Contamination and cross-contamination are terminologies used in the pharmaceutical industry when products undesirably come into contact with or mix with other products or their parts. Contamination can occur in starting materials or products due to contact with other related products. The risk of accidental contamination may arise from the uncontrolled release of dust, gases, particles, … Read more
Pass boxes are cleanroom systems used to transfer materials from one area to another cleaned area through a controlled environment. Pass boxes help control contamination and cross-contamination by passing particular matter present on the surface of materials that are to be transferred. These materials automatically pass through the filter present on the pass box during … Read more
Documentation forms the base of any company’s Quality Management System and serves as an essential GMP requirement. Anyone handling GMP documents and documentation systems must understand the regulatory requirements. Requirement of Good Documentation Practice? Good Documentation Practice is essential for proof of invention, company operations, technology transfer, regulatory requirements, and liability protections. The Documentation System … Read more
GxP in pharmaceuticals is a set of Good Practices; it ensures the quality and effectiveness of products for drugs, food, medical equipment, and other life-serving products as per regulatory standards. Meaning of GxP in Pharmaceuticals: GxP is part of Good practice because it’s related to the manufacturing of life-saving products. GxP helped in controlling the … Read more
There is often confusion surrounding the terms validation, calibration, and qualification within the pharmaceutical industry. Let’s explore their differences with explanatory examples. Difference among Validation, Calibration, and Qualification 1. Qualification: Qualification is the process of planning, conducting, and documenting test results performed on equipment to confirm its operational capability. It demonstrates that the equipment will … Read more
After completing the Design Specification and Design Qualification for new equipment, a user inspection is typically conducted before the delivery to the site. This inspection is referred to as the Factory Acceptance Test (FAT). The manufacturer of a machine will prepare the FAT protocol based on the Design Qualification, as per the built machine specification, … Read more
In the pharmaceutical industry, it’s essential to have sufficient lux or light intensity for carrying out work accurately. If the work area lacks proper illumination, it can lead to issues such as eye strain and fatigue, especially during detailed work. Excessive lighting is also unnecessary, as it may result in glare and dazzle. According to … Read more
These days, choosing the right material for constructing manufacturing equipment parts is an important aspect. Manufacturing equipment is usually made of stainless steel, with various alloys in SS such as 304, 316, and 316L. These alloys are widely used and valuable. Type 304 is a commonly used alloy in the group of steel known as … Read more