Visual Inspector Qualification
Training Program

SSI’s Visual Inspector Training & Qualification Programme is a structured, multi-phase curriculum designed to qualify manual visual inspectors to USFDA, EU GMP, MHRA, and other global regulatory standards — with certification issued upon successful completion.

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90+ Drug Manufacturers Globally

Why Inspector Qualification Matters?

Under USP <1790>, EU GMP Annex 1, and other global regulatory standards, manual visual inspectors must be formally qualified before conducting 100% inspection of injectable products. Inspector qualification is not a one-time event — requalification is required annually, or following any change in product, container, or inspection process.

An unqualified or inadequately qualified inspector programme is one of the most common FDA 483 observations in injectable manufacturing. SSI’s training program addresses this gap with a validated, documented curriculum that is designed to withstand regulatory scrutiny.

Train the Trainer Model

SSI’s training model is designed for scale. Rather than requiring SSI presence for every requalification cycle, we train your designated master trainers to independently qualify and requalify inspectors at your site-using SSI’s curriculum, documentation, and defect kits.

SSI trains master trainers at your facility during the initial engagement

SSI provides the complete training documentation package

Master trainers are certified by SSI to conduct Phase 1, Phase 2, and Phase 3 training independently

Annual SSI review of your master trainer records is available to ensure ongoing compliance

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Programme Overview

Feature

Detail

Curriculum structure

Phase 1 → Phase 2 → Phase 3 qualification stages as per USP 1790

Duration

6 days depending on number of personnel being qualified

Delivery modes

Option A: Virtual (SSI scientists guide training daily via video conference) 

Option B: On-site (SSI scientists conduct training at your facility)

Training model

Train-the-Trainer — SSI trains your designated master trainers, who then qualify and train your site inspectors ongoing

Certification

Certificate of qualification issued upon successful completion of all three phases

Regulatory alignment

USFDA, EU GMP Annex 1, MHRA, JP, TGA and all global regulatory standards

Optional

Annual requalification programme available | triggered also by process changes, prolonged absence, or audit findings

Frequently Asked Questions

What does SSI's visual inspector qualification training include?

Training cover visual inspection principles, defect recognition, inspection technique and the customer’s qualification procedure, followed by documented qualification against the agreed protocol.

Who can SSI train and qualify?

SSI can support qualification of personnel responsible for manual visual inspection, subject to the customer’s procedure, product format and qualification requirements.

Can training be conducted onsite at our facility?

Yes, onsite training and qualification can be scoped where the facility, product and inspection setup are available for the engagement.

Do you provide qualification records and certificates?

Yes. Training and qualification records are provided after completion of the program.

Can SSI provide refresher or requalification training?

Yes, refresher/requalification training can be scoped according to the customer’s internal procedure and required qualification frequency.

Can SSI train inspectors for difficult-to-inspect products?

Yes, training can be tailored to the product/container format and the inspection conditions defined in the customer’s visual inspection program.