SlideShare a Scribd company logo

Good documentation practices

•Download as PPTX, PDF•
•
C
complianceonline123

This quick reference guide discusses key documentation requirements and tips to good documentation practices.

Science
1 of 7
 Guidance ISO 9000:2005 Quality Management Systems- Fundamentals and vocabulary defines a document as an information and its supporting medium.  Medium can be: ◦ magnetic ◦ paper ◦ electronic or optical computer disc ◦ photograph ◦ master sample
Documentation is :  A set of documents (written or graphical procedures, manuals, policies , instructions, specifications) and records (recorded information of performed activity).  A process that involves the systematic interaction of people, events and documents to create the records. Quality can not be assured in a regulated industry without good documentation practices.
ISO 9001:2008 specifically requires the organization to have documented procedures for the following six activities:  Control of documents  Control of records  Internal audit  Control of nonconforming product  Corrective action  Preventive action Additional needed documents are:  Quality policy  Quality objectives  Quality manual
 Approval – specially for work instructions, procedures, manufacturing specifications.  Clarity - documents should not be open to misinterpretation by the users.  Regular review and update - documents must be kept up-to-date and distributed in a controlled manner.  Formal presentation- controlled documents should be prepared in accordance with a written procedure.  Records-related to manufacturing or testing operations should be kept based on record retention policy.
 All entries must be clear and legible.  Never make erasures or write-overs. (Do not turn a 5 to 6, or 9 into 8)  Any written error must be crossed out in such a manner that the original information is still legible.  Do not scribble out or white out entries.  The crossed out section must be initialed and dated by originator. Corrections must be made next to the deleted entry. Write reason for correction.  Use only black or blue permanent ink.  Pencil is not acceptable, since all entries must be permanent and able to be photocopied.  Make the required entries on the record as the work is performed. Do not record information on a separate piece of paper and enter on the record later.  No spaces for handwritten entries are left blank - if unused, they are crossed out or N/A (or similar text) entered.  Ditto marks or continuation lines are not acceptable.
Want to learn more about GDP, its requirements and best practices to comply with them? ComplianceOnline webinars and seminars are a great training resource. Check out the following links:  How to Comply with GDP Requirements?  Good Documentation Practices for GXPs  Introduction to FDA Good Documentation Practices  An Easy to Understand Guide to Good Documentation Practices  Good Laboratory Practices (GLP): Documenting Deviations & Unexpected Circumstances

Recommended

Good documentation practice
Good documentation practiceGood documentation practice
Good documentation practiceM S K Anwar
 
Good Documentation Practice
Good Documentation PracticeGood Documentation Practice
Good Documentation Practicecr7clark
 
GDP Training NS
GDP Training NSGDP Training NS
GDP Training NSNeeraj Shrivastava
 
Good documentation practice
Good documentation practiceGood documentation practice
Good documentation practiceShoab Malek (Certified Quality Auditor)
 
Good documentation practices
Good documentation practicesGood documentation practices
Good documentation practicesshabanaabbas
 
Good Documentation Practices -Do's and Don'ts- (GCP)
Good Documentation Practices -Do's and Don'ts- (GCP)Good Documentation Practices -Do's and Don'ts- (GCP)
Good Documentation Practices -Do's and Don'ts- (GCP)Piyush Wagh
 
GMP - GOOD DOCUMENTATION PRACTICES
GMP - GOOD DOCUMENTATION PRACTICESGMP - GOOD DOCUMENTATION PRACTICES
GMP - GOOD DOCUMENTATION PRACTICESOmkar Phutane
 
1 documents & Requirements
1 documents & Requirements1 documents & Requirements
1 documents & RequirementsICHAPPS
 

Recommended

Good documentation practice
Good documentation practiceGood documentation practice
Good documentation practiceM S K Anwar
 
Good Documentation Practice
Good Documentation PracticeGood Documentation Practice
Good Documentation Practicecr7clark
 
GDP Training NS
GDP Training NSGDP Training NS
GDP Training NSNeeraj Shrivastava
 
Good documentation practice
Good documentation practiceGood documentation practice
Good documentation practiceShoab Malek (Certified Quality Auditor)
 
Good documentation practices
Good documentation practicesGood documentation practices
Good documentation practicesshabanaabbas
 
Good Documentation Practices -Do's and Don'ts- (GCP)
Good Documentation Practices -Do's and Don'ts- (GCP)Good Documentation Practices -Do's and Don'ts- (GCP)
Good Documentation Practices -Do's and Don'ts- (GCP)Piyush Wagh
 
