Pharma Blog
Dietary Reference Intakes for Iron
Salt form conversion Primary functions Sources Dietary Reference Intake Note: vegetarians may require 1.8-fold greater iron intake as nonheme iron less bioavailable than heme iron. Read also:
Risk Analysis and Containment Solutions for High Potent APIs (HPAPIs) Manufacturing
The development of technical solutions for this new approach to containment must necessarily start from embracing the same approach to the topic used by the pharmaceutical companies, and adopt the very same risk analysis principles used in the industry to ascertain the hazards for each and every product, from OEB ... Read More
High Potent APIs (HPAPIs) | Challenges in Development and Manufacturing
Highly potent active pharmaceutical ingredients (HPAPIs) are pharmacologically active substances that exhibit biological activity at extremely low concentrations, such as daily therapeutic dose of <10 mg or an occupational exposure limit (OEL) of < 10 μg/m3 at an eight hour time-weighted average. Each HPAPIs have specific OEL that must be ... Read More
Excel Spreadsheet Validation in Pharmaceutical Industry
What is Excel Spreadsheet? Microsoft Excel is a software program. It is used to create spreadsheets, which are documents in which data is laid out in rows and columns — like a big table. Excel organizes data in columns and rows and can perform calculations on that data using formulas. ... Read More
Difference Between 21 CFR Part 11 and EU GMP Annex 11
Navigating the complex waters of Life Sciences regulations? Two standards tower above the rest – 21 CFR Part 11 and EU GMP Annex 11. Here’s why they’re non-negotiable: Foundation of quality and integrity: Both safeguards ensure the highest standards of Quality, product integrity, and safety in the Life Sciences. Compliance ... Read More
Over-utilization of Proton-Pump Inhibitors
Proton pump inhibitors (PPIs) are among the most commonly used medications in the world. Developed for the treatment and prevention of acid-mediated upper gastrointestinal conditions, these agents are being used increasingly for indications where their benefits are less certain and for indeterminate durations. Long-term PPI use has been associated with ... Read More
Management of SOP’s Lifecycle in Pharma Industry | Part III
A standard operating procedure generally includes an introduction, background, ownership, instructions, and traceability, all outlined in an agreed-upon format and complete with references, appendixes, and annexures. Although the presentation may differ from the order described here, it must comply with Good Document Practice (GDP). The following standard operating procedure sections ... Read More
Management of SOP’s Lifecycle in Pharma Industry | Part II
A SOP is a document that provides high-level guidelines for a process. There are different types of SOPs in the pharmaceutical industry. To be most effective, standard operating procedures should be succinct, intuitive, easy to navigate, traceable, and regularly approved. To ensure compliance and traceability to a qualified state are ... Read More
Management of SOP’s Lifecycle in Pharma Industry | Part I
Standard Operating Procedure (SOP) is a document that provides directions on how tasks and processes should be carried out within a company. Standard Operating Procedures (SOPs) are an integral part of the routine operations in the pharmaceutical industry, and every department has its SOPs. SOP management refers to the systematic ... Read More
GxP Compliance Checklist | 5 Ps
GxP is a bunch of quality guidelines and benchmarks designed to ensure that your products are safe for patient use and adhere to quality standards consistently. GxP applies most readily to pharmaceutical and biopharmaceutical organizations through the requirements of USFDA 21 CFR Part 210 – 211. List of GxP Compliance ... Read More
Calcium Gluconate Injection | Drug Digest
Calcium Gluconate Injection is a form of calcium indicated for pediatric and adult patients for the treatment of acute symptomatic hypocalcemia. DOSAGE AND ADMINISTRATION: MONITORING: CONTRAINDICATIONS: WARNINGS AND PRECAUTIONS: ADVERSE REACTIONS: USE IN SPECIFIC POPULATIONS: NOTES: Read also: Resource Person: Lobna Adi (Clinical Pharmacist)