Quality Assurance

Temperature And Relative Humidity Monitoring In Pharmaceutical Industry

Quality Assurance

Temperature and Relative Humidity Monitoring In Pharmaceutical Industry   The environment inside a pharmacy and pharmaceutical storage areas must be optimal and constant to ensure the effectiveness of the medications within them. The implications of humidity for pharmaceutical are numerous as moisture causes de-sterilization, irreversible destabilization and oxidative degradation because the proteins found in many …

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Common Terms & Definitions used in Qualification & Validation of Heating, Ventilation and Air-Conditioning Systems for Non-Sterile Pharmaceutical Dosage forms.

Quality Assurance

Common Terms & Definitions used in Qualification & Validation of Heating, Ventilation and Air-Conditioning Systems For Non-Sterile Pharmaceutical Dosage Forms.   Design parameters should be set realistically for each project, with a view to creating a cost-effective design, yet still complying with all regulatory standards and ensuring that product quality and safety are not compromised. …

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Principles of Cleaning Validation

Quality Assurance

Principles of Cleaning Validation Cleaning validation should be performed in order to confirm the effectiveness of any cleaning procedure for all product contact equipment. Simulating agents may be used with appropriate scientific justification. Where similar types of equipment are grouped together, a justification of the specific equipment selected for cleaning validation is expected. A visual …

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Pharmaceutical Quality System Elements & Change Management System (ICHQ10)

Quality Assurance

Pharmaceutical Quality System Elements & Change Management System As per ICH Q10 The elements described below might be, required in part under regional GMP regulations. However, the Q10 model’s intent is to enhance these elements in order to promote the lifecycle approach to product quality. These four elements are: • Process performance and product quality monitoring …

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ICH Requirement For Quality manual, Management commitment,Quality Planning & Quality policy (Pharmaceutical Quality System ICH Q10)

Quality Assurance

ICH Requirements For Quality manual, Management commitment,Quality Planning & Quality policy (Pharmaceutical Quality System As Per  ICH Q10) ICH Q10 Guideline deals with Pharmaceutical Quality System which guides about Quality Manual, Management Commitment, Quality planning, Quality Policy & Quality risk management. Now let’s see what ICH Q10 say’s about Pharmaceutical Quality System Q10. Achieve product realisation To …

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Pharmaceutical Quality System (ICH Q10)

Quality Assurance, Uncategorized

Pharmaceutical Quality System Guideline as per ICH Q10.    Introduction This document establishes a new ICH tripartite guideline describing a model for an effective quality management system for the pharmaceutical industry, referred to as the Pharmaceutical Quality System. Throughout this guideline, the term “pharmaceutical quality system” refers to the ICH Q10 model. ICH Q10 describes …

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SOP on Change Control

Quality Assurance, Uncategorized

SOP on Change control The purpose of this SOP is to lay down a procedure to “Change Control” to ensure that the proposed changes shall not affect the strength, identity, safety, purity and quality of the product. PROCEDURE: TYPES OF CHANGE CONTROL: DOCUMENT CHANGE CONTROL (DC) : Initiation of a document or modification of approved …

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SOP For Training of employees

Quality Assurance

Training of employees PROCEDURE:                   Every employee of the organisation shall first undergo an Induction Training and then to be trained on his / her area of operation prior to start the work. Induction Training shall also include a visit and understanding of works done in Departments other than their own. An Induction Training Record …

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