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 →

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) →

What is Variation : Variation means any amendment to the terms of the decision granting the marketing authorization as well as any change to the summary of product characteristics and the documents forming the basis for an authorization to market a medicinal product. European Commission has classified the variation type as   type IA/IAIN, type IB … Continue reading European (EU) Variation Requirements →

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 →

Qualification and Validation are two familiar words in Pharmaceutical . Every body should know the basic things about these two so Let us know what is the difference between these two...... What is Qualification: 1. The act of planning, carrying out and recording the results of tests which is performed on equipment to confirm its … Continue reading Qualification Vs Validation →

Change control and Deviation are two familiar words in Pharmaceutical and both are the parts of Quality Management System (QMS). Every body should know the basic things about these two so Let us know what is the difference between these two and For more Topic or contents you can click or refer to my another … Continue reading Change Control Vs Deviation →

What is Dissolution: Dissolution is the process by which a solid substance enters into a liquid   known as dissolution medium or solvent to form a solution. Dissolution is a test which is used for a pharmaceutical product to evaluate the rate of release of a drug substance from the dosage form. Dissolution test is performed … Continue reading Dissolution Test 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 →

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 pharmapathfinder.com 1. What is Quality Control : The term quality control refers … Continue reading 41 Pharmaceutical Quality Control Interview Questions & Answers →

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 →