SlideShare ist ein Scribd-Unternehmen logo
1 von 13
Downloaden Sie, um offline zu lesen
ASSIGNMENT REPORT ON DOCUMENTATION
ISF COLLEGE OF PHARMACY, MOGA Page | 1
INTRODUCTION
Documentation is a set of documents provided on paper, or online, or on digital or analog media, such
as audio tape or CDs. Examples are user guides, white papers, on-line help, quick-reference guides. It is
becoming less common to see paper (hard-copy) documentation. Documentation is distributed via websites,
software products, and other on-line applications. Documentation is a method of preparing a written
material, which describes the process in terms of specifications ,instructions etc
Document is a piece of written, printed or electronic matter that provides information or evidence. A Good
Documentation is essential part of QA system . Documentation is an important aspect in pharmaceutical
industry irrespective of the fact the manufacturing plant is involved in production of dosage form (or) active
ingredient
Importance of documentation :-
It provides the working details necessary for manufacturing, packaging, quality control. Reduce the risk of
mistakes inherent in verbal communication. They help in decreasing the batch to batch variation so that
quality of product is kept with in the limit of acceptability. Documentation and records are essentials for
obtaining ACCREDIATION ,certification of ISO, and approval by Federal bodies.
Aim of documentationS :-
To define the specifications for all materials To define the methods of manufacture and control. To instruct
the personnel To provide information during investigation To helps in inspection or auditing by Regulatory
authorities
To design an effective & efficient documentation :-
Identify the important characteristics of processing event. •The document directing the manufacturing event
fulfills current regulatory commitments to the agency; it is appropriately written, reviewed and approved.
•The directive document is appropriate for the task to be performed. •The data is authentic, accurate,
complete, legible, accessible. • The data collected fulfills expectations (specifications) and is retrievable for
review or audit.
ASSIGNMENT REPORT ON DOCUMENTATION
ISF COLLEGE OF PHARMACY, MOGA Page | 2
“All documentationshould be legible, clean, readilyidentifiable, retrievable and maintained in facilities that provide a su itable
environment to minimize deterioration or damage and to prevent loss”.
Specifications:-
A document specification contains several parts: a description of the audience(s) for the document a
detailed outline giving the structure and contents of the document a work plan showing who is responsible
for each part of the document what the deadlines are for completing each task.
Three purposes for document specifications:
In the workplace, formal document specifications serve three important functions:
1. Economy of effort,
2. Work planning,
3. Writing organization.
What Good Documentation requires:-
1. APPROVAL
2. CLARITY
3. REGULAR REVIEW AND UPDATE
4. FORMAL PRESENTATION
PROTOCOL FOR DOCUMENTATION
1. Serial number of the Batch Manufacturing Record.
2. Name of the product.
3. Batch/Lot number.
4. Batch/Lot size.
5. Date of commencement of manufacture and date of completion of manufacture.
6. Date of each step in manufacturing.
ASSIGNMENT REPORT ON DOCUMENTATION
ISF COLLEGE OF PHARMACY, MOGA Page | 3
7. Names of all ingredients with the grade given by the quality control department.
8. Quality of all ingredients.
General requirements:-
Each document should have:
1. Have a clear title
2. Have an identification number
3. Be approved by authorized person
4. have the date of issue
5. document should not be hand written
6. Records should be retained at least one year
7. after the expiry date of the finished product
Designing of documents involves the following factors :-
1. Size of the paper
2. Color of the paper
3. All four sides margin must be define generally 25mm from left and 15 mm all sides All documents
must match the requirement
4. All documents must bear the name of the company and logo, if applicable
5. All documents must be approved, authorised, signed and dated by the authorized person.
6. Title and contents of the documents must be self explanatory.
Guidelines for labels :-
Label of finished product contains,
1. Name of the drug product
2. List of the active ingredients,
3. Net contents
ASSIGNMENT REPORT ON DOCUMENTATION
ISF COLLEGE OF PHARMACY, MOGA Page | 4
4. Batch number
5. Expiry date
6. Storage conditions
7. Name and address of the manufacturer
Standard Operating Procedures (SOPs):-
Standard Operating Procedures (SOPs) are issued to specifically instruct employees in areas of
responsibility, work instructions, appropriate specifications and required records A Standard Operating
Procedure (SOP) is a set of written instructions that document a routine or repetitive activity followed by an
organization.
Document :-
Documents is information (meaningful data) and its supporting medium, in form of paper, CD, Computer
file, microfilm, x-Ray film etc. Documents provides information or evidence or may serve as an official
record.
Record :-
Records is a document stating results achieved or provide evidence of activities performed.
GOOD DOCUMENTATIONs PRACTICE :-
Good documentation practice (commonly abbreviated GDP, recommended to abbreviate as GDocP to
distinguish from "good distribution practice" also abbreviated GDP) is a term in the pharmaceutical and
medical device industries to describe standards by which documents are created and maintained. While
some GDP / GDocP standards are codified by various competent authorities, others are not but are
considered cGMP (with emphasis on the "c", or "current"). Some competent authorities release or
adopt guidelines, and they may include non-codified GDP / GDocP expectations. While not law, authorities
will inspect against these guidelines and cGMP expectations in addition to the legal requirements and make
comments or observations if departures are seen. In the past years, the application of GDocP is also
expanding to cosmetic industry, excipient and ingredient manufacturers.
ASSIGNMENT REPORT ON DOCUMENTATION
ISF COLLEGE OF PHARMACY, MOGA Page | 5
GMP Guidelines :-
GMP guidelines specify certain documents to be maintained necessarily:
1. Labels
2. Specifications and testing procedures
3. Records
4. SOPs
NEED OF DOCUMENTATIONS :-
Documentation plays a crucial role in any treatment setting. Documentation helps assure continuity of care.
There are many important moments in treatment. Proper documentation can help the practitioner to recall
those moments. Behaviors and emotions can help tell a story; being able to discover patterns can help to
uncover reasons for certain behavior. Documentation is a very simple tool to help any practitioner is
unveiling patterns. It can help track the progress in addressing thought patterns and unhealthy behaviors. If a
practitioner isn’t utilizing the tool of documentation it would prove to be very difficult to make continual
