Good Documentation Practice (GDocP) is an essential part of the quality assurance and such, related to all aspects of GMP” this definition is based on WHO. It is a systematic procedure of preparation, reviewing, approving, issuing, recording, storing and archival of document.
This presentation is contain information about Documentation System of Pharmaceuticals. This presentation is prepared for training on documentation in Drug International Limited (Herbal Division) Depending on WHO and ICH guideline.
This slide is related to Good documentation Practice in Pharmaceutical Industries. It was presented in the pharmaceutical industry (Chemidrug Industry Private Ltd.) during the training session.
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 industry to describe standards by which documents are created and maintained. While some 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 GDocP expectations. While 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.
Good Documentation Practice (GDocP) is an essential part of the quality assurance and such, related to all aspects of GMP” this definition is based on WHO. It is a systematic procedure of preparation, reviewing, approving, issuing, recording, storing and archival of document.
This presentation is contain information about Documentation System of Pharmaceuticals. This presentation is prepared for training on documentation in Drug International Limited (Herbal Division) Depending on WHO and ICH guideline.
This slide is related to Good documentation Practice in Pharmaceutical Industries. It was presented in the pharmaceutical industry (Chemidrug Industry Private Ltd.) during the training session.
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 industry to describe standards by which documents are created and maintained. While some 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 GDocP expectations. While 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.
ICH Q7A GMP Guidance For API .Good Documentation Practices.Why Documentation is required..? To define the method and control. GOOD DOCUMENTATION PRACTICE
Data integrity, Pharmaceutical industry, Good Manufacturing Practice, GMP, Guidelines, Data management, DI and GMP Compliance, paper and electronic data, Archive and back up
Presentation on data integrity in Pharmaceutical IndustrySathish Vemula
Presentation on data integrity in Pharmaceutical Industry
Contents:
- Definition & Basics
- Criteria for integrity of laboratory data
- Regulatory Requirements
- Barriers to Complete Data
- Possible data integrity problems
- Previous observations
- FDA Warning Letters – 2013
- FDA Warning Letters – 2014
- FDA 483’s related to data integrity
- EU – Non compliance Reports
- WHO - Notice of Concern
- Summary of Data Integrity issues
- Consequences- Rebuilding Trust
- Conclusion
Good Ducumentation Practices by Ninia Didulo.pptxNiniaDidulo1
After you have reviewed the good manufacturing practice presentation, you can able to practice your self on how to perform and execute the good documentation in your work place.
In Pharma and Biotech, Weightage of the Documentation is around 70 % because as per FDA "If you do not have Document, You dint have do it."
So Good Documentation Practice is of tremendous importance for the Industry to comply any regulation like FDA, GMP or ISO.
Good Documentation Practice (GDocP — or GRK for Good Recordkeeping) is an essential component of your overall pharmaceutical quality system (PQS) and quality risk management strategies (QRM).
new guidance on good data management was discussed and its development
recommended. The participants included national inspectors and specialists
in the various agenda topics, as well as staff of the Prequalification Team
(PQT)–Inspections
ICH Q7A GMP Guidance For API .Good Documentation Practices.Why Documentation is required..? To define the method and control. GOOD DOCUMENTATION PRACTICE
Data integrity, Pharmaceutical industry, Good Manufacturing Practice, GMP, Guidelines, Data management, DI and GMP Compliance, paper and electronic data, Archive and back up
Presentation on data integrity in Pharmaceutical IndustrySathish Vemula
Presentation on data integrity in Pharmaceutical Industry
Contents:
- Definition & Basics
- Criteria for integrity of laboratory data
- Regulatory Requirements
- Barriers to Complete Data
- Possible data integrity problems
- Previous observations
- FDA Warning Letters – 2013
- FDA Warning Letters – 2014
- FDA 483’s related to data integrity
- EU – Non compliance Reports
- WHO - Notice of Concern
- Summary of Data Integrity issues
- Consequences- Rebuilding Trust
- Conclusion
Good Ducumentation Practices by Ninia Didulo.pptxNiniaDidulo1
After you have reviewed the good manufacturing practice presentation, you can able to practice your self on how to perform and execute the good documentation in your work place.
