Good Documentation

Practices (GDP)
Prepared By: Michael Adly
Under Supervision : Mr. Girgis Aiad
What are the Definitions ?

• GMP Documentation can be defined as:

Any procedure, instruction, logbook, record, raw data,
manual, or policy associated with the development,
manufacture, testing, marketing, and distribution of a
product required to demonstrate compliance with the GMPs
and other regulatory requirements
• Or more shortly:
A GMP document is any written record associated with the
manufacture, control and distribution of the API or
pharmaceutical product
Why GMP Documentation ?

“If it hasn't been documented, then it hasn't

done or happened!”

“If it is not documented, it is a rumour!”

This is the FDA Inspection Attitude

The product considered as “Adulterated” if

the procedure not followed/ not
documented properly.
Why GMP Documentation ?

Cost for Good

Documentation

Cost for Poor / No

Documentation

Therefore, Documentation Brings Business

Comments at the beginning

• GMP documentation is one critical aspect of our business

and it is a legal requirement too!
• Inspection or audit observations frequently on poor
documentation practices, outdated documents and
inadequate version control,
• Quality can not be assured in a regulated industry
without good documents and good documentation
practices
Keep in mind, after the product is distributed to the
customer, what remains with us is documents.
Comments at the beginning

Why do people sometimes fail to document activities or

events properly?
• People don’t understand the legal requirement of
documentation.
• People do not relate records to auditing.
• People don’t clearly understand what , how or when to
document.
• Procedures may not be completely understood or followed.
• People aren’t always held accountable.
• People will make mistakes.
• People don’t always make corrections properly.
Key Features of Good Documentation

• Careful design of documents should make them easy to read, easy

to understand and easy to complete properly
• Just creating documents is not enough; must follow specific
standards when doing so. Ensure user reads and understand
exactly what it means.
• Master documents must be subject to appropriate controls to
ensure that only one version is current. Such documents must be
approved, signed and dated
• Modifications to master documents must be managed through
change control
• There must be a periodic review of GMP documents to ensure that
they are compliant with current regulatory files and GMP
requirements.
Key Features of Good Documentation

• Original documents should be easily distinguishable from

photocopies, and should have clear and concise information
• Good documents should have sufficient space for entries, to record
variable information and signature and to attach print-outs etc.
• Data entries must be made or completed at the time the action is
performed
• Entries in logbooks should be done in chronological order.
• It is necessary to document anything that directly impacts a
product. Record every procedure you write, form you fill out, and
test you perform.
What should be recorded ?

• All important information that is generated during an

operation or process must be recorded by who performed the
operation and when it was carried out.
• Such information should be legible, accurate, dated, traceable,
and accessible.
“All documentation should be legible, clean, readily identifiable,
retrievable and maintained in facilities that provide a suitable
environment to minimize deterioration or damage and to
prevent loss”
• This information should reflect the complete history of the
manufacture, packaging and control of the product.
Where documentation ?

Documentation during
 Project Design,
 Construction Phase
 Commissioning and start-up
 Qualification and Validations
 Commercial Production,
 Testing and Release,
 Distribution
 Implementation of Quality system
 Regulatory submissions.
 And beyond…………
Types of GMP Documentation

• This Documentation includes, but is not limited to the

following Batch Related Records:
o Master Batch Records (e.g. Processing & Packaging Instructions)
o Batch Records (e.g. Batch manufacturing Records)
o Raw Data Records (charts, chromatograms, etc.)
o Laboratory Records
o Distribution Records
o Standard Operating Procedures (SOPs)
o Specifications and Test Methods
o Records of Raw Materials, Intermediates, Labelling and Packaging
Materials
Types of GMP Documentation

• Non Batch related Records

oQualification and Validation Documents
oChange Control Documentation
oEngineering Drawings
oMaintenance and Calibration Records
oComplaint, Returns and Recalls Records
oEnvironmental Monitoring Records
oUtility Monitoring Records
oLine and Equipment Logs
oPersonnel Training Records
oStability Records
Types of GMP Documentation