progress on any one area, let alone multiple areas.
Any professional is always looking for ways to improve, or a better approach, a more successful course of
treatment, or fresh ideas to tackle ongoing problems. Documentation is crucial in achieving these measures.
Documentation is a great tool in protecting against lawsuits and complaints. Documentation help ensure
consent and expectations. It helps to tell the narrative for decisions made, and how yourself or the client
responded to different situations.
TYPES OF DOCUMENTATIONS :-
There are two types of documentations :-
1. DOCUMENTS :-
In general, a document (noun) is a record or the capturing of some event or thing so that the
information will not be lost. A document is a form of information . A document can be put into an
ASSIGNMENT REPORT ON DOCUMENTATION
ISF COLLEGE OF PHARMACY, MOGA Page | 6
electronic form and stored in a computer as one or more files. Often a single document becomes a
single file.
2. RECORDS :-
Various documents maintained in production department are Raw material records
 Record (computer science), a data structure
 Record, or row (database), a set of fields in a database related to one entity
 Boot sector or boot record, record used to start an operating system
 Storage record, a basic input/output structure
TYPES OF RECORDS USED :-
 Master formula records
 Batch production records
ASSIGNMENT REPORT ON DOCUMENTATION
ISF COLLEGE OF PHARMACY, MOGA Page | 7
 Quality control records
 Calibration records to instrument
 Records for stability studies
Specifications and testing procedures :-
In case of pharmaceutical products we need
1. specifications for Active and inactive starting material
2. Primary, printed and other packaging materials
3. Intermediate and bulk products
4. Finished pharmaceutical products
WHAT CONSTITUETS GOOD DOCUMENTATION PRACTICE :-
 Clearly Written documentation:
 Using indelible ink
 Legible hand written entries
 Reviewing & approving
 Staff Signatures
 Page Numbering
 Concise
 Traceable
 Contemporaneous
 Enduring
 Accessible
DIGITAL DOCUMENTATIONS :-
In earlier days, manual typewriters were used for typing a document, which was replaced by electronic
typewriter and now a computer is used for this purpose. Word processing, data processing,
communication and presentation are the most common activities performed in an office. Office
ASSIGNMENT REPORT ON DOCUMENTATION
ISF COLLEGE OF PHARMACY, MOGA Page | 8
productivity software is used to perform these activities effectively. A document is a paper with written
contents and the process of preparing a document is called documentation. Documentation is required
to preserve the contents for a longer period or to be used as evidence. The documents can be letters,
reports, thesis, manuscripts, legal documents, books, etc. A handwritten document can have certain
disadvantages like understanding the specific handwriting. With the advancement in computer
hardware and software technology, the process of handwritten documentation consequently automated
to computer word processing.
A data entry operator should possess the skills to use the office productivity tools with a good typing
speed. Although typing skill is the essential criteria for Unit 3.indd 45 9/11/2018 5:20:40 PM 46
Domestic Data Entry Operator – Class IX data entry operator, a little care has to be taken while using
the word processing software. A typist used to hit the space bar a number of times to arrange the text.
This is not required in the computer, as the automated features for editing and formatting are available.
Word processing is the use of computer software to enter, edit, format, store, retrieve and print the
document. The document can be a letter, notice, report, business correspondence, etc.
Amendments :- Making a Legible Correction.
Make a single line through the error-never use correction fluid, multiple cross- markerpen to obscure
the original record.
1. Provide a brief comment why the change is required(as appropriate)
2. Initial the change so that it is clear that the correction is deliberate.
3. Record the date of the correction next to the initials so that there is a record of when the change
was made.
Important: Backdatingofentries is not permitted
COMMON DOCUMENTATIONS ERRORS :-
 Entries Not Dated or Identified
 Obliterated Entries
 Entries Not Signed, or Signed or Countersigned without Having Been Read
ASSIGNMENT REPORT ON DOCUMENTATION
ISF COLLEGE OF PHARMACY, MOGA Page | 9
 Entries for Care Performed without Signature
 Illegible Records
 Lots of Blank Spaces on the Page Failure to Document Patient Noncompliance
 Charting Only the Abnormal
Principles of Good Documentation Practice :-
 A document bearing original signatures should never be destroyed.
 Never falsify information.
 Never you a White-out and cover-over-tapes.
 Never obliterate information or record.
 Never over-write a record.
 Never use pencil – all information should be completed in permanent Black or Blue ink.
 No spaces, lines or fields are to be left blank.
 Never use symbols E.g ditto marks or arrows to indicate repetitive and consecutive .
MAKING LEGIBLE CORRECTION :-
ASSIGNMENT REPORT ON DOCUMENTATION
ISF COLLEGE OF PHARMACY, MOGA Page | 10
Benefits of Good Documentation Practice :-
 Leads to a smoother running operation, having complete information and knowing how to
properly deal with issues
 Reduces documentation errors by having the mechanisms to properly record data and correct
errors
 Maintains a level of consistency across an organization in how things are documented and
recorded
 Ensures that documentation is clear, concise, and comprehensible
ASSIGNMENT REPORT ON DOCUMENTATION
ISF COLLEGE OF PHARMACY, MOGA Page | 11
Conclusion
ASSIGNMENT REPORT ON DOCUMENTATION
ISF COLLEGE OF PHARMACY, MOGA Page | 12
It is concluded that good documentation is everyone responsibility in the industry
because the quality ,safety, efficacy of the product will be reflect on the documentation
Documentation is having its own importance in the pharmaceutical industry and good
documentation leads to produce good quality of products. Documentation is a set of
documents provided on paper, or online, or on digital or analog media, such as audio
tape or CDs. Examples are user guides, white papers, on-line help, quick-reference
guides. It is becoming less common to see paper (hard-copy) documentation
Documentation is a set of documents provided on paper, or online, or
on digital or analog media, such as audio tape or CDs. Examples are user guides, white
papers, on-line help, quick-reference guides. It is becoming less common to see paper
(hard-copy) documentation. Documentation is distributed via websites, software
products, and other on-line applications.
References
ASSIGNMENT REPORT ON DOCUMENTATION
ISF COLLEGE OF PHARMACY, MOGA Page | 13
 Guidelines on cGMP and quality of pharmaceutical products by
“S.IYER “ cGMP for pharmaceuticals by “ MANOHAR A POTDAR “
 Pharmaceutical production and management by “CVS
SUBRAMANYAM

