Regulatory Affairs
Regulatory affairs establish common principles and responsibilities that provide a strong scientific database, efficient organizational arrangements, and procedures to underpin decision making for nutraceutical preparations.
Quality Assurance
All validation activities should be planned. The key elements of a validation program should be clearly defined and documented in a validation master plan (VMP) or equivalent documents
Quality Control-Chemical
The term quality control refers to the sum of all procedures undertaken to ensure the identity and purity of a particular pharmaceutical product. Such
procedures may range from the performance of simple chemical experiments which determine the identity and screening for the presence of particular pharmaceutical substance to more complicated requirements of pharmacopoeial monographs.
Quality Control-Microbiology
Microbiology Quality Control Technicians are responsible for assuring quality of the product through all day-to-day operations. They assist the biomanufacturing plant by evaluating raw materials, other supplies and the finished, packaged product. They ensure compliance to common Good Manufacturing Practices
Validation
Validation is done to assure that the processes will produce consistent and repeatable results within the predetermined specifications. Validation is needed as it verifies whether the quality standards and compliance are being met by the product in real time, which is really important in every pharmaceutical facility