Standard Operating Procedure for Gowning and Degowning Procedures

1) Purpose

The purpose of this SOP is to establish standardized procedures for gowning and degowning to ensure that manufacturing personnel maintain a controlled and contaminant-free environment during the production of injection products.

2) Scope

This SOP applies to all personnel who enter controlled environments at [Company Name] for the manufacturing of intramuscular, subcutaneous, and intravenous injection products.

3) Responsibilities

The responsibilities of this SOP include:
– Manufacturing Staff: Adhering to gowning and degowning procedures.
– Supervisors: Monitoring compliance with gowning and degowning practices.
– Quality Assurance (QA) Department: Conducting periodic audits and training on gowning and degowning procedures.

4) Procedure

4.1 Gowning Procedure
4.1.1 Enter the gowning area through the designated entry point.
4.1.2 Remove all personal items such as jewelry, watches, and non-essential clothing.
4.1.3 Perform hand hygiene using soap and water or an alcohol-based hand sanitizer.
4.1.4 Don the sterile gown starting with the hood, followed by the coverall, boots, gloves, and mask. Ensure that each piece is worn correctly and securely.
4.1.5 Check for proper fit and integrity of the gowning materials to ensure no skin or personal clothing is exposed.
4.2 Degowning Procedure
4.2.1 Exit the controlled environment through the designated degowning area.
4.2.2 Remove gowning items in the reverse order of gowning (mask, gloves, boots, coverall, and hood).
4.2.3 Dispose of single-use items in the appropriate waste containers.
4.2.4 Place reusable items in designated containers for cleaning and sterilization.
4.2.5 Perform hand hygiene after degowning.
4.3 Training
4.3.1 The QA Department should provide regular training on gowning and degowning procedures and the importance of maintaining a contaminant-free environment.
4.3.2 Training records should be maintained for each staff member.
4.4 Monitoring and Compliance
4.4.1 Supervisors should conduct daily checks to ensure proper gowning and degowning procedures are followed.
4.4.2 The QA Department should perform periodic audits and report any non-compliance issues, followed by corrective actions.
4.5 Documentation
4.5.1 Maintain records of training sessions, daily compliance checks, and periodic audits.
4.5.2 Ensure all records are signed and dated by the responsible personnel.

5) Abbreviations, if any

– QA: Quality Assurance

6) Documents, if any

– Training Records
– Daily Gowning and Degowning Compliance Checklists
– Audit Reports

7) Reference, if any

– Good Manufacturing Practices (GMP) Guidelines
– International Organization for Standardization (ISO) Standards

8) SOP Version

Version 1.0