The pharmaceutical sector is a highly regulated sector. This is totally justified as medicines can either save someone’s life or make matters worse if proper information about the medical ingredients and their effects are not known. Hence, quality plays a huge role in this industry.
Our consultants has many years of experience in the following fileds:
Quality Control
Quality control essentially deals with designing and producing products as well as services in a way that they either meet or exceed the requirements of the customer. Failure testing and assurance in design as well as production are two important activities of quality control programs.
QC And Pharmacy
Pharmaceutical industries have to adhere to a number of quality standards and practices for being able to sell medicines in the market. Quality systems like good laboratory practice (GLP), good manufacture practice (GMP) and good clinical practice (GCP) are specific to pharmaceutical industry regulations. The principles of these systems primarily cover the procedure quality aspects on a formal basis and not much evaluation is done of the technical aspects. Technical performance gets covered only when a company gets these accreditations. The research and development requirements for satisfying these regulations are different from one country to another, with the strictest of them being in Europe.
Quality Assurance
This covers providing evidence for supporting the claim that quality has been established in work, product or service. For this purpose, suitable standard operating procedures (SOP’s) are to be introduced for defining a standardized procedure of doing operations in an effective manner. This ensures adherence to maximum efficiency and safety requirements of the clinical research activities that have been performed. Such defined procedural information assures auditors and regulatory inspectors of requirements adherence. These SOPs should be sufficiently proliferated amongst all the individuals involved in the procedure and proper training should be provided to them. Such planned implementation of procedures is in complete concordance with the basic PDCA cycle of quality control that asks quality implementers to plan, perform, measure and take necessary actions as per the measured data. For this purpose, SOPs are tailored for clinical, pre-clinical, pharmacokinetics, bio-analysis, regulatory affairs, data management, drug safety, project management, vendor management, supply chain management, change control and crisis management.
Failure Testing
Pharmaceutical research involves trying various combinations of ingredients and individually gauging the effectiveness of each combination. As can be seen, such combinations can run into millions and hence failure testing becomes an important part of quality control in pharmaceutical companies. For instance, even if two ingredients are involved in a medicine, their relative composition can be varied to the extent limited by available measuring technology, so that the ideal combination can be found out. Advanced quality techniques like Design of Experiments are extensively employed in this regard. They greatly reduce the effort involved in the testing process and the results provided by them are definitely more reliable than human analyzed results.
Pharmaceutical industries must comply with the highest quality regulations for winning accreditation and acceptance in the global market.
Quality control is an extremely effective tool in this regard.