5 Tips to Help You Prepare for an FDA Inspection

Regulatory authorities such as the FDA have gotten more stringent with their acceptance criteria, especially when it comes to food and drug or medical device companies. You will not always be informed about an FDA inspection in advance, so you need to be fully prepared at all times if you want to avoid Form 483 […]

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Things You Need To Know About cGMP

CGMP or Current Good Manufacturing Practice regulations are enforced by the US Food and Drug Administration (FDA). They provide for systems which can assure proper monitoring, design and control of manufacturing processes and facilities. By adhering to CGMP regulations, you can assure the quality, strength and purity of any product manufactured by a company. You […]

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Process Optimization and Automation in Pharmaceutical Manufacturing

Process optimization and automation use computers to control a process by optimizing the specified set of parameters without violating any constraints. These are executed to minimize costs, and maximize output and efficiency. You can automate the supervisory control system to deliver better yields, have more stable plant operations, lower the utility consumption, and ensure that […]

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Is Your Internal Quality Audit Effective?

Quality engineering services are becoming a major area of focus for companies in practically any sector, since most of them are heavily reliant on IT for business operations. Quality engineering encompasses a larger view of quality requirements in every area from management to operation, by managing, developing, operating and maintaining high-quality IT systems, software solutions […]

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5 Maintenance Trends Rising to the Forefront in FDA Inspections

While compliance with the FDA’s rules and regulations is already crucial for companies in various sectors like food, biotech and pharmaceuticals, the agency has recently been increasing its focus on asset management and risk-based maintenance while conducting inspections. This shift in attention is a primary concern for the pharma and biotech industries, which are particularly […]

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The Principles of Process Validation – Stages and Types

Current Good Manufacturing Practices (cGMPs) require process validation for finished pharmaceuticals (21CFR 211) and medical devices (21CFR 820). However, until the 2011 guidance guidelines were set in place, there was a lot of uncertainty about how regulations for these sectors were to be implemented. Prior to this, most of the industry adopted the “three-batch practice”, […]

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4 Types of Process Validation in Relation to Production

Process validation is a critical part of quality assurance procedures, for practically any sector or industry today. You can perform process validation at various stages of the production lifecycle to confirm whether your process is effectively controlling the quality of your finished product. Based on the stage of the production lifecycle at which process validation […]

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What Pharma Companies Need to Know about FDA Regulations

Pharmaceutical and biopharmaceutical companies need to be aware of the FDA regulations that they are required to meet, in order to ensure quality compliance and safety for the products they manufacture. All too often, the smallest deviation from standards can result in entire batches being discarded or recalled after they hit the shelves. Not only […]

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FDA Process Validation 101 – A Complete Guide

It is common knowledge that any company within the Food and Drug industry has to maintain certain sets of standard of their products. They cannot create benchmarks unique to themselves and compare the results with those individual standards. Food and Drug Administration state this would cause disparity in composition of similar products, compromise their quality […]

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