Pharma Blog
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
Essential Skills for Pharma Auditors in Today’s Regulatory Landscape
As the pharmaceutical industry continues to evolve amidst regulatory changes and technological advancements, the role of auditors has never been more crucial. Pharma auditors are the guardians of compliance, quality, and integrity, ensuring that products meet the highest standards of safety and efficacy. The importance of their work cannot be ... Read More
Differences in Filing for Drug Master File in US, Canada and Europe
In Europe, when filing for a Drug Master File (DMF), the process revolves around stringent regulatory requirements set by the European Medicines Agency (EMA). In the United States, filing for a Drug Master File (DMF) is governed by the Food and Drug Administration (FDA), which has its unique set of ... Read More
LYRICA (Pregabalin) | Drug Digest
LYRICA (pregabalin) has been Pfizer’s flagship blockbuster brand for many years due to the fact that it has been approved in multiple indications. It has also been the highest-selling neurology brand for several years. As such, the company has tried using aggressive strategies to extend the brand’s lifecycle in order ... Read More
Key Steps for Successfully Replying to Dossier Queries
Here’s a strategy chart outlining the key steps for successfully replying to dossier queries. Understand the Inquiry: Review Dossier Contents: Identify Response Components: Organize Response Structure: Gather Supporting Information: Compliance Check: Clarity and Conciseness: Transparency and Honesty: Quality Assurance: Timely Submission: Follow-Up Protocol: Documentation and Recordkeeping: Read also: Resource Person: ... Read More
Base Line Noise in HPLC
While performing HPLC analysis with an existing method, sometimes we will observe more base line noise. However, we won’t observe that scenario previously. The major probability due to: About dirty mobile phase: Grade of organic solvet used for analysis. Especially In case of THF is there in mobile phase we ... Read More