Blood Centre Licensing Inspection Checklist

When a drug inspector visits for a licensing inspection, keep one indexed pack ready with your current licence and renewal papers, technical staff files, premises and equipment records, and the records named in Schedule F Part XIIB. Rule 122G makes adequate staff, plant, premises and specified records conditions of the licence.¹ Rule 122-I allows the inspecting team to examine those areas, along with your processes and testing facilities.²

Keep your NABH evidence under a separate index. NABH accreditation and statutory licensing are different reviews, even where both reviewers ask for the same donor, testing, component or issue trail.³

Start with the licence and its scope

Your licence is issued in Form 28-C, or Form 28-E where blood products are manufactured.¹ A Form 28-C licence, or its renewal in Form 26G, is valid for five years from the date of grant or renewal unless it is suspended or cancelled sooner.⁴

If renewal is pending, put the application, payment evidence, acknowledgement and later correspondence together. Rule 122F allows a licensee who applied before expiry to continue operating until the order is communicated, so the application date must be easy to prove.⁵ Use the same set when working through your blood bank licence renewal.

Prepare for what Rule 122-I lets inspectors examine

Before a licence is granted or renewed, the licensing authority or Central Licence Approving Authority causes the establishment to be inspected by one or more inspectors, with an expert where needed. They examine the premises, appliances and equipment, processes, testing facilities, and the qualifications of expert and technical staff.²

Afterwards, the inspector forwards a detailed descriptive report with findings on each aspect and a recommendation.⁶ Prepare evidence by inspection area so your staff can answer each observation with the relevant controlled record.

• Staff: appointment, qualification and current duty records
• Premises: premises details and room-use index
• Equipment: inventory and available equipment records
• Processes: controlled procedure index and associated records
• Testing: facility, reagent and test-record index

Do not stage only the registers. If the inspector selects an item of equipment or a technician from the floor, you should be able to move directly from that selection to the corresponding file.

Keep every Schedule F record retrievable

Schedule F Part XIIB Section L names the blood donor record, master records for blood and components, issue register, records of components supplied, anticoagulant bag records, diagnostic kit and reagent register, cross-matching reports, transfusion adverse reaction records, and purchase, use and stock records for disposables.⁷

The closing note to Section L says these records must be kept for five years, but it names no start date.⁷ Rule 122G separately requires testing records to be maintained for five years from the date of manufacture.¹ Keep that distinction visible in your blood bank record retention schedule.

Schedule F Part XIIB requires every donation to be tested for HIV-1 and HIV-2 antibodies, hepatitis B surface antigen, hepatitis C virus antibody, VDRL and malarial parasites.⁷ Your TTI testing records should let the inspector move from the unit identifier to the test entries without searching across unrelated files.

Run one complete unit-trace drill

Select one issued unit and retrieve its donor and master records first. Follow with testing and component processing, then storage, request, crossmatch and issue records, and finally any return or adverse reaction record that applies. This is the practical test behind donor-to-recipient traceability, while any temperature exception should connect to your cold-chain excursion records.

If a link is missing, record the gap and correct it through your centre’s controlled process before treating the file as inspection-ready.

Keep licensing and NABH preparation separate

NABH runs an accreditation programme for blood centres and publishes the applicable accreditation standards and programme documents.³ A licensing inspection begins with the licence conditions and the Drugs and Cosmetics Rules; an NABH assessment begins with the current accreditation standard.

For NABH, index policies, implementation evidence and records against the relevant standard clauses.³ A statutory record may support both reviews, but your two indexes should show why you are producing it.

Use your NABH audit preparation to build the accreditation index, while preserving a separate licensing pack for the drug inspector. One folder for both reviews usually forces the person at the desk to guess which document answers which requirement.

Finish with an inspection-day retrieval check

• Nominate one coordinator and one backup who know both indexes.
• Place controlled originals or authorised records behind every index entry.
• Test one recent unit and one older unit within your retention set.
• Record missing links and correct them through your approved process.
• Make the retrieval path usable during normal operations.

Build the same drill into your compliance workflow. The person answering the inspector should know which screen, register or archive contains the next record.

Your final test is simple: give a staff member a unit identifier and ask for the complete trail without advance warning. Rule 122G places the licence conditions on the licensee, so your centre remains responsible for the records regardless of whether they are kept on paper or in software.¹

Sources

1. Drugs and Cosmetics Rules, 1945, Rule 122G cdsco.gov.in
2. Drugs and Cosmetics Rules, 1945, Rule 122-I cdsco.gov.in
3. NABH Accreditation Standards for Blood Centres, current edition nabh.co
4. Drugs and Cosmetics Rules, 1945, Rule 122H cdsco.gov.in
5. Drugs and Cosmetics Rules, 1945, Rule 122F cdsco.gov.in
6. Drugs and Cosmetics Rules, 1945, Rule 122J cdsco.gov.in
7. Drugs and Cosmetics Rules, 1945, Schedule F Part XIIB cdsco.gov.in