Standard Operating Procedure for Sequential Batch Manufacturing of Elixirs

Department	Elixir Department
SOP No.	SOP/ELX/089/2025
Supersedes	SOP/ELX/089/2022
Page No.	Page 1 of 8
Issue Date	11/04/2025
Effective Date	15/04/2025
Review Date	11/04/2026

1. Purpose

To define the procedure for carrying out sequential batch manufacturing of elixirs in the same equipment to improve efficiency while maintaining GMP compliance, preventing cross-contamination, and ensuring product traceability.

2. Scope

This SOP is applicable to all sequential manufacturing operations of similar or compatible elixir formulations within the same campaign in the Elixir Department.

3. Responsibilities

• Production Operator:
  • Follow sequential batch instructions as per BMR and perform visual inspections between batches.
  • Document all parameters, timings, and line clearances appropriately.
• Production Supervisor:
  • Verify batch-to-batch compatibility and supervise transitions.
  • Ensure partial cleaning or no-cleaning criteria are approved by QA where applicable.
• QA Officer:
  • Review risk assessments for sequential processing and authorize campaign continuation.

4. Accountability

The Head of Production is accountable for implementing sequential batch manufacturing under approved risk control measures and ensuring proper documentation and traceability.

5. Procedure

5.1 Criteria for Sequential Batch Manufacturing

1. Sequential manufacturing is allowed only:
   • Within the same product (e.g., ELX-1028 followed by ELX-1029 of Paracetamol Elixir).
   • With same formulation and strength.
   • Where approved by QA through risk assessment.
2. Incompatible products or allergens must never be processed sequentially without full cleaning.

5.2 Line Clearance and Equipment Preparation

1. Perform visual inspection of tank, transfer lines, filters, and hoses to ensure no visible residue from previous batch.
2. QA to verify and sign the Sequential Batch Authorization Form (Annexure-1).
3. Use same equipment with minimum downtime to avoid microbial contamination.

5.3 Processing the Next Batch

1. Begin next batch within 6 hours of previous batch completion. If delayed, perform hold time study or partial cleaning.
2. Reset batch parameters (e.g., mixing time, RPM, volume) as per new BMR.
3. Start BMR documentation for new batch from step 1 with batch-specific traceability.

5.4 Documentation and Controls

1. Maintain log of equipment use, sequential batches, and visual inspection (Annexure-2).
2. Ensure QA signature before and after campaign sequence.
3. Record cumulative downtime and maintenance performed between batches.

5.5 Cleaning After Final Batch

1. Perform full cleaning and sanitization of all equipment and accessories used.
2. Document cleaning status and QA verification before releasing for next product or campaign.

6. Abbreviations

• SOP: Standard Operating Procedure
• QA: Quality Assurance
• BMR: Batch Manufacturing Record
• GMP: Good Manufacturing Practice

7. Documents

1. Sequential Batch Authorization Form (Annexure-1)
2. Sequential Batch Equipment Log (Annexure-2)
3. Batch Manufacturing Record (BMR)

8. References

• 21 CFR Part 211.67 – Equipment Cleaning and Maintenance
• WHO TRS 986 – GMP for Pharmaceuticals
• ICH Q9 – Quality Risk Management

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Sequential Batch Authorization Form

Batch No. (Previous)	Batch No. (Next)	Product	Equipment ID	QA Authorization	Date
ELX-1027	ELX-1028	Paracetamol Elixir	MX-05	Sunita Reddy	11/04/2025

Annexure-2: Sequential Batch Equipment Log

Date	Batch No.	Equipment ID	Start Time	End Time	Operator	Remarks
11/04/2025	ELX-1028	MX-05	02:00 PM	04:30 PM	Rajesh Kumar	Sequence continued from ELX-1027

Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
01/01/2024	1.0	Initial SOP Release	New SOP	QA Head
11/04/2025	2.0	Added risk-based criteria and equipment log annexure	GMP Enhancement	QA Head