Pharma Blog
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
Computerized System Validation (CSV) Audits
Computerised system validation (CSV) is critical in regulated industries like pharmaceuticals, medical devices, and biotech. It ensures that computerised systems are compliant with guidelines and capable of consistently producing high-quality products and data. A key component of the CSV process is CSV auditing. CSV audits examine and evaluate computerised systems ... Read More
References for Good Pharmacy Practice
Introduction to Good Pharmacy Practice (GPP) Patient Care and Counseling Medication Safety and Quality Assurance Pharmaceutical Supply Chain Management Ethical Considerations in Pharmacy Practice Professional Development and Continuing Education Pharmaceutical Legislation and Regulatory Compliance Information Management and Technology in Pharmacy Practice Read also: Compounding Pharmacy Violations Which Put Patients at ... Read More