Visual Inspection Consulting & Engineering
Technical support for pharmaceutical visual inspection programs — from process and study design to training frameworks, qualification, data review, investigation, and inspection readiness.
Building Robust Visual Inspection Programs
A well-designed visual inspection program is more than equipment and procedures — it is a comprehensive system that integrates personnel qualification, process validation, equipment maintenance, and continuous improvement under a unified regulatory strategy.
Consulting can be scoped around current FDA materials, EU GMP Annex 1, USP <790>/<1790>, ICH guidance, and the customer's applicable product and market requirements. The customer's Quality Unit retains responsibility for approving procedures, acceptance criteria, validation conclusions, and regulatory positions.
Whether you are establishing a new program from scratch, upgrading from manual to automated inspection, or preparing for a regulatory audit — we provide the strategic guidance and technical execution support you need.
Consulting Services
Engagements are defined around the customer's specific product, package, process, evidence, and authorized decision makers.
Process Validation
Risk-based support for manual, semi-automated, and automated inspection protocols, prerequisites, challenge strategies, data review, deviations, and reporting.
Regulatory Source Review
Source-status review across applicable law, compendial standards, guidance, drafts, technical reports, product requirements, and site-defined controls.
Program Development
Frameworks for SOPs, work instructions, defect libraries, governance, trending, investigations, and site-approved acceptance criteria.
Training & Qualification
Inspector qualification program design, Knapp study methodology, probability of detection (PoD) study support, and requalification scheduling.
Risk Assessment
Risk-based approaches to defect classification, reject limit establishment, and process control strategies aligned with ICH Q9 principles.
Audit Readiness
Preparation and support for regulatory inspections and customer audits. Gap assessments, documentation review, and mock audit execution.
Regulatory and Technical References
FDA 21 CFR Part 211
Binding U.S. CGMP requirements relevant to written procedures, in-process control, laboratory controls, container-closure systems, and drug-product release.
USP <790> Visible Particulates in Injections
Compendial chapter addressing visible particulate requirements and acceptance testing for injections; consult the current licensed text.
USP <1790> Visual Inspection of Injections
Informational chapter providing guidance on visual inspection program design, inspector qualification methodology, and statistical approaches.
EU GMP Annex 1 (2022 Revision)
EU GMP requirements for sterile medicinal products; paragraphs 8.30–8.33 address individual inspection, qualification, automated-method validation, defect classification, and trending.
ICH Q9 Quality Risk Management
International guidance on systematic, science-based quality risk management throughout the product lifecycle.
ISO 2859-1 Sampling Procedures
A voluntary attribute-sampling standard that may support an approved AQL sampling scheme where scientifically and procedurally appropriate.
How We Work With You
Flexible engagement models designed to fit your project scope and timeline.
Project-Based
Defined scope, timeline, responsibilities, and deliverables for specific studies, program changes, or inspection-readiness activities.
Illustrative scope: AVI protocol framework, challenge strategy, and data review.
Retainer
Ongoing advisory support with dedicated hours per month for continuous program improvement, regulatory updates, and ad-hoc technical questions.
Example: Monthly review of inspection data trends and quarterly program assessments.
Staff Augmentation
Embedded support may be scoped for longer projects requiring closer collaboration with quality, manufacturing, engineering, or validation teams.
Illustrative scope: scheduled support for a new inspection-program build-out.
Need Expert Visual Inspection Guidance?
Whether you are facing a regulatory gap, planning a technology upgrade, or building a program from the ground up — let us discuss how we can help. Initial consultation is complimentary.