Más contenido relacionado

Was ist angesagt?

Nursing Documentation
Nursing DocumentationNursing Documentation
Nursing DocumentationAhmad Thanin
 
Admission and discharge
Admission and dischargeAdmission and discharge
Admission and dischargeSachin Chhari
 
Babitha's Note on documentation
Babitha's Note on documentationBabitha's Note on documentation
Babitha's Note on documentationBabitha Devu
 
DOCUMENTATION IN NURSING
DOCUMENTATION IN NURSINGDOCUMENTATION IN NURSING
DOCUMENTATION IN NURSINGANILKUMAR BR
 
Minimizing legal liability through effective record keeping
Minimizing legal liability through effective record keepingMinimizing legal liability through effective record keeping
Minimizing legal liability through effective record keepingSiva Nanda Reddy
 
Unit vi documentation and reporting
Unit vi   documentation and reportingUnit vi   documentation and reporting
Unit vi documentation and reportingPallavi Lokhande
 
Nursing process,,,Assessment
Nursing process,,,AssessmentNursing process,,,Assessment
Nursing process,,,AssessmentArifa T N
 
Comfort devices
Comfort devicesComfort devices
Comfort devicesJayaR62
 
DOCUMENTATION OF NURSING PROCESS
DOCUMENTATION OF NURSING PROCESSDOCUMENTATION OF NURSING PROCESS
DOCUMENTATION OF NURSING PROCESSHarsh Rastogi
 
Admission procedure
Admission procedureAdmission procedure
Admission procedureVikas Ghadge
 
RECORDS & REPORTS
RECORDS & REPORTS RECORDS & REPORTS
RECORDS & REPORTS Anu James
 
Principles of Documentation
Principles of  DocumentationPrinciples of  Documentation
Principles of DocumentationJEENA AEJY
 
Nursing records & reports
Nursing records & reportsNursing records & reports
Nursing records & reportsjasleenbrar03
 

Was ist angesagt? (20)

Nursing Documentation
Nursing DocumentationNursing Documentation
Nursing Documentation
 
Admission and discharge
Admission and dischargeAdmission and discharge
Admission and discharge
 
Documentation and Reporting
Documentation and ReportingDocumentation and Reporting
Documentation and Reporting
 
Babitha's Note on documentation
Babitha's Note on documentationBabitha's Note on documentation
Babitha's Note on documentation
 
DOCUMENTATION IN NURSING
DOCUMENTATION IN NURSINGDOCUMENTATION IN NURSING
DOCUMENTATION IN NURSING
 
Minimizing legal liability through effective record keeping
Minimizing legal liability through effective record keepingMinimizing legal liability through effective record keeping
Minimizing legal liability through effective record keeping
 
Unit vi documentation and reporting
Unit vi   documentation and reportingUnit vi   documentation and reporting
Unit vi documentation and reporting
 
Nursing process,,,Assessment
Nursing process,,,AssessmentNursing process,,,Assessment
Nursing process,,,Assessment
 
Bedsore care
Bedsore careBedsore care
Bedsore care
 
Health Assessment
Health AssessmentHealth Assessment
Health Assessment
 
Comfort devices
Comfort devicesComfort devices
Comfort devices
 
DOCUMENTATION OF NURSING PROCESS
DOCUMENTATION OF NURSING PROCESSDOCUMENTATION OF NURSING PROCESS
DOCUMENTATION OF NURSING PROCESS
 
Comfort Devices
Comfort DevicesComfort Devices
Comfort Devices
 
Records and reports
Records and reportsRecords and reports
Records and reports
 
Admission procedure
Admission procedureAdmission procedure
Admission procedure
 
RECORDS & REPORTS
RECORDS & REPORTS RECORDS & REPORTS
RECORDS & REPORTS
 
Principles of Documentation
Principles of  DocumentationPrinciples of  Documentation
Principles of Documentation
 
Fundamentals of nursing. unconsciousness
Fundamentals of nursing. unconsciousnessFundamentals of nursing. unconsciousness
Fundamentals of nursing. unconsciousness
 
Fundamentals of nursing documentation
Fundamentals of nursing documentationFundamentals of nursing documentation
Fundamentals of nursing documentation
 
Nursing records & reports
Nursing records & reportsNursing records & reports
Nursing records & reports
 

Ähnlich wie Documentation assignment

Documentation relating to product development,sop's,cleaning methods,quality ...
Documentation relating to product development,sop's,cleaning methods,quality ...Documentation relating to product development,sop's,cleaning methods,quality ...
Documentation relating to product development,sop's,cleaning methods,quality ...swrk
 
Writing and enforcing effective so ps
Writing and enforcing effective so psWriting and enforcing effective so ps
Writing and enforcing effective so psGRCTS
 
Practice school session on "GOOD Documentation Practices" dated 08.01.2021 by...
Practice school session on "GOOD Documentation Practices" dated 08.01.2021 by...Practice school session on "GOOD Documentation Practices" dated 08.01.2021 by...
Practice school session on "GOOD Documentation Practices" dated 08.01.2021 by...Namdeo Shinde
 
standard operating procedue ppt
standard operating procedue pptstandard operating procedue ppt
standard operating procedue pptShakil Mirza
 
Good documentation practices
Good documentation practicesGood documentation practices
Good documentation practicesPiyush Satvara
 
Importance of documentation for gmp compliance
Importance of documentation for gmp complianceImportance of documentation for gmp compliance
Importance of documentation for gmp complianceJRamniwas
 
GDP-PPT (1).pptx
GDP-PPT (1).pptxGDP-PPT (1).pptx
GDP-PPT (1).pptxjaswanth90
 
Dossier Management and Regulatory Affairs.
Dossier Management and Regulatory Affairs.Dossier Management and Regulatory Affairs.
Dossier Management and Regulatory Affairs.Naila Kanwal
 
Good Documentation Practices
Good Documentation Practices Good Documentation Practices
Good Documentation Practices vishnu gupta
 
Documentation in pharmaceutical industry
Documentation in pharmaceutical industryDocumentation in pharmaceutical industry
Documentation in pharmaceutical industryDevipriya Viswambharan
 
Good Documentation Pactise dr. amsavel
Good Documentation Pactise  dr. amsavelGood Documentation Pactise  dr. amsavel
Good Documentation Pactise dr. amsavelAmsavel Vel
 
LESSON 1 APPLYING QUALITY STANDARDS AQS.pptx
LESSON 1 APPLYING QUALITY STANDARDS AQS.pptxLESSON 1 APPLYING QUALITY STANDARDS AQS.pptx
LESSON 1 APPLYING QUALITY STANDARDS AQS.pptxjonathanlabajo2
 

Ähnlich wie Documentation assignment (20)

Documentation relating to product development,sop's,cleaning methods,quality ...
Documentation relating to product development,sop's,cleaning methods,quality ...Documentation relating to product development,sop's,cleaning methods,quality ...
Documentation relating to product development,sop's,cleaning methods,quality ...
 