GMP - GOOD DOCUMENTATION PRACTICES
GMP - GOOD DOCUMENTATION PRACTICESGMP - GOOD DOCUMENTATION PRACTICES
GMP - GOOD DOCUMENTATION PRACTICESOmkar Phutane
 
1 documents & Requirements
1 documents & Requirements1 documents & Requirements
1 documents & RequirementsICHAPPS
 
Good documentation practices
Good documentation practicesGood documentation practices
Good documentation practicesSushant Sardana
 
good documentation practice
good documentation practice good documentation practice
good documentation practice YannamVasundharaRedd
 
Good documentation practices
Good documentation practicesGood documentation practices
Good documentation practicesBangaluru
 
Good Documentation Practice
Good Documentation PracticeGood Documentation Practice
Good Documentation PracticeManpreet Rait
 
Good Documentation Practice (GDP)
Good Documentation Practice (GDP)Good Documentation Practice (GDP)
Good Documentation Practice (GDP)Hossen M. Faruk
 
Good documentation practice
Good documentation practiceGood documentation practice
Good documentation practicePharmaceutical
 
Presentation for good documentary practices revised shravan
Presentation for good documentary practices revised shravanPresentation for good documentary practices revised shravan
Presentation for good documentary practices revised shravanshravan dubey
 
Good Documentation Practice (GDP)
Good Documentation Practice (GDP)Good Documentation Practice (GDP)
Good Documentation Practice (GDP)AsthaNeupane
 
Good documentation practice
Good documentation practiceGood documentation practice
Good documentation practicevincyrekha
 
Good Documentation Practices
Good Documentation PracticesGood Documentation Practices
Good Documentation PracticesNikhil Soni
 
Good documentation practices
Good documentation practicesGood documentation practices
Good documentation practicesPiyush Satvara
 
Good Documentation Pactise dr. amsavel
Good Documentation Pactise dr. amsavelGood Documentation Pactise dr. amsavel
Good Documentation Pactise dr. amsavelAmsavel Vel
 
Good Documentation Practices
Good Documentation Practices Good Documentation Practices
Good Documentation Practices vishnu gupta
 
Good Documentation Practices
Good Documentation PracticesGood Documentation Practices
Good Documentation PracticesGMP EDUCATION : Not for Profit Organization
 
Good Documentation Practices
Good Documentation PracticesGood Documentation Practices
Good Documentation Practiceskiranreddy munnangi
 
Good documentation practices
Good documentation practicesGood documentation practices
Good documentation practicesG Sundar
 
Gdp alcoa
Gdp alcoaGdp alcoa
Gdp alcoaShruti Kargutkar
 
Good Documentation Practice (GDocP).pdf
Good Documentation Practice (GDocP).pdfGood Documentation Practice (GDocP).pdf
Good Documentation Practice (GDocP).pdfMd. Zakaria Faruki
 
Data integrity in Pharmaceutical industry
Data integrity in Pharmaceutical industry Data integrity in Pharmaceutical industry
Data integrity in Pharmaceutical industry GxPProfessional
 
Good documentation practices
Good documentation practicesGood documentation practices
Good documentation practicesImdad H. Mukeri
 
Pharmaceutical documentation
Pharmaceutical documentationPharmaceutical documentation
Pharmaceutical documentationK V NANDA KUMAR
 
Pharmaceutical Documentation
Pharmaceutical DocumentationPharmaceutical Documentation
Pharmaceutical DocumentationCCL Pharmaceuticals
 

More Related Content

What's hot

Good documentation practices
Good documentation practicesGood documentation practices
Good documentation practicesSushant Sardana
 
Good documentation practices
Good documentation practicesGood documentation practices
Good documentation practicesBangaluru
 
Good Documentation Practice
Good Documentation PracticeGood Documentation Practice
Good Documentation PracticeManpreet Rait
 
Good Documentation Practice (GDP)
Good Documentation Practice (GDP)Good Documentation Practice (GDP)
Good Documentation Practice (GDP)Hossen M. Faruk
 
Good documentation practice
Good documentation practiceGood documentation practice
Good documentation practicePharmaceutical
 
Presentation for good documentary practices revised shravan
Presentation for good documentary practices revised shravanPresentation for good documentary practices revised shravan
Presentation for good documentary practices revised shravanshravan dubey
 
Good Documentation Practice (GDP)
Good Documentation Practice (GDP)Good Documentation Practice (GDP)
Good Documentation Practice (GDP)AsthaNeupane
 
Good documentation practice
Good documentation practiceGood documentation practice
Good documentation practicevincyrekha
 