In Pharma and Biotech, Weightage of the Documentation is around 70 % because as per FDA "If you do not have Document, You dint have do it."
So Good Documentation Practice is of tremendous importance for the Industry to comply any regulation like FDA, GMP or ISO.
Good Documentation Practice (GDocP — or GRK for Good Recordkeeping) is an essential component of your overall pharmaceutical quality system (PQS) and quality risk management strategies (QRM).
new guidance on good data management was discussed and its development
recommended. The participants included national inspectors and specialists
in the various agenda topics, as well as staff of the Prequalification Team
(PQT)–Inspections
The presentation is about documentation in the pharmaceutical industry.
Many important topics are covered i.e. Need, objective, scope, types, and characteristics of documents used in the pharmaceutical industry.
How a document is reviewed, Four tiers of documentation, and the content of main documents like Master formula record, SOPs, Quality audit plan, and reports, and many more topics are covered in this presentation.
Hope you find it helpful.
GxP/GMP & its Consequences to Documentation and Information Technology Systems Galaxy Consulting
Documentation is a critical tool for ensuring GxP/GMP compliance.
In the regulated environment which must be GxP/GMP compliant, document control is the cornerstone of the quality system. It is so important that if an external audit identifies deficiencies in the document control system, the entire organization can be shut down.
There are also GMP requirements for information technology. For a drug to be produced in a GxP/GMP compliant manner, some specific information technology practices must be followed. Computer systems involved in the development, manufacture, and sale of regulated product must meet certain requirements.
Change control within quality management systems (QMS) and information technology (IT) systems is a formal process used to ensure that changes to a product or system are introduced in a controlled and coordinated manner. In the regulated industries, manufactures are required to use a change control procedure.
In this presentation, we discuss the connection between GxP/GMP and document control. We describe details of document control procedures, and the role of Quality Assurance in the documentation systems. We review GMP requirements for information technology and how computer systems including documentation management systems must meet GxP/GMP requirements. We also review change control procedure and how it should be used in GxP/GMP environment.
Ppt presentation on The Documentation techniques utilised for Data maintenance and preservation .
Including its types and Methods
CTD ECTD.
Gives information about how actually data controlled and managed in the order of time .with keeping it safer.
Documentation relating to product development,sop's,cleaning methods,quality ...swrk
COMPLAINT HANDLING IN PHARMACEUTICAL COMPANIES,PRODUCT RECALL,RETENTION RECORDS, DISTRIBUTION RECORDS.prepared by s.susena,m.pharmacy pharmaceutical analysis&QA,ssj college of pharmacy
B PHARMA 6TH SEM
PHRAMACEUTICAL QUALITY ASSURANCE
Pharmaceutical documentation
Need of documentation
Objectives of documents
Scope
Documentation lifecycle
Types of documents
Characteristic of document
Documentation review
Documents model
Standard operating procedures (sop’s)
Master formula record
Batch formula record
Quality audit plan and reports
Specification and test procedures
Good documentation practice
Introduction
What types of documents require to follow Good Documentation Practices?
Meaning of signature
Purpose of documentation
Basic requirements of GDP
Preparation of documents
Cancellation of GMP records
reference
• Analytical Methods
• Policies
• Batch Records
• Protocols
• Bills of Materials (BOMs)
• Test Methods
• Certificate of Analyses (CoA)
• Training
Documentation
• Certificate of Compliance (CoC)
• Logbooks
• Laboratory Notebooks
• Calibration records
• Quality records - non-conformances
- CAPAs
- internal inspection reports
- change control
Antibiotic Stewardship by Anushri Srivastava.pptxAnushriSrivastav
Stewardship is the act of taking good care of something.
