Change control is Managing to control a change in a process/procedure/system through proper and scientific justification, review, approval, implementation, follow-up, and closure. EU GMP Annex 15 Guidelines explain “change control” as: “The given statement describes a formal process in which qualified individuals from relevant fields review proposed or actual changes that could potentially affect the … Read more
Most pharmaceutical manufacturing companies have realized that in order to achieve the goal of long-term business survival in today’s regulated environment, they need to install a full eMES system, also known as the eBMR system. However, the current infrastructure situation prevents such an implementation from proceeding. Before discussing the difference between BMR/BPR and eBMR, it … Read more
Before beginning an on-site audit, the following Check List for Visitors points should be considered: Using the WHO-GMP Document Checklist can help you understand the requirements during visits to the premises. Document Check List for Visitors Format-B: Product summary sheet Conclusion: A Good Manufacturing Practice (GMP) audit checklist is one of the most effective methods … Read more
Six Sigma is an extremely disciplined activity that focuses on growing and giving close to excellent products and services. Six Sigma focuses on what’s necessary for the client. It reduces method variation defects, so nearly all the product or services provided meet client expectations. Six Sigma has been utilized by some of the world’s most … Read more
Good manufacturing practice and current good manufacturing practice are both terms correlated with each other. Both GMP and cGMP same purpose and functionality, They work together to achieve the quality, efficacy, and Productivity of a product’s goods. GMP and cGMP: GMP stands for good manufacturing practice, while cGMP stands for current good manufacturing practice. What … Read more
Recall and complaints both are different things that are used for marketed products. Recall means a company’s removal and correction of a marketed product that the FDA considers to be in violation of GMP. The Recall does not include market withdrawals. Whereas for product Complaints is not good things. It shows customer dissatisfaction with the manufacturer’s … Read more
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
Understand ALCOA, ALCOA+, and ALCOA++ in pharma. GMP data integrity principles, FDA & EMA 2026 expectations, audit trails, and inspection-ready compliance explained.