Pharmaceutical Guidelines

(Good Regulatory practices) Good Regulatory practices (documentation, licenses, renewals, e-governance) in Community Pharmacy, Hospital pharmacy, Pharma Manufacturing, Wholesale business, inspections, import, export of drugs and medical devices. Good Regulatory practices: Introduction: Good Regulatory Practices (GRP) is processes, systems, tools, and methods for improving the quality of regulations that are internationally recognised. Before government initiatives are implemented, GRP systematically implements public consultation and stakeholder involvement, as well as impact analysis of government proposals to ensure they are fit for purpose and will achieve the goals set out. Objectives: GRP provide a means of establishing sound and effective oversight of medical products as an important part of health system performance and sustainability. If consistently and effectively implemented, they can lead to higher quality regulation, improved regulatory decision-making and compliance, incr...

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...

Sterile Pharmaceutical Dosage Forms - Parenteral Preparations                    Learn all about Parenteral preparations including Injections, Powders for Injection, Infusions, Concentrated Solutions for Injection and Implants. Introduction Parenteral Preparations Parenteral preparations are sterile products those are administrated by injection into the body. They may be directly administrated or they may be diluted before administration. Production of Parenteral Products P arenteral preparations are prepared by the methods that maintain their  Sterile , avoid the introduction contaminants and microbial growth. The Parenteral preparations those are in the form of liquids require the base to dissolve them. W ater for In j ection is commonly used in Parenteral preparations. Any other suitable base may be used provided they are safe in the volume of injections administered and also do not interfere with the therapeutic effica...

Sterile Area (Cleanroom) Qualification Sterile area validation has different tests like air supply, air velocity, air changes, flow pattern, filter integrity, pressure test, particle count, temperature, recovery test, microbial count, relative humidity, noise level and vibration test. Sterile Area Sterile area qualification and HVAC system qualification are two different things but most of the tests are same because HVAC system is qualified by its performance as the quality of the area. Qualification document of the HVAC system and the sterile area should be prepared separately. The sterile area can be qualified by applying following tests. 1.0 Air supply capacity: The purpose of this test to demonstrate that the air system is balanced and capable of delivering sufficient air volumes (as per design) to maintain required air change (NLT 20) in the defined area. The air capacity will be demonstrated by following the procedure of: Measure airflow in supply and returned duct Air volume to ...