SOP for Control of Cross-contamination : Pharmaceutical Guidelines

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SOP for Control of Cross-contamination

Standard operating procedure to control the cross contamination in batch during dispensing and manufacturing of product.

1.0 OBJECTIVE

To describe the procedure for controlling and preventing cross-contamination in the dispensing area during operations.

2.0 SCOPE

This procedure applies to the manufacturing facilities.

3.0 RESPONSIBILITY

Warehouse- Officer.

4.0 ACCOUNTABILITY

Warehouse- Asst. Manager.

5.0 PROCEDURE

Following controls are to be maintained in Dispensing area:
5.1 Following the dress code for dispensing areas and always use hand gloves and nose mask while working.
5.2 Ensure that the AHU’s is ON one hour before starting the activity by recording the pressure differential.
5.3 Always clean and disinfect the area as per related SOP before start-up of the activity. Always clean and disinfect the floors, walls, ceiling, doors and other facilities as per the respective SOP.
5.4 Check that the instrument being used is calibrated and within their valid date of calibration.
5.5 Always put status label on all equipment and measuring instrument.
5.6 Ensure that purified water is at the temperature not less than 80 °C through a continuous recirculation loop at the time of usage.
5.7 Maintain the dispensing area at positive pressure.
5.8 In the dispensing area provide adequate segregation for different materials and equipment.
5.9 Keep the personnel traffic at the minimum in dispensing areas.
5.10 Take line clearance every day before starting dispensing activity and after product or batch change over.
5.11 Do the dispensing of all raw materials under the reverse airflow hood, started at least one hour before activity.
5.12 Keep raw materials separately batch wise and with proper identification label on SS pallet.
5.13 Label all sanitizing agents (70%IPA) purified water bottle with collection date and use before dates.
5.14 Dispensed one material at a time.

5.15 Sanitize washed equipment, utensils with freshly prepared 70% IPA solution, dry and covered with the clean polybag when not in use.
5.16 Ensure that all the materials are opened and placed under reverse laminar airflow during dispensing activity.
5.17 Clean the container outside then bring it in the dispensing room.
5.18 Dispense one material at one time.
5.19 Clean area after product change over.
5.20 Ensure S.S.scoops, spatula, etc are clean and dry.

6.0 ABBREVIATIONS

6.1 SOP: Standard Operating Procedure
6.2 AHU: Aur Handling Unit
6.3 IPA: Isp Propyl Alcohol





Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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