Good Documentation Practices
Good Documentation PracticesGood Documentation Practices
Good Documentation PracticesNikhil Soni
 
Good documentation practices
Good documentation practicesGood documentation practices
Good documentation practicesPiyush Satvara
 
Good Documentation Pactise dr. amsavel
Good Documentation Pactise dr. amsavelGood Documentation Pactise dr. amsavel
Good Documentation Pactise dr. amsavelAmsavel Vel
 
Good Documentation Practices
Good Documentation Practices Good Documentation Practices
Good Documentation Practices vishnu gupta
 
Good documentation practices
Good documentation practicesGood documentation practices
Good documentation practicesG Sundar
 
Good Documentation Practice (GDocP).pdf
Good Documentation Practice (GDocP).pdfGood Documentation Practice (GDocP).pdf
Good Documentation Practice (GDocP).pdfMd. Zakaria Faruki
 
Data integrity in Pharmaceutical industry
Data integrity in Pharmaceutical industry Data integrity in Pharmaceutical industry
Data integrity in Pharmaceutical industry GxPProfessional
 
Good documentation practices
Good documentation practicesGood documentation practices
Good documentation practicesImdad H. Mukeri
 

What's hot (20)

Good documentation practices
Good documentation practicesGood documentation practices
Good documentation practices
 
good documentation practice
good documentation practice good documentation practice
good documentation practice
 
Good documentation practices
Good documentation practicesGood documentation practices
Good documentation practices
 
Good Documentation Practice
Good Documentation PracticeGood Documentation Practice
Good Documentation Practice
 
Good Documentation Practice (GDP)
Good Documentation Practice (GDP)Good Documentation Practice (GDP)
Good Documentation Practice (GDP)
 
Good documentation practice
Good documentation practiceGood documentation practice
Good documentation practice
 
Presentation for good documentary practices revised shravan
Presentation for good documentary practices revised shravanPresentation for good documentary practices revised shravan
Presentation for good documentary practices revised shravan
 
Good Documentation Practice (GDP)
Good Documentation Practice (GDP)Good Documentation Practice (GDP)
Good Documentation Practice (GDP)
 
Good documentation practice
Good documentation practiceGood documentation practice
Good documentation practice
 
Good Documentation Practices
Good Documentation PracticesGood Documentation Practices
Good Documentation Practices
 
Good documentation practices
Good documentation practicesGood documentation practices
Good documentation practices
 
Good Documentation Pactise dr. amsavel
Good Documentation Pactise dr. amsavelGood Documentation Pactise dr. amsavel
Good Documentation Pactise dr. amsavel
 
Good Documentation Practices
Good Documentation Practices Good Documentation Practices
Good Documentation Practices
 
Good Documentation Practices
Good Documentation PracticesGood Documentation Practices
Good Documentation Practices
 
Good Documentation Practices
Good Documentation PracticesGood Documentation Practices
Good Documentation Practices
 
Good documentation practices
Good documentation practicesGood documentation practices
Good documentation practices
 
Gdp alcoa
Gdp alcoaGdp alcoa
Gdp alcoa
 
Good Documentation Practice (GDocP).pdf
Good Documentation Practice (GDocP).pdfGood Documentation Practice (GDocP).pdf
Good Documentation Practice (GDocP).pdf
 
Data integrity in Pharmaceutical industry
Data integrity in Pharmaceutical industry Data integrity in Pharmaceutical industry
Data integrity in Pharmaceutical industry
 
Good documentation practices
Good documentation practicesGood documentation practices
Good documentation practices
 

Similar to Good documentation practices

Pharmaceutical documentation
Pharmaceutical documentationPharmaceutical documentation
Pharmaceutical documentationK V NANDA KUMAR
 
Documentation assignment
Documentation assignmentDocumentation assignment
Documentation assignmentAtul Chaudhary
 
Good Ducumentation Practices by Ninia Didulo.pptx
Good Ducumentation Practices by Ninia Didulo.pptxGood Ducumentation Practices by Ninia Didulo.pptx
Good Ducumentation Practices by Ninia Didulo.pptxNiniaDidulo1
 
Good Documentation Practice
Good Documentation PracticeGood Documentation Practice
Good Documentation PracticeDr. Amsavel A
 
