Pharma Blog
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
Treatment Algorithm for Hyponatremia
Today, we want to share an algorithm treatment for hyponatremia, a condition where the sodium level in the blood is abnormally low. Timely and appropriate management of hyponatremia is crucial to ensure the best patient outcomes. Here’s a step-by-step algorithm that can help guide healthcare professionals in their decision-making process: ... Read More
Highlights of Recent FDA Guidance on Nitrosamine Drug Substance
For example, FDA Recommended AI Limits for Certain Hypothetical NDSRIs FDA Recommended AI Limits for Certain NDSRIs Related: APIC Guidance on the Risk Assessment for Presence of N-Nitrosamines in APIs
Stability Requirements for Oral Solid Formulations in ANDA
When submitting an ANDA for a generic drug, one of the critical aspects is ensuring the product’s stability. The drug’s stability is a key factor in maintaining its safety, efficacy, and quality over its intended shelf life. Here are some key considerations: Long-term Stability: The generic drug product should retain ... Read More
Compounding Pharmacy Violations Which Put Patients at Risk
During a recent FDA inspection of a compounding pharmacy, several serious GMP deficiencies were found in the facility intended to produce sterile products. The FDA investigators identified several violations, which put patients at risk. The violations included the preparation, packing, and holding of drug products under unsanitary conditions, resulting in ... Read More
Good Practices for Research and Development (R&D) Facilities | WHO Guideline
With an ever-increasing awareness of the risks in pharmaceutical production and control and the lifecycle approaches being followed, greater emphasis is being placed on ensuring that the research and development of products are appropriately controlled and documented. Consequently, it is necessary that manufacturers of pharmaceutical products are able to submit ... Read More
WHO GMP Guideline for Excipients Used in Pharmaceutical Products
The WHO guideline Good Manufacturing Practices: supplementary guidelines for the manufacture of pharmaceutical excipients, was published in the WHO Technical ReportSeries No 885, 1999. As excipients are sometimes used in large quantities in pharmaceutical dosage forms, and may contain impurities, they can affect the quality of a finished pharmaceutical product. ... Read More