Author: Auditor

SOP for Raw Material Certificate of Analysis Review Procedure

Purpose: The purpose of this procedure is to define the process for reviewing Raw Material Certificates of Analysis (COA) to ensure that the raw materials received meets the required specifications and comply with regulatory requirements. Scope: This procedure applies to all raw materials received by the company. Responsibilities: The Quality Control (QC) team is responsible…

Raw Material Stores

SOP for Raw Material Rejection Procedure

SOP: Raw Material Rejection Procedure 1. Purpose: The purpose of this SOP is to define the procedure for the rejection of raw materials that do not meet the required quality standards. This is to ensure that only high-quality materials are used in the manufacturing of products, thereby meeting customer requirements and improving product quality. 2….

Raw Material Stores

SOP for Raw Material Expiry Date Management Procedure

1. Purpose: The purpose of this SOP is to establish a procedure for the effective management of raw material expiry date to ensure that materials are used within their shelf life. 2. Scope: This procedure applies to all raw materials used in the production processes at the company. 3. Responsibilities: a. Procurement Department: Responsible for…

Raw Material Stores

SOP for Raw Material CoA Retention Procedure

SOP for Raw Material CoA Retention Procedure Purpose: To establish a standard procedure for the retention of raw material Certificate of Analysis (CoA) that ensures that the CoA is available when needed and can be retrieved easily. Scope: This SOP applies to the retention of raw material Certificate of Analysis for all raw materials used…

Raw Material Stores

SOP for Stability Study Report Preparation

SOP for Stability Study Report Preparation: General steps that can be followed: 1. Identify the objective of the stability study and the regulatory guidelines that need to be adhered to. 2. Collect and record all relevant information for the study such as the product name, lot number, manufacturing date, expiration date, storage conditions, and analytical…

Quality Control

SOP for Stability Study Protocol Preparation

SOPs for stability study protocol preparation: 1. Identify the objective of the stability study clearly. This should include the purpose of the study, the samples being studied, the duration of the study, and the expected outcome. 2. Use established guidelines and regulations such as International Council for Harmonisation (ICH) guidelines and Good Manufacturing Practices (GMP)…

Quality Control

SOP for Stability Study Design

Here is the general outline that can be followed while designing an SOP for Stability Study Design: 1. Objective/Purpose: Define the objective or purpose of the study to ensure that all stakeholders involved understand the expected outcome. 2. Scope: Clearly define the scope of the study to ensure everyone involved is aware of the limitations…

Quality Control

SOP for Sterility Assurance Level (SAL) Testing

1. Purpose: The purpose of this Standard Operating Procedure (SOP) is to provide guidance for Sterility Assurance Level (SAL) testing of sterile medical devices and products. 2. Scope: This SOP covers the procedures for conducting SAL testing of sterile medical devices and products. The testing is carried out to ensure that the product is free…

Microbiology Testing

Microbiology Testing: SOP for Media Fill Testing

SOP for Media Fill Testing: 1.0 Purpose: The purpose of this SOP is to outline the procedure for conducting Media Fill Tests in Pharmaceutical Manufacturing. 2.0 Scope: This SOP applies to all personnel involved in Media Fill Testing in Pharmaceutical Manufacturing. 3.0 Responsibility: 3.1 Quality Assurance – Responsible for reviewing the SOP and ensuring adherence…

Microbiology Testing

Raw Material Sampling Plan: Procedure for Water Sampling

The Raw Material Sampling Plan Procedure for Water outlined in this SOP is critical to ensuring the quality and safety of the water used in the manufacturing processes. By following this procedure, the company can ensure that all water used in the manufacturing processes meets the specified quality standards and does not pose any health…

Raw Material Stores