Pharmaceutical documentation himanshu
Pharmaceutical documentation himanshuPharmaceutical documentation himanshu
Pharmaceutical documentation himanshuhimanshu kamboj
 
presentationforgooddocumentarypracticesrevisedshravan-150912105000-lva1-app68...
presentationforgooddocumentarypracticesrevisedshravan-150912105000-lva1-app68...presentationforgooddocumentarypracticesrevisedshravan-150912105000-lva1-app68...
presentationforgooddocumentarypracticesrevisedshravan-150912105000-lva1-app68...VandanaBadaliya
 
pharmaceutical documentation Quality Assuranceand Quality Control sem1.pptx
pharmaceutical documentation Quality Assuranceand Quality Control sem1.pptxpharmaceutical documentation Quality Assuranceand Quality Control sem1.pptx
pharmaceutical documentation Quality Assuranceand Quality Control sem1.pptxKunal10679
 
Jean_Paul_Assam_Assam_-_Documentation.ppt
Jean_Paul_Assam_Assam_-_Documentation.pptJean_Paul_Assam_Assam_-_Documentation.ppt
Jean_Paul_Assam_Assam_-_Documentation.pptAkashChaudhary749568
 
Documentation
DocumentationDocumentation
DocumentationJhinzman1
 
Readymade ISO 45001:2018 Documentation Kit
Readymade ISO 45001:2018 Documentation KitReadymade ISO 45001:2018 Documentation Kit
Readymade ISO 45001:2018 Documentation KitGlobal Manager Group
 
soppresentation-191116160454.pdf
soppresentation-191116160454.pdfsoppresentation-191116160454.pdf
soppresentation-191116160454.pdfSohelBaig3
 
Importance of documentation for gmp compliance
Importance of documentation for gmp complianceImportance of documentation for gmp compliance
Importance of documentation for gmp complianceJRamniwas
 
Quality Course 1
Quality Course 1Quality Course 1
Quality Course 1Fin1
 
ISO 13485:2016 (Medical Devices - Quality Management System) Awareness Training
ISO 13485:2016 (Medical Devices - Quality Management System) Awareness TrainingISO 13485:2016 (Medical Devices - Quality Management System) Awareness Training
ISO 13485:2016 (Medical Devices - Quality Management System) Awareness TrainingOperational Excellence Consulting
 

Similar to Good documentation practices (20)

Pharmaceutical documentation
Pharmaceutical documentationPharmaceutical documentation
Pharmaceutical documentation
 
Pharmaceutical Documentation
Pharmaceutical DocumentationPharmaceutical Documentation
Pharmaceutical Documentation
 
Documentation assignment
Documentation assignmentDocumentation assignment
Documentation assignment
 
Good Ducumentation Practices by Ninia Didulo.pptx
Good Ducumentation Practices by Ninia Didulo.pptxGood Ducumentation Practices by Ninia Didulo.pptx
Good Ducumentation Practices by Ninia Didulo.pptx
 
Good Documentation Practice
Good Documentation PracticeGood Documentation Practice
Good Documentation Practice
 
Pharmaceutical documentation himanshu
Pharmaceutical documentation himanshuPharmaceutical documentation himanshu
Pharmaceutical documentation himanshu
 
presentationforgooddocumentarypracticesrevisedshravan-150912105000-lva1-app68...
presentationforgooddocumentarypracticesrevisedshravan-150912105000-lva1-app68...presentationforgooddocumentarypracticesrevisedshravan-150912105000-lva1-app68...
presentationforgooddocumentarypracticesrevisedshravan-150912105000-lva1-app68...
 
pharmaceutical documentation Quality Assuranceand Quality Control sem1.pptx
pharmaceutical documentation Quality Assuranceand Quality Control sem1.pptxpharmaceutical documentation Quality Assuranceand Quality Control sem1.pptx
pharmaceutical documentation Quality Assuranceand Quality Control sem1.pptx
 
Jean_Paul_Assam_Assam_-_Documentation.ppt
Jean_Paul_Assam_Assam_-_Documentation.pptJean_Paul_Assam_Assam_-_Documentation.ppt
Jean_Paul_Assam_Assam_-_Documentation.ppt
 
Documentation
DocumentationDocumentation
Documentation
 
Readymade ISO 45001:2018 Documentation Kit
Readymade ISO 45001:2018 Documentation KitReadymade ISO 45001:2018 Documentation Kit
Readymade ISO 45001:2018 Documentation Kit
 
Bholakant Raut
Bholakant RautBholakant Raut
Bholakant Raut
 
Sop presentation
Sop presentationSop presentation
Sop presentation
 
soppresentation-191116160454.pdf
soppresentation-191116160454.pdfsoppresentation-191116160454.pdf
soppresentation-191116160454.pdf
 
Importance of documentation for gmp compliance
Importance of documentation for gmp complianceImportance of documentation for gmp compliance
Importance of documentation for gmp compliance
 
