Objective: To determine that process consistently performs as intended by repeatedly running the system on its intended schedules and recording all ...
Objective: To determine that process consistently performs as intended by repeatedly running the system on its intended schedules and recording all relevant information and data. Results m…Full description
Protocol written by _________________________ ________________________________________ ___________________ ____ Date _____________________ _____________________ Approval ___________________________ _________________________________________ _________________________Date ___________Date _____________________ _____________________ Approval __________________________ ________________________________________ __________________________ ____________ Date _____________________ Approval __________________________ ________________________________________ ___________________________ _____________Date Date _____________________ _____________________ ___________________________ _________________________________________ _____________________________ ____________________________ __________________________ ______________________ _________ Objective: To determine that process consistently performs as intended by repeatedly running the system on its intended schedules and recording all relevant i nformation and data. Results must demonstrate that the process meets predetermined specifications under normal conditions, and where appropriate worst case conditions. ___________________________ _________________________________________ _____________________________ ____________________________ __________________________ ______________________ _________ Scope: To be performed with validated equipment in the specified location in validated premises. If equipment or systems or the facility are modified or t he premises where the process takes place is changed, or the process is relocated, the process must be re-validated after the systems, equipment and facility qualifications, as appropriate, have been performed and approved. ___________________________ _________________________________________ _____________________________ ____________________________ __________________________ ______________________ _________ Responsibility:
The persons responsible for the process will perform the validation and record the information. The responsible person will supervise the study, verify the completion of the records and write the report. Quality Assurance will review and approve the Process Validation Protocol and Report. Name of the Personnel
Designation
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2/2/2010 10:32:44 AM
Signature
ASSIGNMENT ON PROCESS VALIDATION/ FORMATS/BIBEK SINGH MAHAT
KU PHARMACEUTICALS PRIVATE LIMITED
PROCESS VALIDATION PROTOCOL
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Materials, Equipments and Documents: Master Formulation Record (MFR), Batch Manufacturing Record, Equipment List with Equipment No. and all t he Standard Operating Procedures (SOPs) for normal operation of the processes under test.
Documents of Normal Operation: Name of the Document
Documen ment No.
Effective ive Date
Master Formulation Record Batch Manufacturing Record
ASSIGNMENT ON PROCESS VALIDATION/ FORMATS/BIBEK SINGH MAHAT
KU PHARMACEUTICALS PRIVATE LIMITED
PROCESS VALIDATION PROTOCOL
[ Page No: 3 of 9]
Procedure:-
Performance:1. Process: Run full process according according to SOP three three times and and record all required data. 2. Deviations to the procedures procedures must be recorded on the data record forms. 3. Analytical tests: Perform the routine tests associated with the process according according to the SOP 4. Test results must be approved by QC.
Evaluation :1. Attach all data data record forms and and charts. 2. Perform all necessary calculations and and statistical analyses (pre-determined). 3. Compare to acceptance criteria. 4. Prepare Deviation Report Report (including the justification of acceptance acceptance and impact on the the process).
Prepare a Process Validation Report:This should include for each validation run: 1. Date study initiated; date completed; observations made; 2. Problems encountered; encountered; completeness of information collected; summary summary of the deviation report; 3. Results of tests and statistical analyses; analyses; do results meet acceptance acceptance criteria; location location of original data; data; 4. Other information relevant to the study. Conclusions will be made on the validity of the process in individual runs and on the three Consecutive Validation Runs. Approval 1. Submit the Document to QA for review and approval. approval. 2. The Process must meet all specifications for three consecutive runs. runs.
