Good Testing Procedure (GTP) for Microbiology – Introduction Microbiological testing ensures products, materials, and environments comply with quality, safety, and regulatory standards. A Good Testing Procedure provides systematic, controlled, and documented methods to produce reliable results. Below are core principles…
The User Requirements Specification describes the business needs for what users require from the system. User Requirements Specifications are written early in the validation process, typically before the system is created. They are written by the system owner and end-users, with…
A Practical Overview Stability studies in pharma are designed to show how the quality of a drug substance or product changes over time under the influence of temperature, humidity and light. The data are used to set shelf-life, re-test period…
A Critical Process Parameter (CPP) is a term used in pharmaceutical production for process variables which have an impact on a critical quality attribute (CQA) and, therefore, should be monitored or controlled to ensure the drug product obtains the desired quality.…
Every activity in Pharma have some frequencies whether it is revision of documents, qualification, validation, stability, Re-testing etc. While Acceptance criteria means numerical limits, ranges, or other criteria for tests that are used for or in making a decision to accept…
A “media fill” (sometimes known as a “process simulation”) is the performance of an aseptic manufacturing procedure using a sterile microbiological growth medium in place of the drug solution. Dry Powder Injection Three Piece Injection Ampoules Liquid Vials
Miscellaneous Documents in Pharma are those documents which does not comes under any dosage form and can be applied in general.
Pharmaceutical formulation is the process of combining various chemical substances with the active drug to form a final medicinal product, which is called a drug mixture or drug formulation. A drug formulation can be given to the patient in various…
Introduction: This User Requirement Specification (URS) defines the requirements for the selection, procurement, installation, qualification, and use of chemical instruments intended for [your organization/laboratory/production facility]. The purpose of this document is to establish a clear understanding between the end users,…
All criticalities that emerged during the FAT exercise are then checked again at the final site, after installation and verification; additional test cases may also be added to the Site Acceptance Test (SAT) protocol to check for potential failure modes. SAT testing…