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WHAT IS PROCESS VALIDATION?

Posted By: Pharmaceutical Guidanaceon: January 20, 2018In: email, Other, Validation & QualificationNo Comments

The process validation is derived from the fact that the specific exercise of process validation should never be designed to fail. Failure in carrying out the process validation assignment i... Read more

Master Plan or Protocol for Process Capability Design and Testing

Posted By: Pharmaceutical Guidanaceon: January 15, 2018In: email, Other Topic, QA & QCNo Comments

Objective Process capability design and testing Types of process Batch, intermittent, continuous Typical processes Chemical, pharmaceutical, biochemical Process definition Flow diagram, in-p... Read more

Checklist of Qualification and Control Documentation

Posted By: Pharmaceutical Guidanaceon: January 15, 2018In: email, Other, Validation & QualificationNo Comments

The FDA, as per existing cGMP regulations and considers process validation necessary because it makes good engineering sense. Subpart Subpart Section of CGMPs Qualification and control docu... Read more

STATISTICAL PROCESS CONTROL AND PROCESS VALIDATION IN PHARMACEUTICALS

Posted By: Pharmaceutical Guidanaceon: January 13, 2018In: email, Other, Validation & QualificationNo Comments

Statistical process control (SPC), also called statistical quality control and process validation (PV) SPC comprises the various mathematical tools (histogram, scatter diagram run chart, and... Read more

Design Qualification of Blister Packing Machine (Model – BQS)

Posted By: Pharma Editoron: May 10, 2017In: email, Other Topic, QualificationNo Comments

OBJECTIVE To design, engineer, and supply the Blister Packing Machine (Model: BQS) and to ensure that it complies with the Scope of Supply. To prove that each operation proceeds as per the... Read more

Design qualification. Pretreatment & purified water generation system

Posted By: Pharma Editoron: May 04, 2017In: email, Other, Validation & QualificationNo Comments

OBJECTIVE AND SCOPE To design the equipment / instrument in conjunction with the design data in order to provide basis for vendor, manufacturer & / or the design engineer for designing t... Read more

Operational qualification for WFI generation plant

Posted By: Pharma Editoron: May 04, 2017In: email, Operational Qualification(OQ), Validation & QualificationNo Comments

OBJECTIVE To establish documentary evidence to demonstrate the WS system is qualified for correct operation as per guidelines outlined in this protocol & operational manual SCOPE OF THIS... Read more

Design Qualification of Vertical Laminar Reverse Flow Powder Containment Station

Posted By: Pharma Editoron: May 02, 2017In: email, Other Topic, QualificationNo Comments

OBJECTIVE To design, engineer and supply the Vertical Laminar Reverse Flow Powder Containment Station to provide assurance that the machine is manufactured as per the URS and it complies wit... Read more

Installation Qualification of Medicament Preparation Vessel

Posted By: Pharma Editoron: May 01, 2017In: email, Installation Qualification(IQ), QualificationNo Comments

PURPOSE: To describe the Installation Qualification of Medicament Preparation Vessel its accessories and to define the Specification of the system in order to: Ensure that the equipment meet... Read more