Standard Operating Procedure for Validation of Processes and Methods in Otic Manufacturing Unit
1) Purpose
To establish procedures for the validation of processes and analytical methods used in the manufacturing of Otic (Ear) Dosage Forms to ensure reliability, accuracy, and consistency of results.
2) Scope
This SOP applies to all processes and analytical methods used in the Otic manufacturing unit, including but not limited to formulation, manufacturing, packaging, and quality control.
3) Responsibilities
Quality Assurance (QA) Department: Responsible for overall validation activities and documentation.
Quality Control (QC) Department: Responsible for validating analytical methods and reviewing validation protocols.
Production Department: Responsible for validating manufacturing processes and ensuring compliance.
R&D Department: Responsible for providing input and support during method development and validation.
4) Procedure
4.1 Process Validation
4.1.1 Protocol Preparation
4.1.1.1 Develop a validation protocol outlining objectives, scope, acceptance criteria, and methodology.
4.1.1.2 Obtain approval from QA and relevant departments before initiating validation studies.
4.1.2 Process Qualification
4.1.2.1 Conduct Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) as per protocol.
4.1.2.2 Document results and deviations encountered during qualification activities.
4.2 Method Validation
4.2.1.1 Develop analytical methods based on product specifications and regulatory requirements.
4.2.1.2 Validate methods for accuracy, precision, specificity, linearity, and robustness.
4.2.2 Validation Protocol
4.2.2.1 Prepare a validation protocol detailing method validation parameters and acceptance criteria.
4.2.2.2 Obtain approval from QA and QC departments before initiating validation studies.
4.3 Validation Execution
4.3.1 Process Validation
4.3.1.1 Execute IQ, OQ, and PQ activities under controlled conditions.
4.3.1.2 Monitor critical process parameters and document deviations and corrective actions.
4.3.2 Method Validation
4.3.2.1 Perform method validation experiments using suitable test samples and standards.
4.3.2.2 Record data, analyze results, and verify compliance with predefined acceptance criteria.
4.4 Validation Report
4.4.1 Compilation of Results
4.4.1.1 Compile validation data, including protocols, results, and conclusions.
4.4.1.2 Review and approve validation reports by QA and relevant departments.
4.4.2 Documentation
4.4.2.1 Maintain all validation records, including protocols, raw data, and final reports.
4.4.2.2 Archive documents as per document retention policies.
5) Abbreviations, if any
SOP: Standard Operating Procedure
IQ: Installation Qualification
OQ: Operational Qualification
PQ: Performance Qualification
6) Documents, if any
Validation protocols
Validation reports
Method validation data and records
7) Reference, if any
GMP guidelines for pharmaceutical manufacturing
ICH guidelines for method validation
8) SOP Version
Version 1.0
