Learn SOP for control of analysis records in QC labs, including raw data handling, numbering, issuance, reconciliation, and GMP compliance.
Definition
An Analysis Record SOP is a structured procedure used in Quality Control laboratories to manage, control, and maintain raw data sheets and analytical records to ensure traceability, data integrity, and regulatory compliance.
| Section | Purpose | Key Activities |
|---|---|---|
| Numbering | Ensure traceability | Unique code assignment |
| Issuance | Controlled document distribution | Register entries |
| Usage | Accurate recording of analysis | Bound books & entries |
| Reconciliation | Prevent misuse | Annual verification |
| Archival | Compliance and retention | 5-year storage |
Step-by-Step SOP
- Assign unique number to raw data sheet
- Issue bound book to QC personnel
- Record usage in register
- Maintain counterpart copies
- Handle additional sheets with approval
- File void sheets with justification
- Reconcile records annually
- Archive records for 5 years
Introduction
In pharmaceutical Quality Control, analysis records and raw data sheets are critical for ensuring data integrity and regulatory compliance. Any discrepancy in documentation can lead to audit observations, product recalls, or regulatory actions.
A well-defined Analysis Record SOP ensures:
- Accurate documentation
- Complete traceability
- Compliance with GMP and ALCOA+ principles
This guide provides a comprehensive SOP for control of analysis records, designed for audit readiness and operational excellence.
1.0 OBJECTIVE
To lay down the procedure for control of the record of analysis.
2.0 SCOPE
Applicable for control of analysis records in Quality Control laboratories.
3.0 RESPONSIBILITY
Officer / Executive – Quality Control
4.0 ACCOUNTABILITY
Manager – Quality Control
5.0 PROCEDURE
5.1 Numbering of Raw Data Sheets
- All raw data sheets shall be pre-numbered
- Format:
- Total 6 numeric characters
- First 2 digits → identification code (e.g., raw material, finished product)
- Last 4 digits → sequential number (e.g., 0001)
✔ Example: 030001
5.2 Issuance of Raw Data Sheets
- Maintain issuance records in register
- Raw data sheets shall be in:
- Bound book format (100 sheets/book)
- Each sheet must have:
- Counterpart copy with same number
5.3 Control of Bound Books
- Issue one book (100 sheets) to QC supervisor
- Record issuance details
- After completion:
- Retrieve counterpart book
- Issue new book
5.4 Maintenance of Records
- Counterparts remain in bound book
- Retain records for 5 years
- Ensure:
- Legibility
- No overwriting
- Complete entries
5.5 Additional Raw Data Sheets
- Issued only when:
- Justification provided
- Approved by QC Manager
5.6 Handling of Void Sheets
- Void sheets must:
- Be marked clearly
- Filed with justification
- Approved by authorized personnel
5.7 Reconciliation of Raw Data Sheets
- Perform annually
- Verify:
- Issued sheets
- Used sheets
- Unused sheets
- Destroy unused sheets by tearing
5.8 Control Number Format
5.9 New Raw Data Sheet Introduction
- Assign new code (AA)
- Maintain in annexure (live document)
- BB = 00 (no revision)
- XX = year
- YY = 00 (first issue)
6.0 ABBREVIATIONS
- SOP – Standard Operating Procedure
- QA – Quality Assurance
- QC – Quality Control
FAQs
1. What is an analysis record in QC?
It is documented raw data and results of analytical testing.
2. Why are raw data sheets pre-numbered?
To ensure traceability and prevent misuse.
3. What is ALCOA+ in documentation?
A principle ensuring data integrity (Attributable, Legible, Contemporaneous, etc.).
4. How long are records retained?
Typically for 5 years.
5. What is a bound book system?
A controlled record system with fixed pages.
6. Can additional sheets be issued?
Yes, with proper justification and approval.
7. What happens to unused sheets?
They are destroyed after reconciliation.
8. Why maintain counterpart copies?
For traceability and audit verification.https://iampharmacist.com/analytical-method-validation/
9. What is QC/AA-BB/XX-YY format?
A structured numbering system for control.
10. Who approves record control?
QC Manager and QA authority.
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