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Sterile Formulation-engineering assurance

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STERILE FORMULATION- VENDOR QUALIFICATION

Vendor qualification is done for Raw material (Active Pharmaceutical Ingredients/Excipients), Packaging Material (Both primary, secondary...
Systems and Equipment Qualification in Pharmaceuticals

1. OBJECTIVE To lay down a procedure for preparation, review, and approval of Performance Qualification (PQ) and Re-Qualification...
CYCLE DEVELOPEMENT STUDY PROTOCOL FOR TUNNEL

1. SCOPE: This protocol is applicable for the cycle development study of tunnel with applicable containers in manufacturin...
Quality assurance terminology and Definitions

S. No. Terms Definition A 1 Acceptance Criteria Th...
Responsibilities of quality assurance department

1. OBJECTIVE To lay down a procedure on responsibilities of Quality Assurance department. 2. SCOPE This proced...
Qualification/ Re-Qualification of Autoclaves

1.0 OBJECTIVE: 1-1 To lay down a procedure for Qualification and Re-qualification of steam sterilizers / Autoclaves. ...
Autoclave Validation

1.1 Verification and sequential operation of sterilization cycles 1.1.1 Test procedure: The prime objective of this test is...
Abbreviations used in pharmaceutical industry

PVP : Process Validation Protocol PVR : Process Validation Report CVP : Cleaning Validation Protocol CVR : Cleaning Validation Report ...

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STERILE FORMULATION- VENDOR QUALIFICATION

Vendor qualification is done for Raw material (Active Pharmaceutical Ingredients/Excipients), Packaging Material (Both primary, secondary...
Systems and Equipment Qualification in Pharmaceuticals

1. OBJECTIVE To lay down a procedure for preparation, review, and approval of Performance Qualification (PQ) and Re-Qualification...
CYCLE DEVELOPEMENT STUDY PROTOCOL FOR TUNNEL

1. SCOPE: This protocol is applicable for the cycle development study of tunnel with applicable containers in manufacturin...
Quality assurance terminology and Definitions

S. No. Terms Definition A 1 Acceptance Criteria Th...
Responsibilities of quality assurance department

1. OBJECTIVE To lay down a procedure on responsibilities of Quality Assurance department. 2. SCOPE This proced...
Qualification/ Re-Qualification of Autoclaves

1.0 OBJECTIVE: 1-1 To lay down a procedure for Qualification and Re-qualification of steam sterilizers / Autoclaves. ...
Autoclave Validation

1.1 Verification and sequential operation of sterilization cycles 1.1.1 Test procedure: The prime objective of this test is...
Abbreviations used in pharmaceutical industry

PVP : Process Validation Protocol PVR : Process Validation Report CVP : Cleaning Validation Protocol CVR : Cleaning Validation Report ...

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