Elixir Department: SOP for Time-Based Sampling Schedule – V 2.0

Standard Operating Procedure for Time-Based Sampling Schedule During Elixir Manufacturing

Department	Elixir Department
SOP No.	SOP/ELX/204/2025
Supersedes	SOP/ELX/204/2022
Page No.	Page 1 of 9
Issue Date	11/04/2025
Effective Date	15/04/2025
Review Date	11/04/2026

1. Purpose

To establish a standardized procedure for implementing and documenting a time-based sampling schedule during the elixir manufacturing process to ensure compliance with Good Manufacturing Practices (GMP) and enable timely process control.

2. Scope

This SOP is applicable to all in-process time-based sampling performed during elixir manufacturing, including sampling for physical, chemical, and microbiological testing at defined intervals.

3. Responsibilities

Production Operator:
- Ensure timely coordination and accessibility for sample collection.
QC Analyst:
- Collect, label, and test samples as per schedule.
- Maintain accurate records of sampling times and results.
QA Officer:
- Verify sampling adherence and review results for compliance.

4. Accountability

The QC Head is accountable for execution and accuracy of the schedule. The Production Head ensures sampling access. QA ensures documentation integrity and regulatory compliance.

5. Procedure

5.1 Establishment of Sampling Schedule

Prepare a

sampling plan during batch planning based on:

Critical process steps (e.g., mixing, dissolution, heating, cooling)
Process duration
Regulatory and internal quality requirements

Define exact sampling intervals (e.g., every 15 min, 30 min, 1 hour) and sample types.

Document in the Time-Based Sampling Schedule Sheet (Annexure-1) and attach to BMR.

5.2 Sampling Execution

Collect samples at predefined times using clean and labeled containers.
Sampling must be carried out in the order listed in the schedule.
Label each sample with:
- Product name
- Batch number
- Sampling time
- Sampling point
- Type of test (e.g., pH, assay, microbial)
Immediately transfer samples to the QC laboratory under appropriate conditions (e.g., temperature).

5.3 Testing and Evaluation

Analyze samples for:
- pH
- API content
- Appearance and clarity
- Conductivity
- Microbial limits (as applicable)
Record test results against each time point in the logbook.
Any deviation or trend indicating instability or abnormality must be reported immediately to QA and Production.

5.4 Deviation Handling

Missed or delayed sampling must be documented with justification.
Initiate deviation report if sampling is missed or time exceeded by more than ±10% of the scheduled time.

5.5 Documentation

Maintain a Time-Based Sampling Logbook (Annexure-2) for each batch.
Attach analytical data and QA review sheets to the BMR.

6. Abbreviations

SOP: Standard Operating Procedure
QA: Quality Assurance
QC: Quality Control
BMR: Batch Manufacturing Record
API: Active Pharmaceutical Ingredient

7. Documents

Time-Based Sampling Schedule Sheet (Annexure-1)
Time-Based Sampling Logbook (Annexure-2)
Batch Manufacturing Record (BMR)

8. References

ICH Q8 – Pharmaceutical Development
21 CFR Part 211.110 – In-Process Sampling and Testing
WHO TRS 986 – Annex 2: GMP for Pharmaceutical Products

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Time-Based Sampling Schedule Sheet

Sampling Time	Test	Location	Sample Collected By	QC Received Time	Remarks
10:00 AM	pH	Mixing Tank	Rajesh Kumar	10:15 AM	Within range

Annexure-2: Time-Based Sampling Logbook

Date	Batch No.	Sampling Point	Test Performed	Result	Tested By	QA Verified
11/04/2025	ELX-0425-023	Middle Layer	API Assay	98.6%	Sunita Reddy	Manoj Sharma

Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
01/01/2024	1.0	Initial Release	New SOP	QA Head
11/04/2025	2.0	Added justification for missed sampling & tighter time limits	GMP Enhancement	QA Head