Standard Operating Procedure for Equipment Qualification in Gels Production
1) Purpose
The purpose of this SOP is to establish procedures for the qualification of equipment used in the manufacturing of gels to ensure that equipment is suitable for its intended use and capable of producing quality products.
2) Scope
This SOP applies to all equipment used in the pharmaceutical manufacturing facility’s gels production department, including but not limited to mixing tanks, filling machines, and packaging equipment.
3) Responsibilities
Quality Assurance (QA) Team: Oversee equipment qualification activities and ensure compliance with SOPs.
Engineering Department: Perform equipment qualification protocols and maintain records.
Production Supervisors: Coordinate equipment qualification activities with production schedules.
4) Procedure
4.1 Equipment Identification
4.1.1 Compile a list of all equipment used in gels production that requires qualification.
4.1.2 Assign unique identification numbers or codes to each piece of equipment for tracking purposes.
4.2 Installation Qualification (IQ)
4.2.1 Verify that equipment is correctly installed according to manufacturer specifications and facility requirements.
4.2.2 Document installation qualification activities and observations.
4.3 Operational Qualification (OQ)
4.3.1 Perform operational tests to ensure equipment operates within defined parameters.
4.3.2 Document operational qualification protocols and results.
4.4 Performance Qualification (PQ)
4.4.1 Conduct performance tests under actual or simulated production conditions to demonstrate consistent performance.
4.4.2 Document performance qualification protocols, acceptance criteria, and results.
4.5 Requalification
4.5.1 Establish a requalification schedule based on equipment criticality and regulatory requirements.
4.5.2 Perform periodic requalification activities to ensure ongoing equipment reliability and compliance.
5) Abbreviations, if any
SOP: Standard Operating Procedure
QA: Quality Assurance
IQ: Installation Qualification
OQ: Operational Qualification
PQ: Performance Qualification
6) Documents, if any
– Equipment List for Qualification
– Installation Qualification (IQ) Reports
– Operational Qualification (OQ) Reports
– Performance Qualification (PQ) Reports
7) Reference, if any
– FDA Guidance for Industry: Process Validation: General Principles and Practices
– EU GMP Annex 15: Qualification and Validation
– Company-specific equipment qualification procedures and guidelines
8) SOP Version
Version 1.0