Tag Archives: Mid and East Antrim

DOCUMENTATION IN PHARMA Well-established documentation system exists to implement Good Documentation Practices, which is a part of Quality Assurance. Clearly written documents are prepared, reviewed and controlled, which prevents the errors from verbal communication and permits traceability for all activities carried out. Quality Assurance is responsible for the revision and …

 WATER SYSTEM: A purified Water system is a basic requirement for Pharmaceutical Industries. Raw Water sourced from industry bore well water is converted into purified water complying with current USP/ BP/ IP/ Ph. Eur. GENERATION OF PURIFIED WATER: The raw water passes through a sand filter through a transfer pump. …

BRIEF DESCRIPTION OF HEATING, VENTILATION, AND AIR CONDITIONING (HVAC) SYSTEMS: To avoid cross-contamination and to maintain relative humidity, temperature, and Pressure Difference of the manufacturing areas with Air handling Units, ­­­­­Air handling Units Provided in the manufacturing, warehouse, quality control, and microbiology section. Temperature and humidity are controlled and maintained …

BATCH MANUFACTURING RECORD OF DRY INJECTION Table of content Batch Details General Instructions Calculation of API Dispensing of raw material API transfer record Dispensing of primary packing materials Component preparation for sterilization Steam sterilization record Vial de-boxing, Staging, and Inspection record Vial washing record Vial depyrogenation record API Canister weight …

WHO – Appendix 3 Cleaning validation Principle Content of Cleaning validation Principle 1.0 Principle 2.0 Scope 3.0 General 4.0  Cleaning validation protocols and reports 4.1 Cleaning validation protocols 4.2 Cleaning validation reports 8.0 Personnel 6.0 Equipment 7.0 Detergents 8.0 Microbiology 9.0 Sampling 9.1 General 9.2 Direct surface sampling (direct method) …

Quality Risk Management in Analytical Laboratory The Quality of the Product Drugs or Drug Product is evaluated in Quality Control analytical laboratories, So It is important to understand that the “services” and “output” of a Quality Control / Analytical Laboratory is directly related to Safety, Identity, Strength, Purity (efficacy), Quality …

Lyophilization of Parenteral Lyophilization or freeze-drying is a process in which water is removed from a product after it is frozen and placed under a vacuum, allowing the ice to change directly from solid to vapor without passing through a liquid phase. The process consists of three separate, unique, and …

Equipment Qualification Contents Validation User Requirement Specification.(URS) Phase of validation Design qualification (DQ) Installation Qualification (IQ) Operation Qualification (OQ) Performance Qualification (PQ) Maintenance Qualification (MQ) Component Qualification (CQ) Instrument Re-Qualification What is Validation According to the Food and Drug Administration (FDA), the goal of validation is to: “Establish documented evidence …

Flow Properties of Powders The use of powders in the pharmaceutical industry has generated a variety of methods for characterizing powder flow. Not surprisingly, scores of references appear in the pharmaceutical literature, attempting to correlate the various measures of powder flow to manufacturing properties. The development of such a variety …

IMPURITIES IN NEW DRUG SUBSTANCES To provide guidance for registration applications on the content and qualification of impurities in new drug substances produced by chemical syntheses and not previously registered in a region or member state Impurities in new drug substances are addressed from two perspectives: Chemistry Aspects include classification …