SlideShare ist ein Scribd-Unternehmen logo

Good documentation practices

•Als PPTX, PDF herunterladen•
•
C
complianceonline123

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

Wissenschaft
1 von 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

Empfohlen

Good Documentation Practice (GDP)
Good Documentation Practice (GDP)Good Documentation Practice (GDP)
Good Documentation Practice (GDP)AsthaNeupane
 
Good Documentation Practice (GDP)
Good Documentation Practice (GDP)Good Documentation Practice (GDP)
Good Documentation Practice (GDP)Hossen M. Faruk
 
1 documents & Requirements
1 documents & Requirements1 documents & Requirements
1 documents & RequirementsICHAPPS
 
Good Documentation Practices ppt
Good Documentation Practices pptGood Documentation Practices ppt
Good Documentation Practices pptTejprakashsharma10
 
Good documentation practice
Good documentation practiceGood documentation practice
Good documentation practiceShoab Malek (Certified Quality Auditor)
 
GDP training.pptx
GDP training.pptxGDP training.pptx
GDP training.pptxCrystalWong82
 
GMP - GOOD DOCUMENTATION PRACTICES
GMP - GOOD DOCUMENTATION PRACTICESGMP - GOOD DOCUMENTATION PRACTICES
GMP - GOOD DOCUMENTATION PRACTICESOmkar Phutane
 
Good documentation practice
Good documentation practiceGood documentation practice
Good documentation practiceM S K Anwar
 

Empfohlen

Good Documentation Practice (GDP)
Good Documentation Practice (GDP)Good Documentation Practice (GDP)
Good Documentation Practice (GDP)AsthaNeupane
 
Good Documentation Practice (GDP)
Good Documentation Practice (GDP)Good Documentation Practice (GDP)
Good Documentation Practice (GDP)Hossen M. Faruk
 
1 documents & Requirements
1 documents & Requirements1 documents & Requirements
1 documents & RequirementsICHAPPS
 
Good Documentation Practices ppt
Good Documentation Practices pptGood Documentation Practices ppt
Good Documentation Practices pptTejprakashsharma10
 
Good documentation practice
Good documentation practiceGood documentation practice
Good documentation practiceShoab Malek (Certified Quality Auditor)
 
GDP training.pptx
GDP training.pptxGDP training.pptx
GDP training.pptxCrystalWong82
 
GMP - GOOD DOCUMENTATION PRACTICES
GMP - GOOD DOCUMENTATION PRACTICESGMP - GOOD DOCUMENTATION PRACTICES
GMP - GOOD DOCUMENTATION PRACTICESOmkar Phutane
 
Good documentation practice
Good documentation practiceGood documentation practice
Good documentation practiceM S K Anwar
 
Good Documentation Practice
Good Documentation PracticeGood Documentation Practice
Good Documentation PracticeManpreet Rait
 
Gdp alcoa
Gdp alcoaGdp alcoa
Gdp alcoaShruti Kargutkar
 
Good documentation practices
Good documentation practicesGood documentation practices
Good documentation practicesshabanaabbas
 
Good documentation practices
Good documentation practicesGood documentation practices
Good documentation practicesImdad H. Mukeri
 
good documentation practice
good documentation practice good documentation practice
good documentation practice YannamVasundharaRedd
 
Good Documentation Practices
Good Documentation PracticesGood Documentation Practices
Good Documentation PracticesNikhil Soni
 
Good documentation practice
Good documentation practiceGood documentation practice
Good documentation practicePharmaceutical
 
Good Documentation Practice (GDocP).pdf
Good Documentation Practice (GDocP).pdfGood Documentation Practice (GDocP).pdf
Good Documentation Practice (GDocP).pdfMd. Zakaria Faruki
 
Good Documentation Pactise dr. amsavel
Good Documentation Pactise dr. amsavelGood Documentation Pactise dr. amsavel
Good Documentation Pactise dr. amsavelAmsavel Vel
 
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 practicevincyrekha
 
Good documentation practices
Good documentation practicesGood documentation practices
Good documentation practicesSushant Sardana
 
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
good documentation practice good documentation practice
good documentation practice YannamVasundharaRedd
 
