have
occurred, that they have been fully investigated. Theoccurred, that they have been fully investigated. The
quality control unit shall be responsible for approvingquality control unit shall be responsible for approving
or rejecting drug products manufactured, processed,or rejecting drug products manufactured, processed,
packed, or held under contract by another company.”packed, or held under contract by another company.”
21 CFR 211.22(a)21 CFR 211.22(a)03/22/15 www.PharmInfopedia.com
21. cGMP: ComplaintscGMP: Complaints
Written procedures describing the handling ofWritten procedures describing the handling of
all written and oral complaintsall written and oral complaints
Review by Quality Control unitReview by Quality Control unit
Possible failure to meet any specificationPossible failure to meet any specification
Determine need for deviation investigationDetermine need for deviation investigation
Adverse Drug Experience report assessmentAdverse Drug Experience report assessment
Documentation of complaint and investigationDocumentation of complaint and investigation
or reason for not investigatingor reason for not investigating
21 C.F.R. 211.19821 C.F.R. 211.19803/22/15 www.PharmInfopedia.com
22. cGMP: Records and ReportscGMP: Records and Reports
Contemporaneous documentation criticalContemporaneous documentation critical
Laboratory and production recordsLaboratory and production records
Trending analysisTrending analysis
Data IntegrityData Integrity
Internal review: OOS results, complaints, R&DInternal review: OOS results, complaints, R&D
External review: FDA inspections, business dealsExternal review: FDA inspections, business deals
(due diligence), and products liability cases(due diligence), and products liability cases
03/22/15 www.PharmInfopedia.com
23. cGMP: ReportscGMP: Reports (cont.)(cont.)
Field Alert ReportsField Alert Reports §§ 314.81(b)(1)314.81(b)(1)
LabelingLabeling
Failure to meet specifications — STABILITY FAILURESFailure to meet specifications — STABILITY FAILURES
Within 3 working days of receiptWithin 3 working days of receipt
Warner Lambert criminal caseWarner Lambert criminal case
Adverse Drug Experience ReportsAdverse Drug Experience Reports §§ 314.80314.80
ASAP but no later than 15 calendar days of initial receiptASAP but no later than 15 calendar days of initial receipt
Foreign and domesticForeign and domestic
Recall Procedures and PreparationRecall Procedures and Preparation03/22/15 www.PharmInfopedia.com
24. cGMP: AuditingcGMP: Auditing
Independent Audit GroupIndependent Audit Group
ResourcesResources
AuthorityAuthority
Global Approach - Harmonization of QualityGlobal Approach - Harmonization of Quality
StandardsStandards
Audit priority systems / specific issuesAudit priority systems / specific issues
Follow-up auditsFollow-up audits
03/22/15 www.PharmInfopedia.com
25. Good Manufacturing PracticeGood Manufacturing Practice
(“GMP”) Compliance:(“GMP”) Compliance:
GMPs EXPLAINEDGMPs EXPLAINED
Presented by
Raymond A. Bonner
Nathan C. Sheers
SIDLEY AUSTIN BROWN & WOOD, LLP
Washington, D.C.
(202) 736-8000
To
The Fourth Annual Pharmaceutical
Regulatory and Compliance Congress
and Best Practices Forum
November 13, 2003