Pharmaceutical Guidelines

Sterility Testing Procedure Learn how to perform the test for sterility for sterile pharmaceutical products by Membrane Filtration Method. 1.0 Equipment Required Sterility Testing Procedure ¤ LAF ¤ Manifold holder assembly ¤ Vacuum pump ¤ Forceps ¤ Scissor 2.0 Material Required © Sample © Sterile 0.45µ Membrane filter © Sterile FTM © Sterile SCDM © Sterile 0.1% w/v Peptone water © 70% sterile IPA Solution © Gas burner © Sterile Filtration assembly © Sterile SCDA plates © Sterile Swab 3.0 Utilities Required Vacuum Pump 4.0 Procedure: Membrane Filtration Method →  Sample for Finished Products: Collect the samples to be tested for sterility as per SOP. Out of the whole sample, randomly select 20 articles (as per Pharmacopoeia) of each lot of batch for both LVP and SVP te rminal ly sterilized products and for aseptically filled products. →  Sample for Intermediates: Randomly collect 16 pre-sterilized bottle samples to be tested for sterility from LVP bottle pack machine (When c...

Sterility Testing by Direct Inoculation Method Direct Inoculation Method Learn the procedure for sterility test for sterile pharmaceutical products by direct inoculation method. 1.0 Objective :  To lay down Standard Operating Procedure is to provide guidelines for sterility testing by Direct Inoculation Method. 2.0 Scope This procedure is applicable for the products manufactured at the location which can not be tested by Membrane Filtration Method. 3.0 Responsibility Implementation: Microbiologist 4.0 Accountability Execution: Manager - QC Review & Approval : AGM - QA / QC Procedure Direct Inoculation Method Sample for Finished Products: Collect the samples to be tested for sterility. Out of the whole sample, randomly select 20 articles of each lot of batch for both LVP and SVP t erminal ly sterilized products and for aseptically filled products.    Sample for Intermediates: Randomly collect 16 pre-sterilized bottle samples to be tested for sterility from LVP bot...

Media Fill Validation -SVP Learn how to validate the aseptic filling process and validation protocol for Media Fill Validation in aseptic pharmaceutical processing and acceptance criteria. 1.0 INTRODUCTION The aseptic filling process can be validated using microbiological growth medium in place of the product. This process of validation also known as a media fill validation, normally includes exposing the microbiological growth medium to product contact surface of equipment, container closure system, and critical environments to closely simulate the same exposure that the product itself will undergo at the time of processing or filling. The sealed containers after filling with the medium are incubated to detect microbial growth for contamination at optimum temperature. 2.0 OBJECTIVE The objective of the validation is to establish documented evidence that the process for aseptic processing of p arenterals liquid/ophthalmic solution will pass the acceptance criteria consistently, when...