Pharma Blog
Drug Development and Approval Process | Part III
When studying a new drug, it can sometimes take many years to learn whether a drug actually provides a real effect on how a patient survives, feels, or functions. A positive therapeutic effect that is clinically meaningful in the context of a given disease is known as clinical benefit. Mindful ... Read More
Drug Development and Approval Process | Part II
FDA Approval: What It Means FDA approval of a drug means that data on the drug’s effects have been reviewed by CDER, and the drug is determined to provide benefits that outweigh its known and potential risks for the intended population. The drug approval process takes place within a structured ... Read More
Drug Development and Approval Process | Part I
Developing New Drugs American consumers benefit from having access to the safest and most advanced pharmaceutical system in the world. The main consumer watchdog in this system is FDA’s Center for Drug Evaluation and Research (CDER). Drug companies seeking to sell a drug in the United States must first test ... Read More
FDA Inspection and Findings on Current Good Manufacturing Practice (CGMP)
The FDA conducted an inspection of a manufacturing facility located in the US and found significant violations of Current Good Manufacturing Practice (CGMP) regulations. The violations identified include the following: The FDA requested the following actions in response to the identified violations: Recommendation: The firm should consideration of engaging a ... Read More
Criteria of Maintaining Audit and Inspection Readiness in Pharmaceutical Industry
To maintain audit and inspection readiness at all times in pharmaceutical industry, following criteria are to be maintained: 1. Clear Communication Channel 2. Document Control and Management 3. Effective Training and Competency Programs 4. Robust Change Control Processes 5. Real-time Monitoring and Data Analytics 6. A Culture of Continuous Improvement ... Read More
Meropenem IV (Carbapenem) | Drug Digest
Meropenem IV (Carbapenem) is a wide spectrum antibiotic that inhibits bacterial cell-wall synthesis by binding to penicillin-binding proteins, resistant to most beta-lactamases. It is used in adults and children 3 months of age and older. Meropenem is indicated for: 1. Complicated Skin/Skin Structure Infections 2. For the treatment of bacterial ... Read More
Saudi Pharmacist Licensure Examination (SPLE)
The Saudi Pharmacist Licensure Examination (SPLE) has been mandated by the Saudi Commission for Health Specialties (SCFHS). The aim of this exam to assess the pharmacist to practice in Saudi Arabia. Primary Requirements for SPLETo apply for the SPLE, you must have a recognized primary degree (Pharm D or B ... Read More
Executing Efficient and Effective CSV Audits
Once planning is complete, it’s time to execute the actual CSV audit. Here are some tips for conducting rigorous, value-adding CSV audits: Interview StakeholdersDiscuss in-depth with stakeholders like system owners, quality managers, and end users. This provides insights into how systems are used and any issues. Examine DocumentationThoroughly review all ... Read More
What Vitamins and Minerals Do Pregnant Women Require?
Pregnancy is a special time for any woman as she nurtures and cares for a new life growing within her. During this time, it’s crucial for a woman to provide her developing baby with the essential nutrients. The baby in the womb relies on the mother for all its nutrients. ... Read More
Top 10 Drugs to Avoid During Pregnancy
In this article we provide you a list of top 10 drugs that are generally advised to be avoided during pregnancy due to potential risks. However, it’s crucial to consult with a qualified healthcare professional before making any decisions, as they can provide personalized advice based on your medical history ... Read More
FDA Compliance Guide on Pre-approval Inspections (PAI) for Drugs
Pre-Approval Inspections (PAIs) are one of several significant milestones with an outsized impact on product approval and market entrance in FDA regulated industries. While organizations that have successfully navigated product development before often ingrain PAI readiness into their processes, companies of all sizes routinely need to devote time and energy ... Read More