Good Documentation Practices
Good Documentation Practices Good Documentation Practices
Good Documentation Practices vishnu gupta
 
Pharmaceutical Data integrity training
Pharmaceutical Data integrity trainingPharmaceutical Data integrity training
Pharmaceutical Data integrity trainingMoataz El Halawany
 
Good documentation practices
Good documentation practicesGood documentation practices
Good documentation practicesBangaluru
 
Good documentation practices
Good documentation practicesGood documentation practices
Good documentation practicesG Sundar
 
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
 
Pharmaceutical documentation
Pharmaceutical documentationPharmaceutical documentation
Pharmaceutical documentationK V NANDA KUMAR
 
Pharmaceutical Documentation
Pharmaceutical DocumentationPharmaceutical Documentation
Pharmaceutical DocumentationCCL Pharmaceuticals
 

Weitere ähnliche Inhalte

Was ist angesagt?

Good Documentation Practice
Good Documentation PracticeGood Documentation Practice
Good Documentation PracticeManpreet Rait
 
Good documentation practices
Good documentation practicesGood documentation practices
Good documentation practicesshabanaabbas
 
Good documentation practices
Good documentation practicesGood documentation practices
Good documentation practicesImdad H. Mukeri
 
Good Documentation Practices
Good Documentation PracticesGood Documentation Practices
Good Documentation PracticesNikhil Soni
 
Good documentation practice
Good documentation practiceGood documentation practice
Good documentation practicePharmaceutical
 
Good Documentation Practice (GDocP).pdf
Good Documentation Practice (GDocP).pdfGood Documentation Practice (GDocP).pdf
Good Documentation Practice (GDocP).pdfMd. Zakaria Faruki
 
Good Documentation Pactise dr. amsavel
Good Documentation Pactise dr. amsavelGood Documentation Pactise dr. amsavel
Good Documentation Pactise dr. amsavelAmsavel Vel
 
Good Documentation Practice
Good Documentation PracticeGood Documentation Practice
Good Documentation Practicecr7clark
 
Good documentation practice
Good documentation practiceGood documentation practice
Good documentation practicevincyrekha
 
Good documentation practices
Good documentation practicesGood documentation practices
Good documentation practicesSushant Sardana
 
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 Practices
Good Documentation Practices Good Documentation Practices
Good Documentation Practices vishnu gupta
 
Pharmaceutical Data integrity training
Pharmaceutical Data integrity trainingPharmaceutical Data integrity training
Pharmaceutical Data integrity trainingMoataz El Halawany
 
Good documentation practices
Good documentation practicesGood documentation practices
Good documentation practicesBangaluru
 
Good documentation practices
Good documentation practicesGood documentation practices
Good documentation practicesG Sundar
 
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
 

Was ist angesagt? (20)

Good Documentation Practice
Good Documentation PracticeGood Documentation Practice
Good Documentation Practice
 
Gdp alcoa
Gdp alcoaGdp alcoa
Gdp alcoa
 
Good documentation practices
Good documentation practicesGood documentation practices
Good documentation practices
 
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 (GDocP).pdf
Good Documentation Practice (GDocP).pdfGood Documentation Practice (GDocP).pdf
Good Documentation Practice (GDocP).pdf
 
Good Documentation Pactise dr. amsavel
Good Documentation Pactise dr. amsavelGood Documentation Pactise dr. amsavel
Good Documentation Pactise dr. amsavel
 
Good Documentation Practice
Good Documentation PracticeGood Documentation Practice
Good Documentation Practice
 
GDP Training NS
GDP Training NSGDP Training NS
GDP Training NS
 
Good documentation practice
Good documentation practiceGood documentation practice
Good documentation practice
 
Good documentation practices
Good documentation practicesGood documentation practices
Good documentation practices
 
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
good documentation practice good documentation practice
good documentation practice
 
Good Documentation Practices
Good Documentation Practices Good Documentation Practices
Good Documentation Practices
 
Pharmaceutical Data integrity training
Pharmaceutical Data integrity trainingPharmaceutical Data integrity training
Pharmaceutical Data integrity training
 
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 -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)
 

