gdp

1. To
Department of Pharmaceutical Analysis
JSS College of Pharmacy
(Jagadguru Sri Shivarathreeshwara University, Mysuru)
Rocklands, Udhagamandalam- 643001
Tamilnadu, India
SEPTEMBER 2017
Presented
By
Mr. Ramshankar Nayak
I Semester M. Pharmacy Course
Good Documentation Practices
(GDP)

2. INTRODUCTION
What is documentation ?
Documentation is a process which comprises of following
 Recording of data
 Approval of documents
 Issue and disposal of documents
 Retrievability of documents
 Presentation of documents
 Review of documents

3. PURPOSE
The purpose of good documentation practices is to provide basic guideline and standard ways for correction of
errors in documentation
 Record
 Regulatory requirement
 Quality maintenance and improvement
 Control the processes (Resource optimization)
 Evidence of work
 End user requirement
 To improve performance

4. BASIC PRINICIPLES OF DOCUMENTATION
 Check the entries to sort the mistakes in documents.
 Be sure that document is correct and complete prior to forwarding for next process.
 Write each word clearly and legibly.
 Know the procedure for cross-out the wrong word or sentence.
 Never use WHITO/BLANCO.
 Every process must be documented.
 Never trust your memory and record all necessary information immediately.
 The work is not completed until it is documented.
 Don’t use pencil on document.
 Back dating on any document is not allowed.

5. Error
A error always come because of mistaken by person or some problem form
any other side like instrument etc.
Mistake
A mistake made in a document that changes its meaning, such as a
typographical error or the unintentional addition or omission of a word.
Malpractice
Malpractice refers to Negligence or Misconduct by a professional person.

6. GDP Standard-
Document creation
• When electronically produced, the documentation must be Checked for accuracy.
• Must be free from error.
• For some types of data, the documentation must be in a format that permits trend
evaluation.
Document approval
• Approved, signed and data by appropriate authorized person.

7. Document signatures
• All documentation used to provide evidence that standards are 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
• Documents shall be signed in permanent ink.
• Signatures shall be kept throughout the life of the document.
• The local date shell be used to date documents.

8. 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 backup.

9. Document modification
• Handwritten modification are signed and dated.
• Appropriate 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.
• A history must be maintained of changes.

10. CORRECTIONS/ADDITIONS
1. In Record
• Single line through the information that needs to be corrected.
• All correction or additions shall be signed and dated.
• Should not to scribble out the original 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.
• Typographical error change or additions do not require approval.

11. TYPES OF THE DOCUMENTS
Documents
Commitment
Relationship between industry and the regulatory
authorities.
E.g.- NDA,SMF
Directive
Relationship between the management and
employees.
E.g.- specification, STPs, SOPs etc.
Record
Relationship between the Employees and the
work they preform
E.g.- Protocols, BMRs, Log books, Calibration
records etc.

12. COPY OF DOCUMENT
Master Copy
• Original copy
of the document
Controlled Copy
• The copy of the
document from
master copy &
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

13. COMMON DOCUMENTATION ERROR
• Missing signature and dates at the time the activity is preformed.
• “Write over” & “Scribbler”
• Non uniform data and signature entry.
• Writing a note that activity was preformed one day and signed for on other day.
• Blank on batch production records.
• Review not signed.
• Too many correction.

15. Some Guidance Documents
• Schedule M of Drug And Cosmetics Act 1940
• ISO - 9001 : 2014
• US FDA CFR sections
–21 CFR 11, 210 & 211

16. BENEFITS OF GOOD DOCUMENTATION
• Unlock the potential of individual using the document.
• Amplify the value of product.
• Build confidence in quality.
• Reduce the efforts to compliance with regulatory bodies.
• Good document enable to achieve the results.

17. REFERENCE
1. Document creation and change request from. HQR -423-01.
2. http://legal-dictionary.thefreedictionary.com/malpractice
3. Schedule M of Drug And Cosmetics Act 1940
4. ISO - 9001 : 2014
5. US FDA CFR sections
6. https://www.slideshare.net/Hardik_Mistry/good-documentation-practice-14427854