Pharmaceutical Quality Assurance

Oct52016 by Pharmaceutical TechNo Comments

GMP Compliance Services for Pharmaceuticals

FDA Approved Devices, Pharmaceutical Quality Assurance

Good Manufacturing Practice, or GMP, is a set of regulations issued by the US Food and Drug Administration under the Federal Food, Drug and Cosmetic Act. They require processors, manufacturers and packagers of medical devices, drugs and foods to take proactive steps towards ensuring the safety, effectiveness and purity of their products. These regulations ensure quality approach and practices to reduce (or remove) errors and contamination, in order to protect consumers. GMP Inspections – Types and Objectives To keep inspections relevant, GMP processes are categorized according to several types, each with different objectives: Pre-Approval Inspection (PAI) The primary objective is to confirm readiness for commercially manufacturing a product, and investigations include: • Ma...

May312016 by Pharmaceutical TechNo Comments

Personalised Cell Therapy

BioPharma, Biotechnology, Pharmaceutical Quality Assurance, Pharmaceutical Research and Development

Personalised treatment Personalised medical treatment has matured to integrate into biopharmaceutical drug development pathways. This type of treatment targets patient/s with a specific drug that matches the specific disease physiopathology and/or patient characteristics e.g. genomic profile, and disease prevalence/severity. Personalised medicine has been generally developed in niche indications or conditions with high unmet need. Cell therapy, transplantation and the HLA matching Cell therapy uses cellular entities as prophylactic or therapeutic drugs/treatments. An ancestor of today’s cell therapy is transplanting hematopoietic stem cells to reset immune systems after intensive leukaemia chemotherapy. Treatment personalisation is essential to match the graft to the recipient(HLA match...

Mar212016 by Pharmaceutical TechNo Comments

Weighing and Dispensing Process and Technology in Pharma Industries

Drug Development, Pharmaceutical Chemicals and Intermediates, Pharmaceutical Excipients and Drug Formulation, Pharmaceutical Instrumentation and Controls, Pharmaceutical Quality Assurance, Pharmaceutical Research and Development

Weighing and dispensing process in pharma industries occupies a high priority position. Over the last decades, increased regulations on the manufacturing processes in pharma manufacturing industries led the focus and result is the advanced technology and stringent policies and frameworks. The pharmaceutical companies can increase the speed and accuracy of their operations with weigh and dispense process technology. While, weighing and dispensing of solids and liquids is a very common activity throughout the pharmaceutical industry processes. Traditionally, workers dispense pharma materials by hand-scooping solids and pumping or pouring liquids. This is generally conducted in a warehouse during chemical production or in a pharmacy during pharmaceutical dosage-form manufacturing. The chanc...

Feb152016 by Pharmaceutical TechNo Comments

Patents: A Way of growth for Pharmaceutical Companies

Pharma Industry, Pharmaceutical Distribution and Logistics, Pharmaceutical Patenting, Pharmaceutical Purchasing, Pharmaceutical Quality Assurance

Recent developments in the pharma sector, triggering the concerns of cold wars amongst few companies pertaining to the patents for certain drugs, it only reflects as to how standard are our patenting laws, and what are the pro’s and con’s of the international patenting procedures of various countries, and how it implicates the growth of the Industry. In 2005, India has amended its Patent Act, to protect the interests of the patenting company. Grating a patent gives the company leverage to manufacturing and marketing of the product in exclusivity for a period of 20 years. Despite of amending the patent laws and the regulations, still the companies couldn’t come to terms with the prevailing conditions of the global market. It’s not a surprising factor, that today there are so many case...