Ähnlich wie 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
 

Ähnlich wie 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
 
soppresentation-191116160454.pdf
soppresentation-191116160454.pdfsoppresentation-191116160454.pdf
soppresentation-191116160454.pdf
 
Sop presentation
Sop presentationSop presentation
Sop presentation
 
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
 

Mehr von 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
 

Mehr von 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
 

Kürzlich hochgeladen

Unit5-Cloud.pptx for lpu course cse121 o
Unit5-Cloud.pptx for lpu course cse121 oUnit5-Cloud.pptx for lpu course cse121 o
Unit5-Cloud.pptx for lpu course cse121 oManavSingh202607
 
Locating and isolating a gene, FISH, GISH, Chromosome walking and jumping, te...
Locating and isolating a gene, FISH, GISH, Chromosome walking and jumping, te...Locating and isolating a gene, FISH, GISH, Chromosome walking and jumping, te...
Locating and isolating a gene, FISH, GISH, Chromosome walking and jumping, te...Silpa
 
GBSN - Biochemistry (Unit 1)
GBSN - Biochemistry (Unit 1)GBSN - Biochemistry (Unit 1)
GBSN - Biochemistry (Unit 1)Areesha Ahmad
 
Biogenic Sulfur Gases as Biosignatures on Temperate Sub-Neptune Waterworlds
Biogenic Sulfur Gases as Biosignatures on Temperate Sub-Neptune WaterworldsBiogenic Sulfur Gases as Biosignatures on Temperate Sub-Neptune Waterworlds
Biogenic Sulfur Gases as Biosignatures on Temperate Sub-Neptune WaterworldsSérgio Sacani
 
PSYCHOSOCIAL NEEDS. in nursing II sem pptx
PSYCHOSOCIAL NEEDS. in nursing II sem pptxPSYCHOSOCIAL NEEDS. in nursing II sem pptx
PSYCHOSOCIAL NEEDS. in nursing II sem pptxSuji236384
 
Connaught Place, Delhi Call girls :8448380779 Model Escorts | 100% verified
Connaught Place, Delhi Call girls :8448380779 Model Escorts | 100% verifiedConnaught Place, Delhi Call girls :8448380779 Model Escorts | 100% verified
Connaught Place, Delhi Call girls :8448380779 Model Escorts | 100% verifiedDelhi Call girls
 
Introduction,importance and scope of horticulture.pptx
Introduction,importance and scope of horticulture.pptxIntroduction,importance and scope of horticulture.pptx
Introduction,importance and scope of horticulture.pptxBhagirath Gogikar
 
Chemical Tests; flame test, positive and negative ions test Edexcel Internati...
Chemical Tests; flame test, positive and negative ions test Edexcel Internati...Chemical Tests; flame test, positive and negative ions test Edexcel Internati...
Chemical Tests; flame test, positive and negative ions test Edexcel Internati...ssuser79fe74
 
FAIRSpectra - Enabling the FAIRification of Spectroscopy and Spectrometry
FAIRSpectra - Enabling the FAIRification of Spectroscopy and SpectrometryFAIRSpectra - Enabling the FAIRification of Spectroscopy and Spectrometry
FAIRSpectra - Enabling the FAIRification of Spectroscopy and SpectrometryAlex Henderson
 
Pests of cotton_Borer_Pests_Binomics_Dr.UPR.pdf
Pests of cotton_Borer_Pests_Binomics_Dr.UPR.pdfPests of cotton_Borer_Pests_Binomics_Dr.UPR.pdf
Pests of cotton_Borer_Pests_Binomics_Dr.UPR.pdfPirithiRaju
 
Vip profile Call Girls In Lonavala 9748763073 For Genuine Sex Service At Just...
Vip profile Call Girls In Lonavala 9748763073 For Genuine Sex Service At Just...Vip profile Call Girls In Lonavala 9748763073 For Genuine Sex Service At Just...
Vip profile Call Girls In Lonavala 9748763073 For Genuine Sex Service At Just...Monika Rani
 
pumpkin fruit fly, water melon fruit fly, cucumber fruit fly
pumpkin fruit fly, water melon fruit fly, cucumber fruit flypumpkin fruit fly, water melon fruit fly, cucumber fruit fly
pumpkin fruit fly, water melon fruit fly, cucumber fruit flyPRADYUMMAURYA1
 
