Frequently Asked Questions

This FAQ covers the most common questions we receive from pharmaceutical manufacturers, contract research organizations, quality teams, and logistics partners worldwide — about our visual inspection defect kits, qualification solutions, training, documentation, shipping, and pricing.

Trusted by
90+ Drug Manufacturers Globally

Choosing the Right SSI Solution

What products and services does SSI provide for visual inspection?

SSI provides turnkey solutions for Visual Inspection for injectable drug manufacturers. We supply Visual Inspection Qualification/Defect Kits, Manual Visual Inspection Booths, CCIT Positive Controls and calibrated particles, along with consulting and particle characterization/analytical services.

What container and product types can SSI supply defect kits for?

SSI supports clear and amber glass vials, lyophilized vials, pre-filled syringes, cartridges, ampoules, BFS containers/bottles, 3-piece ophthalmic bottles, IV bags, dry powder injections, FFS respules and other difficult-to-inspect formats.

We have no in-house experience with visual inspection — where do we start?

SSI can scope the visual inspection lifecycle from baseline/risk assessment through feasibility, equipment selection, qualification, training, defect kits, documentation and ongoing support.

Why should we use a specialist visual inspection supplier instead of preparing our own defect kits?

A specialist supplier can provide standardized defect preparation, calibrated particles, documented defect identity, controlled preparation methods and qualification documentation. For difficult formats such as lyophilized products, specialized preparation can also reduce the risk of damaging or inconsistently positioning defects. Our team has worked in Pharma for 20+ years and have seen where audits can go wrong. Getting it right first time every time is our mantra.

Ordering, Quotation & Commercial Process

How do I get a quotation from SSI?

Customers can contact SSI with their product details and requirement. SSI will clarify the scope, request a URS or configuration details where required, and issue a technical-commercial proposal.

What information should I provide when requesting a quotation?

For defect kits, SSI typically needs container type/size, product type, defect and good-unit quantities, and fill requirements. For equipment or services, the applicable URS, process details and intended use should be provided where available.

Can SSI review our URS before preparing a quotation?

Yes. SSI’s technical team can review a submitted URS, confirm feasibility and clarify requirements before preparing the proposal.

Can SSI support vendor qualification and audits before onboarding?

Yes. SSI can provide standard supplier documentation and support customer vendor-qualification requirements, including questionnaires, certifications, Quality Agreements and audit-related documentation. We support virtual and on-site audits as well.

Can SSI sign an NDA or Quality Agreement?

SSI can review and execute customer NDA and Quality Agreement requirements subject to its internal approval process.

Quality, Documentation & Supplier Qualification

What quality certifications does SSI hold?

SSI is ISO 9001 and ISO 17025 certified.

Can SSI provide supplier qualification questionnaire?

Yes. SSI can provide a redacted version of supplier qualification questionnaire that customers typically share with us.

Can SSI support customer audits?

Yes, customer audit support can be provided subject to scope and scheduling. SSI can also support documentation review and audit-readiness activities.

Can SSI provide a Quality Agreement?

Yes. A signed Quality Agreement is included among the standard supplier-qualification documents SSI can provide, subject to the customer’s requirements and SSI’s approval process.

How does SSI handle damaged or non-viable defect-kit components?

SSI supports the replacement of damaged/non-viable units within the agreed replacement/ revalidation approach. The exact replacement policy should be confirmed in the quotation or quality documentation.

International Supply, Shipping & Logistics

Which countries and regions does SSI supply to?

SSI ships directly from India to customers across North America, Europe, APAC and the Middle East.

How are international shipments handled?

SSI ships vial DHL as our preferred freight forwarding partner. In few cases such as where customer had drug product or immediate delivery is required, we work directly with airlines.

Who handles customs clearance and import documentation?

Responsibility depends on the agreed Incoterm. SSI can provide the agreed commercial, packing and supporting documentation, while customs clearance and import taxes are handled according to the selected delivery arrangement.

Can SSI ship directly to our contract manufacturer or equipment vendor?

Yes. SSI can ship kits directly to a third-party AVI or leak-test equipment vendor once the delivery and shipment details are finalized.

Does SSI have a US or other regional distribution center?

No. SSI currently ships from India for all regions, including the US

How long does it take to receive a defect kit?

