Good documentation practices

Presented by – Sweety Shukla

Good Documentation Practices :
Good documentation practice is a term in the pharmaceutical and medical device
industries to describe standards by which documents are created and maintained. Also
known as good record-keeping practice or GRK, is a set of internationally accepted
guidelines that ensure the reliability, integrity, and veracity of data collected during the
research, development, manufacturing, and testing of drugs and medical devices.

•Legal documents – business records, audit statements, and company

policies
•Customer information – contact numbers, email addresses, and
transaction history
•Procedural documents – standard operating procedures(SOPs), work
For Example : instructions, and training documents
•Evidence of compliance – to confirm that SOPs have been followed and
that business processes are compliant with regulations and standards
•Testing or analysis records – for when the quality of a product is
checked or assured, when verifying the effectiveness of a product,
or capturing data that is critical to the safety and quality of the product
Why GDP is important :
Good Documentation Practices are the key to GMP compliance and ensure traceability of all development, manufacturing, and testing
activities. Documentation provides the route for auditors to assess the overall quality of operations within a company and the final product.

➢ Good documentation constitutes an essential part of the quality assurance system. Clearly written procedures prevent errors resulting
from spoken communication, and clear documentation permits the tracing of activities performed.

➢ Documents must be designed, prepared, reviewed, and distributed with care.

➢ Documents must be approved, signed, and dated by the appropriate competent and authorized persons.

➢ Documents must have unambiguous contents. The title, nature, and purpose should be clearly stated. They must be laid out in an orderly
fashion and be easy to check. Reproduced documents must be clear and legible.

➢ Documents must be regularly reviewed and kept up-to-date. When a document has been revised, systems must be operated to prevent
inadvertent use of superseded documents (e.g., only current documentation should be available for use).
Purpose of Laboratory Documentation

To provide the basic guidelines for good document practices with regard to
creation, approval, review, maintenance, correction or errors, verification
and archiving, etc

Ensures documented evidence, and traceability, provides records and

audit trails for investigation

Ensures availability of data for validation, review, and statistical analysis.

Control of Process - Ensures all staff knows what to do and when to do it.

To improve performance
Principles of Good Documentation Practice :
A document bearing
original signatures
should never be
destroyed.

Never use symbols e.g

ditto marks or arrows to Never falsify
indicate repetitive and information
consecutive

No spaces, lines or
Never you a White-out
fields are to be left
blank and cover-over-tapes

Never use pencil – all

information should be
completed in Never obliterate
permanent Black or information or record
Blue ink

Never over-write a
record.
Documentation and records used throughout the manufacturing process, as
well as supporting processes, such as quality control and assurance, must meet
the basic requirements of GDP, including the following:

Batch Recor d For ms Bills of Mater ials (BOMs) Specifications Policies Pr otocols

Standar d Oper ating

For ms/Log sheets Checklists Test Methods Wor k Instr uctions (WIs) Pr ocedur es (SOPs)

Electr onic and har dcopy

Quality r ecor ds (e.g. non-
confor mance, cor r ective and Cer tificate of Analyses (CoA)
Tr aining Assessments pr eventative actions, inter nal or Cer tificate of Compliance Technical tr ansfer r eports V alidation documentation
(CoC)
inspection, change contr ol,
tr aining r ecor ds, etc.)
Recordkeeping Categories :
Documents and records can fall into various classification systems, and in general, there are 4 key classifications for documentation.
• Primary Records (examples: production formulas, supply source documents, contracts, packaging instructions)
• Procedures or supporting procedures (instructions and guidebooks, SOPs)
• Subsidiary records (help meet GMP, e.g. calibration readings reports, printouts, other supporting documents)
• Quality Control records (testing results, testing methods, recall procedures, investigations, self-inspection reports, CAPA, and more)

Basic requirements for good documentation practices will include, but not be limited to, the following
components:
• Accuracy
• Data Integrity (protected, secure, and backed-up data systems)

• Contemporaneous recordkeeping (timely, immediately/real-time)

• Legible
• Readily identifiable as to who recorded it (no shared passwords or shared data system log-ins, no forging of signatures even if
requested)
• Readily accessible when required

• Signature record log and register

Benefits of Good Documentation Practice

Build confidence in the Laboratory Quality System

Reduce efforts to comply with regulatory bodies

Allows for achievements of required results.

Correct, complete, current, and consistent information effectively

meets customers’ and stakeholders’ requirements.

Enables the Laboratory activities to be arranged into functional

patterns for specific action.

Create structures so that staff can systematically coordinate to

conduct business.

Training of Laboratory staff.

Solve complicated problems

Reduce or eliminate assumptions and second-guessing.