Author: KBS.

A Standard Operating Procedure SOP for Internal Audits in Pharmaceuticals is a crucial document that outlines the systematic and standardized approach to conducting internal audits within a pharmaceutical company. Internal audits play a significant role in ensuring compliance with regulatory requirements, identifying areas for improvement, and maintaining the overall quality of pharmaceutical operations. Below is an example outline for an SOP for internal audits in the pharmaceutical industry: OBJECTIVE To define a standardized auditing process for internal audit to evaluate the compliance status to the Quality Management system, GMP and relevant regulatory requirements. REASON To identify strength and opportunity for improvement in operations so minimizing product quality risk. ...

Establishing Standard Operating Procedures Good Data and Record Management Practices (SOP for SOPs) also known as Good Documentation Practices (GDocP), is crucial in maintaining a high standard of data and record management within an organization. The following is a template outline for an SOP for SOPs, emphasizing good data and record management practices. PURPOSE All the Quality Management System and Good Manufacturing Practices (GMP) documents are prepared, properly reviewed and approved by appropriate authorities prior to issue or available at the appropriate locations. All Quality System records related to Quality Management System and GMP are properly identified, filed, indexed, stored, retained and disposed of. Distribution / Circulation/Retrieval Implementation Control. ...

A Standard Operating Procedure SOP for Vendor Qualification in Pharmaceuticals Industry is a crucial document that outlines the steps and criteria for assessing and approving suppliers and vendors. This SOP ensures that the vendors selected meet the necessary quality and regulatory standards to maintain the integrity of pharmaceutical manufacturing processes. Below is a sample outline for a Vendor Qualification SOP: PURPOSE: The purpose of this SOP is to outline the procedure for screening of potential external providers / vendor’s and to assist in evaluation, pre-qualification, selection and reassessment of Raw, Packing and General Materials (Local & Import) supplies by developing enrich vendor database, uphold external provider/vendor information pool to develop partnering/long ter...

SOP for Corrective Action in Pharmaceuticals Industry is crucial for maintaining quality and efficiency in any organization. Here's a general outline that you can customize based on your specific industry or organizational needs. Ensure that the SOP is easily accessible to all relevant personnel and is reviewed periodically to reflect any changes in processes or requirements. Regular training and awareness programs can help ensure that all team members are familiar with the Corrective Action Procedure. Objective: This procedure establishes the process to identify, track, complete the investigation of the problem and correct the causes of existing non-conformances including complaints in products, processes, the Pharmaceuticals Industry Quality Management System, and services in the Pharm...