Documentation
DocumentationDocumentation
Documentation
 
Docmentation complete
Docmentation completeDocmentation complete
Docmentation complete
 
Documentation
DocumentationDocumentation
Documentation
 
Writing and enforcing effective so ps
Writing and enforcing effective so psWriting and enforcing effective so ps
Writing and enforcing effective so ps
 
Practice school session on "GOOD Documentation Practices" dated 08.01.2021 by...
Practice school session on "GOOD Documentation Practices" dated 08.01.2021 by...Practice school session on "GOOD Documentation Practices" dated 08.01.2021 by...
Practice school session on "GOOD Documentation Practices" dated 08.01.2021 by...
 
Pharmaceutical Documentation
Pharmaceutical DocumentationPharmaceutical Documentation
Pharmaceutical Documentation
 
standard operating procedue ppt
standard operating procedue pptstandard operating procedue ppt
standard operating procedue ppt
 
GMP documentation
GMP documentationGMP documentation
GMP documentation
 
Good documentation practices
Good documentation practicesGood documentation practices
Good documentation practices
 
Importance of documentation for gmp compliance
Importance of documentation for gmp complianceImportance of documentation for gmp compliance
Importance of documentation for gmp compliance
 
GDP-PPT (1).pptx
GDP-PPT (1).pptxGDP-PPT (1).pptx
GDP-PPT (1).pptx
 
Documentation
Documentation Documentation
Documentation
 
Documentation
DocumentationDocumentation
Documentation
 
Dossier Management and Regulatory Affairs.
Dossier Management and Regulatory Affairs.Dossier Management and Regulatory Affairs.
Dossier Management and Regulatory Affairs.
 
Documentation and records
Documentation and recordsDocumentation and records
Documentation and records
 
Good Documentation Practices
Good Documentation Practices Good Documentation Practices
Good Documentation Practices
 
Documentation in pharmaceutical industry
Documentation in pharmaceutical industryDocumentation in pharmaceutical industry
Documentation in pharmaceutical industry
 
Good Documentation Pactise dr. amsavel
Good Documentation Pactise  dr. amsavelGood Documentation Pactise  dr. amsavel
Good Documentation Pactise dr. amsavel
 
LESSON 1 APPLYING QUALITY STANDARDS AQS.pptx
LESSON 1 APPLYING QUALITY STANDARDS AQS.pptxLESSON 1 APPLYING QUALITY STANDARDS AQS.pptx
LESSON 1 APPLYING QUALITY STANDARDS AQS.pptx
 

Mehr von Atul Chaudhary

Drug excipient interaction assignment
Drug excipient interaction assignmentDrug excipient interaction assignment
Drug excipient interaction assignmentAtul Chaudhary
 
3 d printing of pharmaceuticals
3 d printing of pharmaceuticals3 d printing of pharmaceuticals
3 d printing of pharmaceuticalsAtul Chaudhary
 
Common techanical document(ctd)
Common techanical document(ctd)Common techanical document(ctd)
Common techanical document(ctd)Atul Chaudhary
 
3 d printing presentation
3 d printing presentation3 d printing presentation
3 d printing presentationAtul Chaudhary
 
3 d printing presentation
3 d printing presentation3 d printing presentation
3 d printing presentationAtul Chaudhary
 
Thin layer chromatography
Thin layer chromatographyThin layer chromatography
Thin layer chromatographyAtul Chaudhary
 
Phospholipid complex ppt
Phospholipid complex pptPhospholipid complex ppt
Phospholipid complex pptAtul Chaudhary
 

Mehr von Atul Chaudhary (11)

Texture analyzer
Texture analyzerTexture analyzer
Texture analyzer
 
Texture analyzer
Texture analyzerTexture analyzer
Texture analyzer
 
Drug excipient interaction assignment
Drug excipient interaction assignmentDrug excipient interaction assignment
Drug excipient interaction assignment
 
3 d printing of pharmaceuticals
3 d printing of pharmaceuticals3 d printing of pharmaceuticals
3 d printing of pharmaceuticals
 
Common techanical document(ctd)
Common techanical document(ctd)Common techanical document(ctd)
Common techanical document(ctd)
 
3 d printing presentation
3 d printing presentation3 d printing presentation
3 d printing presentation
 
3 d printing presentation
3 d printing presentation3 d printing presentation
3 d printing presentation
 
Thin layer chromatography
Thin layer chromatographyThin layer chromatography
Thin layer chromatography
 
Supac
SupacSupac
Supac
 
Cosmeceuticals ppt
Cosmeceuticals pptCosmeceuticals ppt
Cosmeceuticals ppt
 
Phospholipid complex ppt
Phospholipid complex pptPhospholipid complex ppt
Phospholipid complex ppt
 

Último

ASTRINGENTS.pdf Pharmacognosy chapter 5 diploma in Pharmacy
ASTRINGENTS.pdf Pharmacognosy chapter 5 diploma in PharmacyASTRINGENTS.pdf Pharmacognosy chapter 5 diploma in Pharmacy
ASTRINGENTS.pdf Pharmacognosy chapter 5 diploma in PharmacySumit Tiwari
 
Pharmacology chapter No 7 full notes.pdf
Pharmacology chapter No 7 full notes.pdfPharmacology chapter No 7 full notes.pdf
Pharmacology chapter No 7 full notes.pdfSumit Tiwari
 
Alamkara theory by Bhamaha Indian Poetics (1).pptx
Alamkara theory by Bhamaha Indian Poetics (1).pptxAlamkara theory by Bhamaha Indian Poetics (1).pptx
Alamkara theory by Bhamaha Indian Poetics (1).pptxDhatriParmar
 
