Good Manufacturing Practices (GMPs) CGMPs provide systems that assure proper design, monitoring, and control of manufacturing processes and facilities. Good Manufacturing Practices (GMPs) are the basic manufacturing and environmental conditions required to produce pharmaceutical products. They ensure that ingredients, products, and packaging materials are handled safely and that pharmaceutical products are processed in a suitable … Read more
Liquid pharmaceutical Preparations A solution is a homogenous one-phase system consisting of two or more components. →solvent + solute • The solvent is that phase in which the dispersion occurs and the solute is that component that is dispersed as small molecules or ions in the solvent. • Liquid preparations: the formulation prepared by dispersing … Read more
PARENTERAL PREPARATIONS Parenteral preparations are sterile preparations intended for administration by injection, infusion, or implantation into the human or animal body. Parenteral preparations may require the use of excipients, for example, to make the preparation isotonic with respect to blood, to adjust the pH, to increase solubility, to prevent deterioration of the active substances, or … Read more
Most common types of pharmaceutical contamination Contamination can lead to objectionable results in the Pharma industry. It can conciliate the safety of patients, staff, and the environment – as well as affect the market. High standards of hygiene are important to maintain, only preventing the bio-burden levels by means of effective cleaning is not sufficient: … Read more
HVAC SYSTEM & TEST FOR HVAC QUALIFICATION What is HVAC? It controls Temperature, Humidity and Air quality inside a building. HVAC technology aims to provide thermal comfort and acceptable indoor air quality. HVAC system design is a sub discipline of mechanical engineering, based on the principles of thermodynamics, fluid mechanics, and heat transfer. The HVAC system … Read more
Change Control – Strategies for Successful Company-Wide Implementation Good Manufacturing Practices (GMP), manufacturers must comply with numerous requirements. Industry must document instructions for manufacture and quality control procedures. They must specify materials needed and define the basic conditions required for a reproducible quality, such as suitable rooms, qualified facilities, trained personnel and type of documentation. … Read more
Hold Time Study Protocol 1. Objective \ Scope 1.1. Hold time study data shall give the assurance of the maximum allowable hold times for bulk and in-process drug products. Generally, one lot can be used for validating hold times if any inconsistency results were observed then another two lots can be used for this study. … Read more
ACTIONS TO BE TAKEN BY INSPECTORATES IN RESPONSE TO THE REPORTING OF CRITICAL AND MAJOR DEFICIENCIES Compliance and enforcement measures are dependent upon a number of factors, including the significance of violations such as a “Critical” deficiency and a large number of “Major” deficiencies, the history of the site, potential risks to products, and assessment … Read more
GMP Deficiencies in Pharmaceutical Industry “Critical and Major deficiencies” The findings of a Good Manufacturing Practice (GMP) inspection can have a substantial impact on both your organization and, subsequently, public health. If the deficiencies found are classified as significant, they may necessitate cessation of manufacturing activities and/or product withdrawal from the market. In the advent … Read more
Air Handling Unit (AHU) and Working Principle An Air Handling Unit (AHU) is used to re-condition and circulate air as part of a heating, ventilating, and air-conditioning system. The basic function of the AHU is to take in outside air, re-condition it, and supply it as fresh air to a building. All exhaust air is … Read more