Antimicrobial stewardship is a coordinated program that promotes the appropriate use of antimicrobials (including antibiotics), improves patient outcomes, reduces microbial resistance, and decreases the spread of infections caused by multidrug-resistant organisms.
WHO launched the Global Antimicrobial Resistance and Use Surveillance System (GLASS) in 2015 to fill knowledge gaps and inform strategies at all levels.
ACCORDING TO apic.org,
Antimicrobial stewardship is a coordinated program that promotes the appropriate use of antimicrobials (including antibiotics), improves patient outcomes, reduces microbial resistance, and decreases the spread of infections caused by multidrug-resistant organisms.
ACCORDING TO pewtrusts.org,
Antibiotic stewardship refers to efforts in doctors’ offices, hospitals, long term care facilities, and other health care settings to ensure that antibiotics are used only when necessary and appropriate
According to WHO,
Antimicrobial stewardship is a systematic approach to educate and support health care professionals to follow evidence-based guidelines for prescribing and administering antimicrobials
In 1996, John McGowan and Dale Gerding first applied the term antimicrobial stewardship, where they suggested a causal association between antimicrobial agent use and resistance. They also focused on the urgency of large-scale controlled trials of antimicrobial-use regulation employing sophisticated epidemiologic methods, molecular typing, and precise resistance mechanism analysis.
Antimicrobial Stewardship(AMS) refers to the optimal selection, dosing, and duration of antimicrobial treatment resulting in the best clinical outcome with minimal side effects to the patients and minimal impact on subsequent resistance.
According to the 2019 report, in the US, more than 2.8 million antibiotic-resistant infections occur each year, and more than 35000 people die. In addition to this, it also mentioned that 223,900 cases of Clostridoides difficile occurred in 2017, of which 12800 people died. The report did not include viruses or parasites
VISION
Being proactive
Supporting optimal animal and human health
Exploring ways to reduce overall use of antimicrobials
Using the drugs that prevent and treat disease by killing microscopic organisms in a responsible way
GOAL
to prevent the generation and spread of antimicrobial resistance (AMR). Doing so will preserve the effectiveness of these drugs in animals and humans for years to come.
being to preserve human and animal health and the effectiveness of antimicrobial medications.
to implement a multidisciplinary approach in assembling a stewardship team to include an infectious disease physician, a clinical pharmacist with infectious diseases training, infection preventionist, and a close collaboration with the staff in the clinical microbiology laboratory
to prevent antimicrobial overuse, misuse and abuse.
to minimize the developme
Global launch of the Healthy Ageing and Prevention Index 2nd wave – alongside...ILC- UK
The Healthy Ageing and Prevention Index is an online tool created by ILC that ranks countries on six metrics including, life span, health span, work span, income, environmental performance, and happiness. The Index helps us understand how well countries have adapted to longevity and inform decision makers on what must be done to maximise the economic benefits that comes with living well for longer.
Alongside the 77th World Health Assembly in Geneva on 28 May 2024, we launched the second version of our Index, allowing us to track progress and give new insights into what needs to be done to keep populations healthier for longer.
The speakers included:
Professor Orazio Schillaci, Minister of Health, Italy
Dr Hans Groth, Chairman of the Board, World Demographic & Ageing Forum
Professor Ilona Kickbusch, Founder and Chair, Global Health Centre, Geneva Graduate Institute and co-chair, World Health Summit Council
Dr Natasha Azzopardi Muscat, Director, Country Health Policies and Systems Division, World Health Organisation EURO
Dr Marta Lomazzi, Executive Manager, World Federation of Public Health Associations
Dr Shyam Bishen, Head, Centre for Health and Healthcare and Member of the Executive Committee, World Economic Forum
Dr Karin Tegmark Wisell, Director General, Public Health Agency of Sweden
CRISPR-Cas9, a revolutionary gene-editing tool, holds immense potential to reshape medicine, agriculture, and our understanding of life. But like any powerful tool, it comes with ethical considerations.
