Standard Operating Procedure (SOP)

Here’s a detailed Standard Operating Procedure (SOP) for Entry Into and Exit From the Suspension Manufacturing Area, followed by a list of relevant #hashtags you can use for documentation, training, or knowledge-sharing purposes.

1.0 Objective

To lay down the procedure for controlled entry and exit of personnel in the Suspension Manufacturing Area to prevent contamination, ensure hygiene, and maintain GMP compliance.

2.0 Scope

This SOP applies to all employees and visitors entering or exiting the Suspension Manufacturing Area at [Company Name].

3.0 Responsibility

4.0 Definitions

• GMP: Good Manufacturing Practice

• Suspension: A pharmaceutical formulation containing solid particles dispersed in a liquid

• Cleanroom: Controlled environment with low levels of pollutants used in manufacturing

5.0 Materials Required

• Disposable gown / cleanroom attire

• Head cap

• Face mask

• Gloves

• Footwear / shoe covers

• Hand sanitizer / disinfectant

• Gowning logbook

6.0 Entry Procedure

6.1 General Instructions

1. Ensure you are not suffering from any communicable disease before entry.

2. Personal items like mobile phones, jewelry, and watches must be left in lockers.

6.2 Gowning Procedure

1. Enter the change room through the designated personnel entry door.

2. Remove street clothes and change into company-approved cleanroom garments.

3. Wash hands thoroughly with antiseptic soap and dry with a sterile tissue.

4. Wear:

   • Cleanroom gown

   • Head cap (cover all hair)

   • Face mask (cover mouth and nose properly)

   • Gloves

   • Cleanroom footwear or shoe covers

5. Sanitize hands again before entering the airlock.

6. Enter the airlock and wait for a few seconds (if interlock system present).

7. Proceed into the Suspension Manufacturing Area only when fully gowned.

8. Log your name, date, and time of entry in the Area Entry Register.

7.0 Exit Procedure

1. Exit the area through the designated exit airlock.

2. Remove gloves and dispose of them in the appropriate bin.

3. Remove face mask, head cap, and gown in sequence, disposing of disposables or placing reusables in the laundry bin.

4. Wash and sanitize hands properly.

5. Change back into street clothes in the change room.

6. Record exit time in the Area Entry Register.

8.0 Precautions

• Do not re-enter without following full entry procedure.

• Always wear a fresh mask, cap, and gloves each time.

• Follow unidirectional flow (entry and exit through designated doors).

• Report any deviation in gowning or hygiene to the supervisor.

9.0 Documentation

Maintain the following:

• Gowning/Entry Register: Name, ID, date, time in/out, signature

• Deviation Log (if any non-compliance occurs)

10.0 Abbreviations

• SOP: Standard Operating Procedure

• GMP: Good Manufacturing Practice

• QA: Quality Assurance

11.0 Annexures

• Annexure 1: Entry/Exit Register Format

• Annexure 2: Gowning Checklist

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