Standard lead time is roughly 2–3 weeks from receipt of the order and required fill material, with additional time for international freight/customs where applicable. Onsite deployment may be considered when shipping timelines are restrictive.

How long does it take to receive a Visual Inspection Booth?

Typical delivery is approximately 4–6 weeks from receipt of order. Our customized models may require lead times of 6-8 weeks.

Regulatory & Technical

What regulatory frameworks does SSI's work reference?

SSI’s work references USP <1790>, USP <790>, USP <1>, USP <1207>, EMA Annex 1, EP 2.9.20, EP 5.17.12, JP 6.06, 21 CFR Part 11, and relevant expectations from authorities such as USFDA, MHRA and TGA and all global regulatory standards

Does SSI's visual inspection equipment support 21 CFR Part 11?

The VIB-300 includes audit trails, e-signature support and data logging/export designed for applications requiring these controls and is fully compliant with 21 CFR Part 11.

How is the minimum particle size for a qualification kit determined?

It is generally set around the applicable probability-of-detection threshold and the risk assessment onsite.

Does a manual-inspection kit need the same challenge frequency as an AVI qualification kit?

No. AVI systems require routine challenge testing appropriate to the validated system, while manual visual inspection relies on periodic inspector qualification/requalification according to the customer’s procedure and applicable requirements.

Can defect kits be used for opaque containers?

For opaque containers, 100% visual inspection may not be feasible. SSI can support off-line destructive QC sampling approaches where appropriate, subject to the customer’s risk assessment and applicable standards.

Company & Working with SSI

How many customers has SSI worked with?

SSI has worked with 90+ injectable drug manufacturers worldwide, with direct shipments across North America, Europe, APAC and the Middle East.

What makes SSI's defect kits different from conventional visual inspection kits?

Our team has 20+ year of production and quality experience across sterile manufacturing sites. We have seen multiple audits and know where things can go wrong. Our consultative approach ensures your program is audit ready from day one.

Can SSI support customers outside India directly?

Yes. SSI ships directly to customers in multiple international regions from India and can also support onsite deployment of our scientists where applicable.

Trusted by Leading Pharma Companies

Hear directly from pharmaceutical professionals who trust our solutions to deliver quality, reliability, and performance.

"SSG is a one-stop solution for all visual inspection needs. From particulate defects, size verification, and source validation to kit preparation and seamless handover, their expertise is evident. The SSG team truly understands pharma regulations and acknowledge the importance of setting industry standards.“

Dr. Reddy's Laboratories Ltd.

"We really appreciate all of your support in getting our Manual Visual Inspection Defect Kits ready for qualifying our inspectors. You've been right there, helping wherever and whenever needed for the past few months. From ordering supplies to supervising the set-up of the supply - we are grateful for your timely support and for providing all required documents for regulatory audits. We are honored by your assistance and look forward to continuing our collaboration"

PAR Pharma

"SSG is a one-stop solution for all visual inspection needs - from particulate defects and sizing to certification and kit handover. The execution was seamless, and the team demonstrated a deep understanding of pharma regulatory requirements. The documentation provided fully meets compliance standards. We're pleased to see an Indian supplier offering high-quality standard defect kits with proper regulatory documentation. Delivery was on time, and service support has been excellent. I highly recommend Siddhi Sai to anyone planning to procure defect kits"

Zydus Lifesciences Ltd. (SEZ Onco Injectable)

“Exceptional support for technical clarifications, with prompt responses to particle adhesion issues. The team ensures thorough follow-ups until resolution and provides additional samples swiftly when required”

Biocon, Bangalore, India

“Reliable and prompt support at all times. The team provides excellent assistance and is highly recommended for Knapp kits and defect kits”

STERIL-GENE, Pondicherry, India

"We procured the known particle size kit for both vials and PFS from SSG. The quality of the units was excellent, and the response and support from the SSG team were outstanding. I highly recommend SSG to anyone looking for a reliable known particle kit supplier."

BE Pharmaceuticals

"We procured a particle size kit for vials from the SSG team and received exceptional service. The timely delivery and extended support in designing particles for the injectable process enabled us to qualify our inspection process on schedule. Thank you, SSG team!“

Mankind Pharma, Paonta Sahib, H.P., India