Unveiling CRISPR: This naturally occurring bacterial defense system (crRNA & Cas9 protein) fights viruses. Scientists repurposed it for precise gene editing (correction, deletion, insertion) by targeting specific DNA sequences.
The Promise: CRISPR offers exciting possibilities:
Gene Therapy: Correcting genetic diseases like cystic fibrosis.
Agriculture: Engineering crops resistant to pests and harsh environments.
Research: Studying gene function to unlock new knowledge.
The Peril: Ethical concerns demand attention:
Off-target Effects: Unintended DNA edits can have unforeseen consequences.
Eugenics: Misusing CRISPR for designer babies raises social and ethical questions.
Equity: High costs could limit access to this potentially life-saving technology.
The Path Forward: Responsible development is crucial:
International Collaboration: Clear guidelines are needed for research and human trials.
Public Education: Open discussions ensure informed decisions about CRISPR.
Prioritize Safety and Ethics: Safety and ethical principles must be paramount.
CRISPR offers a powerful tool for a better future, but responsible development and addressing ethical concerns are essential. By prioritizing safety, fostering open dialogue, and ensuring equitable access, we can harness CRISPR's power for the benefit of all. (2998 characters)
One of the most developed cities of India, the city of Chennai is the capital of Tamilnadu and many people from different parts of India come here to earn their bread and butter. Being a metropolitan, the city is filled with towering building and beaches but the sad part as with almost every Indian city
Navigating Challenges: Mental Health, Legislation, and the Prison System in B...Guillermo Rivera
This conference will delve into the intricate intersections between mental health, legal frameworks, and the prison system in Bolivia. It aims to provide a comprehensive overview of the current challenges faced by mental health professionals working within the legislative and correctional landscapes. Topics of discussion will include the prevalence and impact of mental health issues among the incarcerated population, the effectiveness of existing mental health policies and legislation, and potential reforms to enhance the mental health support system within prisons.
CHAPTER 1 SEMESTER V PREVENTIVE-PEDIATRICS.pdfSachin Sharma
This content provides an overview of preventive pediatrics. It defines preventive pediatrics as preventing disease and promoting children's physical, mental, and social well-being to achieve positive health. It discusses antenatal, postnatal, and social preventive pediatrics. It also covers various child health programs like immunization, breastfeeding, ICDS, and the roles of organizations like WHO, UNICEF, and nurses in preventive pediatrics.
Telehealth Psychology Building Trust with Clients.pptxThe Harvest Clinic
Telehealth psychology is a digital approach that offers psychological services and mental health care to clients remotely, using technologies like video conferencing, phone calls, text messaging, and mobile apps for communication.
R3 Stem Cells and Kidney Repair A New Horizon in Nephrology.pptxR3 Stem Cell
R3 Stem Cells and Kidney Repair: A New Horizon in Nephrology" explores groundbreaking advancements in the use of R3 stem cells for kidney disease treatment. This insightful piece delves into the potential of these cells to regenerate damaged kidney tissue, offering new hope for patients and reshaping the future of nephrology.
2. GOOD DOCUMENTATION CONSTITUTES AN
ESSENTIAL PART OF THE QUALITY
ASSURANCE SYSTEM.
Schedule M : Good Manufacturing practices, 12 : Documentation and records
EU GMP – Chapter 4: Documentation
3. What is Good Documentation Practice (GDP) ?
Purpose of Good Documentation Practices ?
Standards of the GDP
Types of the Documents
Typical elements of the Document
Common Documentation Errors
How to acquire good documentation practice ?
Benefits of the GDP
CONTENTS
4. GENERAL PHILOSOPHY OF ANY QUALITY
SYSTEM
Say What you do?
Do what you say ?
Prove what you say and do
5. WHAT IS
DOCUMENTATION ?
To Document each Activity you perform
No, Documentation is a Process, Which comprises of Following :
- Recording of Data
- Approval of Documents
- Issuance and Disposal of Documents
- Retrievability of Documents
- Presentation of Documents
- Review of Documents
6. GOOD DOCUMENTATION PRACTICE
(GDP)
"Right-first-time“ approach for the document is GDP
(to ensure identity, authenticity and accuracy of records.)
