• Pictorial presentation not available in sampling change room (Minor)
  • Manufacturer released /approved label not defaced (Minor)
  • Policy for usage of raw materials having retest date claim by manufacturer not defined in in SOP (Minor)
  • Dispensing scoop status label not available of cleaned on, previous product, Use up to Most of the tools were not having marking/ embossing (Minor)
  • Status Labels (approve) were not available on core of foil (Minor)
  • Primary, Secondary and tertiary materials storage area Need proper segregation. (Major)
  • Daily balance verification of balance was carried out up to 60 kg whereas it was in use up to 160 kg (operating use) hence verification of balance was not being carried out to the operating range of balance.(Major)
  • There was no bifurcation in quarantine & under test area whereas common room available for staging both sate material.(Major)
  • Sampling booth log book found lacking with the start time of sampling booth to trace out pre stabilization time of booth prior to start of sampling operation whereas per SOP  RLAF & light should be switch on prior to 15 minute of operation hence doubted that same seems not followed as evident.(Major)
  • Balance platform of the sampling booth need to be perforated.(Minor)
  • Define Limit of the pressure gauge of sampling booth is in mm of water but warehouse person affixed the limit label as NLT 10 Pascal & recording the same.
  • Sampling booth was common for sampling of raw material & packing material hence risk needs to be assessed through formal risk assessment tool with defined risk mitigation plan. (Major)
  • There were no defined criteria for minimum quantity of MRN (material return note).(Minor)
  • Cross over bench of dispensing area not found fixed hence may fails to solve the intended purpose of cross over mechanism.(Minor)
  • In existing scenario there are no defined criteria of allowed variance for observed difference of actual vs. physical quantity of material eg. API, Excipient, Primary packing material, printed packing material, at any stage of process after receiving the material, so that case need to be report in GMP system and investigation has to be triggered as there is always chances of variance because material eg. Carton, literature not going to be received on counting and always scope of variation in RM because of process loss or mishandling.(Major)
  • Usage log of the vacuum cleaner found lacking with the traceability of the cleaning on weekly & daily basis.(Major)
  • Insect-O-Cuter SOP found lacking with the procedure for disposition procedure of insect. Alert & action limit also need to be define on that basis spraying frequency defined.(Minor)
  • Plant found lacking with certificates as well stamped on the weights on yearly basis.(Major).
  • Site is found lacking with the procedure for handling of materials with procedure in case of break down in SAP/ERP.(Major).
  • Handling & Cleaning of the sampling as well as dispensing Aids need to be revised with actual procedure of the cleaning as Potable water line not found in the cleaning area but as per SOP cleaning shall be done with potable water. Cleaning format also need to be revise for the traceability of the cleaning & ID no of the scoops.(Major).
  • List of Dedicated Scoops is not available for the API.(Major).
  • Vehicle status Inspection was not covered in the RM/PM receiving check list. (Major).
  • Plant is found lacking in the procedure for Handling of the Spillage.(Minor)
  • FG Store Maximum & Minimum limit Temperature & Humidity need to be recorded in FG Store during daily recording activity.(Minor)
  • SOP for the sampling of the packing materials found lacking with the procedure of stratified sampling.(Minor)
  • Inward register is Raw materials sampling release & retained sample the content of the SOP is not matching with the content of the SAP/ERP generated format.(Major).
  • Label of Approved/Under Test & Returned is not part of SOP.(Minor)


  • Purified water loop not available in Granulation Water for cleaning taken from washing area .(Major)
  • Dispensed packing material not having status labels /details like No., B. No. (Minor)
  • Cross over bench not flush to wall in packing area  (Minor)
  • Cleaning status labels not available on Sieves, mesh and change parts of cleaned on, previous product, Use up to etc. (Minor)
  • Stage wise COA not available along with BMR/BPR. (Minor)
  • Dust collector not found cleaned of core granulation (Major)
  • Food grade oil certificate is having circulatory oil 220 is formulated from highly refined petroleum oil and fortified with performance Need to confirm suitability for pharma products. (Major)
  • Dies and punches used having rust and no buffing done. (Major)

 Quality Control:

  • Backup of chromatography taken Data retention policy of soft copies not available. (Minor)
  • Instrument and computer time not matching , computer showing 11:05 , HPLC instrument having 11:19 (Minor)
  • HPLC calibration, pump flow calibration not performed for all pumps being quaternary HPLC (Minor)
  • Balance not calibrated as per operating range. Having operating range 0.0100 to 160.0000gm, Daily verification performed using 0.0100 and max. 100.0000gm. Monthly calibration performed using maximum weight 50.0000gm
  • Spirit level verification before calibration not part of daily verification. (Major)
  • Blank auto zero is not part of UV sequence and reading not taken during analysis. (Minor)
  • Oven temperature and carrier gas flow not measured with external devices /standards during during calibration. (Minor)
  • WFI conductivity limit mentioned NMT 5.0µs/cm instead of 1.3 µs/cm. (Minor)
  • Packing material grammage specimen not attached with report.(Minor)
  • Working standard stored in HDPE bottle with induction seal.Check feasibility of Glass bottle with screw cap. (Comment)
  • Sodium hydroxide solution kept in glass bottle instead of HDPE bottle. (Minor)


  • Water system: Existing water system old and not complying current requirements such as flow meter not available in distribution loop. Temperature sensor not available for monitoring of temperature during during sanitization. UV not available at return loop.
  • Qualification status not available on AHU.
  • Differential pressure not monitored across the filter .Filter identification not available. Cleaning record not having checked by sign in logbook. (Major)
  • Compressed air filter replace details not available. (Minor)

 Quality Assurance :

  • Frequency of dress change 3 days instead of 1 days in SOP. (Minor)
  • Related substance test not part of specification and performed during stability of Cefixime tablets. (Minor)
  • Visual inspector qualification kit not available. Inspection defect kit not available in inspection area. (Minor)

About Pharmaguidanaces Channel

Ms. Abha Maurya is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 18 years of rich experience in pharmaceutical field. During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube

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