By Mr.

Vikram Joshi
vikram.joshi@ranbaxy.com
“ Quality is never an accident, it is
the result of high intention, sincere
effort, intelligent direction and
skillful execution. It represents the
wisest of many alternatives”.
DOCUMENTS: -
 As discrete packages of recorded information
are the tools of quality assurance.
 Used to establish standard specification and
processes that assures compliance with
standard specifications and processes
 Quality can not be assured in a regulated
industry without good documents and good
documentation practices
 A document system is an interdependent,
interrelated set of documents, each with a
defined purpose and a consistent format.
 Documentation is a process that involves the
systematic interaction of people, events and
documents to create the records of the
organization / corporation.
 PURPOSE OF DOCUMENT
SYSTEM
 “Each manufacturer shall establish effective
quality system, instructions and procedures in
accordance with the requirements of this part
and maintain the established quality system
instructions and procedures effectively.
 No matter what type of product is developed
and produced, it must be safe, effective and fit
for its intended use.
 Quality characteristics are established in
documents.
 Documents declare product standards and
describe how to monitor, test and judge for
compliance with these standards.
 BASIC REQUIREMENTS FOR
ASSURING THE QUALITY
 Establish the quality.
 Determine which attributes of the resources,
process or product are critical to product
use or performance.
 Chose quality parameters and test methods
that are scientifically rigorous and then
document them
 Maintain the Quality / Monitor the quality
Established quality system parameters to be
met routinely and asssure control is
effective
 BASIC REQUIREMENTS FOR
ASSURING THE QUALITY
Manage Charge:
 Recording the change and providing
appropriate rationale in writing for that
change
Evidence:
 Have written evidence of the established
quality standards, of the maintenance and
monitoring programs, of the monitoring
data and of any changes that occur
 DOCUMENT SYSTEM BASICS
 A document system is an interacting set of
documents, each with a defined purpose and
consistent document.
 The documents can:
 Assure that quality standards are
consistently met
 Communicate these standards to all who
interact with product
 Interact in a manner that reduce redundancy
and increase the flexibility of the system
when changes occur
 A DOCUMENT SYSTEM OF
YOUR OWN
 The types of documents, number of documents
and the level of detail in documents will vary
from company to company depending on the
following:
 The type of product (its classification of risk)
 The unique nature of the product, the product
delivery system or the manufacturing process
 The size of the company
 The education and training of the employees
 How much the company does (Develops,
manufactures, packages, distributes products)
 Keep the expectations in corporate documents
simple and relevant, make them your own
 What is Documentation ?
To Document each Activity you perform

No, Documentation is a Process, Which comprises

of Following :
- Recording of Data
- Review of Documents
- Approval of Documents
- Issuance and Disposal of Documents
- Retrievability of Documents
- Presentation of Documents
 What is Documentation
 The information provided by a creator which provides
enough information to establish basis, history and context
and to enable its use by others.
 It needs to be sufficiently detailed to allow the data creator to
use the material in the future, when the data creation process
has started to fade from memory.
 It also needs to be comprehensive enough to enable others
to explore the resource fully, and detailed enough to allow
someone who has not been involved in the data creation
process to understand the data collection and the process by
which it was created."
Good Documentation Practices
 Just creating documents is not enough; you must follow
specific standards when doing so. Following established
practices allows everyone who reads your documentation to
understand exactly what you mean.
 Key documents with the potential to impact product quality
must be retained to provide a traceable, historical record of
all activities. Documentation must be readily retrievable in
order to meet requirements associated with product
investigations, periodic product review, or formal audits
 It is necessary to document anything that directly impacts a
product. Record every procedure you write, form you fill out,
and test you perform. Using a standard format eliminates
discrepancies between documents from different sources.
 ESSENTIAL CHARACTERISTICS
To design an effective & efficient documentation process first
identify the important characteristics of processing event.
 The document directing the manufacturing event fulfills
current regulatory commitments to the agency; it is
appropriately written, reviewed and approved
 The directive document is appropriate for the task to be
performed
 The data is authentic; the individual responsible for
performing the work has entered the data on an
appropriate data collection document
 The data is accurate
 The data is complete. There is no missing information,
and there is no work as yet uncompleted that will impact
the occurrence of the data presented.
 ESSENTIAL CHARACTERISTICS
 The data is legible, consistently recorded and
trustworthy
 The data collected fulfills expectations (specifications)
 The data is accessible to those who need to review it,
audit it or use it to perform trending analysis.
 The original data and the original documents
(manufacturing record) is retrievable for review or audit
 The original manufacturing record is secure

