A cold storage chamber is a specially designed facility or room that maintains a low temperature to store pharmaceuticals material , and other temperature-sensitive materials. This controlled environment helps to slow down spoilage, maintain quality, and extend the shelf life of products.
Objective of Performance Qualification:
The objectives of this Performance Qualification (PQ) are as follows:
- To verify that the equipment performs in accordance with set acceptance criteria and complies with cGMP requirements.
- To demonstrate that the system will perform consistently within its operating range.
Following execution of the protocol, a validation report will be written and approved. All results, conclusions and variances will be addressed and final disposition of the equipment will be stated. Successful completion of this protocol and approval of the performance qualification report will verify that cold chamber supplied by M/s. Cold Star Refrigeration and installed in quality control department meets all the acceptance criteria and is ready for its intended use.
Performance qualification
The performance qualification of cold chamber shall be performed by doing following tests.
- Empty chamber heat distribution study (Single day)
- Partial loaded chamber heat penetration study (Three consecutive days)
- Full loaded chamber heat penetration study (Three consecutive days)
- Door open and door close study (for information only)
- Power outage test (for information only)
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Table of content
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Protocol Approval
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Overview
- Objective
- Scope
- Responsibility
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Frequency of qualification
- Performance qualification
- Performance re-qualification criteria
Methodology
- Equipment and material
- Test Procedure
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Partial loaded chamber heat penetration study
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- Full loaded chamber heat penetration study
- Door open and door closure study
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- Power outage test
Acceptance criteria
Result
Conclusion
Referance
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Signature log
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Deviation Report
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Deviation Log
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Revision History
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