Pharmaguideline

PHARMACEUTICAL QUALITY SYSTEM Objective: Achieve product realization Establish and maintain a state of control Facilitate continual  improvement   ICH-Q10: PHARMACEUTICAL QUALITY SYSTEM The pharmaceutical quality system “assures  that the desired product quality is routinely  met, suitable process performance is  achieved, the set of controls are appropriate,  improvement opportunities are identified  and evaluated, and the body of knowledge is  continually expanded PQS – IMPLEMENTATION Quality System  Element are  described in Quality  Manual BASIC OF GMP Quality, safety and Effectiveness  must be designed and built into  the product. Quality cannot be  tested into the product. Product Quality depend on: Each step in manufacturing process must be controlled to maximize the  probability that finished product will meet all its quality and design  specification GMP GUIDANCE / REFERENCE - FDA FDA-CFR Part 211 Sec. 211.100 Written procedures; deviations There shall be written procedures fo

What is Continued Process Verification (CPV) ? Continued Process Verification (CPV) is part of the FDA guidelines on Process Validation with a product lifecycle concept. The guideline is also an integration of the International Conference on Harmonisation (ICH) guidance for industry Q8 (Pharmaceutical Development), Q9 (Quality Risk Management) and Q10 (Pharmaceutical Quality Systems) Continued Process Verification The lifecycle concept links product and process development, qualification of the commercial manufacturing process, and maintenance of the process in a state of control during routine commercial production Process Validation is defined as the collection and evaluation of data, from the process design stage through commercial production, which establishes scientific evidence that a process is capable of consistently delivering quality product. The FDA guidance describes process validation in three stages: CPV • Stage 3 CPV is the process by which we verify that our product co

Introduction Medicated creams and lotions are designed to be easy and pleasant for the customer to use. The development pathway can be challenging as these products are often complex mixtures with sophisticated requirements that are achieved via successful execution of a meticulous formulation program. For contract research organizations (CROs) that offer formulation development, the complexity of developing a semisolid formulation is often challenged by aggressive timelines frequently sought by the customer. Physicochemical characterization on the drug of interest is often limited or incomplete, an additional challenge in the development of an effective formulation. This white paper presents strategies which can be employed to develop a formulation more rapidly. Note that this may not be the composition of the final formulation, but can be used to initiate proof-of-concept studies and add formulation criteria to the development process. This white paper contains two major sections

New Jersey is respected globally for its strength in the pharmaceutical industry. The state is home of the biggest pharmaceutical companies like  Novo Nordisk,  Novartis, Merck & Co., Johnson & Johnson, Bristol-Myers Squibb, and Bayer Healthcare. Why are so many pharmaceutical companies based in New Jersey? 1. The synergy between pharmaceutical company created ecosystem for pharmaceutical to grow 2. Transportation. New Jersey has largest port, port Newark. 3. Large Highly educated workforce like pharmacist, engineer and researcher 4. Large access to massive pharmaceutical market like New York,  Connecticut, Pennsylvania, Delaware, Maryland. This page contains a list of Best pharmaceutical companies in New Jersey  Ferring Pharmaceuticals, Inc. A visionary, privately-held biopharmaceutical company that develops, manufactures and markets effective and innovative products in reproductive health, women’s health, urology, gastroenterology, endocrinology and orthopaedics. Address: 100