Quality Course 1
Quality Course 1Quality Course 1
Quality Course 1
 
Pa2
Pa2Pa2
Pa2
 
ISO 13485:2016 (Medical Devices - Quality Management System) Awareness Training
ISO 13485:2016 (Medical Devices - Quality Management System) Awareness TrainingISO 13485:2016 (Medical Devices - Quality Management System) Awareness Training
ISO 13485:2016 (Medical Devices - Quality Management System) Awareness Training
 
Faheem- CV
Faheem- CVFaheem- CV
Faheem- CV
 
Thiruchelvan K
Thiruchelvan KThiruchelvan K
Thiruchelvan K
 

More from complianceonline123

Fda adverse event reporting requirements for otc drugs
Fda adverse event reporting requirements for otc drugsFda adverse event reporting requirements for otc drugs
Fda adverse event reporting requirements for otc drugscomplianceonline123
 
Social media risks rules policies procedures
Social media risks rules policies proceduresSocial media risks rules policies procedures
Social media risks rules policies procedurescomplianceonline123
 
Excel spreadsheets how to ensure 21 cfr part 11 compliance
Excel spreadsheets how to ensure 21 cfr part 11 complianceExcel spreadsheets how to ensure 21 cfr part 11 compliance
Excel spreadsheets how to ensure 21 cfr part 11 compliancecomplianceonline123
 
Out in the open protecting your privacy in the digital age
Out in the open protecting your privacy in the digital ageOut in the open protecting your privacy in the digital age
Out in the open protecting your privacy in the digital agecomplianceonline123
 
Reaching Clean Power Plan Goals at No Cost: Securing the Smart Grid’s Potential
Reaching Clean Power Plan Goals at No Cost: Securing the Smart Grid’s PotentialReaching Clean Power Plan Goals at No Cost: Securing the Smart Grid’s Potential
Reaching Clean Power Plan Goals at No Cost: Securing the Smart Grid’s Potentialcomplianceonline123
 
Audit Process: How to Successfully Plan Audit
Audit Process: How to Successfully Plan Audit Audit Process: How to Successfully Plan Audit
Audit Process: How to Successfully Plan Audit complianceonline123
 
Aml non bank finanacial institutions
Aml non bank finanacial institutionsAml non bank finanacial institutions
Aml non bank finanacial institutionscomplianceonline123
 
Gdp how to manage documentation lifecycle
Gdp how to manage documentation lifecycleGdp how to manage documentation lifecycle
Gdp how to manage documentation lifecyclecomplianceonline123
 

More from complianceonline123 (20)

Fda adverse event reporting requirements for otc drugs
Fda adverse event reporting requirements for otc drugsFda adverse event reporting requirements for otc drugs
Fda adverse event reporting requirements for otc drugs
 
Social media risks rules policies procedures
Social media risks rules policies proceduresSocial media risks rules policies procedures
Social media risks rules policies procedures
 
Fmla ada overlap
Fmla ada overlapFmla ada overlap
Fmla ada overlap
 
Hipaa enforcement examples
Hipaa enforcement examplesHipaa enforcement examples
Hipaa enforcement examples
 
Excel spreadsheets how to ensure 21 cfr part 11 compliance
Excel spreadsheets how to ensure 21 cfr part 11 complianceExcel spreadsheets how to ensure 21 cfr part 11 compliance
Excel spreadsheets how to ensure 21 cfr part 11 compliance
 
Retail loss
Retail lossRetail loss
Retail loss
 
Hipaa privacy rule
Hipaa privacy ruleHipaa privacy rule
Hipaa privacy rule
 
Fda warning letters
Fda warning lettersFda warning letters
Fda warning letters
 
Dietary supplement
Dietary supplementDietary supplement
Dietary supplement
 
Out in the open protecting your privacy in the digital age
Out in the open protecting your privacy in the digital ageOut in the open protecting your privacy in the digital age
Out in the open protecting your privacy in the digital age
 
Reaching Clean Power Plan Goals at No Cost: Securing the Smart Grid’s Potential
Reaching Clean Power Plan Goals at No Cost: Securing the Smart Grid’s PotentialReaching Clean Power Plan Goals at No Cost: Securing the Smart Grid’s Potential
Reaching Clean Power Plan Goals at No Cost: Securing the Smart Grid’s Potential
 
Audit Process: How to Successfully Plan Audit
Audit Process: How to Successfully Plan Audit Audit Process: How to Successfully Plan Audit
Audit Process: How to Successfully Plan Audit
 
Basics of internal audit
Basics of internal auditBasics of internal audit
Basics of internal audit
 
