Standard Operating Procedure for Cross-Contamination Prevention during Dispensing
| Department | Sterile Injectable Manufacturing |
|---|---|
| SOP No. | SOP/SIM/103/2025 |
| Supersedes | SOP/SIM/103/2022 |
| Page No. | Page 1 of 12 |
| Issue Date | 18/06/2025 |
| Effective Date | 20/06/2025 |
| Review Date | 18/06/2026 |
1. Purpose
To define the measures required to prevent cross-contamination during the dispensing of raw materials in sterile injectable manufacturing, thereby ensuring product quality and patient safety.
2. Scope
This SOP applies to all dispensing operations involving active pharmaceutical ingredients (APIs), excipients, and other raw materials at designated dispensing booths within sterile
injectable manufacturing areas.
3. Responsibilities
- Dispensing Operator: Ensure proper cleaning, segregation, and dedicated usage of materials and equipment.
- Production Supervisor: Monitor adherence to this SOP and arrange for cleaning validation, if required.
- QA Officer: Perform in-process checks and line clearance before each dispensing operation.
4. Accountability
The Production Head is accountable for enforcing and auditing this procedure to minimize contamination risks.
5. Procedure
5.1 General Controls
- Only one material should be dispensed in the dispensing booth at any given time.
- Ensure product labels are clearly affixed and contain correct material identification details.
- Display “Under Dispensing” signage during operation to restrict access.
5.2 Cleaning and Line Clearance
- Clean the dispensing booth before and after every batch using lint-free cloth and disinfectant (IPA 70%).
- Verify cleaning using a checklist and obtain QA clearance before dispensing.
- Document pre- and post-cleaning activities in the Cleaning Log (Annexure-1).
5.3 Equipment and Tools
- Use dedicated scoops, spatulas, containers, and balances for each material, labeled appropriately.
- Where equipment sharing is necessary, clean and verify as per validated cleaning procedure.
5.4 Air Handling and Flow Controls
- Ensure HEPA filters and laminar airflow units are operating correctly.
- Maintain unidirectional airflow and differential pressure of 10–15 Pa between adjacent areas.
5.5 Material Movement and Personnel Hygiene
- Use designated trolleys for transferring dispensed materials to the next processing stage.
- Personnel must wear full PPE and sanitize gloves with IPA every 30 minutes during dispensing.
6. Abbreviations
- SOP: Standard Operating Procedure
- HEPA: High-Efficiency Particulate Air
- IPA: Isopropyl Alcohol
- QA: Quality Assurance
7. Documents
- Cleaning Log – Annexure-1
- Line Clearance Form – Annexure-2
- Material Dispensing Log – Annexure-3
8. References
- EU GMP Annex 1 – Manufacture of Sterile Medicinal Products
- ICH Q9 – Quality Risk Management
- WHO GMP Guidelines for Pharmaceutical Products
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | Manufacturing Executive | QA Executive | Head QA |
| Department | Production | Quality Assurance | Quality Assurance |
11. Annexures
Annexure-1: Cleaning Log
| Date | Booth ID | Before Use | After Use | Operator | QA Verified |
|---|---|---|---|---|---|
| 18/06/2025 | DISP-003 | ✔ | ✔ | J. Mehta | A. Singh |
Annexure-2: Line Clearance Form
| Date | Batch No. | Product | QA Sign | Remarks |
|---|---|---|---|---|
| 18/06/2025 | VX21A | Injection Caffeine | S. Kumar | Cleared |
Annexure-3: Material Dispensing Log
| Date | Material Name | Qty Dispensed | Booth ID | Operator |
|---|---|---|---|---|
| 18/06/2025 | Sodium Ascorbate | 250 g | DISP-003 | M. Pawar |
Revision History
| Revision Date | Revision No. | Details | Reason | Approved By |
|---|---|---|---|---|
| 05/01/2022 | 1.0 | Initial Release | New SOP | QA Head |
| 18/06/2025 | 2.0 | Updated controls and added new annexures | Periodic Review | QA Head |