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February 25, 2025

Standard Operating Procedure (SOP) for Cleaning, Derouging, and Passivation of Stainless Steel Parts of a Purified Water System

Document ID: SOP-TEMP-001 (Example) Revision Number: 01 (Example) Effective Date: 2024-03-08 (Example) Author: [Your Name/Department] Approver: [QA/QC Department] 1. Purpose: This SOP outlines the procedure for cleaning, derouging, and passivating the stainless steel components of the purified water system to ensure the removal of organic and inorganic contaminants, including rouge (iron oxide), and to establish a passive chromium oxide layer […]

0 3 min read
February 25, 2025

Standard Operating Procedure (SOP) for Validation of Deviation Management in Analytical Laboratory

Document ID: SOP-TEMP-001 (Example) Revision Number: 01 (Example) Effective Date: 2024-03-08 (Example) Author: [Your Name/Department] Approver: [QA/QC Department] 1. Purpose: This SOP outlines the procedure for validating the deviation management system within a drugs testing and analytical laboratory. This validation aims to ensure the system effectively identifies, documents, investigates, and resolves deviations from established procedures, standards, and quality requirements, maintaining […]

0 3 min read
February 21, 2025

Standard Operating Procedure for Calibration Procedure (Ice Point) for Thermometers and Thermocouples

Document ID: SOP-TEMP-001 (Example) Revision Number: 01 (Example) Effective Date: 2024-03-08 (Example) Author: [Your Name/Department] Approver: [QA/QC Department] 1.0 Purpose This Standard Operating Procedure (SOP) outlines the procedure for calibrating thermometers and thermocouples using the ice point method. This method provides a reliable and practical way to establish a reference point at 0°C (32°F) for accurate temperature measurements. This calibration […]

0 5 min read
February 21, 2025

Standard Operating Procedure for In-House Trial Procedure in a Pharmaceutical Manufacturing Firm

Document ID: SOP-MFG-001 (Example) Revision Number: 01 (Example) Effective Date: 2024-03-22 (Example) Author: [Your Name/Department – e.g., Process Development] Approver: [QA/Manufacturing Department] 1.0 Purpose This Standard Operating Procedure (SOP) outlines the procedures for conducting in-house trials (also known as pilot trials, scale-up studies, or engineering runs) within [Organization Name/Pharmaceutical Manufacturing Firm]. In-house trials are small-scale experiments or manufacturing runs conducted […]

0 6 min read
February 21, 2025

Standard Operating Procedure for In-House Trial Procedure in a Pharmaceutical Analytical Laboratory

Document ID: SOP-LAB-001 (Example) Revision Number: 01 (Example) Effective Date: 2024-04-05 (Example) Author: [Your Name/Department – e.g., Analytical Development] Approver: [QA/QC Department] 1.0 Purpose This Standard Operating Procedure (SOP) outlines the procedures for conducting in-house trials (also known as feasibility studies, method development studies, or validation studies) within the analytical laboratory of [Organization Name/Pharmaceutical Manufacturing Firm]. In-house trials in this […]

0 6 min read
February 20, 2025

Validation of Laboratory Instruments

The validation of laboratory instruments is a critical aspect of ensuring the reliability and accuracy of data generated in any laboratory setting. A robust validation process provides documented evidence that an instrument performs as intended, consistently and reliably, within its specified operating range. This article provides a detailed guide to the validation of laboratory instruments, covering key aspects from initial […]

0 6 min read
February 20, 2025

Equipment Specification and Qualification in Pharmaceutical Firms

In the highly regulated pharmaceutical industry, ensuring the quality and consistency of products is paramount. A crucial aspect of this quality assurance process is the proper specification and qualification of equipment. This article provides a detailed guide to equipment specification and qualification within pharmaceutical firms, outlining the key documents, procedures, and responsibilities involved. 1. Introduction: The Importance of Equipment Specification […]

0 6 min read
February 19, 2025

Standard Operating Procedure For Revalidation Procedure

Purpose: This document outlines the procedure for revalidating equipment, processes, and systems to ensure continued compliance with established standards and regulatory requirements. 1. Revalidation Categories 1.1. Process Revalidation: Generally, process revalidation (excluding sterile/aseptic processes) is not routinely performed. Validated status is maintained through the change control system. Revalidation outside of change control is considered only if there are repeated or […]

0 3 min read
February 19, 2025

Standard Operating Procedure (SOP) – Validation: Concept and Procedure

1.0 Purpose This SOP defines the validation process, encompassing the philosophy, responsibilities, procedures, documentation requirements, and revalidation program, to ensure consistent production of products meeting pre-determined specifications and quality attributes. 2.0 Scope This SOP applies to all validation activities related to new and existing equipment, processes, and systems within the manufacturing facility. 3.0 Definitions Validation: Establishing documented evidence that provides […]

0 5 min read
February 19, 2025

Performance Parameters Required for Assay Validation

This document provides a detailed overview of analytical method validation, covering performance parameters, validation steps, method capability, specificity, linearity, sensitivity, ruggedness, method transfer, stability-indicating assays, and compendial method validation. Performance Parameters Required for Assay Validation (Ref. USP 25 and ICH Q2A/B) The following performance parameters are typically required for assay validation, though some may depend on the specific test: Method […]

0 5 min read