Proper control of documentation also requires that

responsibility for each processing step to be assigned

“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”
 DOCUMENTATION LIFE CYCLE
 Document creation, Review Approval: -
Authorized document review and approval signatures
are responsible for directing the manufacturing, the
security, original, approved documents is the
responsibility of QA.
 Document use & Data collection: -
Responsibility of all technicians, engineers, scientists,
operating persons who are trained and authorized to
collect and record data
 Data Verification: -
Responsibility of suppervisors, managers and all
individuals trained & authorized to review data
 Record Review & Product disposition / Approval: -
Responsibility of QA or those trained & authorized to
review records
 DOCUMENTATION LIFE CYCLE
 Record Achieving:-
Records are Accessible, Retrievable, Secure is the
responsibility of QA & relevant departments

 Record Destruction: -
As per SOPs that directs the destruction of documents

Every signature associated with documents review &

approval, data collection and record review and approval
should add value to the document. Every one who signs
a document or a record should know what their
signature means. Only those individuals trained and
authorized to sign documents should sign them.
 Why Documentation
 There is a saying in the pharmaceutical
industry: 'if it hasn't been documented, then
it hasn't happened!'
 Good documentation practice constitutes an
essential part of the QA system.
 Documentation system must be proactive
vehicle of communication.

Your documentation is an advertisement for

your work.
 WHY DOCUMENTATION ?

Cost for Good

Documentation

Cost for Poor/No

Documentation

THEREFORE, DOCUMENTATION BRINGS BUSINESS

 Here are some selected GDP
references from 21CFR58:
 All data generated during the conduct of a
study, except those that are generated by
automated data collection systems, shall be
recorded directly, promptly, and legibly in ink.
 All data entries shall be dated on the date of
entry and signed or initialed by the person
entering the data.
 Any change in entries shall be made so as not
to obscure the original entry, shall indicate the
reason for such change, and shall be dated
and signed or identified at the time of the
change.
 WHERE DOCUMENTATION ?
 Documentation during Project Design,
 Documentation during Construction Phase,
 Documentation during Commissioning and
start-up,
 Documentation during Qualification and
Validations
 Documentation during Commercial
Production,
 Documentation during Testing and Release,
 Documentation for Regulatory submissions.
 Documentation beyond………...
 Types of Documents

There are three types of Documents

 Commitment Documents : Relationship

between industry and the regulatory
authorities
 Directive Documents : Relationship
between the Management and Employees
 Record Documents : Relationship
between the Employees and the Work
they perform
 Some Examples are :
 Commitment Documents : New Drug
Applications (NDAs), Drug Master Files
(DMFs) etc.
 Directive Documents : Specifications,
STPs, SOPs, MPRs etc.
 Record Documents : Protocols, BPRs, Log
Books, Calibration Records etc.
 DIRECTIVE DOCUMENTS
 Working documents that establish the standards for
resources, processing, products & quality system
 Describe how to do it……???
 Describe how to do routine work
 Several types of directive documents
 The different types are determined by the specific,
functional purpose of the document in the document
system
 In order to facilitate the development, production,
testing and distribution of a product in a defined
manner
 Reviewed and approved by both management and the
individuals responsible for performing the work
 COMMITMENT DOCUMENTS
 Presents corporate goals, expectations and
standard of practice
 Describes what to do
 Consensus of purpose, direction and
authorization for projects
 Organize the work in a manner that assures
efficient and effective work flow
 Commitments documents can also be written to
establish internal commitments.
 These documents such as master plans;
organize and prioritize the work in a manner that
supports good business practice as well as
regulatory compliance
 COMMITMENT DOCUMENTS
 Written to lead and guide the work and
workers
 To be used as active documents that are
consulted and followed routinely
 Content must be consistent and rigorous in
order to lead and guide the work and the
workers
 Must describe the work as it will be done
 Deviations from regulatory submissions can
have signification impact on product quality
 Any deviation must be documented and
managed
 What Good Documentation
requires :
 APPROVAL - this applies particularly to
work instructions, procedures, manufacturing
formulae and specifications.
 Approval should be by the relevant technical,
management and quality personnel, to
ensure that documents comply with the
principles of GMP and the specific product
marketing and manufacturing authorisations
 What Good Documentation
requires :
 CLARITY - they should not be open to
misinterpretation by the users. They should
be written in a way that makes them easy to
check, particularly when they will form part
of a product manufacturing history.