If your Document says “What actions took place in the development
or manufacturing of product so that anyone, including auditor or
inspector has documented evidence that you did exactly what you
said ” that is GDP.
7. REGULATORY
REQUIREMENTS
⚫ FDA Q7A Good Manufacturing Practice Guidance for Active
Pharmaceutical Ingredients, Section VI. Documentation and Records
ICH Good Manufacturing Practice Guide for API Q7, Section 6
Documentation and Records
21CFR58 : Good laboratory practice, Subpart J.
ISO 9001- 2008, Clause 4.2 : Documentation requirements
Guide to GMP for Medicinal Products Part 1, Chapter 4 Documentation:
PIC/S PE 009-8 (Part I)
8. THE PURPOSE OF
DOCUMENTATION
Proof of fact
Record
Regulatory requirement
Quality maintenance and improvement (Better risk management
and robust quality systems)
Control the processes (Resource optimization )
“Your documentation is an advertisement for your work”
End User requirements
To improve performance
⚫ Enables important messages to be communicated clearly and
accurately.
10. DOCUMENTATION LIFE
CYCLE
Document creation & Approval: -
The process owner or the authorized person should write as per the
specific format and template and circulate the document after getting
approval of QA.
Document use & Data collection: -
Responsibility of all technicians, engineers, scientists, operating persons
who are trained and authorized to collect and record data.
Data Verification: -
Responsibility of supervisors, managers and all individuals trained &
authorized to review data.
Record Review & Product disposition / Approval: -
Responsibility of QA or those trained & authorized to review records
11. CONT….
Record Archiving:-
Records are Accessible, Retrievable, Secure is the responsibility of QA &
relevant departments
Record Destruction: -
As per SOPs that directs the destruction of documents
12. WHO PARTICIPATES IN CREATING THE
DOCUMENTS?
Everyone involved in the process or procedure
Managers
Team Leads
Staff doing the work or impacted by the work
Include ALL departments and divisions impacted
Consultants may assist
13. WHEN ?
New Process or
Procedure
During implementation, all
documentation is created and
tested by all impacted
departments
Change to an existing
Process or Procedure
During implementation, all
documentation is reviewed,
updated, and tested by all
impacted departments
Periodic Review
Annually, review all documentation
to ensure it is accurate. Use as
part of continuous process
improvement cycle to evaluate need
for change
14. WHERE IS DOCUMENTATION
REQUIRED ?
Documentation during Project Design,
Documentation during Construction Phase,
Documentation during Commissioning and start-up,
Documentation during Qualification and Validations
Documentation during Commercial Production,
Documentation during Testing and Release,
Documentation for Regulatory submissions.
Documentation beyond…………
15. GDP
STANDARDS
Document creation
Contemporaneous with the event they describe
When electronically produced, the documentation must be
checked for accuracy
Free from errors
For some types of data, the documentation must be in a format
that permits trend evaluation
Document approval
Approved, signed, and dated by appropriate authorized
personnel.
16. DOCUMENT SIGNATURES
All documentation used to provide evidence that standards are
being followed must be signed and dated by authorized person as
it adds value to the document.
Means of Signature
For the approval
Authorized person involved in it
No signature pads, scanned signatures, or duplicated original
signatures shall be used to replace a handwritten signature by
the person signing.
Documents shall be signed in permanent ink.
Signatures shall be kept throughout the life of the document.
The local date shall be used to date documents.