AI Uses and Misuses: Academic and Workplace Applications
AI Uses and Misuses: Academic and Workplace ApplicationsAI Uses and Misuses: Academic and Workplace Applications
AI Uses and Misuses: Academic and Workplace ApplicationsStella Lee
 
How to Customise Quotation's Appearance Using PDF Quote Builder in Odoo 17
How to Customise Quotation's Appearance Using PDF Quote Builder in Odoo 17How to Customise Quotation's Appearance Using PDF Quote Builder in Odoo 17
How to Customise Quotation's Appearance Using PDF Quote Builder in Odoo 17Celine George
 
The OERs: Transforming Education for Sustainable Future by Dr. Sarita Anand
The OERs: Transforming Education for Sustainable Future by Dr. Sarita AnandThe OERs: Transforming Education for Sustainable Future by Dr. Sarita Anand
The OERs: Transforming Education for Sustainable Future by Dr. Sarita AnandDr. Sarita Anand
 
Certification Study Group - Professional ML Engineer Session 3 (Machine Learn...
Certification Study Group - Professional ML Engineer Session 3 (Machine Learn...Certification Study Group - Professional ML Engineer Session 3 (Machine Learn...
Certification Study Group - Professional ML Engineer Session 3 (Machine Learn...gdgsurrey
 
25 CHUYÊN ĐỀ ÔN THI TỐT NGHIỆP THPT 2023 – BÀI TẬP PHÁT TRIỂN TỪ ĐỀ MINH HỌA...
25 CHUYÊN ĐỀ ÔN THI TỐT NGHIỆP THPT 2023 – BÀI TẬP PHÁT TRIỂN TỪ ĐỀ MINH HỌA...25 CHUYÊN ĐỀ ÔN THI TỐT NGHIỆP THPT 2023 – BÀI TẬP PHÁT TRIỂN TỪ ĐỀ MINH HỌA...
25 CHUYÊN ĐỀ ÔN THI TỐT NGHIỆP THPT 2023 – BÀI TẬP PHÁT TRIỂN TỪ ĐỀ MINH HỌA...Nguyen Thanh Tu Collection
 
Research Methodology and Tips on Better Research
Research Methodology and Tips on Better ResearchResearch Methodology and Tips on Better Research
Research Methodology and Tips on Better ResearchRushdi Shams
 
3.14.24 Gender Discrimination and Gender Inequity.pptx
3.14.24 Gender Discrimination and Gender Inequity.pptx3.14.24 Gender Discrimination and Gender Inequity.pptx
3.14.24 Gender Discrimination and Gender Inequity.pptxmary850239
 
3.12.24 Freedom Summer in Mississippi.pptx
3.12.24 Freedom Summer in Mississippi.pptx3.12.24 Freedom Summer in Mississippi.pptx
3.12.24 Freedom Summer in Mississippi.pptxmary850239
 
LEAD6001 - Introduction to Advanced Stud
LEAD6001 - Introduction to Advanced StudLEAD6001 - Introduction to Advanced Stud
LEAD6001 - Introduction to Advanced StudDr. Bruce A. Johnson
 
Dhavni Theory by Anandvardhana Indian Poetics
Dhavni Theory by Anandvardhana Indian PoeticsDhavni Theory by Anandvardhana Indian Poetics
Dhavni Theory by Anandvardhana Indian PoeticsDhatriParmar
 
HỌC TỐT TIẾNG ANH 11 THEO CHƯƠNG TRÌNH GLOBAL SUCCESS ĐÁP ÁN CHI TIẾT - HK2 (...
HỌC TỐT TIẾNG ANH 11 THEO CHƯƠNG TRÌNH GLOBAL SUCCESS ĐÁP ÁN CHI TIẾT - HK2 (...HỌC TỐT TIẾNG ANH 11 THEO CHƯƠNG TRÌNH GLOBAL SUCCESS ĐÁP ÁN CHI TIẾT - HK2 (...
HỌC TỐT TIẾNG ANH 11 THEO CHƯƠNG TRÌNH GLOBAL SUCCESS ĐÁP ÁN CHI TIẾT - HK2 (...Nguyen Thanh Tu Collection
 
POST ENCEPHALITIS case study Jitendra bhargav
POST ENCEPHALITIS case study  Jitendra bhargavPOST ENCEPHALITIS case study  Jitendra bhargav
POST ENCEPHALITIS case study Jitendra bhargavJitendra Bhargav
 
BBA 205 BUSINESS ENVIRONMENT UNIT I.pptx
BBA 205 BUSINESS ENVIRONMENT UNIT I.pptxBBA 205 BUSINESS ENVIRONMENT UNIT I.pptx
BBA 205 BUSINESS ENVIRONMENT UNIT I.pptxProf. Kanchan Kumari
 
BÀI TẬP BỔ TRỢ TIẾNG ANH 11 THEO ĐƠN VỊ BÀI HỌC - CẢ NĂM - CÓ FILE NGHE (GLOB...
BÀI TẬP BỔ TRỢ TIẾNG ANH 11 THEO ĐƠN VỊ BÀI HỌC - CẢ NĂM - CÓ FILE NGHE (GLOB...BÀI TẬP BỔ TRỢ TIẾNG ANH 11 THEO ĐƠN VỊ BÀI HỌC - CẢ NĂM - CÓ FILE NGHE (GLOB...
BÀI TẬP BỔ TRỢ TIẾNG ANH 11 THEO ĐƠN VỊ BÀI HỌC - CẢ NĂM - CÓ FILE NGHE (GLOB...Nguyen Thanh Tu Collection
 
3.12.24 The Social Construction of Gender.pptx
3.12.24 The Social Construction of Gender.pptx3.12.24 The Social Construction of Gender.pptx
3.12.24 The Social Construction of Gender.pptxmary850239
 
Riti theory by Vamana Indian poetics.pptx
Riti theory by Vamana Indian poetics.pptxRiti theory by Vamana Indian poetics.pptx
Riti theory by Vamana Indian poetics.pptxDhatriParmar
 

Último (20)

