Good Documentation Practices

This presentation is prepared by “ Drug Regulations” a
non profit organization which provides free online
resource to the Pharmaceutical Professional.
Visit http://www.drugregulations.org for latest
information from the world of Pharmaceuticals.
5/14/2015 1

 This presentation will cover all
aspects of GDP as per the proposal in
the
◦ Proposed USP–NF General Chapter
<1029>.
5/14/2015 2
Drug Regulations - Online Resource latest information.

 Documentation
◦ Foundation of all quality systems
◦ Clear, complete, accurate records
essential to all operations and
procedures.
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 Essential element in regulated manufacturing
and laboratory environments.
 Close adherence to GDP is required for an
auditable account of work performed.
 Required for all documentation included in a
fully developed quality system.
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 General Chapter Provides guidelines on how
to develop and maintain good
documentation practices .
 Address a need for descriptions of what
constitutes good documentation
◦ Records of all types that are clear, accurate, and complete.
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 General chapter provides guidelines to be used in the
production and control of
◦ Pharmaceutical products
◦ Active pharmaceutical ingredients (APIs)
◦ Excipients
◦ Dietary supplements
◦ Food ingredients
◦ Medical devices.
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 General chapter describes the underlying principles of
proper documentation for GMP operations
 Assists the user in the evaluation and reconstruction of
GMP activities.
 Guidelines will
◦ Help building basic foundation of a quality system
◦ Ensure proper documentation as well as record integrity and
control.
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 This chapter covers
◦ Different levels and types of documentation
◦ Paper and electronic records : raw data, reports, protocols,
and procedures related to manufacturing controls and
analytical data.
◦ Recommendations on information that should be recorded
for various types of GMP documents.
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 PRINCIPLES OF GOOD DOCUMENTATION
◦ Document all steps
◦ Manufacturing, testing, packaging, or holding
◦ Raw material, component, API, finished product
◦ Other similar items
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 PRINCIPLES OF GOOD DOCUMENTATION Manual or
electronic records include the following, as applicable:
◦ Records should be clear, concise, accurate, and legible.
◦ Data entries should be recorded promptly when actions are
performed.
◦ Backdating and postdating are prohibited.
◦ Initial & Date All corrections with an explanation included in
cases where the reason for the change is not obvious.
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 PRINCIPLES OF GOOD DOCUMENTATION Manual or electronic records include the
following, as applicable:
◦ Data entries should be traceable to the person who made the
entry.
◦ Do not use of shorthand notations.
◦ Place controls to protect the integrity of the records.
◦ In case of thermal paper use a copy with verification of its
accuracy;
 Analyst should initial and date the copy.
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 PRINCIPLES OF GOOD DOCUMENTATION Manual or electronic records
include the following, as applicable:
◦ An adequate documentation system required for
traceability and availability of records.
◦ Pre number notebooks, data sheets, and worksheets
◦ Retain records as per regulatory requirements.
◦ Paginate attachments (supporting documents) with a
reference to the parent document.
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 DATA COLLECTION AND RECORDING
◦ Formats for data collection and recording include:
◦ Paper forms, data sheets, and worksheets
◦ Notebooks and logbooks
◦ Instrument printouts
◦ Electronic data obtained with a system such as
 Electronic data system,
 Laboratory information management system (LIMS),
 Electronic laboratory notebook (ELN).
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◦ Record all data directly and legibly in indelible ink when
the activity is performed.
◦ Do not use sticky notes and other transitory loose
papers .
◦ All data entries should be traceable to who made the
entry and when.
◦ Electronic records must meet the requirements of 21
CFR, Part 11.
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◦ Change to an entry
 Make in a way so that original entry is not obscured
 Give an explanation for the change when change is
not obvious.
 Changes should be traceable to who made the
change and when.
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◦ Use notebook pages and worksheets
consecutively
◦ Record information chronologically
◦ Give unique identity to GMP records using
version control
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◦ Complete all data entry fields.
◦ Draw a single line and/or “N/A” through
portion(s) of a page that are not used.
◦ If an electronic record provides traceability of
who filled each field and when, the field can be
left blank.
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◦ Decimals less than one should be preceded by a
zero.
◦ Follow rounding rules and guidelines on
significant figures described in USP–NF.
◦ Express all dates so that the day, month, and
year is clearly understood.
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◦ Review all documentation
◦ A confirmation by second person may be required
to confirm the accuracy, compliance, and
completeness.
◦ Maintain an official record of signature and initials
for each employee.
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◦ Controls should be in place for assigning signature
approval requirements and delegation of signature
authority, when needed.
◦ Initial & date instrument printouts and data sheets
 Should contain a unique, traceable reference or
 affix to a reference document.
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◦ Verified copies of raw data may be substituted for the
original
◦ Sign all multiple page documents on the first page with a
note indicating the total number of pages.
 The first page and all subsequent pages should have a unique,
traceable reference to the activity being performed, such as the
notebook reference, study number, or worksheet reference.
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 Laboratory Record
◦ Each record should be concise, clear, legible, and
accurate, and detail the following:
◦ Description of materials, such as reagents.
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◦ This information typically includes
 Material name
 Manufacturer
 Lot number
 Titer or Concentration,
 Expiration date,
 Quality (if known),
 Areference to the lab notebook if prepared in the lab.
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◦ Identification of equipment used.
 Equipment name, unique control number, and calibration
expiration date.
◦ Procedures used
◦ Measurements
◦ Formulae and calculations
