Quality Assurance

SOP For Corrective Action and Preventive Actions

Quality Assurance

SOP For Corrective Action and Preventive Actions   OBJECTIVE: Lay down the procedure for corrective and preventive action programme in executing and documenting activities’ for continued compliance and improvement in process as per cGMP. SCOPE: This SOP is applicable to the procedure for Corrective Action and Preventative Actions (CAPA) program at manufacturing facility… RESPONSIBILITY: Officer […]

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Performance Qualification (PQ) Protocol & Report Format In Pharmaceuticals.

Quality Assurance

Performance Qualification In Pharmaceutical Industry. Systems and equipment should consistently perform in accordance with design specifications. The performance should be verified in accordance with a performance qualification protocol. There should be documented records for the verification of performance (performance qualification report) to indicate the satisfactory performance over a period of time. Manufacturers should justify the

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Operational Qualification (OQ) Protocol & Report Format In Pharmaceuticals.

Quality Assurance

Operational Qualification (OQ) In Pharmaceuticals. Systems and equipment should operate correctly and their operation should be verified in accordance with an operational qualification protocol. Critical operating parameters should be identified. Studies on the critical variables should include conditions encompassing upper and lower operating limits and circumstances (also referred to as “worst case conditions”). Operational qualification

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Installation Qualification (IQ) Protocol and Report in Pharmaceuticals  

Quality Assurance

Installation Qualification (IQ) Protocol and Report in Pharmaceuticals.   Installation Qualification:- Systems and equipment should be correctly installed in accordance with an installation plan and installation qualification protocol. Requirements for calibration, maintenance and cleaning should be drawn up during installation. Installation qualification should include identification and verification of all system elements, parts, services, controls, gauges

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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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SOP For Risk Management

Quality Assurance

SOP For Risk Management. Objective :- The purpose of this SOP is to lay out the procedure for Risk Management (risk identification, analysis, evaluation, reduction / mitigation, communication and conclusion of risk in order to ensure the quality, safety, integrity and purity of the drug product by using FMEA (Failure Mode Effect Analysis). Scope:-  The

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Quality Risk Management In Pharmaceutical Industry.

Quality Assurance

Quality Risk Management In Pharmaceutical Industry. Quality risk management: A systematic process for the assessment, control, communication and review of risks to the quality of the drug (medicinal) product across the product lifecycle. Principles of Quality Risk Management Two primary principles of quality risk management are: The evaluation of the risk to quality should be

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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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