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Quality Assurance/Quality Control:

Quality Assurance/Quality Control Pharmaceutical Industry

Definition :

Definition A process that is used to ensure a certain level of quality in a product or service May include actions a business deems necessary to provide for the control and verification of certain characteristics of a product or service Usually involves thoroughly examining and testing the quality of products or the results of services The basic goal of this process is to ensure that the products or services that are provided meet specific requirements and characteristics, such as being dependable, satisfactory, safe and fiscally sound.

QA/QC Tests:

QA/QC Tests In case of tablets: (the following parameters have to be taken into consideration and normally tested) in-process control residual solvents from granulation potency of the mixture weight variation in compressing Friability Hardness disintegration time Thickness assays/tests on the finished product Appearance content uniformity microcount and pathogens dissolution rate In case of capsules: in-process control potency of the powder mixture weight variation proper capsules sealing disintegration time on the finished product Appearance dissolution rate microcount and pathogens

Improving QA/QC:

Improving QA/QC Centralize the management of an organization’s quality processes, ensuring standards are enforced across global operations and geographical boundaries. The tendency in pharma companies is to have different locations working in their own unique silos, with disparate processes and ways of managing these processes. =2612

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