screening using vibratory sifters or hand sieves.

3. Responsibilities

• Production Operator: Perform screening as per defined mesh size and record activities.
• Production Supervisor: Verify equipment setup, process parameters, and cleanliness before use.
• QA Officer: Approve area and equipment line clearance before screening and verify final documentation.

4. Accountability

The Production Head is accountable for proper execution of screening. QA Head is responsible for final approval and release of screened batch.

5. Procedure

5.1 Pre-Screening Preparation

1. Ensure the drying operation is complete and final LOD results are within specification.
2. Confirm the equipment (sieve, sifter, container) is cleaned and labeled “CLEANED”.
3. Verify line clearance from QA using the Screening Line Clearance Checklist (Annexure-1).

5.2 Equipment Setup

1. Choose appropriate sieve mesh size as per Master Batch Record (e.g., 40#, 60#, or 80#).
2. Assemble the screen securely onto the sifter or frame.
3. Ensure the container to collect screened API is clean and labeled with product details.
4. Record equipment ID and sieve mesh size in the Batch Manufacturing Record (BMR).

5.3 Screening Process

1. Load dried API powder gradually into the screen feed hopper or tray.
2. If using vibratory sifter, start the motor and set the vibration frequency (e.g., 30–50 Hz) based on product flow.
3. Allow material to pass through completely, gently tapping or adjusting flow if clogging occurs.
4. Visually check for any oversized material retained and document if any foreign matter is observed.
5. Transfer the screened API into cleaned SS containers lined with double polybags.

5.4 Post-Screening Activity

1. Weigh total quantity of screened API and update in the BMR.
2. Label each container with:
   • Product Name
   • Batch No.
   • Net Weight
   • Screened on (Date)
3. Submit sample for final analysis to QC.
4. Clean equipment as per SOP/API/074/2025 and label “To Be Cleaned”.

6. Abbreviations

• API: Active Pharmaceutical Ingredient
• SOP: Standard Operating Procedure
• QA: Quality Assurance
• BMR: Batch Manufacturing Record
• LOD: Loss on Drying

7. Documents

1. Screening Line Clearance Checklist (Annexure-1)
2. Equipment Cleaning Record
3. Batch Manufacturing Record

8. References

• ICH Q7 – Good Manufacturing Practice for Active Pharmaceutical Ingredients
• FDA 21 CFR Part 211 – Current GMP for Finished Pharmaceuticals
• Internal QA Guidelines for Equipment Usage

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Screening Line Clearance Checklist

Date	Batch No.	Sieve Size	Area Clean	Equipment Clean	Line Cleared By (QA)	Remarks
13/04/2025	API-20250413	60#	Yes	Yes		Approved for screening

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
01/01/2022	1.0	Initial SOP Release	New SOP	QA Head
13/04/2025	2.0	Included vibratory sifter controls and checklist	Regulatory Audit Feedback	QA Head