Free trade zones
Free trade zonesFree trade zones
Free trade zones
 
Sec what you need to know
Sec what you need to knowSec what you need to know
Sec what you need to know
 
Auditing your grc programs
Auditing your grc programsAuditing your grc programs
Auditing your grc programs
 
Aml non bank finanacial institutions
Aml non bank finanacial institutionsAml non bank finanacial institutions
Aml non bank finanacial institutions
 
Gdp how to manage documentation lifecycle
Gdp how to manage documentation lifecycleGdp how to manage documentation lifecycle
Gdp how to manage documentation lifecycle
 
Workplace harrasment
Workplace harrasmentWorkplace harrasment
Workplace harrasment
 
Information security threats
Information security threatsInformation security threats
Information security threats
 

Recently uploaded

Large scale production of streptomycin.pptx
Large scale production of streptomycin.pptxLarge scale production of streptomycin.pptx
Large scale production of streptomycin.pptxCherry
 
Seminar of U.V. Spectroscopy by SAMIR PANDA
Seminar of U.V. Spectroscopy by SAMIR PANDA Seminar of U.V. Spectroscopy by SAMIR PANDA
Seminar of U.V. Spectroscopy by SAMIR PANDASAMIR PANDA
 
Citrus Greening Disease and its Management
Citrus Greening Disease and its ManagementCitrus Greening Disease and its Management
Citrus Greening Disease and its Managementsubedisuryaofficial
 
Cancer cell metabolism: special Reference to Lactate Pathway
Cancer cell metabolism: special Reference to Lactate PathwayCancer cell metabolism: special Reference to Lactate Pathway
Cancer cell metabolism: special Reference to Lactate PathwayAADYARAJPANDEY1
 
The ASGCT Annual Meeting was packed with exciting progress in the field advan...
The ASGCT Annual Meeting was packed with exciting progress in the field advan...The ASGCT Annual Meeting was packed with exciting progress in the field advan...
The ASGCT Annual Meeting was packed with exciting progress in the field advan...Health Advances
 
Richard's entangled aventures in wonderland
Richard's entangled aventures in wonderlandRichard's entangled aventures in wonderland
Richard's entangled aventures in wonderlandRichard Gill
 
THE IMPORTANCE OF MARTIAN ATMOSPHERE SAMPLE RETURN.
THE IMPORTANCE OF MARTIAN ATMOSPHERE SAMPLE RETURN.THE IMPORTANCE OF MARTIAN ATMOSPHERE SAMPLE RETURN.
THE IMPORTANCE OF MARTIAN ATMOSPHERE SAMPLE RETURN.Sérgio Sacani
 
PRESENTATION ABOUT PRINCIPLE OF COSMATIC EVALUATION
PRESENTATION ABOUT PRINCIPLE OF COSMATIC EVALUATIONPRESENTATION ABOUT PRINCIPLE OF COSMATIC EVALUATION
PRESENTATION ABOUT PRINCIPLE OF COSMATIC EVALUATIONChetanK57
 
Structures and textures of metamorphic rocks
Structures and textures of metamorphic rocksStructures and textures of metamorphic rocks
Structures and textures of metamorphic rockskumarmathi863
 
Astronomy Update- Curiosity’s exploration of Mars _ Local Briefs _ leadertele...
Astronomy Update- Curiosity’s exploration of Mars _ Local Briefs _ leadertele...Astronomy Update- Curiosity’s exploration of Mars _ Local Briefs _ leadertele...
Astronomy Update- Curiosity’s exploration of Mars _ Local Briefs _ leadertele...NathanBaughman3
 
Transport in plants G1.pptx Cambridge IGCSE
Transport in plants G1.pptx Cambridge IGCSETransport in plants G1.pptx Cambridge IGCSE
Transport in plants G1.pptx Cambridge IGCSEjordanparish425
 
RNA INTERFERENCE: UNRAVELING GENETIC SILENCING
RNA INTERFERENCE: UNRAVELING GENETIC SILENCINGRNA INTERFERENCE: UNRAVELING GENETIC SILENCING
RNA INTERFERENCE: UNRAVELING GENETIC SILENCINGAADYARAJPANDEY1
 
insect taxonomy importance systematics and classification
insect taxonomy importance systematics and classificationinsect taxonomy importance systematics and classification
insect taxonomy importance systematics and classificationanitaento25
 
insect morphology and physiology of insect
insect morphology and physiology of insectinsect morphology and physiology of insect
insect morphology and physiology of insectanitaento25
 
