Elixir Department: SOP for Addition of Color Solutions – V 2.0

Standard Operating Procedure for Addition of Color Solutions in Elixir Manufacturing

Department	Elixir Department
SOP No.	SOP/ELX/088/2025
Supersedes	SOP/ELX/088/2022
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 the controlled addition of permitted color solutions during the manufacturing of elixirs, ensuring product consistency, safety, and regulatory compliance.

2. Scope

This SOP applies to all batches of elixir products where colorants are used for aesthetic or identification purposes in the Elixir Department.

3. Responsibilities

Production Operator:
- Weigh, dissolve, and add color solutions as per batch manufacturing record (BMR).
- Ensure homogeneous mixing and proper labeling of containers.
Production Supervisor:
- Verify correct colorant, quantity, and process timing.
- Authorize addition based on stage completion.
QA Officer:
- Review BMR entries and validate the correct use of approved colorants.

4. Accountability

The Head of Production is accountable for ensuring color solutions are added under controlled conditions and documented accurately.

5. Procedure

5.1 Selection of Colorants

Use only colors approved by regulatory authorities

such as CDSCO, US FDA, or as per Schedule Q of Drugs and Cosmetics Rules (India).

Verify that the correct color name, batch number, and expiry are mentioned in the BMR.

Colorants must be stored in designated areas away from APIs and excipients.

5.2 Preparation of Color Solution

Wear appropriate PPE and operate under a laminar flow unit if required.
Weigh the specified amount of colorant on a calibrated balance.
Dissolve the colorant in pre-measured quantity of purified water or suitable solvent as mentioned in the BMR.
Filter the solution through a 0.2 mm mesh stainless steel sieve before use.

5.3 Addition to the Batch

Confirm that all prior batch manufacturing steps (e.g., API dissolution, pH adjustment) are completed.
Slowly add the prepared color solution into the main batch under continuous stirring to ensure uniform distribution.
Monitor visual appearance and check for homogeneity.

5.4 Documentation

Record colorant name, batch number, quantity used, solvent, and time of addition in the BMR and Color Addition Log (Annexure-1).
Ensure both operator and supervisor sign off on the activity.

5.5 Special Precautions

Do not use expired or non-approved colorants.
Avoid over-addition. If reprocessing is required, escalate to QA immediately.
Colorant containers should be handled with clean gloves and closed immediately after use.

6. Abbreviations

SOP: Standard Operating Procedure
BMR: Batch Manufacturing Record
QA: Quality Assurance
CDSCO: Central Drugs Standard Control Organization
PPE: Personal Protective Equipment

7. Documents

Color Addition Log (Annexure-1)
BMR (Color Addition Section)
COA of Colorant (Annexure-2)

8. References

Schedule Q – Drugs and Cosmetics Rules, India
21 CFR Part 74 – Listing of Color Additives Subject to Certification
ICH Q7 – GMP for APIs

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Color Addition Log

Date	Batch No.	Color Used	Quantity (mg)	Diluent	Added By	Verified By
11/04/2025	ELX-1027	Sunset Yellow FCF	150 mg	Purified Water	Rajesh Kumar	Sunita Reddy

Annexure-2: Certificate of Analysis (CoA) for Colorant

Colorant Name	Batch No.	Test Performed	Result	Status
Sunset Yellow FCF	SY-2205	Identification, Purity, Microbial Limit	Complies	Approved

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 color solution filtration step and CoA tracking	Process Improvement	QA Head