Inspection procedure by FDA regulatory

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Naripen Goyal
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Last Updated on August 9, 2023 by The Health Master

Inspection procedure by FDA regulatory

Inspection procedure should be followed by FDA regulatory Officers

Pre requisites:-

Office records :-

Correct name of the firm

Address with GPS location.

Address of Head Office.

Licences and their Number.

Validity dates.

List of approved items.

Copy of not-responded notices or memo.

Copy of reply claiming updation on infrastructure.

Closed matters of CAPA, corrective action and preventive actions executed.

Any matters pending regarding quality issues.

Last inspection observations.

Inspections report

Include status as given in para(1) on First page of inspection report.


A:        upon arrival at site, demand and inspect  

  •        maintenance of site master file
  •        list of SOPs
  •       list of products manufactured in last 12 months
  •       list of out of specification batches.
  •       list of NOS notices
  •        list of drugs recalled
  •        list of prosecutions in other states

(B)       Tour of the site: Infrastructure as per Schedule M.

  • Preventive maintenance plan and display for the month date wise.
  • Entrance to manufacturing area.
  • Presence of house fly, insects or sings of rodents visits. Signs of spiders, sign of roosting birds spilling excreta.
  •  Start from receiving bay: to exterior cleaning area, to verification area, to quarantine area to RM sampling area, tor Under Test RM store to Approved RM store. Check records and physical verification at random and labelling of containers: RISK BASED INSPECTION: Labelling in proper order, similar named drugs containers, similar shape and size containers, look alike packs. Storage of benzyl alcohol if used in injection. Storage conditions. In packing material store stiff to detect evidence for visit of rodents in dark corner and space near walls
  • Manufacturing: identity and wt verification area, orderly placement or machines. Cleanliness, BMR, stage status, release of equipment by QA. Dress code, name of persons to be verified from training records, In process control sampling and testing. Any presence of spiders, house fly etc. arrangement to remove wastages from manufacturing area. RISK BASED INSPECTION: Work in Progress Quarantine, arrange to prevent cross mixing. Labelling of look alike products etc
  • Utilities: water treatment plant, records, storage tank WFI, RISK ASSESMENT: sterilization of WFI storage tank. Guard vent. Arrangement of Poatble water, DM or Purified water Production, online conductivity meter
  • Utility: supply of Nitrogen gas %age purity. Sterilisation of Nitrogen gas, sampling and testing.
  • Electricity supply and generator start up time in relation to recovery period in sterile filling and sealing area
  • HVAC: connection to various areas common to one AHU. Change and cleaning for filters. Provisions of manometer for display of pressure difference across HEAPA filters feeding to sterile area. Speed, air changes and monitor of particulate matter. RISK procedure of change of inflow filters to AHU which run 24 hours through out the year.
  • Chillers for conditioning of air
  • Inspection tables for metal detection on oral solid dosage form
  • Optical inspection of injections
  • Arrangement for reprocessing
  • Arrangement for disposal of empty containers, drums cartons bearing labels of drugs
  • Arrangement for disposal of beta lactam smeared containers boxes, drums and bags
  • Disposal of rejected ampoules vials and bungs RISK

The observations should be recorded in the report without keeping in mind as to the Rule applicable. Rules applicable should be identified while making list of contravention and the same may be incorporated in the show cause notice by the LA.

Before closing the report it should be discussed with the representative of the firm and signed by the representative and any other persons on behalf of the firm.

Under each signature name of the person and his legal status should be mentioned.

The signature of the Regulatory Officer discharging his jurisdictional duty as inspector in the territory should be on extreme right but with in the limit of text body on each page with name and designation. As per rule three copies have to be made and disposed.

The inspection report should be evidence base and not dependent on statement of persons on behalf of the firm.

Language should be simple, with short sentences, with common use of technical words in law and technology.

Ambiguous words used mut be explained there and then.

Minimum use of acronym or abbreviations, that too widely used and known.

Additional: it would be proper that the government notification under section 21 of the Drugs and Cosmetics Act is written on the first page itself below the name of the area drugs inspector carrying out inspection, alone or with team.


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