17. HANDWRITTEN ENTRIES
Adequate space is provided for expected handwritten entries
Handwritten entries are in indelible ink
Critical entries must be independently checked
(SPV, or second person verified)
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
A stamp in lieu of a handwritten signature is not acceptable
18. DOCUMENT MAINTENANCE
Regularly reviewed and kept current
Record for the creating, issuing and modification should be
there
Retained and available for appropriate duration & in appropriate
condition
Electronic document management systems are validated
Electronic records are backed up
19. DOCUMENT MODIFICATION
Handwritten modifications are signed and dated
Where appropriate, the reason for alteration must be noted
("E.E." is a common abbreviated reason, indicating "Entry Error")
Controls exist to prevent the inadvertent use of superseded
documents
Electronic versions can only be modified by authorized personnel
and controlled by password or other means
A history must be maintained of changes and deletions to
electronic versions as well as paper documents.
Uncontrolled changes can have a substantial impact on a company‟s
ability to demonstrate compliance to their specific standards.
Reference : Document Creation and Change Request form. HQR - 423 -01.
20. CORRECTIONS/ADDITIONS
1. In Record
Single line through the information that needs to be corrected.
All corrections or additions shall be signed and dated.
Should not to scribble out the original data, use white out or
write over data .
2. In Document
Only personnel who have already been approved to write or make
changes to document can correct or add to documents.
Non-typographical error corrections or additions indicating a
change in data or acceptance status require a comment. And
routed through full document Change control.
Typographical error change or additions do not require approval.
Reference : Document Creation and Change Request form. HQR - 423 -01.
21. DOCUMENT REVIEW
Responsibility of supervisors, managers and all individuals trained
& authorized to review documents and data at specific time
interval.
An approved list of designees, originators, and reviewers shall be
maintained.
Designees
If a designee is to be used, then that person signs his/her name,
adds the words “signing for,” and adds the original printed name
of the approver.
Designees must have the knowledge, skills, and abilities to
perform the assigned authorship, verification, or approval
activity.
24. TYPES OF THE
DOCUMENTS
Commitment Documents :
Relationship between industry and the regulatory authorities
Exa : NDA, SMF
Directive Documents :
Relationship between the Management and Employees
Exa : Specifications, STPs, SOPs, MFRs etc.
Record Documents :
Relationship between the Employees and the Work they perform
Exa : Protocols, BMRs, Log Books, Calibration Records etc.
25. COPY OF THE
DOCUMENTS
Clear, legible
Errors should not introduced during copying
No any copy is allowed unless if it is stamped particularly
Master Copy
Original copy of the document
Controlled Copy
The copy of the document from master copy and used in regulated
environment signed and stamped by qualified person.
Uncontrolled copy
The copy of the document from master copy, made for information
purpose only.
Superseded copy
Old version of the copy which is replaced by the latest version of the
document
Obsolete copy
Copy of the document which is to be discontinued
26. CONT….
Standard operating procedures
Equipment assembly and validation
Analytical apparatus and calibration
Maintenance, cleaning, and sanitization
Personnel matters including qualification, training, and hygiene
Environmental monitoring
Pest control and assigning responsibility for cleaning and sanitation
Complaints, Recalls, Returns and Sampling
For testing materials and products at different stages of manufacture describing
the methods and equipment to be used.
For the internal labelling, quarantine and storage of starting materials, packaging
materials and other materials
For the receipt of each delivery of starting material and printed packaging
material.
27. TYPICAL ELEMENTS OF A
DOCUMENTATION
SYSTEM
Logo
Title
Doc. no
Effective date
Revision
Page no
Signature
Format
Stamp
28. DOCUMENT NUMBERING
All document shall have a unique document number.
This is typically issued by a document control department or
person (Quality Assurance).
29. DATE & TIME
A legal date is comprised of a month, day, and year, although not
necessarily in that order. Local conventions are assumed unless
otherwise specified in an SOP.
It should be in uniform format. For example : DD/MM/YY or
DD/MM/YYYY
Postdating (entering a date of the future) is not permitted
Backdating (entering a date on a day after the entry was made or
the task was performed) is not permitted
If times are required, procedures identifying approved guidelines
for documenting date and time (AM/PM or 24 hr) shall be
defined.
30. DOCUMENT EFFECTIVE DATE
Date of the change or the date from which the document become
live.
