Standard Operating Procedure for Gowning Procedure

1) Purpose

This SOP outlines the gowning procedures to be followed by personnel entering controlled environments, such as cleanrooms, to prevent contamination of pharmaceutical products.

2) Scope

This SOP applies to all personnel who are required to gown and enter controlled environments within the pharmaceutical manufacturing facility.

3) Responsibilities

Personnel entering controlled environments are responsible for following the gowning procedures outlined in this SOP. Quality Assurance (QA) oversees compliance with this SOP and regulatory requirements.

4) Procedure

4.1 Gowning Requirements

1. Ensure personnel are trained on gowning procedures and hygiene practices before entering controlled environments.
2. Verify that cleanroom garments (e.g., coveralls, hoods, boots) are correctly sized and in good condition.

4.2 Gowning Sequence

1. Perform hand hygiene using approved methods (e.g., hand washing, sanitization).
2. Don gowning attire in a designated gowning area according to the gowning sequence specified for the cleanroom class.
3. Ensure proper donning of garments to prevent skin and hair exposure.

4.3 Entry Procedure

1. Proceed to the entry point of the controlled environment after completing gowning.
2. Undergo a visual inspection by a trained observer to ensure compliance with gowning requirements.

4.4 Behavior in Cleanrooms

1. Maintain appropriate behavior and movements within the cleanroom to minimize particle generation and contamination risks.
2. Report any breaches in gowning integrity or observed contamination incidents to supervisors immediately.

4.5 Exit Procedure

1. Upon exiting the controlled environment, remove gowning attire in the designated doffing area.
2. Dispose of single-use garments properly or place reusable garments for laundering or sterilization.

4.6 Training and Record Keeping

1. Provide regular training sessions on gowning procedures and cleanliness practices for personnel.
2. Maintain records of gowning training, gowning qualification, and any deviations noted during gowning inspections.

5) Abbreviations, if any

SOP: Standard Operating Procedure
QA: Quality Assurance

6) Documents, if any

Gowning Procedure Protocol, Gowning Training Records, Gowning Inspection Reports

7) Reference, if any

Regulatory guidelines such as EU GMP Annex 1 Manufacture of Sterile Medicinal Products, ISO 14644 Cleanrooms and associated controlled environments, FDA Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing – Current Good Manufacturing Practice

8) SOP Version

Version 1.0