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INTRODUCTION
Documentation is a set of documents provided on paper, or online, or on digital or analog media, such
as audio tape or CDs. Examples are user guides, white papers, on-line help, quick-reference guides. It is
becoming less common to see paper (hard-copy) documentation. Documentation is distributed via websites,
software products, and other on-line applications. Documentation is a method of preparing a written
material, which describes the process in terms of specifications ,instructions etc
Document is a piece of written, printed or electronic matter that provides information or evidence. A Good
Documentation is essential part of QA system . Documentation is an important aspect in pharmaceutical
industry irrespective of the fact the manufacturing plant is involved in production of dosage form (or) active
ingredient
Importance of documentation :-
It provides the working details necessary for manufacturing, packaging, quality control. Reduce the risk of
mistakes inherent in verbal communication. They help in decreasing the batch to batch variation so that
quality of product is kept with in the limit of acceptability. Documentation and records are essentials for
obtaining ACCREDIATION ,certification of ISO, and approval by Federal bodies.
Aim of documentationS :-
To define the specifications for all materials To define the methods of manufacture and control. To instruct
the personnel To provide information during investigation To helps in inspection or auditing by Regulatory
authorities
To design an effective & efficient documentation :-
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, accurate,
complete, legible, accessible. • The data collected fulfills expectations (specifications) and is retrievable for
review or audit.
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“All documentationshould be legible, clean, readilyidentifiable, retrievable and maintained in facilities that provide a su itable
environment to minimize deterioration or damage and to prevent loss”.
Specifications:-
A document specification contains several parts: a description of the audience(s) for the document a
detailed outline giving the structure and contents of the document a work plan showing who is responsible
for each part of the document what the deadlines are for completing each task.
Three purposes for document specifications:
In the workplace, formal document specifications serve three important functions:
1. Economy of effort,
2. Work planning,
3. Writing organization.
What Good Documentation requires:-
1. APPROVAL
2. CLARITY
3. REGULAR REVIEW AND UPDATE
4. FORMAL PRESENTATION
PROTOCOL FOR DOCUMENTATION
1. Serial number of the Batch Manufacturing Record.
2. Name of the product.
3. Batch/Lot number.
4. Batch/Lot size.
5. Date of commencement of manufacture and date of completion of manufacture.
6. Date of each step in manufacturing.
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7. Names of all ingredients with the grade given by the quality control department.
8. Quality of all ingredients.
General requirements:-
Each document should have:
1. Have a clear title
2. Have an identification number
3. Be approved by authorized person
4. have the date of issue
5. document should not be hand written
6. Records should be retained at least one year
7. after the expiry date of the finished product
Designing of documents involves the following factors :-
1. Size of the paper
2. Color of the paper
3. All four sides margin must be define generally 25mm from left and 15 mm all sides All documents
must match the requirement
4. All documents must bear the name of the company and logo, if applicable
5. All documents must be approved, authorised, signed and dated by the authorized person.
6. Title and contents of the documents must be self explanatory.
Guidelines for labels :-
Label of finished product contains,
1. Name of the drug product
2. List of the active ingredients,
3. Net contents
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4. Batch number
5. Expiry date
6. Storage conditions
7. Name and address of the manufacturer
Standard Operating Procedures (SOPs):-
Standard Operating Procedures (SOPs) are issued to specifically instruct employees in areas of
responsibility, work instructions, appropriate specifications and required records A Standard Operating
Procedure (SOP) is a set of written instructions that document a routine or repetitive activity followed by an
organization.
Document :-
Documents is information (meaningful data) and its supporting medium, in form of paper, CD, Computer
file, microfilm, x-Ray film etc. Documents provides information or evidence or may serve as an official
record.
Record :-
Records is a document stating results achieved or provide evidence of activities performed.
GOOD DOCUMENTATIONs PRACTICE :-
Good documentation practice (commonly abbreviated GDP, recommended to abbreviate as GDocP to
distinguish from "good distribution practice" also abbreviated GDP) is a term in the pharmaceutical and
medical device industries to describe standards by which documents are created and maintained. While
some GDP / GDocP standards are codified by various competent authorities, others are not but are
considered cGMP (with emphasis on the "c", or "current"). Some competent authorities release or
adopt guidelines, and they may include non-codified GDP / GDocP expectations. While not law, authorities
will inspect against these guidelines and cGMP expectations in addition to the legal requirements and make
comments or observations if departures are seen. In the past years, the application of GDocP is also
expanding to cosmetic industry, excipient and ingredient manufacturers.
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GMP Guidelines :-
GMP guidelines specify certain documents to be maintained necessarily:
1. Labels
2. Specifications and testing procedures
3. Records
4. SOPs
NEED OF DOCUMENTATIONS :-
Documentation plays a crucial role in any treatment setting. Documentation helps assure continuity of care.
There are many important moments in treatment. Proper documentation can help the practitioner to recall
those moments. Behaviors and emotions can help tell a story; being able to discover patterns can help to
uncover reasons for certain behavior. Documentation is a very simple tool to help any practitioner is
unveiling patterns. It can help track the progress in addressing thought patterns and unhealthy behaviors. If a
practitioner isn’t utilizing the tool of documentation it would prove to be very difficult to make continual
progress on any one area, let alone multiple areas.
