QC (Quality Control) chemical testing ensures raw materials, intermediates, and finished products meet defined specifications. Adherence to Good Testing Procedures is essential for accurate, reliable, and compliant results. Below are the core principles and practices of GTP in QC chemical…
Job Descriptions in the pharmaceutical industry vary greatly depending on the role, but I’ll give you a clear template you can adapt for most positions (e.g., Production, Quality Assurance, Quality Control, Regulatory Affairs, R&D). Below is a general job description…
QC (Quality Control) chemical testing ensures raw materials, intermediates, and finished products meet defined specifications. Adherence to Good Testing Procedures is essential for accurate, reliable, and compliant results. Below are the core principles and practices of GTP in QC chemical…
🧪 Qualification of IPQC Instruments in Pharma ✅ What are IPQC Instruments? IPQC (In-Process Quality Control) instruments are devices used during manufacturing to monitor and control product quality in real time.Examples: Because they directly impact product quality decisions, their qualification…
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