◦ Results and conclusions
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 Equipment Related Documentation
◦ All Manufacturing , testing, packing, or holding equipment
used for raw material, component, API, finished product, or
other similar item
◦ Maintain and qualify for its intended use.
◦ Documentation related to equipment includes:
 Policies and procedures for operation and maintenance
 Maintenance logs
 Calibration or qualification records
 Instrument labeling
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 Investigations and Deviations
◦ Document all
 Aberrations
 Anomalies
 Exceptions, and
 Issues related to manufacturing, testing, packing, or holding of
 a raw material, component, API, finished product, or other similar
item should be documented.
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◦ Evaluate & Investigate the deviation as appropriate.
◦ Justify planned and unplanned deviations
◦ Have procedures for documenting, evaluating, and
investigating such events.
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◦ Documentation of the investigation should include the following:
 Description of the event
 Root cause investigation and trend analysis
 Responsibilities of people involved in the investigation or
deviations
 Corrective Action and Preventive Action (CAPA) with timelines
Review and approval
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 Batch Records
◦ Create a Master Batch Record (MBR) as a template for the
manufacture of a specific product.
◦ Base executed Batch Record on the MBR
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 Batch Records
◦ Document the steps and materials involved in the production of a
specific batch of
 Raw material
 Component
 API
 Finished product
 or other similar item.
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 Batch Records
◦ Following sections are included and should be approved
◦ Approval by appropriate representative from the
manufacturing site or packaging site:
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 Batch Records Should contain
◦ Header information (e.g., product name, batch number,
manufacturing site)
◦ Unit of operation (e.g., blending, coating, filling)
◦ Manufacturing process
◦ Target weights (raw materials)
◦ Conditions (time, temperature)
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 Batch Records Should contain
◦ Deviations and investigations
◦ In process sampling or testing
◦ Critical information, as applicable
◦ Sampling plan for release, stability, and retention Review and
approval with approval dates
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 Certificate of Analysis
◦ Purpose is to report analytical results for a specific batch of
 Raw material
 Component
 API
 Finished product
 Other similar item.
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◦ COA should be approved by an appropriate
representative from the testing site & contain
 Vendor or supplier information
 Product information (name and strength)
 Results for the specific batch, with name of test,
acceptance criteria, and result for each test
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◦ COA should be approved by an appropriate
representative from the testing site & contain
 Conformance statement
 Reference to method and specification document
 Reference of data source
 Approval and date
 Expiration date or retest information
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 Standard Operating Procedures
◦ SOP’s provide directions to trained personnel regarding a given
set of activities.
◦ SOPs should be clear and concise.
◦ The following sections are typically included in an SOP:
 Purpose and scope
 Instructions and procedure
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 Standard Operating Procedures
◦ The following sections are typically included in an SOP:
 Responsibilities and roles
 Materials or equipment, as appropriate
 Definitions or references, as needed
 Review and approval
 Revision history
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 Protocols & Reports
◦ Many tasks and activities in the laboratory are executed on
the basis of a predefined, preapproved protocol.
◦ The results of these activities are then documented in a
final report with conclusions.
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◦ Examples of such activities are as follows:
 Equipment qualification
 Analytical method validation or verification
 Manufacturing process validation
 Analytical method or manufacturing technology transfer
 Cleaning validation
 Stability study or testing
 Comparability study
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◦ Both the protocol and the report should typically include
the following sections:
 Purpose
 Plan or instructions
 Predetermined acceptance criteria
 Deviations or investigations, including impact assessment
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◦ Both the protocol and the report should typically include
the following sections:
 Assessment or evaluation
 Data reference
 Review and approval
 Revision history
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 Analytical Methods
 Provides direction on how to perform a given analytical test.
Following sections will typically be included in the analytical
method:
◦ Purpose
◦ Test information
◦ Product information Safety information
◦ Materials and equipment
◦ Procedure, as applicable
◦ System suitability
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 Analytical Methods
 Provides direction on how to perform a given analytical test.
Following sections will typically be included in the analytical
method:
◦ Preparation of solutions and reagents
◦ Preparation of standards and samples
◦ Instrument parameters
◦ Calculations and reporting Review and approval with approval dates
◦ Revision history
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 Training Documentation
◦ Personnel should be trained to perform their assigned tasks.
◦ The training should be documented, and the training records
should be retained and kept readily accessible.
◦ Training records should be reviewed on a periodic basis for
accuracy and completeness.
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 Training Documentation
 In general, training documentation should include:
◦ Training description
◦ Name of training
◦ Version
◦ Mode (self training or instructor led)
◦ Completion date
◦ Information on the trainer’s qualifications
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 Retention of Documents
◦ Establish an adequate policy for record retention and
archiving
◦ Retention time depends on the regulatory requirements
◦ However, it should be at least 1 year after the batch
expiration date
5/14/2015 47

This presentation is prepared by “ Drug Regulations” a
non profit organization which provides free online
resource to the Pharmaceutical Professional.
Visit http://www.drugregulations.org for latest
information from the world of Pharmaceuticals.
5/14/2015 48

Good Documentation Practices

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