| Protocol Preparation and Approval Preparation and Checking:
Approval:
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| Objective: The objective of the protocol is to establish documentary evidence for the Rapid Mixer Granulator to demonstrate that unit is qualified for correct operation as per guidelines outlined in this protocol. Scope: This procedure applies to the performance qualification of Rapid Mixer Granulator Comprising of the following tests 1. Air flow laminarity by smoke test 2. Non viable particulate count. 3. Viable particle count Responsibility: 1. Preparation, Review and approval of the protocol. 2. Providing required support during operation and preparation of PQ report. 3. Execution of Viable Particle count Contractor: 1. Execution of protocol. 2. Collection of data and preparation of final PQ report. Pre Requisite:
References: United State Pharmacopoeia 29 ISO 14644 EQUIPMENT VALIDATION The simulation of the process was carried out by connection with the specific machine. Simulation of the process consists of the following:
PERFORMANCE QUALIFICATION EVALUATION: NAME OF PRODUCT: PERFORMANCE CRITERIA – BEFORE BLENDING:
PERFORMANCE CRITERIA – AFTER BLENDING:
Performance Qualification Summary and conclusion: _________________________________________________________________
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_________________________________________________________________ Abbreviation
Performance Qualification Approval The performance qualification documents is studied and approved by the Undersigned Authorized Personnel. The approved Performance Qualification supersedes all the previous agreed specification. Report Preparation and Review:
Report Approval:
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