QA & QC

SOP FOR BUBBLE POINT TEST Introduction Membrane filters have been used successfully for many years to remove yeast, bacteria and particulate from fluid streams. The ultimate integrity test for a sterilizing grade membrane filter is the bacterial challenge. Unfortunately, this is a destructive test; the filter cannot be used afterwards …

SOP For Analytical Method Validation protocol                                                                                         …

SOP on CLINICAL TRIAL PROTOCOL The contents of a trial protocol should generally include the following topics. However, site specific information may be provided on separate protocol page(s), or addressed in a separate agreement, and some of the information listed below may be contained in other protocol referenced documents, such …

All Post URL of Drugs formulations Tablets MFR of Albendazole Tablets – (drugsformulations.com) MFR of Alfacalcidol & Calcium Carbonate Tablets (drugsformulations.com) MFR of Sildenafil Citrate Tablets (drugsformulations.com) MFR of Paracetamol & Dicyclomine HCl Tablets – (drugsformulations.com) MFR of Dextromethorphan, Bromhexine, Chlorpheniramine Maleate & Guaifenesin  Tablets (drugsformulations.com) Dextromethorphan (drugsformulations.com) Spiramycin Tablet (drugsformulations.com) MFR of Propranolol Hydrochloride …

UV LAMP EFFICACY TEST WHAT IS UV LIGHT? The light with a wavelength of 10-400 nano meters (nm) in sunlight is called ultraviolet light, and it can be divided into UVA, UVB, and UVC (200 nm to 275 nm) according to different wavelength bands. Among them C-band ultraviolet rays destroy …

UV efficacy Challenge test Evaluation of ultraviolet irradiation efficacy in an automated system for the aseptic compounding using challenge test Objective Ultraviolet (UV) irradiation efficacy in the intravenous compounding robot APOTECA chemo was evaluated to define the best operative conditions in terms of sterility and time optimization. Design The challenge …

Cleaning Validation Glossary of Terms 1 Acceptable daily intake An amount of a substance administered or consumed on a daily basis that will not produce a pharmacological or toxic response 2 Analyte Substance for which an analysis is being performed 3 API Active pharmaceutical ingredient 4 Automated cleaning A cleaning …

SOP on SOP Objective : To lay down a procedure for the preparation, approval and control of Standard Operating Procedures. Scope: This Standard Operating Procedure is applicable for the preparation and implementation of all Standard Operating Procedures to be followed at Pharmaceutical Company. Responsibility Staff of Initiator Department shall be …

QUALITY SYSTEMS MODEL The goal  is to describe a model for use in pharmaceutical manufacturing that can help manufacturers comply with the CGMP regulations. It should be noted that implementing an effective quality system in a manufacturing organization will require a significant investment of time and resources. However, we believe …

CGMPS AND THE CONCEPTS OF MODERN QUALITY SYSTEMS Quality should be built into the product, and testing alone cannot be relied on to ensure product quality. Several key concepts are critical for any discussion of modern quality systems. The following concepts are used throughout this guidance as they relate to …