Compliance4All:- Good Documentation Practices (GDP) is a quintessential part of regulated manufacturing and laboratory environments. GDP has to be adhered to in the regulated industries because it is the only truly authentic method of ensuring that documents are audited and accounted for.

1. Good Documentation
Practices in manufacturing
and
laboratory environments.

3. *Good Documentation Practices (GDP) is a quintessential
part of regulated manufacturing and laboratory
environments. GDP has to be adhered to in the regulated
industries because it is the only truly authentic method of
ensuring that documents are audited and accounted for.
*GDP is also essential to keep track of and maintain control
at all stages of the process and the product. GDP is thus a
core requirement of a thoroughly developed Quality
System.

5. Basis for GDP in USP:

6. *GDP for USP is also formulated on the same principle
and rationale on which any GDP is built: proper,
accurate and comprehensive records are the backbone
to proper documentation, which is the basis for all
major and minor procedures and operation.
*GDP for USP has guidelines in the General Chapter
1029. These guidelines are given with the intention of
helping build a foundation for the Quality Systems,
apart from also ensuring the integrity and control of
documents.

7. These GDP's are meant for use in the production and control of
the following:
*Active pharmaceutical ingredients (APIs)
*Medical devices
*Excipients
*Pharmaceutical products
*Dietary supplements
*Food ingredients
The General Chapter explains the justification for putting in place
Good Documentation Practices in USP and helps the user evaluate
and construct GMP activities.

8. In what areas are GDP's listed out
in Chapter 1029?

9. GDP's for USP are mentioned in relation to electronic and paper
records, which include reports, raw data, protocol, and
procedures concerning analytical data and manufacturing
controls, and has recommendations on the kind of information
that should be recorded for different kinds of documents that
require GMP.
A prominent amendment brought into the new chapter 1029 is
that there is no longer a distinction between instructions and
records, and all records and instructions are broadly merged into
"records".

10. Some broad requirements of
GDP as set out in Chapter 1029

11. USP Good Documentation Practices spell out a number of
principles. Some of these include:
There should be clarity, accuracy, conciseness and legality of
records
Every time an action is performed, there should be a
documentation
Anyone dealing with documents should not backdate or postdate
any action
The initial of the person who carried out a change should attest
her initials and offer an explanation whenever an amendment is
made

12. Electronic or manual records should go by the following GDP's:
*Any data entry should be traced back to the person who did the
entry
*Shorthand notations are not allowed
*Controls should be put in place to ensure integrity of the record
*When a thermal paper is used, a verified copy of its accuracy
should be retained, and the user should initial it with the date.