Validation
We can manage all your validation requirements from project management to report writing that is from URS, FRS, DQ, FAT, SAT, Commissioning documents, VMP, IQ, OQ, PQ, PV to Validation report writing. Our experienced validation engineers can be based in your facility to execute validation testing and work with you to streamline the testing to increase efficiency and optimise testing value.
We can provide solutions for conducting risk assessments using tools like fish bone, 5 why, FMEA.
Equipment Validation
Equipment
cGMP Validation provides Commissioning and Qualification services for a wide variety of process equipment, including, but not limited to, the types listed below.
BIOREACTOR SYSTEMS
- Fermentor Systems
- Reaction Vessel Systems
- Media Prep Vessel Systems
- Mixers, Agitators
- Filtration Systems
- Glassware, Parts Washers
- Autoclaves, Sterilizers
- Depyrogenation Ovens & Tunnels
- Sterilization Tunnels
- Aseptic Processing Equipment
INCUBATORS
- Reach-In Freezers
- Reach-In Refrigerators
- Warehouse Coolers
- Warehouse Freezers
- Stability Chambers
- Laminar Flow Units
- Biosafety Cabinets
- Fume Hoods
- Isolators, Glove Boxes, RABS
- Vial, Ampule Fillers Raw Material Dispensing Systems
BLENDERS
- Fluid Bed Dryers
- Spraydryers
- Granulators
- Tablet Presses
- Encapsulators
- Solid Dosage Fillers
- Capping Equipment
- Label & Packaging Equipment
- Inspection Systems
- Centrifuges Visual Inspection machine
Process Validation
Processes
cGMP Validation provides Validation services for many process, including, but not limited to, the types listed below.
- ANALYTICAL METHODS VALIDATION
- ENVIRONMENTAL CROSS CONTAMINATION STUDY
- SHIPPING VALIDATION
- ASEPTIC PROCESS VALIDATION
- CLEANING VALIDATION CIP / CLEANING VALIDATION
- SIP / STERILIZATION VALIDATION
cGMP Validation provides Validation services for Product Validation
- PARENTERALS
- LIQUIDS
- SUSPENSIONS
- TABLETS / CAPLETS
- OINTMENTS
- POWDERS
Validation Protocol
Our protocols include customized validation approaches and methodology with clearly defined pre-determined acceptance criteria. We offer fast documentation turnaround and can often schedule validation projects with short lead times. Principle benefits include reduced cost and time to achieve a compliant system. We use a pragmatic integrated approach to commissioning and validation activities, ensuring sound documented compliance with cGMP for all our assignments. We offer full validation services associated with manufacturing projects as well as offer services to retrospectively validate existing manufacturing processes.
We can assist you with interpretation of regulations in determining the validation requirements; manage implementation of methodologies and prepare necessary reports. Our experienced staff will ensure that protocols are written and executed according to user requirements, specifications, applicable regulations, and SOPs. We can provide versatile services which include any or all of the following:
- Protocol Generation
- Protocol Execution
- Final Report Preparation
- Quality Review
Product Validation
We provides validation service for your products by verifying that the product specification is describing a product that you know will be successful and also meets its specification requirements.
QC/Microbiology Method Validation
WE provides validation services to determine the suitability of a test method towards its intended purpose. During the validation process, the methods performance characteristics are also estimated. The validation is done on the following parameters.
- Precision
- Accuracy
- Range and Linearity
- Limit of Detection and Limit of Quantification
- Specificity and Selectivity
- Robustness
Cleaning Validation
In a pharmaceutical environment, ensuring that your equipment and utensils are cleaned, maintained and sanitised at appropriate intervals to prevent malfunctions or contamination in your drug products is essential. Our pharmaceutical cleaning validation service includes total carbon analysis and total organic carbon testing (TOC) a quick, accurate and inexpensive screening protocol for validating small molecule drugs, peptides, proteins and cleaning detergents. cGMPs include the prevention of possible contamination and cross-contamination of pharmaceutical starting materials and products to assure the effectiveness and consistency of a cleaning process to remove residues and contaminants. We can help you:
- Validate small molecule drugs, peptides, proteins and cleaning detergents
- Salvage expensive production runs through rapid detection of contamination
- Meet all your regulatory obligations
Revalidation
We offer re-validation services on items that are dismissed, repaired, integrated/coupled, relocated, or after a specified time lapse. Re-validation can also be conducted when/where a change occurs during the courses of activities, such as
- Sample matrices
- Production scales
- Out-of- specification
(OOS) investigations, due to the contamination of testing reagents, glasswares, the aging of equipment/devices etc. In GLP accredited laboratories, verification/revalidation will even be conducted very often against the monographs.
Facilities Design or Validation
Isha’s is skilled in assisting organizations as they encounter facilities design, construction, or adaptation—or as they encounter facilities-related compliance problems. Through a powerful blend of compliance, regulatory, scientific, and technical expertise, is highly effective in:
- Analyzing, developing, and/or enhancing engineering requirements, specifications, and drawings, including HVAC, water, sterilization, and dust-control systems
- Developing environmental and processing-room requirements
- Recommending effective flow of materials, equipment, and personnel
- Assessing and enhancing facilities requirements vis-à- vis manufacturing, assembly, packaging/labeling, and distribution operations
- Addressing the facilities requirements of laboratory operations
- Performing factory acceptance testing of equipment (FAT)
- Conducting audits during construction and installation phases
- Qualifying facilities for sterile, low-bioburden, and non-sterile products
- Qualifying facilities for intermediates, APIs, and finished drug products
- Qualifying facilities for medical device components and finished products
Utility Systems Qualification
cGMP Validation provides Commissioning and Qualification services for a wide variety of utility systems, including, but not limited to, the types listed below.
- CHILLED WATER / GLYCOL SYSTEMS
- USP / PW WATER GENERATION AND DISTRIBUTION SYSTEMS
- WFI GENERATION AND DISTRIBUTION SYSTEMS
- PLANT STEAM SYSTEMS
- PURE / CLEAN STEAM SYSTEMS
- CLEAN-IN- PLACE SYSTEMS
- COMPRESSED AIR SYSTEMS
- CCOMPRESSED GAS SYSTEMS
- CHVAC SYSTEMS
- CWASTE NEUTRALIZATION SYSTEMS
- CTANK FARMS
- CSTEAM/STERILIZE-IN- PLACE SYSTEMS
cGMP Validation also provides Factory Acceptance Testing and Site Acceptance Testing support.
- CLEANROOM / CONTROLLED AREA CONSTRUCTION
- ENVIRONMENTAL BASELINE STUDIES
- HVAC PERFORMANCE QUALIFICATION
- PREPARATION OF SOPS FOR PROCESS FLOW
Laboratory Instruments
cGMP Validation provides Qualification services for a wide variety of utility systems, including, but not limited to, the types listed below.
- BIOROBOTIC SYSTEMS
- WEIGHING AND DISPENSING SYSTEMS
- LABORATORY INFORMATION MANAGEMENT SYSTEMS
- GC, HPLC AND SOFTWARE
- MICROPLATE READERS
- LABORATORY CENTRIFUGES