Body fluids_tonicity_dehydration_hypovolemia_hypervolemia.pptx
Body fluids_tonicity_dehydration_hypovolemia_hypervolemia.pptxBody fluids_tonicity_dehydration_hypovolemia_hypervolemia.pptx
Body fluids_tonicity_dehydration_hypovolemia_hypervolemia.pptxmuralinath2
 
EY - Supply Chain Services 2018_template.pptx
EY - Supply Chain Services 2018_template.pptxEY - Supply Chain Services 2018_template.pptx
EY - Supply Chain Services 2018_template.pptxAlguinaldoKong
 
THYROID-PARATHYROID medical surgical nursing
THYROID-PARATHYROID medical surgical nursingTHYROID-PARATHYROID medical surgical nursing
THYROID-PARATHYROID medical surgical nursingJocelyn Atis
 
Circulatory system_ Laplace law. Ohms law.reynaults law,baro-chemo-receptors-...
Circulatory system_ Laplace law. Ohms law.reynaults law,baro-chemo-receptors-...Circulatory system_ Laplace law. Ohms law.reynaults law,baro-chemo-receptors-...
Circulatory system_ Laplace law. Ohms law.reynaults law,baro-chemo-receptors-...muralinath2
 
In silico drugs analogue design: novobiocin analogues.pptx
In silico drugs analogue design: novobiocin analogues.pptxIn silico drugs analogue design: novobiocin analogues.pptx
In silico drugs analogue design: novobiocin analogues.pptxAlaminAfendy1
 
SAMPLING.pptx for analystical chemistry sample techniques
SAMPLING.pptx for analystical chemistry sample techniquesSAMPLING.pptx for analystical chemistry sample techniques
SAMPLING.pptx for analystical chemistry sample techniquesrodneykiptoo8
 

Recently uploaded (20)

Large scale production of streptomycin.pptx
Large scale production of streptomycin.pptxLarge scale production of streptomycin.pptx
Large scale production of streptomycin.pptx
 
Seminar of U.V. Spectroscopy by SAMIR PANDA
Seminar of U.V. Spectroscopy by SAMIR PANDA Seminar of U.V. Spectroscopy by SAMIR PANDA
Seminar of U.V. Spectroscopy by SAMIR PANDA
 
Citrus Greening Disease and its Management
Citrus Greening Disease and its ManagementCitrus Greening Disease and its Management
Citrus Greening Disease and its Management
 
Cancer cell metabolism: special Reference to Lactate Pathway
Cancer cell metabolism: special Reference to Lactate PathwayCancer cell metabolism: special Reference to Lactate Pathway
Cancer cell metabolism: special Reference to Lactate Pathway
 
The ASGCT Annual Meeting was packed with exciting progress in the field advan...
The ASGCT Annual Meeting was packed with exciting progress in the field advan...The ASGCT Annual Meeting was packed with exciting progress in the field advan...
The ASGCT Annual Meeting was packed with exciting progress in the field advan...
 
Richard's entangled aventures in wonderland
Richard's entangled aventures in wonderlandRichard's entangled aventures in wonderland
Richard's entangled aventures in wonderland
 
THE IMPORTANCE OF MARTIAN ATMOSPHERE SAMPLE RETURN.
THE IMPORTANCE OF MARTIAN ATMOSPHERE SAMPLE RETURN.THE IMPORTANCE OF MARTIAN ATMOSPHERE SAMPLE RETURN.
THE IMPORTANCE OF MARTIAN ATMOSPHERE SAMPLE RETURN.
 
PRESENTATION ABOUT PRINCIPLE OF COSMATIC EVALUATION
PRESENTATION ABOUT PRINCIPLE OF COSMATIC EVALUATIONPRESENTATION ABOUT PRINCIPLE OF COSMATIC EVALUATION
PRESENTATION ABOUT PRINCIPLE OF COSMATIC EVALUATION
 
Structures and textures of metamorphic rocks
Structures and textures of metamorphic rocksStructures and textures of metamorphic rocks
Structures and textures of metamorphic rocks
 
Astronomy Update- Curiosity’s exploration of Mars _ Local Briefs _ leadertele...
Astronomy Update- Curiosity’s exploration of Mars _ Local Briefs _ leadertele...Astronomy Update- Curiosity’s exploration of Mars _ Local Briefs _ leadertele...
Astronomy Update- Curiosity’s exploration of Mars _ Local Briefs _ leadertele...
 