Non Batch related Records (continued):

oFailure Investigation and Reporting Records
oCleaning and Sanitization Records
oEntry Records for Controlled Areas
oPest Control Records
oAudit and Regulatory Inspection Reports
oRegulatory Files

Other documentation that must be ensured :

o SOP Annexes
o Computer files
o Process Flow and other Diagrams, pictorial displays (e.g. gowning )
o Technical Reports
o Labels (room and equipment status, sampling, material status)
Purposes of GMP Documentation

• To understand what needs to be done (the

process)
• To understand how to do it (the method)
• To understand why it needs to be done (the
context)
• To understand who must do it (the responsibility)
• To understand when to do it (frequency, close out)
• …. At the end: to ensure that there is an adequate
record of who did what, when, how and why!
Purposes of GMP Documentation

• If you cannot answer all of the questions from the

previous slide, then the documentation (system) has
somehow failed.

• PROCEDURES SHALL BE WRITTEN AND FOLLOWED

• It is a concern if an SOP has not been in place
• But it is a violation of the GMP requirements, if the SOP
is present, but not followed.
Document Retention and Archiving

 Documents relevant to the manufacturing and

analysis of medicinal products (also includes
equipment-related documents, qualification and
validation documentation), must be stored for at
least one year after the expiration date of the
medicinal product.
 Many companies retain the documentation for a
longer period of time in case evidence is required
in a legal dispute. ‫نــع‬
‫زاـ‬
Document Retention and Archiving

 For development products, the document

retention period is at least five years following
completion or cancellation of the last clinical
investigation for which the batch was used.
 It is in the interests of the company to retain
development documents longer than any other
documents to demonstrate a continuous history
of development as the process itself often lasts for
several years.
Document Retention and Archiving

 The US GMP Regulations do not address

the time-frame for retention of records of
development products.
 The premises in which the documentation
is stored must not be accessible to
unauthorized persons and must be
protected against fire or water damage.
Document Retention and Archiving

 If the documents are archived on optical

media or magnetic tapes, they must be
available for the duration of the prescribed
period, this means that suitable readers
must also be archived and data must be
copied over from the media once a specific
running time has elapsed to prevent ageing
effects.
Document Retention and Archiving

 Thermal paper is not suitable for archiving

(not document quality). Relevant
documents must be copied on to normal
paper, and an initialed copy must be
included in the documentation alongside
the original.
Tips to Good Documentation Practices/
Record keeping procedures:

 All entries must be clear and legible

 Never make erasures or write overs.
 Do not scribble out or "white out" entries;
Thus, the integrity of the record will not be in question.
 Any written error must be crossed out in such a manner that the
original information is still legible.
 The crossed out section must be initialed and dated by originator.
Corrections must be made adjacent to the deleted entry. Write reason
for correction eg Transposition, Illegible entry, Scale zero error
 DO NOT USE “write-overs” (Don’t turn a “6” or “9” into an “8”.)
 Never vary your initials or signature
 Eg. Weight of material - 14.5 kg 14.75 kg Ams 13/12/07
Tips to Good Documentation Practices/
Record keeping procedures:

 In order to make subsequent checks of the

documentation easier, it is useful to introduce uniform
abbreviations for specific corrections such as:
-TY typographical error
-TE transfer error
-CE calculation error
-SUP supplementation
Tips to Good Documentation Practices

 When portions of a page or a complete page remain unused, a

single line must be drawn angularly across the unused portion.
Sign and date the crossed out section and provide an explanation
 Eg- Not applicable; Remaining pages not used refer new note
book
 Ensure the pagination (all pages to be numbered; could be page
X of Y for loose sheets and page x.. For bound books)
 Make the required entries on the record as the work is
performed.

Do not record information on a separate

piece of paper /temporary entry and
enter on the record later
Tips to Good Documentation Practices

•Use only black or blue permanent ink. The

ink should not run or smear if the record is
splashed with liquid. All entries must be
permanent and able to be photocopied.
•Don’t use pens like gel pens, ink pens for
making entries. Don’t use pens like red, green
color ink.

