7-Documentation

• After completing this

lecture, the students ...
1. Know the concept of
documentation.
2. Understand different guidelines for
good documentation.
3. Differentiate between quality
manual and policies.
4. Understand each step of GMP to
achieve documentation.
5. Realize the elements to be covered
in mistakes correction.
A Famous Proverb says:
“IF YOU HAVE NOT
DOCUMENTED AN ACTIVITY,
YOU HAVE NOT DONE IT”
• “ 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.”
• Clearly written documentation prevents
errors that may arise in oral or casually
written communication.
• It provides assurance that quality related
activities are carried out exactly the way they
have been planned and approved
Purpose of documentation
• To ensure that there are specifications for all
materials and methods of manufacture
• Employees know what to do
• Responsibilities and authorities are identified
• Ensure that authorized persons have all
information necessary for release
• Provide audit trail
• Forms the basis for improvement.
Principle of documentation
• It shall be able to record executed activities for
maintenance, storage, quality control, distribution
and other specific matters.
• For all manufacturing activities, a documentation
system must be prepared.
• The system consisting of manufacturing formulae and
instructions, specifications, procedures and records
must be free from errors and clearly established.
• A document bearing original signatures should
never be destroyed.
• Never falsify information
• Never you a White-out and cover-over-tapes
 Properties of documentation system
• Able to record the complete history of batch.
• Adequate to permit investigation.
• Documents shall contain all information, to be
kept up to date and any amendment shall be
performed by following proper document
change control procedure.
• It shall include provision for periodic review.
• Product related records shall be retained for at
least one year after the expiry date of the
finished product.
Reasons for Documentation
• If an instruction or record is poorly documented, then
the manufacturer or Quality assurance/control of a
product can be negatively impacted, potentially
reducing patient safety.
• Consequently, the standards of documentation within a
company can directly impact the level of success in
manufacturing quality products that are safe as well as
success during audit situations.
• Ensures documented evidence, traceability, provide
records and audit trails for investigation
• Ensures availability of data for validation, review and
statistical analysis.
Electronic Data
• Data may be recorded by electronic systems,
photographic or other reliable means.
• There shall be detailed procedure (e.g. SOP) relating to
the system in use.
• Be checked and verified for accuracy of the records
• Be authorized personnel to enter or modify data in the
computer.
• Be a record of changes and deletions
• Be traceability to all raw data
• Be restricted by passwords or other means for access
• Be independently checked and verified for the result
of entry of critical data.
• Be protection and back-up for all batch records.
Types of documents
• Quality manual
• Policies
• Standard operating procedures (SOPs)
• Batch records
• Test methods
• Specifications
• Logbooks
• Narrative
• Flowchart
• A global company document that describes, in
paragraph form, regulations or that the company
is required to follow.
• Documents that describe in general terms, and
not with step-by-step instructions, how specific
GMP aspects (such as security, documentation,
health, and responsibilities) will be implemented.
Batch records
• These documents are typically used and
completed by the manufacturing department.
• Batch records provide step-by-step instructions
for production-related tasks and activities,
besides including areas on the batch record itself
for documenting such tasks.
Test methods
• These documents are typically used and
completed by the quality control (QC)
department.
• Test methods provide step-by-step instructions
for testing supplies, materials, products, and
other production-related tasks and activities,
e.g., environmental monitoring of the GMP
facility.
• Test methods typically contain forms that have
to be filled in at the end of the procedure.
Specifications
• Documents that list the requirements that a
supply, material, or product must meet before
being released for use or sale.
• The QC department will compare their test
results to specifications to determine if they
pass the test.
• Bound collection of forms
used to document activities.
• Logbooks are used for
documenting the operation,
maintenance, and
calibration of equipment
and to record critical
activities, e.g., monitoring
of clean rooms, solution
preparation, recording of
deviation, change controls
and its corrective action
assignment.
Narrative document
• The most common format being used
• The narrative document can be described as the
following:
Ø Policy reference
Ø Objective : why and for what
Ø Coverage area
Ø Document reference
Ø Responsible person
Ø Detail procedure
Ø Record if needed
Flowchart document
• Schematic representation which describe the
flow of processes in certain target activity.
• Very clear and easy to understand.
• For complicated process, sometimes flowchart
alone might not be able to capture detailed
information, therefore it should be combined
with a narrative.
Requirements for Good documentation
 Approve, review & update documents
 Change & current revision status of document
 Relevant versions of applicable documents
 Document remain legible and readily identifiable
 Documents of external origin identified
 Prevent unintended use of obsolete documents.
Constitutes of Documentation
 Clearly Written documentation
 All documents must be accurate & written in a manner
that prevents errors and ensure consistency.
 Using indelible ink: Don’t use pencil or ink that can be
erased
 Legible hand written entries
 Reviewing & approving
 Staff Signatures: Hand written Signature must be
unique to the individual and listed within the site
signature register to ensure that signature is traceable
to a member of staff.
 Page Numbering
Correction of mistakes
• Make a single line through the error
• never use correction fluid, multiple cross or
marker pen to obscure the original record.
• Provide a brief comment why the change is
required.
• Initial the change so that it is clear that the
correction is deliberate.
• Record the date of the correction next to the
initials so that there is a record of when the
change was made.
Common Documentation Errors
 Missing signature and dates at the time of
activity performed.
 The write-over
 Non-uniform date and signature entry
 Writing a note that activity was performed on
one day and signed for on other day.
 Blank spaces
 Illegible writing
 Too many corrections