Any professional is always looking for ways to improve, or a better approach, a more successful course of
treatment, or fresh ideas to tackle ongoing problems. Documentation is crucial in achieving these measures.
Documentation is a great tool in protecting against lawsuits and complaints. Documentation help ensure
consent and expectations. It helps to tell the narrative for decisions made, and how yourself or the client
responded to different situations.
TYPES OF DOCUMENTATIONS :-
There are two types of documentations :-
1. DOCUMENTS :-
In general, a document (noun) is a record or the capturing of some event or thing so that the
information will not be lost. A document is a form of information . A document can be put into an
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electronic form and stored in a computer as one or more files. Often a single document becomes a
single file.
2. RECORDS :-
Various documents maintained in production department are Raw material records
Record (computer science), a data structure
Record, or row (database), a set of fields in a database related to one entity
Boot sector or boot record, record used to start an operating system
Storage record, a basic input/output structure
TYPES OF RECORDS USED :-
Master formula records
Batch production records
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Quality control records
Calibration records to instrument
Records for stability studies
Specifications and testing procedures :-
In case of pharmaceutical products we need
1. specifications for Active and inactive starting material
2. Primary, printed and other packaging materials
3. Intermediate and bulk products
4. Finished pharmaceutical products
WHAT CONSTITUETS GOOD DOCUMENTATION PRACTICE :-
Clearly Written documentation:
Using indelible ink
Legible hand written entries
Reviewing & approving
Staff Signatures
Page Numbering
Concise
Traceable
Contemporaneous
Enduring
Accessible
DIGITAL DOCUMENTATIONS :-
In earlier days, manual typewriters were used for typing a document, which was replaced by electronic
typewriter and now a computer is used for this purpose. Word processing, data processing,
communication and presentation are the most common activities performed in an office. Office
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productivity software is used to perform these activities effectively. A document is a paper with written
contents and the process of preparing a document is called documentation. Documentation is required
to preserve the contents for a longer period or to be used as evidence. The documents can be letters,
reports, thesis, manuscripts, legal documents, books, etc. A handwritten document can have certain
disadvantages like understanding the specific handwriting. With the advancement in computer
hardware and software technology, the process of handwritten documentation consequently automated
to computer word processing.
A data entry operator should possess the skills to use the office productivity tools with a good typing
speed. Although typing skill is the essential criteria for Unit 3.indd 45 9/11/2018 5:20:40 PM 46
Domestic Data Entry Operator – Class IX data entry operator, a little care has to be taken while using
the word processing software. A typist used to hit the space bar a number of times to arrange the text.
This is not required in the computer, as the automated features for editing and formatting are available.
Word processing is the use of computer software to enter, edit, format, store, retrieve and print the
document. The document can be a letter, notice, report, business correspondence, etc.
Amendments :- Making a Legible Correction.
Make a single line through the error-never use correction fluid, multiple cross- markerpen to obscure
the original record.
1. Provide a brief comment why the change is required(as appropriate)
2. Initial the change so that it is clear that the correction is deliberate.
3. Record the date of the correction next to the initials so that there is a record of when the change
was made.
Important: Backdatingofentries is not permitted
COMMON DOCUMENTATIONS ERRORS :-
Entries Not Dated or Identified
Obliterated Entries
Entries Not Signed, or Signed or Countersigned without Having Been Read
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Entries for Care Performed without Signature
Illegible Records
Lots of Blank Spaces on the Page Failure to Document Patient Noncompliance
Charting Only the Abnormal
Principles of Good Documentation Practice :-
A document bearing original signatures should never be destroyed.
Never falsify information.
Never you a White-out and cover-over-tapes.
Never obliterate information or record.
Never over-write a record.
Never use pencil – all information should be completed in permanent Black or Blue ink.
No spaces, lines or fields are to be left blank.
Never use symbols E.g ditto marks or arrows to indicate repetitive and consecutive .
MAKING LEGIBLE CORRECTION :-
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Benefits of Good Documentation Practice :-
Leads to a smoother running operation, having complete information and knowing how to
properly deal with issues
Reduces documentation errors by having the mechanisms to properly record data and correct
errors
Maintains a level of consistency across an organization in how things are documented and
recorded
Ensures that documentation is clear, concise, and comprehensible
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Conclusion
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It is concluded that good documentation is everyone responsibility in the industry
because the quality ,safety, efficacy of the product will be reflect on the documentation
Documentation is having its own importance in the pharmaceutical industry and good
documentation leads to produce good quality of products. Documentation is a set of
documents provided on paper, or online, or on digital or analog media, such as audio
tape or CDs. Examples are user guides, white papers, on-line help, quick-reference
guides. It is becoming less common to see paper (hard-copy) documentation
Documentation is a set of documents provided on paper, or online, or
on digital or analog media, such as audio tape or CDs. Examples are user guides, white
papers, on-line help, quick-reference guides. It is becoming less common to see paper
(hard-copy) documentation. Documentation is distributed via websites, software
products, and other on-line applications.
References
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Guidelines on cGMP and quality of pharmaceutical products by
“S.IYER “ cGMP for pharmaceuticals by “ MANOHAR A POTDAR “
Pharmaceutical production and management by “CVS
SUBRAMANYAM