manufacturing. This SOP ensures compliance with GMP and maintains product sterility.

2. Scope

This SOP applies to all sterile components that are received, handled, visually inspected, and aseptically dispensed in the sterile component preparation areas of the injectable manufacturing facility.

3. Responsibilities

• Warehouse Executive: Responsible for receiving and issuing sterile components in appropriate packaging conditions.
• Aseptic Area Staff: Handles components under laminar airflow conditions using sterile techniques.
• QA Executive: Verifies sterility tags, inspection records, and approves batch usage.

4. Accountability

The Head of Manufacturing is accountable for implementation and oversight of this SOP, ensuring strict adherence to aseptic practices and documentation requirements.

5. Procedure

5.1 Receipt and Transfer

1. Receive sterile components from suppliers along with Certificate of Sterility and CoA.
2. Ensure all components are in double- or triple-layer sterile packaging with intact tamper-proof seals.
3. Transfer to sterile quarantine storage as per material movement SOP.

5.2 Verification and Visual Inspection

1. Inspect components for physical damage, color changes, particulate matter, and seal integrity under controlled lighting.
2. Record inspection results in the Sterile Component Inspection Log (Annexure-1).
3. Components failing visual inspection must be segregated and labeled “REJECTED.”

5.3 Area Preparation for Dispensing

1. Verify cleaning status of RLAF/laminar booth before use.
2. Perform sanitization using sterile 70% IPA and allow for contact time.
3. Ensure gowning is performed per aseptic entry SOP (validated garments, gloves, masks, etc.).

5.4 Aseptic Dispensing of Sterile Components

1. Open outer packaging of sterile components in outer zone, and inner sterile packs inside RLAF.
2. Use sterile forceps or gloved hands (disinfected with sterile IPA) to handle components.
3. Count and dispense as per BMR/BPR with ±1% tolerance.
4. Place components in sterile polybags or trays and seal immediately.
5. Affix sterile labels indicating name, quantity, date, and operator initials.

5.5 Documentation and Release

1. Record all dispensed quantities and traceability in the Component Dispensing Log (Annexure-2).
2. QA Officer to verify all documentation, inspection records, and approve release in Release Authorization Form (Annexure-3).

6. Abbreviations

• SOP: Standard Operating Procedure
• QA: Quality Assurance
• CoA: Certificate of Analysis
• BMR: Batch Manufacturing Record
• IPA: Isopropyl Alcohol
• RLAF: Reverse Laminar Air Flow

7. Documents

1. Sterile Component Inspection Log – Annexure-1
2. Component Dispensing Log – Annexure-2
3. Release Authorization Form – Annexure-3

8. References

• WHO TRS 961 Annex 6 – GMP for Sterile Medicinal Products
• ICH Q9 – Quality Risk Management
• Schedule M – Indian GMP

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation	Warehouse Executive	QA Officer	Head – Manufacturing
Department	Warehouse	Quality Assurance	Sterile Injectable Manufacturing

11. Annexures

Annexure-1: Sterile Component Inspection Log

Date	Component	Batch No.	Inspected By	Observation	Status
17/06/2025	Rubber Stopper	RS-2025-BN01	Rajesh Kumar	No defects	Approved

Annexure-2: Component Dispensing Log

Date	Component	Batch No.	Qty	Dispensed By	Verified By
17/06/2025	Rubber Stopper	RS-2025-BN01	5,000 Nos	Meena Iyer	Sunita Reddy

Annexure-3: Release Authorization Form

Component Name	Rubber Stopper
Batch Number	RS-2025-BN01
Quantity Released	5,000 Nos
Released By (QA)	Sunita Reddy
Date	17/06/2025

Revision History

Revision Date	Revision No.	Details	Reason	Approved By
10/03/2022	1.0	Initial release	GMP compliance	QA Head
17/06/2025	2.0	Added RLAF setup and inspection log	Annual Review	QA Head