❤Jammu Kashmir Call Girls 8617697112 Personal Whatsapp Number 💦✅.
❤Jammu Kashmir Call Girls 8617697112 Personal Whatsapp Number 💦✅.❤Jammu Kashmir Call Girls 8617697112 Personal Whatsapp Number 💦✅.
❤Jammu Kashmir Call Girls 8617697112 Personal Whatsapp Number 💦✅.Nitya salvi
 
Pests of cotton_Sucking_Pests_Dr.UPR.pdf
Pests of cotton_Sucking_Pests_Dr.UPR.pdfPests of cotton_Sucking_Pests_Dr.UPR.pdf
Pests of cotton_Sucking_Pests_Dr.UPR.pdfPirithiRaju
 
SAMASTIPUR CALL GIRL 7857803690 LOW PRICE ESCORT SERVICE
SAMASTIPUR CALL GIRL 7857803690 LOW PRICE ESCORT SERVICESAMASTIPUR CALL GIRL 7857803690 LOW PRICE ESCORT SERVICE
SAMASTIPUR CALL GIRL 7857803690 LOW PRICE ESCORT SERVICEayushi9330
 
Forensic Biology & Its biological significance.pdf
Forensic Biology & Its biological significance.pdfForensic Biology & Its biological significance.pdf
Forensic Biology & Its biological significance.pdfrohankumarsinghrore1
 
dkNET Webinar "Texera: A Scalable Cloud Computing Platform for Sharing Data a...
dkNET Webinar "Texera: A Scalable Cloud Computing Platform for Sharing Data a...dkNET Webinar "Texera: A Scalable Cloud Computing Platform for Sharing Data a...
dkNET Webinar "Texera: A Scalable Cloud Computing Platform for Sharing Data a...dkNET
 
9654467111 Call Girls In Raj Nagar Delhi Short 1500 Night 6000
9654467111 Call Girls In Raj Nagar Delhi Short 1500 Night 60009654467111 Call Girls In Raj Nagar Delhi Short 1500 Night 6000
9654467111 Call Girls In Raj Nagar Delhi Short 1500 Night 6000Sapana Sha
 

Kürzlich hochgeladen (20)

Unit5-Cloud.pptx for lpu course cse121 o
Unit5-Cloud.pptx for lpu course cse121 oUnit5-Cloud.pptx for lpu course cse121 o
Unit5-Cloud.pptx for lpu course cse121 o
 
Locating and isolating a gene, FISH, GISH, Chromosome walking and jumping, te...
Locating and isolating a gene, FISH, GISH, Chromosome walking and jumping, te...Locating and isolating a gene, FISH, GISH, Chromosome walking and jumping, te...
Locating and isolating a gene, FISH, GISH, Chromosome walking and jumping, te...
 
GBSN - Biochemistry (Unit 1)
GBSN - Biochemistry (Unit 1)GBSN - Biochemistry (Unit 1)
GBSN - Biochemistry (Unit 1)
 
Biogenic Sulfur Gases as Biosignatures on Temperate Sub-Neptune Waterworlds
Biogenic Sulfur Gases as Biosignatures on Temperate Sub-Neptune WaterworldsBiogenic Sulfur Gases as Biosignatures on Temperate Sub-Neptune Waterworlds
Biogenic Sulfur Gases as Biosignatures on Temperate Sub-Neptune Waterworlds
 
PSYCHOSOCIAL NEEDS. in nursing II sem pptx
PSYCHOSOCIAL NEEDS. in nursing II sem pptxPSYCHOSOCIAL NEEDS. in nursing II sem pptx
PSYCHOSOCIAL NEEDS. in nursing II sem pptx
 
Connaught Place, Delhi Call girls :8448380779 Model Escorts | 100% verified
Connaught Place, Delhi Call girls :8448380779 Model Escorts | 100% verifiedConnaught Place, Delhi Call girls :8448380779 Model Escorts | 100% verified
Connaught Place, Delhi Call girls :8448380779 Model Escorts | 100% verified
 
Introduction,importance and scope of horticulture.pptx
Introduction,importance and scope of horticulture.pptxIntroduction,importance and scope of horticulture.pptx
Introduction,importance and scope of horticulture.pptx
 
Chemical Tests; flame test, positive and negative ions test Edexcel Internati...
Chemical Tests; flame test, positive and negative ions test Edexcel Internati...Chemical Tests; flame test, positive and negative ions test Edexcel Internati...
Chemical Tests; flame test, positive and negative ions test Edexcel Internati...
 
