Month: May 2020

Post-approval changes in the US

Changes to products licensed by the US FDA are achieved via the provision of supplements to the original new drug application (NDA). AR: Annual Report Changes that can be submitted in an annual report are of a minor in nature and that have minimal potential to cause an adverse effect on the identity, strength, quality, … Continue reading Post-approval changes in the US


New drug Application (NDA) Vs Abbreviated New drug Application (ANDA)

What is New drug Application (NDA) : A new drug application (NDA) is a complete document that must be submitted to the U.S. Food and Drug Administration (FDA) in order to request approval for marketing a new drug in the United States. 2. Drugs for which NDAs are submitted required four phases of clinical trials and drugs that … Continue reading New drug Application (NDA) Vs Abbreviated New drug Application (ANDA)

Packing Validation

Packing validation is performed to confirm that the resulting product from a specified packaging process consistently conforms to product attributes & requirements. Manufacturing and packaging facility has been qualified to meet cGMP requirements. Equipment’s / Instruments to be used in packing has been qualified / calibrated. Machine feasibility studies shall be performed (wherever required) with … Continue reading Packing Validation

Change Control Procedure

What is Change Control: Any planned permanent or temporary departure or modification or addition or deletion from an approved/qualified process/policy/document/system/material/method/equipment etc. is called as change and the document which is required to capture all the activities is called change control. Change control can be Permanent or Temporary. What is Change control Procedure: A formal system … Continue reading Change Control Procedure

41 Pharmaceutical Quality Control Interview Questions & Answers

Below are some Interview Questions and answers which can help the freshers as well as experience personnel for interview preparation so please Read and share if you think it useful and for more details you can click or refer to my another website named as 1. What is Quality Control : The term quality control refers … Continue reading 41 Pharmaceutical Quality Control Interview Questions & Answers

Requirement of Audit Trail in Pharmaceuticals

Audit Trail Log What is Audit Trail : An audit trail or  audit log is a security-relevant chronological record, set of records, or destination and source of records that provide documentary evidence of the sequence of activities that have affected at any time a specific operation, procedure, or event.  Audit trail means a secure, computer-generated, time-stamped electronic … Continue reading Requirement of Audit Trail in Pharmaceuticals