ASTRINGENTS.pdf Pharmacognosy chapter 5 diploma in Pharmacy
ASTRINGENTS.pdf Pharmacognosy chapter 5 diploma in PharmacyASTRINGENTS.pdf Pharmacognosy chapter 5 diploma in Pharmacy
ASTRINGENTS.pdf Pharmacognosy chapter 5 diploma in Pharmacy
 
Pharmacology chapter No 7 full notes.pdf
Pharmacology chapter No 7 full notes.pdfPharmacology chapter No 7 full notes.pdf
Pharmacology chapter No 7 full notes.pdf
 
Alamkara theory by Bhamaha Indian Poetics (1).pptx
Alamkara theory by Bhamaha Indian Poetics (1).pptxAlamkara theory by Bhamaha Indian Poetics (1).pptx
Alamkara theory by Bhamaha Indian Poetics (1).pptx
 
AI Uses and Misuses: Academic and Workplace Applications
AI Uses and Misuses: Academic and Workplace ApplicationsAI Uses and Misuses: Academic and Workplace Applications
AI Uses and Misuses: Academic and Workplace Applications
 
ANOVA Parametric test: Biostatics and Research Methodology
ANOVA Parametric test: Biostatics and Research MethodologyANOVA Parametric test: Biostatics and Research Methodology
ANOVA Parametric test: Biostatics and Research Methodology
 
How to Customise Quotation's Appearance Using PDF Quote Builder in Odoo 17
How to Customise Quotation's Appearance Using PDF Quote Builder in Odoo 17How to Customise Quotation's Appearance Using PDF Quote Builder in Odoo 17
How to Customise Quotation's Appearance Using PDF Quote Builder in Odoo 17
 
The OERs: Transforming Education for Sustainable Future by Dr. Sarita Anand
The OERs: Transforming Education for Sustainable Future by Dr. Sarita AnandThe OERs: Transforming Education for Sustainable Future by Dr. Sarita Anand
The OERs: Transforming Education for Sustainable Future by Dr. Sarita Anand
 
Certification Study Group - Professional ML Engineer Session 3 (Machine Learn...
Certification Study Group - Professional ML Engineer Session 3 (Machine Learn...Certification Study Group - Professional ML Engineer Session 3 (Machine Learn...
Certification Study Group - Professional ML Engineer Session 3 (Machine Learn...
 
25 CHUYÊN ĐỀ ÔN THI TỐT NGHIỆP THPT 2023 – BÀI TẬP PHÁT TRIỂN TỪ ĐỀ MINH HỌA...
25 CHUYÊN ĐỀ ÔN THI TỐT NGHIỆP THPT 2023 – BÀI TẬP PHÁT TRIỂN TỪ ĐỀ MINH HỌA...25 CHUYÊN ĐỀ ÔN THI TỐT NGHIỆP THPT 2023 – BÀI TẬP PHÁT TRIỂN TỪ ĐỀ MINH HỌA...
25 CHUYÊN ĐỀ ÔN THI TỐT NGHIỆP THPT 2023 – BÀI TẬP PHÁT TRIỂN TỪ ĐỀ MINH HỌA...
 
Research Methodology and Tips on Better Research
Research Methodology and Tips on Better ResearchResearch Methodology and Tips on Better Research
Research Methodology and Tips on Better Research
 
3.14.24 Gender Discrimination and Gender Inequity.pptx
3.14.24 Gender Discrimination and Gender Inequity.pptx3.14.24 Gender Discrimination and Gender Inequity.pptx
3.14.24 Gender Discrimination and Gender Inequity.pptx
 
3.12.24 Freedom Summer in Mississippi.pptx
3.12.24 Freedom Summer in Mississippi.pptx3.12.24 Freedom Summer in Mississippi.pptx
3.12.24 Freedom Summer in Mississippi.pptx
 
LEAD6001 - Introduction to Advanced Stud
LEAD6001 - Introduction to Advanced StudLEAD6001 - Introduction to Advanced Stud
LEAD6001 - Introduction to Advanced Stud
 
Dhavni Theory by Anandvardhana Indian Poetics
Dhavni Theory by Anandvardhana Indian PoeticsDhavni Theory by Anandvardhana Indian Poetics
Dhavni Theory by Anandvardhana Indian Poetics
 
HỌC TỐT TIẾNG ANH 11 THEO CHƯƠNG TRÌNH GLOBAL SUCCESS ĐÁP ÁN CHI TIẾT - HK2 (...
HỌC TỐT TIẾNG ANH 11 THEO CHƯƠNG TRÌNH GLOBAL SUCCESS ĐÁP ÁN CHI TIẾT - HK2 (...HỌC TỐT TIẾNG ANH 11 THEO CHƯƠNG TRÌNH GLOBAL SUCCESS ĐÁP ÁN CHI TIẾT - HK2 (...
HỌC TỐT TIẾNG ANH 11 THEO CHƯƠNG TRÌNH GLOBAL SUCCESS ĐÁP ÁN CHI TIẾT - HK2 (...
 
POST ENCEPHALITIS case study Jitendra bhargav
POST ENCEPHALITIS case study  Jitendra bhargavPOST ENCEPHALITIS case study  Jitendra bhargav
POST ENCEPHALITIS case study Jitendra bhargav
 
BBA 205 BUSINESS ENVIRONMENT UNIT I.pptx
BBA 205 BUSINESS ENVIRONMENT UNIT I.pptxBBA 205 BUSINESS ENVIRONMENT UNIT I.pptx
BBA 205 BUSINESS ENVIRONMENT UNIT I.pptx
 
BÀI TẬP BỔ TRỢ TIẾNG ANH 11 THEO ĐƠN VỊ BÀI HỌC - CẢ NĂM - CÓ FILE NGHE (GLOB...
BÀI TẬP BỔ TRỢ TIẾNG ANH 11 THEO ĐƠN VỊ BÀI HỌC - CẢ NĂM - CÓ FILE NGHE (GLOB...BÀI TẬP BỔ TRỢ TIẾNG ANH 11 THEO ĐƠN VỊ BÀI HỌC - CẢ NĂM - CÓ FILE NGHE (GLOB...
BÀI TẬP BỔ TRỢ TIẾNG ANH 11 THEO ĐƠN VỊ BÀI HỌC - CẢ NĂM - CÓ FILE NGHE (GLOB...
 
