What is Media Fill The Media fill or Broth fill technique is one in which a liquid microbiological nutrient growth medium is prepared and filled in a simulation of normal manufacturing operation. The microbiological growth medium such as Soybean Casein Digest Medium (SCDM) is processed and handled in a manner which simulates “normal” manufacturing process … Continue reading Media Fill Process →

General Pattern: Locate the problem by ranking possible causes.Verify the presence of the most probable cause.If present – fix the problem, otherwise verify the existence of the next possible cause. First try to distinguish System problem or Method Problem HPLC System Components Pump Injector/ Autosampler Column Detector Data System/Integrator Method vs. System Troubleshooting System Parameters … Continue reading HPLC Troubleshooting →

User requirement specification (URS) is a list of all the requirements from the user, like equipment to be purchased. After the preparation of the list, the documents are sent to the manufacturer to get the required materials as per the given criteria. The user department will raise the indent for his requirement regarding machine equipment or … Continue reading User Requirement specification (URS) of Equipment’s in Pharmaceutical →

Introduction :This chapter defines the requirements for good documentation practices which build a basic foundation for a good quality management system. Good documentation practices are those measures that collectively and individually ensure documentation, whether paper or electronic, is secure, attributable, legible, traceable, permanent, contemporaneously recorded, original, and accurate.Good documentation practices follow to protect the integrity … Continue reading Requirements for Good Documentation Practices (GDP) →

Guideline : Health Products and Food Branch Inspectorate  Cleaning Validation Guideline-   Health Canada. Definition: Cleaning Validation: Cleaning validation is documented evidence that an approved cleaning procedure will provide equipment which is suitable for processing medicinal products. Types of contaminants Chemical - Residues of the previous productBiological - MicroorganismsPhysical    - Particulate matter Solubility of API shall … Continue reading Cleaning Validation in Pharmaceutical Industry →

Definition : What is stability studies The ability of a pharmaceutical product to retain its physical and chemical properties within specified limits throughout its shelf life. Types of Stability Studies : Long term testing Stability studies under the recommended storage condition for the re-test period or shelf life proposed (or approved) for labeling. Intermediate testing … Continue reading Guidelines for Pharmaceutical Stability Study →

DEFINATION: New Vendor: Manufacturer identified by Formulation Development or purchase department as a manufacturer to supply of a specific material from a specific manufacturing site. Approved Vendor: Manufacturer of raw material, primary and printed packaging material, which has been approved by QA to supply a specific material from specific site, based on the satisfactory cGMP … Continue reading Vendor Management System in Pharmaceutical Industry →

What is Quality Management system : A Quality management system (QMS) is the core of any quality and compliance process. It is a regulatory requirement that the Food and Drug Administration (FDA) and other global regulatory bodies consider critical. An automated QMS system reduces audit time and findings and lowers the risk of product recalls. … Continue reading Quality Management System (QMS)Importance in Pharmaceutical Industry →