1. Objective 1.1 The intention of this procedure is to facilitate the creation of best practices as to the right approach with regard to sampling during process validation. It embraces types of sample, sampling and sample collection, sample handling, analysis, documentation, and reporting that are critical in establishing product quality as well as compliance to regulatory requirements. 2. Scope 2.1 […]
Introduction The pharmaceutical line of business has evolved significantly since it was started Trading. Due to enhancing need for quality and safety of drugs, frequent evaluating of the processes used in the production of these drugs has become a critical issue. Practical approach to achieve this objective as highlighted involves revalidation of pharmaceutical process. In the pharmaceutical context revalidation can […]
1. Introduction Standard Operating Procedure (SOP) as used in the pharmaceutical industry is an important document that is designed to provide details of a specific process or operation and dictates proper means to perform that operation. Lastly, SOPs are very useful and also when it comes to compliance with set regulations, but SOPs give directives to employees to adhere to […]
Comprehensive CIP cleaning validation for pharmaceutical manufacturing. Validate your Clean-in-Place systems to maintain GMP compliance.
Theriva Biologics, Inc. is a diversified clinical-stage company developing therapeutics designed to treat cancer and related diseases in areas of high unmet need. It is advancing a new oncolytic adenovirus platform. Its candidates are VCN-01, SYN-004 (ribaxamase) and SYN-020. VCN-01 is an oncolytic adenovirus designed to replicate selectively and aggressively within tumor cells, and to degrade the tumor stroma barrier […]
There is something called personalized medicine in relation to healthcare, and for example pharmacogenomics and small-molecule drugs. Personalized medicine is an emerging model approaches to the treatment of patients. It means prescribing every individual the treatment he or she deserves to be given. This method takes into account the ability, disability, genes, the environment and lifestyle of the client. It […]
The quality and safety of pharmaceutical products depend a lot on HEPA testing. Poly alpha olefin vs dioctyl phthalate play big roles in this. Knowing about pao vs dop helps keep products pure. Choosing between poly alpha olefin and dioctyl phthalate matters a lot in HEPA filter testing. Learning about pao vs dop helps you understand their effects. This knowledge […]
Bionomics Ltd is an Australia-based clinical-stage biopharmaceutical company. The Company is focused on development of novel drug candidates focused on the treatment of serious central nervous system disorders. It is developing novel allosteric ion channel modulators to treat patients suffering from serious central nervous system (CNS) disorders with high unmet medical need. It is advancing its lead drug candidate, BNC210, […]
Introduction A Validation Master Plan often abbreviated as the VMP provides an extensive description of the principles that are related to the qualification of a particular facility. It defines which systems and areas need validation and provides a comprehensive plan of how to become, and remain, a qualified facility. In other words, the VMP simply translates the validation strategy down […]
Latest developments, a significant alert of an important medication has been formally announced by the Government authorities after the DTL Multan (WHO Prequalified) test report no. TRA-01-105008237/DTL dated 21-12-2024, wherein Tablet Novidat 500 mg (Ciprofloxacin) Batch #FIM063 not Manufactured by M/s Sami Pharmaceuticals Karachi, was declared as spurious and falsified. This post aims to furnish general public with critical information […]