• Pencil writing is not acceptable,

due to the high quality of laser printers that

nowadays are frequently standard equipment in
many offices and often print in color, it possible to
use pens like red, green color ink.
Tips to Good Documentation Practices

 Use correct rounding off procedures and significant figures

 When a comment or explanation is required, make all
statements objective. Avoid personal comments and
opinions.
 When dating a signature, use the actual day the signature
was signed.
 If the activity being recorded occurs on more than one day,
the record must clearly indicate where the "break"
occurred. This can be accomplished by drawing a horizontal
line through the procedure at the break" and indicating the
new date or making entries that are initiated and dated
appropriately.
Tips to Good Documentation Practices

• Never sign your name for performance of a job for work

actually performed by someone else.
• When one or more person complete a task, all must sign.
• When spaces or cells do not contain information, EACH
must contain the appropriate “not applicable” entry.
• Spaces and cells cannot be left “blank”!
• Do not use bracket/brace, arrow to link
• Don’t remove any pages or portions from a note book
• Do not change the paper size/quality/colour
• Use polyvinyl alcohol base gum or white glue for pasting of
graphs etc
Tips to Good Documentation Practices

 Data may be attached to the page, however, it must

be firmly attached. Label, sign and date the
attachment.
 If a record becomes messy and extremely difficult to
read or damaged, do not discard. Inform
QA/supervisor and transcribing the data to a clean
record sheet and attaching the original record sheet.
Provide an explanation for the transcription.
 Use clear transparent tape for mending (patch-up).
 Computer print outs taken on thermal paper or easily
fading inks should be photocopied and maintained.
Tips to Good Documentation Practices

• Proper review will prevent the Non-compliances/

observation;
• Sincere and effective review shall be done; not just
signing as reviewer;
• The following shall be reviewed but not limited to;
– Incomplete entries, signature
– missing records and out-prints
– Illegible entries / unacceptable corrections
– Traceability of relevant records /cross references
– Deviations, if any investigation the impact on the product
– Valid calibrations and service intervals of test equipment
– Compliance with specifications,
– Calculations
 Tips to Good Documentation Practices

Clearly Record the Data

What’s that number?

Is it 27? 29? 24? 2%
Hmmmm. What do we do now?
Observations on poor documentation practices

• Document error correction not signed/dated, and didn’t include a

reason for the correction
• Write-overs, multiple line-through and use of "White-out" or other
masking device
• Sample sequence table and audit trail not documented (if its not
documented, it didn’t happen)
• SOP related to production, calibration, storage and maintenance
not authorized by the QA head
• The delegation for the batch release, in case of absence of the QA
manager, not recorded / documented
• Out-of-specification (OOS) procedure not detailed enough; flow
chart and /or check-list not available.
Observations on poor documentation practices

• The records did not contain the complete raw data for all the
laboratory testing performed.
• The periodic calibration of the laboratory instruments was not
documented completely in the laboratory records.
• The records did not include the reason for the modification of a
test method.
• The laboratory records did not include a statement on the identity
of the reference standards used and on the method with which
these were produced.
• The laboratory records did not include the initials or signature of a
second person showing that the original records had been
reviewed for accuracy, completeness, and compliance with
established methods.
Summary and Conclusions
• GMP Documentation is one critical
aspect of our business.
• Documentation must be consistent and
systematic
• Documentation practices must assure
that records meet GMP requirements
• Documentation process must be
controlled to minimize redundancies in
the work flow
• Inspections and audits regularly identify
issues with documentation system.
Summary and Conclusions

• Document management system

needs to be clear and logical
 Use a top down approach (QA must
take the lead!)
 Use flow chart and other tools to
define documentation needs
 Includes all types of documentation
(including electronic)
 Ensure a robust document cycle from
drafting to archiving
• Review and evaluate the
performance of documentation
system.