In the pharmaceutical industry, “deviation in pharma” refers to any departure from approved processes, procedures, specifications, or expected outcomes. These deviations can occur during manufacturing, testing, packaging, or storage of pharmaceutical products. Managing deviations is critical to ensure product quality,…
Types of Market Complaints Complaint Handling Process in Pharma Regulatory Expectations Complaint Trending and Analysis Best Practices Q1: What is a market complaint?A: A market complaint is any written, verbal, or electronic communication from a customer, patient, or healthcare provider…
“Incidents in Pharma” can refer to a wide range of unplanned events or deviations that occur during pharmaceutical manufacturing, testing, storage, or distribution. These incidents can affect product quality, patient safety, regulatory compliance, and operational efficiency. Common Types of Incidents…
Change Control in pharma is a structured, documented process used to manage any planned change that may impact product quality, patient safety, regulatory compliance or validated status of facilities, utilities, equipment, documents and computerized systems. A robust change control system…
In pharma, artworks are the controlled master designs for all printed packaging components—cartons, labels, foils, leaflets, shippers, inserts, booklets, and sometimes on-pack overprint layouts. They translate the approved product information (name, strength, composition, warnings, storage, manufacturer details, batch/expiry fields, barcodes/2D…
Line clearance in the pharmaceutical industry is a critical process that ensures a production line is free from contaminants, previous product residues, and unauthorized materials before starting a new batch or product. It helps maintain Good Manufacturing Practices (GMP) and…
Why Pharma Policies Are Important Key Pharma Policies (Typical Set) You can adapt or expand this list based on your company size and complexity. Structure of a Good Pharma Policy A clear policy document usually includes:
Self-inspection in the pharmaceutical industry is a critical aspect of Good Manufacturing Practices (GMP) compliance. It involves an internal audit conducted by a pharmaceutical company to evaluate its processes, facilities, and systems to ensure they meet regulatory requirements and internal…
Contamination and Cross-Contamination in Pharmaceuticals are critical concerns in maintaining product quality, safety, and regulatory compliance. Here’s a clear breakdown of both concepts, causes, risks, and control strategies: 1. Definitions Contamination Unintended introduction of impurities (chemical, microbial, physical, or foreign…
A User Requirement Specification (URS) is a formal document that outlines the needs of a user for a system, product, or service. In the pharmaceutical industry, a URS is a crucial document that ensures that equipment, processes, or systems meet regulatory standards…
The URS is a definition of requirements to fulfil the demands of the process from the Users’ point of view. The success of a GMP clean room design is dependent on a clear and concise User Requirement Specification (URS) to take…
A User Requirement Specification for DPI is a formal document that defines the requirements for using a system in a regulated environment, such as a pharmaceutical facility. It’s a living document that can be updated as requirements change and is typically prepared…