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Last updated: Jul 8, 2026
Official signed PDF · SIPL/QAS/017
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Good Documentation Procedure (GDP)

Purpose

  • The purpose of this SOP is to ensure that all external documents are properly controlled and records generated are properly kept.

Scope

  • This procedure is applicable to all documents / records generated by the company and external origin documents.

Reference(S) & Attachment(S)

  • References
  • ISO 15378:2017 & ISO 9001:2015
  • Section 4.18 of cGMP
  • Attachments
  • Attachment-I : Master List of Formats : SIPL/QAS/017/F01/00
  • Attachment-II : Master List of Signatures : SIPL/QAS/017/F02/00

Responsibility

  • Respective Department Personnel:
  • To use documents / formats approved by the QA Head.
  • QA Head / MR:
  • To control any document / format used by any department.

Distribution

  • All Departments

Definition(S) & Abbreviation(S)

  • Definitions
  • External origin documents: All those documents which are not prepared by the company but are used for reference.
  • Records: All filled formats used as evidence of any operations.
  • Abbreviations
  • Nil

Procedure

  • External Origin Documents
  • The MR will identify all external origin documents used / referred to by the company for smooth operations.
  • The front page of all such documents will be controlled by use of a stamp.
  • Internal Documents
  • All documents shall be stored as per their department and document numbers.
  • Copies of all documents shall be either controlled (only limited copies with proper record) or uncontrolled (any copy with no stamp of controlled copy shall be treated as uncontrolled).
  • All superseded / obsolete copies of the original document shall be preserved for at least two years for reference. The controlled copies shall be destroyed immediately upon revision.
  • Electronic documents (soft copies) shall also be controlled with document numbers. A backup of all computers shall also be taken onto a hard disk on a monthly basis.
  • Record Control
  • All records which support the Quality Management System are referenced in the appropriate procedure, work instruction, quality plan etc. A list and various files are maintained by each function head.
  • All personnel have been advised to fill the records legibly and identifiable to the product / process involved.
  • Storage: Records shall be stored in suitably protected and secure facilities so as to:
    • Be easily retrievable.
    • Minimize deterioration.
    • Be protected from damage.
    • Prevent loss / unauthorized access or tampering such as alteration.
  • Control

    • Currently maximum records are on hard prints and controlled by the MR through the Master List of Formats. All other electronic records are secured by data backup on the server handled by the IT department.

    • All the records are made directly after performing the activities. All records are dated and signed by the activity owner.

    • Any corrections in records are avoided. If any correction in an entry is done, then it is ensured that they are:

    • .1

    • .2

    • .3

Dated and signed by the activity owner.

Only one cut will be put on such an entry so that the cut portion can be read easily. No use of fluid or eraser is done for correction.

  • Critical stages are defined by the management and their records are always cross-checked.
  • Retention: All records related to a batch are kept for 2 years.
  • Disposition: After expiry of the retention period, quality records are destroyed after approval from the Operation Head / QA Head by any appropriate means, preferably by shredding. A record of records / documents destroyed shall be maintained for reference.

Revision History

Revision No.

Effective Date

CC No.

Details of revision: New SOP

Engineering / IT

Human Resource and Administration

Definition(S) & Abbreviation(S)

  • Definitions
  • Data Integrity: The degree to which data is complete, consistent, accurate, trustworthy and reliable, and these characteristics are maintained throughout the data life cycle.
  • ALCOA+: A framework for data quality — Attributable, Legible, Contemporaneous, Original, Accurate, plus Complete, Consistent, Enduring and Available.
  • Raw Data: Original records and documentation, retained in the format in which they were originally generated (paper or electronic), that permit the full reconstruction of the activity — e.g. the printed strip-chart of a coating oven, the balance printout for GSM, the original entry in the printing logbook.
  • Metadata: Data that describe the attributes of other data and provide context and meaning — e.g. the time stamp, user ID, instrument ID and units associated with a QC test result.
  • Audit Trail: A secure, computer-generated, time-stamped electronic record that allows reconstruction of the course of events relating to the creation, modification or deletion of a record, including the 'who, what, when and why'.
  • Dynamic Record: Records with an interactive interface where the format may be changed and data re-processed.
  • Hybrid System: A system combining paper and electronic records — e.g. an electronic balance whose printout is manually pasted into a QC worksheet.
  • Data Life Cycle: All phases of data from initial generation and recording, through processing, use, retention, archival and retrieval, to destruction.
  • Good Documentation Practice (GDP): Practices that ensure records are recorded accurately, contemporaneously and legibly, as defined in
  • Abbreviations
  • ALCOA+ : Attributable, Legible, Contemporaneous, Original, Accurate (+ Complete, Consistent, Enduring, Available)
  • CAPA : Corrective Action and Preventive Action
  • DI : Data Integrity
  • GDP : Good Documentation Practice
  • QA : Quality Assurance
  • QC : Quality Control
  • SOP : Standard Operating Procedure
  • IT : Information Technology
  • ID : Identification

Procedure

  • Data Integrity Principles – ALCOA+
  • All data at SIPL, whether paper or electronic, shall comply with the following principles:
    • Attributable: Every record shall clearly identify who performed the activity and when. Sign / initial and date every entry; every electronic action shall be traceable to a unique named user.
    • Legible: Records shall be readable and permanent. Use indelible blue / black ink; never use pencil, correction fluid, or overwriting. Corrections as per GDP (single-line cross-out, initial, date, reason).
    • Contemporaneous: Data shall be recorded at the time the activity is performed — e.g. the coating-oven temperature is logged as it is read, not reconstructed at end of shift.
    • Original: The first / source record (or a certified true copy) shall be retained — e.g. the original balance printout for GSM, the original in-process check sheet on the slitter.
    • Accurate: Data shall be correct, truthful and free from errors; instruments shall be calibrated and within validity before use.
    • Complete: All data, including repeat / re-tests, out-of-specification results and associated metadata / audit trails, shall be retained. Nothing shall be selectively deleted.
    • Consistent: Data shall be recorded in the expected sequence with correct, synchronised date / time stamps.
    • Enduring: Records shall be recorded on controlled, durable media (issued formats / logbooks, validated electronic storage), not on loose scraps, hands or Post-it notes.
    • Available: Records shall be retrievable for review, audit or inspection throughout the defined retention period.
  • Data Governance & Culture
  • Top management shall establish and communicate a data integrity policy and lead by example, ensuring staff are not placed under undue pressure (e.g. production targets) that could compromise data.
  • An open, no-blame reporting culture shall be maintained so that errors and breaches can be reported and corrected without fear of unfair reprisal.
  • A data integrity risk assessment (Attachment-I) shall be performed for each process area and computerised system at least once every two years and upon any significant change (via Change Control, SIPL/QAS/002).
  • Control of Paper Records
  • All logbooks, worksheets, in-process check sheets and formats shall be pre-printed with a format number, issued and retrieved by QA. Loose or uncontrolled paper shall not be used to record raw data.
  • Entries and corrections shall follow GDP (SIPL/QAS/017): contemporaneous, indelible, single-line cross-out with initial, date and reason; no obliteration or correction fluid.
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