Pharma Blog
Guidelines on Packaging for Pharmaceutical Products | Part I
All medicinal products need to be protected and “consequently need to be packaged in containers that conform to prescribed standards, particularly with respect to the exclusion of moisture and light and the prevention of leaching of extractable substances into the contents and of chemical interaction with the contents. The complexity ... Read More
Dietary Reference Intakes for Calcium and Vitamin D
Calcium and vitamin D are two essential dietary supplement for their role in bone health. Institute of Medicine (IOM) share the nutrient reference values of calcium and vitamin D, known as Dietary Reference Intakes (DRIs) for calcium and vitamin D. Calcium Salt form conversion Primary functions Essential role in blood ... Read More
Tips for Laboratory Design in Pharmaceutical Industry
1. Consider the purpose and requirements of the lab: Before designing the lab, clearly define its purpose and the specific requirements it needs to fulfill. This will help in determining the layout, equipment, and space needed. 2. Optimize space utilization: Efficiently utilize the available space by carefully planning the layout ... Read More
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