Transport in plants G1.pptx Cambridge IGCSE
Transport in plants G1.pptx Cambridge IGCSETransport in plants G1.pptx Cambridge IGCSE
Transport in plants G1.pptx Cambridge IGCSE
 
RNA INTERFERENCE: UNRAVELING GENETIC SILENCING
RNA INTERFERENCE: UNRAVELING GENETIC SILENCINGRNA INTERFERENCE: UNRAVELING GENETIC SILENCING
RNA INTERFERENCE: UNRAVELING GENETIC SILENCING
 
insect taxonomy importance systematics and classification
insect taxonomy importance systematics and classificationinsect taxonomy importance systematics and classification
insect taxonomy importance systematics and classification
 
insect morphology and physiology of insect
insect morphology and physiology of insectinsect morphology and physiology of insect
insect morphology and physiology of insect
 
Body fluids_tonicity_dehydration_hypovolemia_hypervolemia.pptx
Body fluids_tonicity_dehydration_hypovolemia_hypervolemia.pptxBody fluids_tonicity_dehydration_hypovolemia_hypervolemia.pptx
Body fluids_tonicity_dehydration_hypovolemia_hypervolemia.pptx
 
EY - Supply Chain Services 2018_template.pptx
EY - Supply Chain Services 2018_template.pptxEY - Supply Chain Services 2018_template.pptx
EY - Supply Chain Services 2018_template.pptx
 
THYROID-PARATHYROID medical surgical nursing
THYROID-PARATHYROID medical surgical nursingTHYROID-PARATHYROID medical surgical nursing
THYROID-PARATHYROID medical surgical nursing
 
Circulatory system_ Laplace law. Ohms law.reynaults law,baro-chemo-receptors-...
Circulatory system_ Laplace law. Ohms law.reynaults law,baro-chemo-receptors-...Circulatory system_ Laplace law. Ohms law.reynaults law,baro-chemo-receptors-...
Circulatory system_ Laplace law. Ohms law.reynaults law,baro-chemo-receptors-...
 
In silico drugs analogue design: novobiocin analogues.pptx
In silico drugs analogue design: novobiocin analogues.pptxIn silico drugs analogue design: novobiocin analogues.pptx
In silico drugs analogue design: novobiocin analogues.pptx
 
SAMPLING.pptx for analystical chemistry sample techniques
SAMPLING.pptx for analystical chemistry sample techniquesSAMPLING.pptx for analystical chemistry sample techniques
SAMPLING.pptx for analystical chemistry sample techniques
 

Good documentation practices

  • 1.
  • 2.  Guidance ISO 9000:2005 Quality Management Systems- Fundamentals and vocabulary defines a document as an information and its supporting medium.  Medium can be: ◦ magnetic ◦ paper ◦ electronic or optical computer disc ◦ photograph ◦ master sample
  • 3. Documentation is :  A set of documents (written or graphical procedures, manuals, policies , instructions, specifications) and records (recorded information of performed activity).  A process that involves the systematic interaction of people, events and documents to create the records. Quality can not be assured in a regulated industry without good documentation practices.
  • 4. ISO 9001:2008 specifically requires the organization to have documented procedures for the following six activities:  Control of documents  Control of records  Internal audit  Control of nonconforming product  Corrective action  Preventive action Additional needed documents are:  Quality policy  Quality objectives  Quality manual
  • 5.  Approval – specially for work instructions, procedures, manufacturing specifications.  Clarity - documents should not be open to misinterpretation by the users.  Regular review and update - documents must be kept up-to-date and distributed in a controlled manner.  Formal presentation- controlled documents should be prepared in accordance with a written procedure.  Records-related to manufacturing or testing operations should be kept based on record retention policy.
  • 6.  All entries must be clear and legible.  Never make erasures or write-overs. (Do not turn a 5 to 6, or 9 into 8)  Any written error must be crossed out in such a manner that the original information is still legible.  Do not scribble out or white out entries.  The crossed out section must be initialed and dated by originator. Corrections must be made next to the deleted entry. Write reason for correction.  Use only black or blue permanent ink.  Pencil is not acceptable, since all entries must be permanent and able to be photocopied.  Make the required entries on the record as the work is performed. Do not record information on a separate piece of paper and enter on the record later.  No spaces for handwritten entries are left blank - if unused, they are crossed out or N/A (or similar text) entered.  Ditto marks or continuation lines are not acceptable.
  • 7. Want to learn more about GDP, its requirements and best practices to comply with them? ComplianceOnline webinars and seminars are a great training resource. Check out the following links:  How to Comply with GDP Requirements?  Good Documentation Practices for GXPs  Introduction to FDA Good Documentation Practices  An Easy to Understand Guide to Good Documentation Practices  Good Laboratory Practices (GLP): Documenting Deviations & Unexpected Circumstances