Food Chain and Food Web (Ecosystem) EVS, B. Pharmacy 1st Year, Sem-II
Good documentation practice
1.
2.
3. CONTENTS
• DEFINITIONS
• ALCOA (+) PLUS
• PRINCIPLE OF GOOD DOCUMENTATION
• TYPES OF GMP DOCUMENTS
• LABORATORY RECORDS
• EQUIPMENT RELATED DOCUMENTATION
• DEVIATION AND INVESTIGATIONS
• BATCH RECORDS
• CERTIFICATE OF ANALYSIS
• STANDRD OPERATING PROCEDURE
• PROTOCOLS AND RECORDS
• TRIANING DOCUMNTATION
• RETENTION TIME OF DOCUMENTS
• PROCEDURE OF DOCUMENTATION
• DO’S & DON’T’S
4. DOCUMENTATION:
Documentation is a set of documents that provides official
information or evidence or serves as a record.
GOOD DOCUMENTATION PRACTICE :
Methods for recording ,correcting and managing data,
documents and records, to ensure the reliability and integrity.
DATA INTEGRITY :
Data integrity is the degree to which a collection of data is
complete, consistent, accurate throughout the data life cycle.
META DATA:
Data that provides information about other data
AUDIT TRAIL:
Information associated with actions that related to the creation,
modification or deletion of records.
DEFINITIONS:
6. A Commenly used acronym for “ Attributable, Legible, Contemporaneous, Original
and Accurate”.
ATTRIBUTABLE:
Who acquired the data or performed an action and when?
LEGIBLE :
Readable and understandable by all users of document.
CONTEMPORANEOUS:
Data must be document at the time of activity
ORIGINAL:
Data should be original or true copy
ACCURATE:
Data are correct, truthful, complete, valid and reliable.
ALCOA
7. ALCOA expanded to ALCOA PLUS
COMPLETE:
All the data including the repeat analysis. No deletion.
CONSISTENT:
Consistent generation of records and the time stamps
ENDURING:
Data recorded in controlled work sheets or validated systems.
AVAILABLE:
Data available for review, audit, inspection for the life of the record.
ALCOA PLUS
8. PRINCIPLES OF GOOD DOCUMENTATION
• Clear and legible records.
• Data entry should be recorded at the time of activity.
• Backdating and postdating are not allowed.
• Corrections to entries should be dated and signed.
• Data entry should be traceable to the person who made the
entry.
• Uncommon abbreviation and acronym should be defined.
• Control should be place to protect the integrity of the record.
9. PRINCIPLES OF GOOD DOCUMENTATION
• Printouts taken on the thermal paper or easily fading inks should
be photocopied.
• Notebooks, Data sheets and Worksheets should be traceable.
• Documentation system is needed to ensure the data integrity and
availability of records.
• During the retention period, the records should be readily
available.
• All pages should be paginated. Attachments to be paginated with a
reference to parent document.
11. LABORATORY RECORDS
Laboratory records should be organized to ensure that the records are
concise ,clear, legible and accurate and detail the following:
• Description of Materials(E.g. Reagents)
• Identification of equipment used
• Procedures Used
• Measurements
• Formulae and Calculations
• Results and Conclusions.
12. EQUIPMENT RELATED DOCUMENTATION
All equipment used in laboratory should be maintained, qualified
and documented
• Policies and procedures for operation and maintenance
• Equipment use
• Maintenance records
• Calibration or qualification records
• Instrument labeling
13. DEVIATION AND INVESTIGATIONS
All aberrations, anomalies and exceptions should be documented.
• Description of the event
• Root cause investigation
• Evaluation of data trend
• Responsibilities of people involved in the deviation/investigations
• Impact assessment
• Corrective action and preventive action(CAPA) with timelines
• Review and approval
14. BATCH RECORDS
A Master Batch Record (MBR) created as a template for the manufacture of specific
product.
• Header information (E.g. product name, batch number, Manufacturing site)
• Unit of operation (E.g. blending, coating, milling)
• Manufacturing process
• Target weights (raw materials)
• Conditions (time, temperature)
• Deviations and investigations
• In-process sampling or testing
• Other critical information, as applicable
• Sampling plan for release, stability, and retention
• Review and approval
15. CERTIFICATE OF ANALYSIS
Report of analytical results.
• Vendor, supplier, or manufacturer information (as applicable)
• Product information (name and strength)
• Results for the specific batch, with name of test, acceptance criteria, and
result for each test
• Conformance statement or equivalent
• Reference to procedure and specification document
• Reference of data source
• Approval and date
• Expiration date or retest information
16. STANDRAD OPERATING PROCEDURE
Provide directions to trained personnel regarding a given set of
activities.
• Purpose and scope
• Instructions and procedure
• Responsibilities and roles
• Materials or equipment, as appropriate
• Definitions or references, as needed
• Review and approval
• Revision history
17. PROTOCOLS AND REPORTS
Activities and tasks executed on the basis of predefined, preapproved
protocols.
• Equipment qualification
• Analytical method validation or verification
• Manufacturing process validation
• Analytical method or manufacturing technology transfer
• Cleaning validation
• Stability study or testing
• Comparability study
18. PROTOCOLS AND REPORTS
Protocols and reports should included following sections.
• Purpose
• Plan or instructions
• Predetermined acceptance criteria
• Deviations or investigations, or a reference to (for report only)
• Assessment or evaluation (for report only)
• Data reference (for report only)
• Review and approval
• Revision history
19. ANALYTICAL PROCEDURES
Direction to an operator on how to perform a given analytical Test.
• Purpose
• Test information
• Product information
• Safety information, if applicable
• Materials and equipment
• Procedure, as applicable
• System suitability
• Preparation of solutions and reagents
• Preparation of standards and samples
• Instrument parameters
• Calculations and reporting
• Review and approval with approval dates
• Revision history
20. TRAINING DOCUMNETATION
Training record should be documented, retained and readily
available.
• Training description including name of training, version, and
mode (self-training or instructor led)
• Completion date
• Information on the trainer, as applicable
21. RETENTION OF DOCUMNETS
Retention time length of document depends on the regulatory
requirements or company procedures.
However it should be at least 1 year after the batch expiration
date.
24. GOOD DOCUMENTATION PRACTICE
DO’S:
• Use pre numbered bounded note book.
(Every register form/note shall have header, date of opening, date of closing, Table of
content)
• Enter complete and accurate information at the time of activity.
• Enter signature or Initials (According to procedure)
• When more than one person completed the task, all person should be sign.
• Use a non water soluble black or blue color ball point pen to make entries.
• Corrections to written records must be made properly.
• Draw a single line through the incorrect entry.
• Write initials and date of correction.
• Record the Data clearly.
• When Spaces or shell don’t contain information, entry N/A.
• Limit the use of abbreviation and acronym.
• Second verification is must.
25. GOOD DOCUMENTION PRACTICE
DONT’S
• Don’t do any temporary entries in a bit paper of hand.
• Don’t remove any pages from note book.
• Don’t enter your performed by sign for the work performed by someone else.
• Don’t back date or post date.
• Don’t do over write.
• Don’t mask the original entry.
• Don’t use gel pens and ink pens.
• Don’t use red or green color ink pens.
• Don’t use correction liquid.
• Don’t vary your signature or initial.