3.12.24 The Social Construction of Gender.pptx
3.12.24 The Social Construction of Gender.pptx3.12.24 The Social Construction of Gender.pptx
3.12.24 The Social Construction of Gender.pptx
 
Riti theory by Vamana Indian poetics.pptx
Riti theory by Vamana Indian poetics.pptxRiti theory by Vamana Indian poetics.pptx
Riti theory by Vamana Indian poetics.pptx
 

Documentation assignment

  • 1. ASSIGNMENT REPORT ON DOCUMENTATION ISF COLLEGE OF PHARMACY, MOGA Page | 1 INTRODUCTION Documentation is a set of documents provided on paper, or online, or on digital or analog media, such as audio tape or CDs. Examples are user guides, white papers, on-line help, quick-reference guides. It is becoming less common to see paper (hard-copy) documentation. Documentation is distributed via websites, software products, and other on-line applications. Documentation is a method of preparing a written material, which describes the process in terms of specifications ,instructions etc Document is a piece of written, printed or electronic matter that provides information or evidence. A Good Documentation is essential part of QA system . Documentation is an important aspect in pharmaceutical industry irrespective of the fact the manufacturing plant is involved in production of dosage form (or) active ingredient Importance of documentation :- It provides the working details necessary for manufacturing, packaging, quality control. Reduce the risk of mistakes inherent in verbal communication. They help in decreasing the batch to batch variation so that quality of product is kept with in the limit of acceptability. Documentation and records are essentials for obtaining ACCREDIATION ,certification of ISO, and approval by Federal bodies. Aim of documentationS :- To define the specifications for all materials To define the methods of manufacture and control. To instruct the personnel To provide information during investigation To helps in inspection or auditing by Regulatory authorities To design an effective & efficient documentation :- Identify the important characteristics of processing event. •The document directing the manufacturing event fulfills current regulatory commitments to the agency; it is appropriately written, reviewed and approved. •The directive document is appropriate for the task to be performed. •The data is authentic, accurate, complete, legible, accessible. • The data collected fulfills expectations (specifications) and is retrievable for review or audit.
  • 2. ASSIGNMENT REPORT ON DOCUMENTATION ISF COLLEGE OF PHARMACY, MOGA Page | 2 “All documentationshould be legible, clean, readilyidentifiable, retrievable and maintained in facilities that provide a su itable environment to minimize deterioration or damage and to prevent loss”. Specifications:- A document specification contains several parts: a description of the audience(s) for the document a detailed outline giving the structure and contents of the document a work plan showing who is responsible for each part of the document what the deadlines are for completing each task. Three purposes for document specifications: In the workplace, formal document specifications serve three important functions: 1. Economy of effort, 2. Work planning, 3. Writing organization. What Good Documentation requires:- 1. APPROVAL 2. CLARITY 3. REGULAR REVIEW AND UPDATE 4. FORMAL PRESENTATION PROTOCOL FOR DOCUMENTATION 1. Serial number of the Batch Manufacturing Record. 2. Name of the product. 3. Batch/Lot number. 4. Batch/Lot size. 5. Date of commencement of manufacture and date of completion of manufacture. 6. Date of each step in manufacturing.
  • 3. ASSIGNMENT REPORT ON DOCUMENTATION ISF COLLEGE OF PHARMACY, MOGA Page | 3 7. Names of all ingredients with the grade given by the quality control department. 8. Quality of all ingredients. General requirements:- Each document should have: 1. Have a clear title 2. Have an identification number 3. Be approved by authorized person 4. have the date of issue 5. document should not be hand written 6. Records should be retained at least one year 7. after the expiry date of the finished product Designing of documents involves the following factors :- 1. Size of the paper 2. Color of the paper 3. All four sides margin must be define generally 25mm from left and 15 mm all sides All documents must match the requirement 4. All documents must bear the name of the company and logo, if applicable 5. All documents must be approved, authorised, signed and dated by the authorized person. 6. Title and contents of the documents must be self explanatory. Guidelines for labels :- Label of finished product contains, 1. Name of the drug product 2. List of the active ingredients, 3. Net contents
  • 4. ASSIGNMENT REPORT ON DOCUMENTATION ISF COLLEGE OF PHARMACY, MOGA Page | 4 4. Batch number 5. Expiry date 6. Storage conditions 7. Name and address of the manufacturer Standard Operating Procedures (SOPs):- Standard Operating Procedures (SOPs) are issued to specifically instruct employees in areas of responsibility, work instructions, appropriate specifications and required records A Standard Operating Procedure (SOP) is a set of written instructions that document a routine or repetitive activity followed by an organization. Document :- Documents is information (meaningful data) and its supporting medium, in form of paper, CD, Computer file, microfilm, x-Ray film etc. Documents provides information or evidence or may serve as an official record. Record :- Records is a document stating results achieved or provide evidence of activities performed. GOOD DOCUMENTATIONs PRACTICE :- Good documentation practice (commonly abbreviated GDP, recommended to abbreviate as GDocP to distinguish from "good distribution practice" also abbreviated GDP) is a term in the pharmaceutical and medical device industries to describe standards by which documents are created and maintained. While some GDP / GDocP standards are codified by various competent authorities, others are not but are considered cGMP (with emphasis on the "c", or "current"). Some competent authorities release or adopt guidelines, and they may include non-codified GDP / GDocP expectations. While not law, authorities will inspect against these guidelines and cGMP expectations in addition to the legal requirements and make comments or observations if departures are seen. In the past years, the application of GDocP is also expanding to cosmetic industry, excipient and ingredient manufacturers.
