Validation
Validation
To ensure that the products are fit for intended use, the company must show in a documented form that the processes, methods, tests, activities, and equipment they deploy can repeatedly produce the desired result. Therefore, each critical step in the manufacturing process must be verified to perform as intended under defined conditions. It is considered that if manufacturers are using validated procedures & methods, they can manufacture Pharmaceutical and medical device products within the specifications with minimum variation.
Our consultants are aware of all the regulations and standards that need to comply for Validation. They are experts in the preparation, execution of protocols, and drafting of reports and besides it, also have extensive experience in different Validations and can assist but not limited to:
- Instrument/Equipment Validation
- Cleaning Validation
- Computer System Validation
- Process Validation
- Test Method Validation
- Validation Master Plan and Validation regulatory compliance
- Validation Protocols (IQ, OQ, PQ)
- Validation Deliverables URS, FS, DS, FAT, SAT
- IQ, OQ, PQ
- Traceability matrix
- Validation Summary Report
- Generating Protocols, SOP’s, Summary Reports, ensuring Clean in Place (CIP), etc.
- Risk assessment to identify Critical Process Parameters and Critical Quality Attributes
- Worst-Case product, Procedure, Equipment Selection, Clean, Dirt hold time, and Cleaning frequency
- Define and justify the sampling site (hard-to-clean areas), Deviations Handling
- Cleaning Verification: Sampling, Swab Sampling, Rinse, Coupon Sampling
- Cleaning Validation Acceptance: Sampling/Qualification and Testing
- Software Development Life Cycle (SDLC)
- Master Validation Plan, Traceability Matrix
- Good Automated Manufacturing Practices (GAMP5)
- URS, FRS, Design Specification
- Risk Assessment in Computer System Validation
- Validation Plans and Master Validation Plans
- Design Qualification (DQ)
- Installation Qualification (IQ)
- Operational Qualification (OQ) and Performance Qualification (PQ), FAT, SAT
- 21 CFR Part 11, Annex 11, IEC 62304
- Process Design, Process Engineering, Pilot studies
- Design of Experiments
- Critical Process Parameters and Critical Quality Attributes
- Process Qualification, Process Performance Qualification
- Test Method Characterization
- Non-Destructive and Destructive Testing Methods
- Gage (R&R)
- Method Development
- Method Verification and Acceptance Criteria
“Your trust – Our Quality”
At Career Prime, we understand the needs of clients, thus we strive to supply the best of the consultants to clients as per their skillsets and experience.
177 Center Point Rd,
Suite 104, Weatherford
Texas 76087
+1 656 2074158
hr@careerprimesolutions.com
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