Pharmaceutical Companies and the Effective Quality System

1. Why an Effective Quality System is a must for pharmaceutical companies? Since being directly associated with the manufacturing of drugs which will affect human life, pharmaceutical industry should have an effective quality system. It is one of the most regulated industry with specific quality systems such as good laboratory practice (GLP), good clinical practice (GCP) and good manufacture practice (GMP). Though there are so many quality control measures being taken, the main emphasis is still on the formal quality aspects and not on the technical aspects. The challenge this industry is facing today is the implementation of a quality and robust control system. The quality system should focus on both formal quality and the technical aspects associated with the manufacturing of drugs. The various measures which are taken for the quality control are listed below in a nutshell. These are the most common things which are carried out by every pharmaceutical company. Quality Assurance (QA) is the process of providing details needed to maintain quality in work throughout the manufacturing process. If the activities are performed in a systematic way and according to the details mentioned in the QA, the output will be errorless. Quality Assurance is important for introducing rules which are fit for the purpose and bring out the best result in the first effort itself. Standard Operating Procedure (SOP) is a set of instructions in the detailed manner. SOP will lead to a definite or a standard procedure with better quality and maximum effectiveness. It is Pharmaceutical Raw Material - Company

2. Why an Effective Quality System is a must for pharmaceutical companies? essential to achieve uniformity in the various functions associated with manufacturing of drugs. SOP is a must for achieving maximum safety and efficiency in the activities. It gives the roadmap which needs to be followed while production of drugs to meet the obligations and regulations norms of industry. Inspection & Auditing is the process of finding out any deviations from the standard procedures of the industry. The person involved with the execution of these activities should follow the SOP to understand the mistakes committed in the process. The SOP reveals whether the processes undertaken are in adherence with the set standard or not. SOP is very important to understand the deviation from the standard and what steps can be taken to rectify the deviation. QA paradigms is another way to measure the compliance of the quality system with the standards mentioned in the SOP. One of the most widely used paradigm for quality management is PDCA (Plan-Do-Check-Act). In order to comply with this approach, SOP can be made according to the requirements of the industry. Various SOP can be prepared for regulatory affairs, project management, data management, etc which will be beneficial for PDCA. Tatva Chintan Pharma Chem Pvt. Ltd , a leading raw material supplier for various pharmaceuticals companies in India and abroad has a wide variety of various chemical products like specialty chemicals, quaternary phosphonium salts, methylating agents, electrolyte chemicals, etc. It has made a name for itself with the kind of quality it provides at such a competitive price. The quality product supplied by them at such an affordable price has made them a big hit in the industry. Pharmaceutical Raw Material - Company