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Observations & Compliances response of GMP Inspections

Observations & Compliances response of GMP Inspections

Observations 1:

In the DM water plant, there were no records maintained for the change of air filters from the compressor to the degasser.

Response:

The procedure for the replacement of filters has been incorporated in the SOP for the replacement of cartridge filters. A format is also included in the SOP to record the replacement of filters.

A copy of SOP for replacement of cartridge filters is attached as Attachment.

Observations 2:

In the tablet section, there was no detailed checklist for inspection of punches and dies before issuance and after usage.

Response:

The SOP “Handling of Punches and Dies in Tablet Section” has been revised to incorporate the procedure for inspection of punches and dies before and after every use. A format is also introduced to record the same.

A copy of SOP “Handling of Punches and Dies in Tablet Section” is attached as an Attachment.

Observations 3:

The hardness tester used in IPQC was faulty at the time of inspection.

Response:

We have procured two new hardness testers. In which one is underuse and the second one is in spare.

A copy of the indent, purchase requisition, and the purchase order is attached as Attachment.

Observations 4:

There are no records maintained on the frequency for carrying out the challenge test on the metal detector.

Response:

The SOP for operation and cleaning of Metal Detector has been revised to incorporate the frequency for carrying out the challenge test on the metal detector. A format is also introduced to record the same.

A copy of SOP for operation and cleaning of Metal Detector is attached as Attachment.

Observations 5:

In the liquid section, there was no status label for the transfer of hosepipe (sugar syrup) and it was also stored in a folded manner not allowing proper drainage after cleaning.

Response:

The training has been imparted to the concerned personnel regarding status labeling and storage of accessories after use to allow proper drainage of water after cleaning.

A copy of the training record is attached an Attachment.

Observations 6:

The pH meter electrode was stored in 0.1M KCl instead of 3M KCl as per the user’s manual.

Response:

There is some misunderstanding. As per user’s manual 3M KCl solution is used for filling inside the Combined electrode. 3M KCl is not used for storage of Electrode.

A copy of user’s manual of pH meter is attached as an Attachment.

Observations 7:

The Holmium filter and polystyrene strip had no validity certificates.

Response:

The order has been placed for New Holmium Filter and Polystyrene film with validation certificates.

A copy of Indent, purchase requisition, and the purchase order is attached as an Attachment.

Observations 8:

There was no system for verification of volumetric glassware for accuracy as they are dried at 60 degrees in the oven.

Response:

New “SOP For Calibration of Volumetric glassware” prepared and Record of Calibration of Volumetric glassware’s maintained.

A copy of “SOP For Calibration of Volumetric glassware” is attached as Attachment.

Observations 9:

In the SOP for documents and data, there was no procedure to guide how the documents of external origin would be handled such as Pharmacoepeas.

Response:

The procedure for handling external origin documents has been introduced in the SOP for Document and data control.

A copy of the SOP for Document and data control is attached as an Attachment for reference.

Observations 10:

Samples for microbiological analysis were stored in the refrigerator for reference standards.

Response:

A separate Refrigerator has been installed for samples for microbial analysis in a microbiological laboratory.

Photographs are attached as Attachment.

Observations 11:

The firm needs to install an online TOC analyzer for the continuous monitoring of total organic carbon.

Response:

We have already generated the purchase order for the online TOC (Total Organic Carbon) analyzer. This TOC shall be installed in the water generation and distribution system.

A copy of the purchase order is attached as Annexure.

Observations 12:

The firm is advised to perform de dusting operation of received materials in a segregated area.

Response:

PVC (Polyvinyl chloride) small partition to be installed in de-dusting area for receiving bay to prevent the movement of dust generated from de-dusting area to staging area of receiving bay.

Observations 13:

The firm is advised to avoid the placement of equipment nearer to the return riser.

Response:

Corrective action has been taken to avoid the placement of equipment near to return riser and the activity shall be implemented in all concerned areas of manufacturing.

Training has been imparted to concerned personnel on SOP on control of contamination.

A copy of training record is attached as Annexure-2.