 Good documentation design will help to

minimize errors
 What Good Documentation
requires :
 REGULAR REVIEW AND UPDATE -
documents must be kept up-to-date with
changes in regulations or processes and
should be distributed in a controlled manner
to ensure that only the most recent versions
are available for use. They must also be
available to those who need them, where
they need them!
 What Good Documentation
requires :

 FORMAL PRESENTATION - controlled

documents should be prepared in accordance
with a written procedure, now a days
probably using a computerised
documentation control system.
 What Good Documentation
requires :
 Records should be made at the time of
each action - do not rely on memory for their
completion.
 Records relating to manufacturing or testing
operations should be kept for at least one
year after their expiry.
 What Good Documentation
requires :

 If documents or data are stored

electronically, the computer system must be
validated to assure data security and
integrity.
 Provisions must also be made to retrieve the
stored data, possibly years after they have
been generated:
Strengths of Good Documentation

 Clear Objective of the document

 Clarity of Scope
 Who should prepare ? Should know ?
 Layout of the document in mind
 Put pieces together
 Explain the activity performed logically
 Use short, simple, easy to understand
sentences
Strengths of Good Documentation
 Maintain flow of script
 Match script to the sequence of events of
the activity
 Use correct data format
 Meaningful data will give meaningful
information
 Draw neat and correct inference
 Conclusion & Summary
Get your document edited by an expert
What are our Major Documents
 CCIFs
 Failure Investigation & Reports
 Planned & Unplanned Deviation Reports
 Filling of BPRs
 APRs
 Validation Protocols & Reports
 Raw Data & proper Recording
 Log Sheets
 Sketches - Diagrams - P&Ids – Schematics
 Plant Development Reports
 Engineering Documents
 CCIFs
 Incomplete Forms / columns
 Justification for change not in line with the
changes proposed.
 Attachments accompanying the CCIF :
 Not attached in sequence
 Total no. of pages not mentioned
 All annexures not referenced on the CCIF
 Annexures do not have reference of CCIF
 Unsigned annexures
 Items which are not required are left blank
(“Not required” to be entered)
 OOS
 Many OOS Results unreported, therefore
no investigations
 Investigations not thoroughly performed
 Investigation should lead to assignable
reason, at least probable reasons
 Report should include back-up notes on
points covered during investigation
 Follow SOP on Investigation of OOS
result(s)
 Filling of BPR
 Missing signatures & dates
 Over-writing without correction, sign,
date
 No remarks for correction
 Control Number not recorded correctly
 Time/Date and PC Number recorded in
BPR not matching with in-process
production Log Books

BPRs are the first major Exhibits reviewed by FDA

 DOCUMENTATION: PROCESSING
& CONTROL

The documentation process defines the

relationship between the corporation and
regulatory authorities. (Commitment
Documents)
 Corporate management and the workers
(Directive Documents)
 The workers and the work that they perform
 The record of the events directed in directive
documents is evidence
 Records can be used as evidence against a
company by FDA- in court
 DOCUMENTATION: PROCESSING
& CONTROL
 Evidence can be used by a company to
defend it self in court
 The quality of the documents can be directly
and adversely affected by the quality of the
document processing procedures that directs
 creation, review, approval, distribution,
change and archiving of documents
 Every person must be trained to complete
documents properly; improper use of the
documents can lead to inaccurate, inadequate
or incomplete documents
The Resources and raw materials of
the documentation processes are as
follows:-
– Directive documents that provide instructions
– Data collection documents that provide a format for data
collection
– Data or information observed or collected from
processing events
– Operating personals or scientists who have been trained
to follow instruction and collect data
– Quality of these resources and materials must be
assured
– These resources / raw materials interact in a systematic
manner
– Data is collected according to an established process
The Resources and raw materials of
the documentation processes are as
follows:-
– To produce the final product data document
– Quality of interaction of these resources that can have
the greatest impact on the quality of final
documentation
– Proper design and control of this documentation
process is essential
– Many things that can go wrong, when moving
hundreds of documents through the documentation
process
– Process controls are added to assure the integrity and
reliability of the documentation process
21 CFR 211.188 (a) Controlled, Documented
issue of production
batch records.

21 CFR 211.194 (a) Verification of laboratory

test data for “Accuracy,
Completeness compliance
with established standards”

Controls are either industry standard or

corporate –based controls that help
assure efficient and effective
processing.
 DOCUMENT PROCESSING
PROCEDURES TO BE SURVEYED

 Why are delays occurring?

