The Most Important Compliance Best Practices You Need to Know

Annual Product Review (APR) - Product Quality Review (PQR) reports are the first documents reviewed by health authorities while inspecting a manufacturing facility. The importance of this report is such that even a small error in reported data may have severe impact on product quality and patient safety. Considering its criticality and importance, organizations must try to eliminate errors through process standardization and automation.

This White Paper by Aman Gupta explains six steps that can lead to successful execution of APR-PQR process automation, helping eliminate regulatory reporting errors.

About the Author:

Aman Gupta is an experienced business process consultant. He has worked in several industries including Pharma to help clients in streamlining their processes for productivity gains. He is a CPIM & CSCP (Certified in Production and Inventory Management & Certified Supply Chain Professional), having good command on process areas like demand management, regulatory compliance, online campaign management, supply chain and software package implementation. He can be reached at [email protected].

In this article, Yara Almouti, an expert on pharmaceutical cGMP, will further detail the requirements of ISO 14644-1. The article discusses the statistical treatment of the particle concentration test results data, and gives an example of the application of all the theories and equations mentioned in the previous article in this series.

Internal Audit, a term hated by most in the organization. Audit team will probe into all the activities for conformity. Internal audit team works on behalf of the organization for internal purposes and forms the basis for company’s self declaration of conformity. These audits are scheduled and completed within the specified time to ensure the company’s quality management systems are maintained as per ISO 9001 standard requirements and are maintained as per company’s requirement and audits criteria.

Internal audit report provides the visibility to the top management vis-a-vis the conformance to the established criteria. What are the ISO 9001 Standard requirements for maintaining internal audit system?

Many companies across all industries have decided to focus on their core competencies and have outsourced manufacturing of some components, as well as specialty services to a partner, who may only be a driving distance away. However, ensuring quality of the outsourced components and services is a challenge for most organizations.

Six Sigma is a set of concepts and methodologies that aims at achieving perfect business processes wherein the total number of defects never exceeds 3.4 per million opportunities that exists for such defects to occur. Six sigma uses a wide variety of statistical tools and techniques some of them being control charts, defect measurements matrices, pareto diagram, process mapping, SPC, FMEA etc.

Six Sigma relies on two key methodologies viz; DMAIC (Design, Measure, Analyze, Improve and Control) and DMADV (Design, Measure, Analyze, Design and Verify) for making necessary improvements in business processes.

More on Six Sigma and its methodologies read on