FAIRSpectra - Enabling the FAIRification of Spectroscopy and Spectrometry
FAIRSpectra - Enabling the FAIRification of Spectroscopy and SpectrometryFAIRSpectra - Enabling the FAIRification of Spectroscopy and Spectrometry
FAIRSpectra - Enabling the FAIRification of Spectroscopy and Spectrometry
 
Pests of cotton_Borer_Pests_Binomics_Dr.UPR.pdf
Pests of cotton_Borer_Pests_Binomics_Dr.UPR.pdfPests of cotton_Borer_Pests_Binomics_Dr.UPR.pdf
Pests of cotton_Borer_Pests_Binomics_Dr.UPR.pdf
 
CELL -Structural and Functional unit of life.pdf
CELL -Structural and Functional unit of life.pdfCELL -Structural and Functional unit of life.pdf
CELL -Structural and Functional unit of life.pdf
 
Vip profile Call Girls In Lonavala 9748763073 For Genuine Sex Service At Just...
Vip profile Call Girls In Lonavala 9748763073 For Genuine Sex Service At Just...Vip profile Call Girls In Lonavala 9748763073 For Genuine Sex Service At Just...
Vip profile Call Girls In Lonavala 9748763073 For Genuine Sex Service At Just...
 
pumpkin fruit fly, water melon fruit fly, cucumber fruit fly
pumpkin fruit fly, water melon fruit fly, cucumber fruit flypumpkin fruit fly, water melon fruit fly, cucumber fruit fly
pumpkin fruit fly, water melon fruit fly, cucumber fruit fly
 
❤Jammu Kashmir Call Girls 8617697112 Personal Whatsapp Number 💦✅.
❤Jammu Kashmir Call Girls 8617697112 Personal Whatsapp Number 💦✅.❤Jammu Kashmir Call Girls 8617697112 Personal Whatsapp Number 💦✅.
❤Jammu Kashmir Call Girls 8617697112 Personal Whatsapp Number 💦✅.
 
Site Acceptance Test .
Site Acceptance Test .Site Acceptance Test .
Site Acceptance Test .
 
Pests of cotton_Sucking_Pests_Dr.UPR.pdf
Pests of cotton_Sucking_Pests_Dr.UPR.pdfPests of cotton_Sucking_Pests_Dr.UPR.pdf
Pests of cotton_Sucking_Pests_Dr.UPR.pdf
 
SAMASTIPUR CALL GIRL 7857803690 LOW PRICE ESCORT SERVICE
SAMASTIPUR CALL GIRL 7857803690 LOW PRICE ESCORT SERVICESAMASTIPUR CALL GIRL 7857803690 LOW PRICE ESCORT SERVICE
SAMASTIPUR CALL GIRL 7857803690 LOW PRICE ESCORT SERVICE
 
Forensic Biology & Its biological significance.pdf
Forensic Biology & Its biological significance.pdfForensic Biology & Its biological significance.pdf
Forensic Biology & Its biological significance.pdf
 
dkNET Webinar "Texera: A Scalable Cloud Computing Platform for Sharing Data a...
dkNET Webinar "Texera: A Scalable Cloud Computing Platform for Sharing Data a...dkNET Webinar "Texera: A Scalable Cloud Computing Platform for Sharing Data a...
dkNET Webinar "Texera: A Scalable Cloud Computing Platform for Sharing Data a...
 
9654467111 Call Girls In Raj Nagar Delhi Short 1500 Night 6000
9654467111 Call Girls In Raj Nagar Delhi Short 1500 Night 60009654467111 Call Girls In Raj Nagar Delhi Short 1500 Night 6000
9654467111 Call Girls In Raj Nagar Delhi Short 1500 Night 6000
 

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