  • 5. ASSIGNMENT REPORT ON DOCUMENTATION ISF COLLEGE OF PHARMACY, MOGA Page | 5 GMP Guidelines :- GMP guidelines specify certain documents to be maintained necessarily: 1. Labels 2. Specifications and testing procedures 3. Records 4. SOPs NEED OF DOCUMENTATIONS :- Documentation plays a crucial role in any treatment setting. Documentation helps assure continuity of care. There are many important moments in treatment. Proper documentation can help the practitioner to recall those moments. Behaviors and emotions can help tell a story; being able to discover patterns can help to uncover reasons for certain behavior. Documentation is a very simple tool to help any practitioner is unveiling patterns. It can help track the progress in addressing thought patterns and unhealthy behaviors. If a practitioner isn’t utilizing the tool of documentation it would prove to be very difficult to make continual progress on any one area, let alone multiple areas. Any professional is always looking for ways to improve, or a better approach, a more successful course of treatment, or fresh ideas to tackle ongoing problems. Documentation is crucial in achieving these measures. Documentation is a great tool in protecting against lawsuits and complaints. Documentation help ensure consent and expectations. It helps to tell the narrative for decisions made, and how yourself or the client responded to different situations. TYPES OF DOCUMENTATIONS :- There are two types of documentations :- 1. DOCUMENTS :- In general, a document (noun) is a record or the capturing of some event or thing so that the information will not be lost. A document is a form of information . A document can be put into an
  • 6. ASSIGNMENT REPORT ON DOCUMENTATION ISF COLLEGE OF PHARMACY, MOGA Page | 6 electronic form and stored in a computer as one or more files. Often a single document becomes a single file. 2. RECORDS :- Various documents maintained in production department are Raw material records  Record (computer science), a data structure  Record, or row (database), a set of fields in a database related to one entity  Boot sector or boot record, record used to start an operating system  Storage record, a basic input/output structure TYPES OF RECORDS USED :-  Master formula records  Batch production records
  • 7. ASSIGNMENT REPORT ON DOCUMENTATION ISF COLLEGE OF PHARMACY, MOGA Page | 7  Quality control records  Calibration records to instrument  Records for stability studies Specifications and testing procedures :- In case of pharmaceutical products we need 1. specifications for Active and inactive starting material 2. Primary, printed and other packaging materials 3. Intermediate and bulk products 4. Finished pharmaceutical products WHAT CONSTITUETS GOOD DOCUMENTATION PRACTICE :-  Clearly Written documentation:  Using indelible ink  Legible hand written entries  Reviewing & approving  Staff Signatures  Page Numbering  Concise  Traceable  Contemporaneous  Enduring  Accessible DIGITAL DOCUMENTATIONS :- In earlier days, manual typewriters were used for typing a document, which was replaced by electronic typewriter and now a computer is used for this purpose. Word processing, data processing, communication and presentation are the most common activities performed in an office. Office
  • 8. ASSIGNMENT REPORT ON DOCUMENTATION ISF COLLEGE OF PHARMACY, MOGA Page | 8 productivity software is used to perform these activities effectively. A document is a paper with written contents and the process of preparing a document is called documentation. Documentation is required to preserve the contents for a longer period or to be used as evidence. The documents can be letters, reports, thesis, manuscripts, legal documents, books, etc. A handwritten document can have certain disadvantages like understanding the specific handwriting. With the advancement in computer hardware and software technology, the process of handwritten documentation consequently automated to computer word processing. A data entry operator should possess the skills to use the office productivity tools with a good typing speed. Although typing skill is the essential criteria for Unit 3.indd 45 9/11/2018 5:20:40 PM 46 Domestic Data Entry Operator – Class IX data entry operator, a little care has to be taken while using the word processing software. A typist used to hit the space bar a number of times to arrange the text. This is not required in the computer, as the automated features for editing and formatting are available. Word processing is the use of computer software to enter, edit, format, store, retrieve and print the document. The document can be a letter, notice, report, business correspondence, etc. Amendments :- Making a Legible Correction. Make a single line through the error-never use correction fluid, multiple cross- markerpen to obscure the original record. 1. Provide a brief comment why the change is required(as appropriate) 2. Initial the change so that it is clear that the correction is deliberate. 3. Record the date of the correction next to the initials so that there is a record of when the change was made. Important: Backdatingofentries is not permitted COMMON DOCUMENTATIONS ERRORS :-  Entries Not Dated or Identified  Obliterated Entries  Entries Not Signed, or Signed or Countersigned without Having Been Read
  • 9. ASSIGNMENT REPORT ON DOCUMENTATION ISF COLLEGE OF PHARMACY, MOGA Page | 9  Entries for Care Performed without Signature  Illegible Records  Lots of Blank Spaces on the Page Failure to Document Patient Noncompliance  Charting Only the Abnormal Principles of Good Documentation Practice :-  A document bearing original signatures should never be destroyed.  Never falsify information.  Never you a White-out and cover-over-tapes.  Never obliterate information or record.  Never over-write a record.  Never use pencil – all information should be completed in permanent Black or Blue ink.  No spaces, lines or fields are to be left blank.  Never use symbols E.g ditto marks or arrows to indicate repetitive and consecutive . MAKING LEGIBLE CORRECTION :-
  • 10. ASSIGNMENT REPORT ON DOCUMENTATION ISF COLLEGE OF PHARMACY, MOGA Page | 10 Benefits of Good Documentation Practice :-  Leads to a smoother running operation, having complete information and knowing how to properly deal with issues  Reduces documentation errors by having the mechanisms to properly record data and correct errors  Maintains a level of consistency across an organization in how things are documented and recorded  Ensures that documentation is clear, concise, and comprehensible
  • 11. ASSIGNMENT REPORT ON DOCUMENTATION ISF COLLEGE OF PHARMACY, MOGA Page | 11 Conclusion
  • 12. ASSIGNMENT REPORT ON DOCUMENTATION ISF COLLEGE OF PHARMACY, MOGA Page | 12 It is concluded that good documentation is everyone responsibility in the industry because the quality ,safety, efficacy of the product will be reflect on the documentation Documentation is having its own importance in the pharmaceutical industry and good documentation leads to produce good quality of products. Documentation is a set of documents provided on paper, or online, or on digital or analog media, such as audio tape or CDs. Examples are user guides, white papers, on-line help, quick-reference guides. It is becoming less common to see paper (hard-copy) documentation Documentation is a set of documents provided on paper, or online, or on digital or analog media, such as audio tape or CDs. Examples are user guides, white papers, on-line help, quick-reference guides. It is becoming less common to see paper (hard-copy) documentation. Documentation is distributed via websites, software products, and other on-line applications. References
  • 13. ASSIGNMENT REPORT ON DOCUMENTATION ISF COLLEGE OF PHARMACY, MOGA Page | 13  Guidelines on cGMP and quality of pharmaceutical products by “S.IYER “ cGMP for pharmaceuticals by “ MANOHAR A POTDAR “  Pharmaceutical production and management by “CVS SUBRAMANYAM