Effective date changes on every new change in the document.
And each change should be recorded at change history at the
front page of the document
Document Review Date
Date given to the document after the respective departmental
head review the document in consultation with actual user.
And after approval all the master and controlled copies are
stamped as “REVIEWED” on the document with review and next
review date.
31. DOCUMENT REVIEW
Document review will focus on the document‟scontent, context,
format and grammar.
The document quality attributes of concern document review are
correctness, usability, appropriateness and maintainability.
Review factors and criteria are :
Adherence to standards
Consistency and traceability
Readability, comprehensibility, and general understandability
Technical adequacy and feasibility of approach
Degree of completeness
Testability of requirements
Use of appropriate requirement, design, or coding techniques
Appropriate level of details
Reference : http://www.wildfire.gov/pmu/pmo-rchive/products/documents/Review_Guidelines.pdf
32. DOCUMENT REVISION
All documents shall have a revision level & latest document should live.
Two type of the revision
1. Routine revision :
- No technical or editorial modification but at the end of the two
years of the effective date.
- HOD will review and if there is no any change then HOD shall send
internal communication that this document doesn‟t need revision.
- If yes then Review the document and stamped as “REVIEWED”
- Valid only twice then document is revised as per DCC procedure.
2.Technical or editorial revision :
This type of the revision shall be carried out by Document change
control procedure and recorded.
Every piece of a document shall be marked with the page number as
well as the total number of pages in the documents. X of Y.
33. SIGNATURE & DATE
Document which doesn‟t has sign and date of the approval
consider as the incomplete document.
All documents shall be signed by the originator.
No signature pads, scanned signatures, or duplicated original
signatures shall be used to replace a handwritten signature by
the person signing.
Documents shall be signed in permanent ink.
Signatures shall be kept throughout the life of the document.
The local date shall be used to date documents.
34. Missing signature and dates at the time the activity is
performed.
The “write over” and the “scribbler”.
Non uniform date and signature entry.
Data entries that do not correspond to the batch record
instructions.
Writing a note that activity was performed on one day and
signed for on other day.
Blanks on batch production records.
Pre-recording of data.
Incomplete references.
Review not signed.
Illegible writing.
Too many corrections.
COMMON DOCUMENTATION ERROR
36. HOW TO ACQUIRE GD
PRACTICE ?
FDA statement should drilled into you from day one
„'If you didn't document it, then it didn't happen„‟.
On one hand do the work, On other make the document
Use indelible (water-resistant) blue or black ink
Never use White ink to remove error
Do not use pencil or felt-tipped marker
Never overwrite or Scribbled the entry. Just single cut the error
with sign and date.
Never leave space or blank in the document and Draw a diagonal
line through any blank fields or empty spaces at the bottom of a
page and include 'N/A' along with your initials and date.
37. CONT….
NEVER BACK DATE, NEVER POST DATE AND DATE IN
UNIFORM FORMAT
EACH PAGE IN A CONTROLLED NOTEBOOK
CHRONOLOGICALLY.
WHEN ENTERING REPETITIVE DATA, DO NOT USE DITTO
MARKS.
FOR INSTRUMENT PRINTOUTS, ADHERE WITH
CLEAR ADHESIVE TAPE AND INCLUDE YOUR
SIGNATURE AND DATE WHERE THE PRINTOUT IS ATTACHED.
SIGNATURE LOGS MUST BE
MAINTAINED, INDICATINGEACH EMPLOYEES
• PRINTED NAME, SIGNATURE AND DATE.
WE SHOULD FORGET THE SYNDROME “WE CAN FIX THE
Reference : HQR - 423 - 02 Employee Signature Form
38. BENEFITS OF GOOD
DOCUMENTATION
Unlock the potential of individual using the document
Amplify the value of your product
Build confidence in your quality
Good Documentation helps to save the papers
Reduce the efforts to compliance with regulatory bodies
Good documentation enables to achieve the results that you are
seeking for.