Observations 14:

The firm is advised to perform quality check against manufacturer/supplier COA of lubricants meant for lubricating punches & dies.

Response:

Currently, we are following the manufacturer’s recommendation/ declaration of NSF international for the release of lubricant i.e. ‘OMNI LUBE FG 1460’ for lubrication of punches and dies.

The SOP on approval of contract laboratory and the external agency has been revised to incorporate the verification against manufacturer/ supplier COA.

A copy of revised SOP is attached as Annexure.

The manufacturer declaration copy is attached as Annexure.

Observations 15:

The firm need to display the possible rejections during visual inspection in the Dry Powder Syrup section.

Response:

The SOP on visual inspection has been revised to incorporate different types of filled and sealed bottles defects.

The pictorial presentation of different types of filled and sealed bottles defects has been displayed near the visual inspection conveyor on Dry Syrup packing line.

A copy of revised SOP  is attached as Annexure.

Photographs of displayed pictorial presentation on Dry Syrup packing line are attached as Annexure.

Observations 16:

The firm needs to take possible measures to control the operation of blenders both mechanically as well as electronically in order to avoid any possible hazards/injuries to employees.

Response:

The conta blender was designed in consideration of a safety railing (i.e. safety railing is provided in all rotating sides) as an additional feature.

The blender operation is electronically & mechanically controlled if the door of the blender room is opened, the rotation of the blender stops automatically and it has also been demonstrated during the inspection.

Observations 17:

The firm is advised to avoid permanently keeping Vacuum cleaner and other utensils not required for routine operation for filling & sealing of Dry Syrup.

Response:

The observed vacuum cleaner & other utensils dedicated for Dry Syrup Filling and sealing operation only. The concerned personnel has been instructed to keep these items in material airlock during filling operation.

Training has been imparted to concerned personnel and a copy of training record is attached as Annexure.

Observations 18:

The firm is advised to place the Thermohygrometer in the RM store (OSD) based on the location identified (Worst location) by thermal mapping.

Response:

The protocol for Temperature and Relative Humidity mapping is to be revised for the placement of the Thermo hygrometer in the Raw Material store having the worst location.

A draft copy of the protocol for Temperature and Relative Humidity mapping is attached as Annexure.

Observations 18:

The firm is advised to perform and maintain records for the Light intensity test of the visual inspection booth.

Response:

SOP on Visual Inspection is to be revised and to incorporate the light intensity test in the visual inspection booth.

A draft copy of revised SOP  is attached as Annexure.

Observations 19:

The firm is advised to check the pressure difference in the sterility room of the microbiology laboratory.

Response:

The SOP on Monitoring of Temperature, RH, and differential room pressure in Microbiology Laboratory shall be revised to change the differential pressure limits in sterility testing area change room-I to change room-II from 5 Pascal to 15 Pascal.

A draft copy of revised SOP  is attached as Annexure.

Photograph of tag showing revised differential pressure limits is attached as Annexure-

A copy of training record has been attached as Annexure.

Observations 20:

The firm needs to display the psychometric chart in the control sample room and also advised to make proper documents for easy traceability

Response:

In the control sample room, Dry Bulb and Wet Bulb hygrometer is replaced by Digital Thermohygrometer through change control.

The SOP for Monitoring of Temperature, Relative Humidity, and Pressure Differential) has been revised.

A copy of revised SOP  is attached as Annexure.

Photographs of the digital hygrometer placed in the control sample room are attached as Annexure.

A copy of training record has been attached as Annexure.

Copy of three days monitoring record has been attached as Annexure.

Observations 21:

The firm is advised to dispense and prepare the Rubber stopper (washing & sterilization) separately for each batch.

Response:

The rubber stoppers were validated through steam sterilizer & bung processor having minimum load nos. (5000) and maximum load nos. (80,000) and these validated loads shall be used in routine manufacturing activities.

If a single batch dispensed with two different lots of rubber stoppers, those sterilization reports shall be enclosed to Batch Manufacturing Records.

A copy of the sterilization report is attached for reference purposes as Annexure.

 

About Pharmaceutical Guidanace

Mr. Shiv Kumar is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 14 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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