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

CMO/CDMO

Clinical Phase

Technology Vendors

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