If you were to walk into a pharma or med-tech manufacturing environment/site, explain how it would look different: Regulatory Compliance Assignment, UU, Ireland

Part 1: If you were to walk into a pharma or med-tech manufacturing environment/site, explain how it would look different to a car component manufacturing facility. Please list and explain the differences, if any, that one might observe.

Part 2: Describe the QMS system of a medical device facility. Describe components of QMS/structure/standards adhered to/internal audits/supplier controls/manufacturing controls/CAPA /packaging/labeling etc.

Scenario A

Product blending operation is not run for the duration specified in the batch record. This non-conformance took place in Plant 5.

Background: Active Pharmaceutical Ingredients (API) and excipients were blended (mixed} in order to achieve homogeneity. This is carried out in the manufacture of solid dosage forms to ensure each tablet will contain the correct dose of API and the correct amount of excipients.

Today at 5 pm during the blending of Batch 20 of Product Y in blender B1 O the process operator realized that the blending of the batch had stopped after 15 minutes instead of 60 minutes as specified in the batch record.  He found that the timer was incorrectly set for 15 minutes. The shift supervisor was notified, then R&D and Quality were informed. R&D, with the agreement of Quality, advised that blending be resumed for the additional 45 minutes. R&D then conducted an investigation to determine if there was any quality impact on the product – they proved that there was no quality impact.

Investigation into the non-conformance revealed that it occurred as a result of operator error.  It was decided that the master batch record for blending product Y in blender B1O would be updated to include a check by a second person to ensure that the correct time had been entered prior to starting the operation. The Production Team Leader was assigned this task. The target date for completion is one month from today.

It was discovered that two other products are blended in blender B10, Product D and Product E. The master batch records for blending of these products in blender B10 would be updated to include a check to ensure that the correct time had been entered prior to starting the operation. The Production Team Leader was assigned this task. The target date for completion is three months from today.

Scenario B

During the API chemical processing stage, the quantity of solvent added to the vessel was in excess of that specified in the batch record.  This non-­ conformance took place in Plant 5.

Background: During the manufacture of Product B the batch record specifies adding 1,000 Litres of isopropanol to reaction vessel 8 via the head tank.  The head tank has a capacity of 200 Litres and consequently must be filled five times in order to add the required amount of solvent.   This is the stage that the non-conformance occurred.

Today at 3.15 pm during the production of Batch 17 of Product B in reaction vessel RVS 1,200 Litres of isopropanol was added. This is 200 Litres in excess of the quantity specified in the batch record. The shift supervisor was notified and Quality was contacted.

R&D, with the agreement of Quality, decided that the batch should proceed without further action as it was not possible to remove the excess solvent without impacting the batch. R&D  subsequently conducted an investigation to determine if there was any quality impact on the product – they proved that there was a quality impact and that it would be necessary to reprocess the batch.

Investigation into the non-conformance revealed that it occurred as a result of operator error due to inadequate controls. In the future, a batch meter would be installed which will shut off automatically when the correct volume of isopropanol is added to reaction vessel 8.

In fact, isopropanol is added to reaction vessels 6 and 7 also so a similar problem could potentially arise for additions to these vessels. The Engineering Team Leader was assigned this task with a target completion of three months from today for the installation of all three batch meters, generation of SOP, delivery of training to impacted personnel, and inclusion of batch meters on the Calibration and Preventative Maintenance schedule.