Process Validation
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Our skills and know-how to
validate your pharmaceutical drug production
LabAnalysis Process Pharma is a sister company part of LabAnalysis Group.
LabAnalysis Process Pharma qualified laboratories, located near Milan (Italy), are fully equipped for any kind of validation activities and process development such as filtration patterns, single use components and systems, in-process materials and primary packaging qualification. The synergy with LabAnalysis Group ensures a 360° support for any type of other analytical assessments for validation, quality control and investigational purpose.
LabAnalysis Process Pharma
1000+
Validation Project concluded
25+
Years of experience in filter and SUS validation
14000+
Lab & offices dedicated sqm
Our Principal Markets
Authorizations
LabAnalysis Process Pharma works in synergy with the LabAnalysis Group’s laboratory facilities with the following authorizations.
GMP Certificate by AIFA Italian Medicines Agency
FDA Approved by US Food & Drug Administration
GLP Certificate by Italian Ministry of Health
UNI EN ISO 9001
UNI ISO 45001
UNI EN ISO 14001
Services
Product and Process Filter Validation
Compatibility Studies
Extractables and Leachables Studies
Adsorption Studies
Viability Studies
Bacterial Retention Studies
Product wet integrity test
Extractables and Leachables Studies in Elastomeric closures, Glass and Plastics
Qualifications and Quantifications of organic and inorganic compounds applying several analytical techniques
Inner surface durability of Glass Containers (USP 1660)
Compatibility Studies of material in contact with drug product
Adsorption Studies of material in contact with drug product
Toxicological Evaluation and Assessment
Cleaning Validation
Validation Master Plan
S.O.P. Development and Review
Cleaning Validation Protocols and Reports
Grouping & Bracketing Approach
Toxicological Assessment (PDE)
In process qualification studies for
Tubing
Connection
Biocontainer
Process equipment or material in contact with the pharmaceutical formulation
Single Use System Validation
Process Optimization Study
Screening
Filterability
Feasibility
Scale-up studies
Risk Assessment
LabAnalysis Process Pharma experts are operative members within pharma regulatory recognized association (PDA), qualified trainers for regulatory agencies (AIFA; ANM; EOF) and educational programs (university master).
Product Types
Pharmaceutical Products
Biotech/Biologics
API
Vaccines
Customer Types
CMO/CDMO
Medical device manufacturers
Technology Vendors
Consultancy Companies