Month: March 2019

Process Validation Sample Protocol


Protocol Approval : Protocol shall be prepared by Quality Assurance or Technology Transfer department and Shall be Reviewed by Production, Quality Control, Regulatory affairs (for regulatory filling) , Qualified person or customer (if required) and Approved by Quality assurance. Before start of the activity protocol shall be approved and Training shall be imparted to the … Continue reading Process Validation Sample Protocol

Process Validation in Pharmaceuticals Manufacturing


What is Process Validation: 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. Process validation involves a series of activities taking place over the lifecycle of the product and process. Process … Continue reading Process Validation in Pharmaceuticals Manufacturing

Yellow Card in Medicines and Healthcare Products Regulatory Agency (MHRA) and its Reporting details at a Glance


What is Yellow Card Scheme in UK : The Yellow Card Scheme is the UK system for collecting information on suspected adverse drug reactions (ADRs) to medicines. The Yellow Card Scheme is essential in helping the MHRA to monitor the safety of all healthcare products in the UK to ensure they are acceptably safe for patients and those who … Continue reading Yellow Card in Medicines and Healthcare Products Regulatory Agency (MHRA) and its Reporting details at a Glance

Medicines and Healthcare products Regulatory Agency (MHRA) and its Role and Responsibility


Who is MHRA : The Medicines and Healthcare products Regulatory Agency (MHRA) is an executive agency of the Department of Health and Social Care in the United Kingdom (UK) which is responsible for ensuring that medicines and medical devices work and are acceptably safe. When MHRA Formed : MHRA was formed in 2003 with the merger of the Medicines Control Agency (MCA) and the Medical Devices Agency … Continue reading Medicines and Healthcare products Regulatory Agency (MHRA) and its Role and Responsibility

United State Food and Drug Administration (USFDA) and Form 483 and Warning Letters at a Glance


Who is USFDA : The Food and Drug Administration (FDA) is an agency within the U.S. Department of Health and Human Services. The FDA was empowered by the United States Congress to enforce the Federal Food, Drug, and Cosmetic Act, which serves as the primary focus for the Agency. The FDA is led by the Commissioner of Food and … Continue reading United State Food and Drug Administration (USFDA) and Form 483 and Warning Letters at a Glance