A large mid-western pharmaceutical company embarked on a large capital project to increase their global production of several drugs. This expansion project required the construction of three (3) new buildings, as well as various utility and manufacturing equipment additions. The scope of Performance Validation’s commissioning and validation work including the following systems:
Performance Validation (PV) developed and executed the applicable commissioning, installation, operational, and performance qualification deliverables to ensure that all the systems included in our scope were installed and functioned as required by the client and per vendor recommendations.… more
Are you a 503B trying to understand the FDA Regulation and Inspection Guide? Do you feel like these guys?
I have a limited number of FDA Guidebooks that contain the FDA regulations 21 CFR parts 210 and 211 cGMPs in Manufacturing, Processing, Packing, or holding of drugs and finished pharmaceuticals AND the Drug Manufacturing Inspections: Compliance Manual for FDA Staff (7356.002) Drug inspections.… more
As reported by the Pew Charitable Trust, Feb 26. 2018:
This year’s theme for the ISPE 2018 Annual Meeting and EXPO is Vision to Reality: Delivering Next Generation Therapies.
One of the frequent challenges when delivering next generation therapies is available manufacturing space. Either the existing facility is committed to current products with no excess capacity, or the time/cost to reconfigure the existing facility to meet the manufacturing conditions required by the new therapy doesn’t fit within the project budget/timeline.… more
On Sept 27, 2018 FDA shared recent case reports of dosing errors and confusion with the labeled strength expression for certain compounded unjectable products. Both MedWatch reports attributed the medication error to the labeling of the drug (IV/Syringe) packaging. See Differences in strength expression on product lables of compounders and contentional manufacturers may lead to dosing errors.… more
FDA has posted 17 Form 483s, to 503B facilities, thus far in the third quarter of 2018. FDA has identified 68 observations of potentially objectionable issues within these 17 facilities. A summary of the 2018 Q3 FDA Observations follows:
Table 1 – 68 observations categorized by topic
|Category of Observation||Frequency of occurance|
|Poor Facility Design||7|
|Critical Air Flow||3|
|Finished product testing||2|
|Adverse Event Reporting||1|
As we can see from the above table, the two largest groupings of observations fall into the disinfection and aseptic techique. … more
Performance Validation’s quality management system is based on ISO 9001:2008, Quality management system – Requirements. As you are aware, ISO 9001:2008 was revised to ISO 9001:2015. A three year period was provided to allow companies to review and revise their quality systems to the new standard. … more
Are you really ready for your initial or follow up 503B cGMP Inspection?
Most 503B outsourcing facilities would assume they are ready for inspection, but often this is not the case. Thus far in 2018 – FDA has issued 62 Form 483’s to 503B Outsourcing Facilities at the conclusion of the 503B cGMP inspection.… more
Josh Ciesiolka is a Senior Validation Engineer and certified project leader at Performance Validation. Josh has led a number of complex Lyophilization projects including retrofit of existing units, installation of new units and integration with automated loading and unloading systems. He is PV’s technical expert in regards to the commissioning, qualification, and validation of Lyophilization equipment and processes. … more