REPORT
PREPARATION
AND
DOCUMENTATION
PRESENTED BY – SINGH DEVENDRA
Table of content
● Introduction on Report
● Report preparation according to GLP
● Points covered in report
● Benefits of report preparation in Pharma industry
● Introduction on Documentation
● Documentation Types
● Good documentation practice
● Principles of GDP
● According to GDP…..
REPORT
● Report is defined as the detailed write up, gives the clear and complete
idea about the features for proposed project.
● After studying the report, one can form an idea, regarding the entire
features of the project. Hence the report should be prepared in a simple
form, comprehensive and understandable, by all non technical officers, in
order to produce a clear picture of the complete project.
● A formal document that presents information clearly and
systematically.Reports provide data, analysis, and recommendations for
decision making.
Report Preparation according to GLP
● The Guidance for the Preparation of GLP Inspection
Reports developed by the Panel on GLP set forth below
suggests elements and/or concepts that can
contribute to a useful report of a GLP inspection and
study audit. It may be used by Member countries as a
component of their compliance monitoring
programme.
Points To Be Covered In Report
1. Test facility 2. Quality
4. Test
organization Assurance 3. Facilities
systems
and personnel programme
5. Test and 6.
7. Study
reference Performance
results
items of the study
Benefits of Report Preparation in
Pharma industry
1. Regulatory Compliance
Comprehensive reports aid in navigating complex regulatory requirements and maintaining
market approval
2. Quality Assurance
Detailed reporting helps ensure the consistency and reliability of pharmaceutical processes and
products.
3. Innovation and R&D
Effective reporting supports the continuous improvement and development of new
pharmaceutical solution.
DOCUMENTATION
Documentation is any communicable material that is used to describe,
explain or instruct regarding some attributes of an object, system or
procedure, such as its parts, assembly, installation, maintenance and
use.
Documentation provides both,
1. Information on when, where, who, why & how to complete tasks
2. Evidence providing that the tasks have been completed.
DOCUMENTATION TYPE
Handwritten Documentation
Electronic Data Capture
Entry Into Electronic System
Copying Raw Data
Transcription of Paper Records To Computer Database
GOOD DOCUMENTATION PRACTISE
● Good Documentation Practice (GDP) is a set of guidelines and
procedures established to create, review, approve, distribute and
maintain documentation within regulated industries such as
pharmaceuticals, healthcare and manufacturing. The guidelines for
GDP were created to address the specific documentation
requirement within Good Laboratory Practice (GLP).
Principles of GDP
1. Legibility: All documentation should be clear, concise, easily readable and understood by
others.
2. Traceability: Each document should contain enough information the study, phase and
personnel involved.
3. Accuracy: All, recorded data should be true and reflect exactly what was observed or
performed.
4. Completeness: Documents should provide a comprehensive record of the study activities
including any deviations or unexpected events without any exclusions.
5. Timeliness: Documentation should be completed promptly to ensure that observations,
results and other important information are recorded in a timely manner.
6. Archiving: Documents should be organized and stored safely to enable easy retrieval and
long term preservation in a controlled and secured environment
According to GDP
● A document with original signatures should never be destroyed.
● Never falsify information
● Never do white-out and cover-over-tapes
● Never obliterate information or record
● Never over-write a record.
● Never use pencil - use permanent ink for writing
● No spaces, lines or fields are to be left blank
● Never use symbols e.g ditto marks or arrows to indicate repetitive and
consecutive entry
REFERENCES
● https://public-library.safetyculture.io/products/good-laboratory-practice-glp-rep
ort-template
● https://proto.ufsc.br/files/2012/03/glp_trainee_green.pdf
● https://biobide.com/good-laboratory-practice-guide
● https://dst.gov.in/sites/default/files/No9.pdf
● https: //ntp.niehs.nih.gov/sites/default/files/iccvam/suppdocs/feddo
cs/oecd/oecd_glpcm.pdf
● https://dst.gov.in/sites/default/files/No2.pdf
● https://www.oecd.org/en/publications/guidance-for-the- preparation-of-glp-
inspection-reports
THANK
YOU….