 Is there redundancy in the system?
Do records disappear?
 Are documents inconsistently completed?
 Has the product been released with records
missing?
Note:- More Control does not necessarily lead
to greater order or more security.
 Following is a list of concerns when
designing documented processing
control: -
 When documents or records are transferred from
one department to another or from one building
to another the transfer should be recorded
 When documents or records are waiting to be
processed, they should always be stored in
designated location. Apply the same principles
to the security of documents during review
process
 Critical processing steps should be checked
include document issue, data collection,
document review. More review signatures on a
document does not necessarily result in a more
through review
 Records must always be completely
identified and this identity should be
consistent and easily available.
 Every page of every document should be
consistently labeled with the document
identification number/ code, the document
revision number/code, the product
identification number / code and product lot
number.
 Every signature associated with document
review and approval should add value to the
document
 Every one who signs a document or record
should know what their signatures means
 Only those individuals trained and
authorized to sign documents should sign
them
 It remains a challenge in normal systems to
know who is trained and authorized to sign
what document

Note: - This is a fundamental quality

assurance requirement for the processing of
documents

 Databases should be qualified or validated

 There should be procedure in place to direct
the data entry process
 Here are some selected GDP
references from 21CFR211:
 To assure uniformity from batch to batch, master production and
control records for each drug product, including each batch size
thereof, shall be prepared, dated, and signed (full signature,
handwritten) by one person and independently checked, dated,
and signed by a second person.
 An accurate reproduction of the appropriate master production
or control record, checked for accuracy, dated, and signed;
 The initials or signature of the person who performs each test
and the date (s) the tests were performed... The initials or
signature of a second person showing that the original records
have been reviewed for accuracy, completeness, and
compliance with established standards... Complete records shall
be maintained of any modification of an established method
employed in testing. Such records shall include the reason for
the modification and data to verify that the modification produced
results that are at least as accurate and reliable for the material
being tested as the established method.
Example of typical guidelines found in
Good Documentation
Practices/Recordkeeping procedures:
 All entries must be clear and legible
 Never make erasures or writeovers. Any written error must be
crossed out in such a manner that the original information is still
legible. Do not scribble out or "white
out" entries. Thus, the integrity of the record will not be in
question.
 The crossed out section must be initialed and dated by
originator. Corrections must be made adjacent to the deleted
entry.
 Data may be attached to the page, however, it must be firmly
attached. Label, sign and date the attachment. The location of
the attachment in the record is indicated with "bridging".
Approved methods of bridging are cross hatching or signing
across the edge of the attachment and page.
 Example of typical guidelines found in
Good Documentation
Practices/Recordkeeping procedures:
 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 when necessary.
This is not applicable to blank portions on preprinted documents such
as MBRs.
 Use only black or blue permanent ink. The ink should not run or smear
if the record is splashed with liquid. Pencil is not acceptable, since all
entries must be permanent and able to be photocopied.
 Make the required entries on the record as the work is performed. Do
not record information on a separate piece of paper and enter on the
record later
 All planned and unplanned deviations from the approved production
procedure or testing/inspection plan as described in GMP controlled
documentation must be documented using a Discrepancy Report. The
DR# should be indicated in the record at the location of the change.
Example of typical guidelines found in
Good Documentation
Practices/Recordkeeping procedures:

 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.
 If a record becomes messy and extremely difficult to read, do
not discard. Consult supervisor prior to transcribing the data to
a clean record sheet and attaching the original record sheet.
Provide an explanation for the transcription.
 SUMMARY

 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
 Tips of Good Documentation
 Each entry in the record shall be legible (readable)
and be written in blue ink.
 Never use Pencil, Correction Fluid, Eraser etc.
 No page or column shall remain blank/ unfilled. NA
shall be entered.
 All records/documents are maintained in a
presentable manner.
 Tips of Good Documentation
Errors in manual entries in various documents shall
be rectified in blue ink as follows : Wrongly mentioned
as 000.
001 08.09.2004
MPR Firmed up on the basis of Dev. 000 MPR effective
01.07.2004.

Draft MPR attached as Annexure – I.

.
 Learnings.
 Good Documentation Practices should be
everyone’s concern.
 Foundation of a sound documentation
system begins with the engineering
documents as well as their management.
 Engineering is the provider
 Production is the customer
 QA is the gatekeeper.
 Validation is the hold-up and
 Everyone just wants to pass the
baton.
 Learning
 “More the better” is not the right dogma
 More entries we make, the greater
the opportunity for error.
 But, if we reduce the documentation,
we may omit critical and vital data.
 Any activity becomes creative, if the Doer
cares about doing it right or better.
 Each Activity is a “forward Certification” if
performed with proper perspective and
documented in a right way.
 Always to remember

 Truly, documentation is our Business, and

to remain profitable, we should forget the
syndrome “We can fix the documentation
later .......”.
Thanks