USFDA Audit Points/ Observations : Pharmaceutical Guidelines

USFDA Audit Points/ Observations

US FDA audit observations and points observed during the inspection in pharmaceutical manufacturing facility.
USFDA Audit Points in Quality Control
  • Assay value in COA and calculation sheet does not match.
  • Report does not mention the quantity of sample that is taken for analysis.
  • No datasheet for actual analysis done.
  • CFU/ml should actually be termed as the microbiological limit test.
  • Raw data not attached to report or no reference given.
  • The total fungal count is to be changed to total yeast & mold count.
  • Water analysis 10 ml of volume to be taken as per specification but the sample is weighed.
  • Chromatogram of assay no peak ID for compound and no sign of analyst or checked by.
  • RT given in specification & chromatogram does not match.
  • Standard 2 injection given in specification only injected once.

  • The vast difference in 2 areas of the same sample subsequent injections (6 digits & 7 digits) through area present is the same.
  • Acidity/ alkali mentioned on COA but specification mentions acidity only
  • Non-volatile residue calculation wrong, no weights attached.
  • Assay – Chromatographic conditions not mentioned in teat report.
  • No identification of standard injection. No analyzed or checked by sign on the chromatogram.
  • Assay, no peak identification, no checked by sign, COA attached at the end,  does not Match for B.No, and values of Water and assay
  • manufacturer not listed  in the approved vendor list.
  • Assay – resolution solution not prepared or injected.
  • Last digit of B.No. not captured in COA. 
  • In Specs Assay is given as purity,
  • Manufacturer not in approved vendor list.
  • checklist missing.
  • MFG COA no reviewed by sign.
  • Sampling details, quantity sampled given as 5 instead of 200 ml as given in the specification.
  • Actual description to be written either colorless or yellow.
  • Pack description missing on the checklist
  • No sign on use test report
  • Calibration Status  and
  • Presence of documents checked as per schedule for 2005 and 2006
  • In STP of product calculation should be multiplied by 1000.

USFDA Audit Points in Engineering
  • HVAC load at the time of installation of plant, no document available.
  • SOP for preparation of drawing not available, in which all the details will be captured e.g Drawing No. Obsolete drawings etc.
  • Drawings not updated e.g Room names not updated, female change room, branding area etc
  • Legend not defined.
  • Segregation drawing not updated.
  • Pressure differential segregation not justified between packing hall and primary packing cubicles.
  • Segregation limit rationales not defined and validated
  • Engineering change control not completed
  • Calibration plan not available.
  • Calibration execution details not available
  • Documents are not signed e.g facility maintenance checklist
  • SOP for receiving equipments in the plant are not available.
  • Schedule plan of Preventive maintenance not approved.
  • Tracking system of preventive maintenance plan execution not prepared.
  • No issuance of preventive maintenance schedule for concern department as per SOP
  • SOP not followed for numbering system.
  • Checklist for preventive maintenance not available for equipments like drum mixer, branding machine, tablet inspection belt so need to review with respect to equipment available as on date
  • Preventive Maintenance schedule plan not approved, Tracking system for Preventive maintenance plan execution not prepared.
  • No document availability for Plan verse Action of Preventive maintenance. Engineering SOP regarding the Work Permit not followed, engineering personnel follows work permit of EHS department SOP.
  • No log book is with page numbering.
  • Running of AHU depending upon production needs, no document prepare for the same, as earlier all the AHU’s are in operation but because of cost cutting, AHU runs based on production need,
  • No document prepare i.e. on what basis we change our system from AHU running through out the day and at present only when the room is in use.

  • No Change control initiated.List of critical spare not available.
  • No. of spare filters list not available.Filter cleaning / inspection.
  • No list available and plan ver action.Adequate space not available for Acid solvents, so solvents are kept on the floor.
  • Inventory document not updated.
  • Fire Extinguisher found on the service floor backside of AHU
  • Obsolete drawing on Display of Water system.
  • No Roofing in water system.





Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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