Procedure for Dispensing Colorants and Pigments
| Department | Production/Quality Assurance (QA)/Quality Control (QC)/Warehouse |
|---|---|
| SOP No. | SOP/Ointment/174 |
| Supersedes | V 1.0 |
| Page No. | Page X of Y |
| Issue Date | [Insert Issue Date] |
| Effective Date | [Insert Effective Date] |
| Review Date | [Insert Review Date] |
1. Purpose
The purpose of this Standard Operating Procedure (SOP) is to establish a systematic method for the safe and accurate dispensing of colorants and pigments in pharmaceutical manufacturing. Proper dispensing ensures batch uniformity, prevents cross-contamination, and complies with Good Manufacturing Practices (GMP) and regulatory guidelines.
2. Scope
This SOP applies to all personnel in the Production, Quality Assurance (QA), Quality Control (QC), and Warehouse departments involved in the dispensing, weighing, and handling of colorants and pigments in pharmaceutical manufacturing.
3. Responsibilities
- Weighing Operator: Dispenses colorants and pigments according to batch requirements.
- QA Officer: Ensures compliance with safety and quality standards.
- QC Analyst: Verifies the identity and consistency of colorants and pigments.
- Warehouse Supervisor: Manages the storage and retrieval of colorant and pigment containers.
- Production Supervisor: Oversees the dispensing process and ensures adherence to protocols.
4. Accountability
The QA Manager is accountable for ensuring that all colorant and pigment dispensing activities comply with GMP, FDA, ICH, WHO, and company policies.
5. Procedure
5.1 Preparation for Dispensing
- Ensure the **dispensing room is clean** and meets environmental control conditions:
- Temperature: **15-25°C**
- Humidity: **30-50% RH**
- Verify that the
weighing balance is **calibrated and functional**.
Check the **colorant or pigment label** for:
Ensure personal protective equipment (PPE) is worn:
- Material name
- Batch number
- Manufacturing and expiry date
- Storage conditions
- Gloves
- Face masks
- Safety goggles
- Protective gowns
5.2 Dispensing Process
- Place a **”Weighing in Progress”** sign outside the dispensing area.
- Use a **pre-verified and calibrated weighing balance**.
- Before weighing:
- Tare the balance correctly.
- Use an **appropriate weighing container**.
- Ensure that the colorant or pigment is **free from clumps or contamination**.
- During weighing:
- Dispense the required quantity as per the **Batch Manufacturing Record (BMR)**.
- Ensure a **uniformly mixed** colorant if blending is required.
- Record the weight in the **Colorant Dispensing Log (Annexure-1).**
5.3 Handling and Storage
- Store colorants and pigments in **designated areas with appropriate labels**.
- Ensure **airtight sealing** of colorant containers after dispensing.
- Protect light-sensitive colorants by storing them in **light-proof packaging**.
- Highly potent pigments should be handled in **dedicated ventilated booths**.
5.4 Handling Dispensing Deviations
- If the weighed quantity exceeds or falls below the tolerance limit:
- Stop weighing and notify QA immediately.
- Reweigh the material under supervision.
- Record the deviation in the **Dispensing Deviation Log (Annexure-2).**
- Rejected colorants must be:
- Quarantined and labeled as “Rejected”.
- Disposed of following waste disposal guidelines.
5.5 Post-Dispensing Activities
- Securely seal and label all colorants and pigments.
- Ensure proper documentation of all dispensed weights.
- Clean the balance and surrounding area to remove residual particles.
- Submit the completed dispensing log to the **QA department for review.**
5.6 Equipment Calibration and Maintenance
- Weighing balances must be calibrated **daily before use.**
- QA must perform **weekly verification** of calibration records.
- Defective balances must be **tagged as “Out of Service”** and reported for maintenance.
6. Abbreviations
- GMP – Good Manufacturing Practices
- QA – Quality Assurance
- QC – Quality Control
- BMR – Batch Manufacturing Record
- FDA – Food and Drug Administration
- ICH – International Council for Harmonisation
7. Documents
- Colorant Dispensing Log (Annexure-1)
- Dispensing Deviation Log (Annexure-2)
8. References
- ICH Q7 – GMP for Active Pharmaceutical Ingredients
- WHO Guidelines on Safe Handling of Colorants
- FDA Guidance on Pharmaceutical Manufacturing
9. SOP Version
Version 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Colorant Dispensing Log
| Date | Colorant Name | Batch No. | Required Weight | Actual Weight | Operator | QA Review |
|---|---|---|---|---|---|---|
| 02/02/2025 | Red Lake | CLR-1001 | 3.0 kg | 3.01 kg | John Doe | Approved |
Annexure-2: Dispensing Deviation Log
| Date | Colorant Name | Batch No. | Deviation Type | Root Cause | Corrective Action | QA Approval |
|---|---|---|---|---|---|---|
| 02/02/2025 | Red Lake | CLR-1001 | Overweight | Operator Error | Reweighed | Approved |