Pharma Digest
An Overview of Supply Chain Management in Pharmaceutical Industry
Supply chain management is the successful management and planning of all supply chain activities that take place in a business. This can include logistics, sourcing and product development. Its aim to gain competitive advantages and customer satisfaction with better use of assets and resources. The coordination of daily information about ... Read More
Quality Plan for a Product or Service Realization
The product and service provision planning process defines the following controls, as appropriate to the product. This plan is sometimes called a quality plan. The quality objectives and regulations The necessary processes, documents and resources The required checks and criteria for product acceptance The records needed Planning also leads into ... Read More
CAPA Management in FDA Regulated Industry
A CAPA plan is a quality management strategy used in the manufacturing and production industries to identify and rectify defects to ensure they won’t repeat again in the future. Once a CAPA plan is implemented, it must illustrate ten objectives to meet the intent of the FDA 21 CFR 820.100 ... Read More
Product Quality and Performance Tests for the Microsphere Drug Products
Microparticulate systems such as microspheres, microcapsules, or any particle in a micrometer scale (usually of 1–1000 µm) are widely used as drug delivery systems, owing to their higher therapeutic and diagnostic performance compared to conventional drug delivery forms. These systems can be manufactured with many raw materials, especially polymers, most ... Read More
The Power of Root Cause Analysis | A Lifeline for the Pharmaceutical Industry
The pharmaceutical industry operates under a microscope, with every step demanding unwavering adherence to stringent quality standards. A single mistake can have devastating consequences, from product recalls to compromised patient safety. This is where “Root Cause Analysis (RCA)” takes center stage, becoming a vital tool for preventing future failures and ... Read More
SOP for CAPA (Corrective and Preventive Action) Handling Procedure
1.0 PURPOSE To lay down a procedure to be followed for administration of corrective and Preventive actions (CAPA) including tracking and reporting of the status of CAPA. 2.0 SCOPE 2.1 This procedure is applicable for all Corrective and Preventive Action that are recommended if any, but not limited to the ... Read More
Internal Audit Process in the Pharma Industry
In the ever-evolving landscape of the pharmaceutical industry, the role of Quality Assurance departments has never been more critical. As professionals committed to ensuring the highest standards of product quality and patient safety, we often find ourselves at the heart of rigorous internal audit processes. But what makes these audits ... Read More
Batch Record Review in the Life Sciences Industry
In the life sciences sector, ensuring product quality and compliance is paramount. One critical aspect of maintaining these standards is the thorough review of batch records. Here’s why effective batch record review is essential and how it can be optimized: Regulatory Compliance: Batch records are legal documents required by regulatory ... Read More
Site Master File in Pharmaceutical Industry
In the world of pharmaceutical manufacturing, understanding and maintaining high standards of quality is not just important, it’s imperative. A key element in this quality assurance landscape is the Site Master File (SMF), but what is it? An SMF is a comprehensive document that provides detailed information about the production ... Read More
Root Cause Analysis (RCA) in Pharma Industry
Root cause analysis (RCA) is a structured method for identifying the main cause of a problem and implementing changes to the system. RCA tools and techniques that can be used in CAPA The 5 Whys: A simple technique that involves asking “why” five times to get to the root cause ... Read More
The Power of Effective Change Control Programs in Pharma Industry
In the fast-evolving landscape of the life sciences industry, the ability to manage change effectively isn’t just beneficial; it’s essential. Change control programs are at the heart of this, ensuring that any changes in processes, equipment, or materials are implemented in a controlled and systematic manner. Why is this important? ... Read More