Documentation
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
Difference Between Batch Record and Master Batch Record
To ensure quality and safety in pharmaceutical production, Good Manufacturing Practices (GMP) require detailed documentation of production processes. What is a master batch record? A master batch record (MBR), also known as a master production record (MPR) is a document that contains the approved ingredients, formulation, and instructions guiding the ... Read More
Annual Product Review in Pharmaceutical Industry
An annual product review (APR) should be conducted for every commercial product in pharmaceutical industry. The objective of this review is to: APR Relationship to the Quality System SOP for Annual Product Review (APR) Table of Contents Scope and Objectives 1. Applied separately to each product, or product groups, annually. ... Read More
Batch Production Record in Pharmaceutical Industry
Batch production record an important tool in Pharma industry. Always I do believe that, every GMP document in the Pharma industry should be written and reviewed by subject matter experts (SMEs). The insights of the document author and reviewer help in making the document written in logical sense with clear ... Read More