Is Your Manufacturing Facility FDA Compliant?

Okay, you are in the business of manufacturing pharmaceutical products, and in specific terms, you adhere to norms and regulations in every manner. Imagine if FDA makes a surprise visit to your facility, then how do you react? That’s annoying matter because when we aren’t prepared for an inspection, we feel what if some flaws or errors get noticed.

Basically, FDA teams conduct inspections in accordance to their scheduled visits where a company may receive notice; other way, inspectors from the drug authority can turn up unexpected and there is no obligation that they provide you with a notice.

Obviously, for the sake of inspection we sometimes prepare our facilities and ourselves thoroughly, and once the inspection is done, we become lenient in some ways. Either documents remain irregularly updated and or processes are left with little attention.

In one case, the FDA sent a team of inspectors to tour a respective facility that was involved in manufacturing injectables and oral solids. After a whole day audit at the entire plant, FDA inspectors identified numerous violations and made major observations regarding the manifest regulatory discrepancies. Later on, the FDA addressed the manufacturing plant to take immediate corrective actions and preventive actions (CAPA) against the several deviations from cGMP. 

It’s not a question of small or big company, but as a pharma entity, it has to adhere to rules and regulations. Sometimes, even good, influential relations with FDA may give a feeling that you can escape the severity of FDA warnings. That’s a sheer mistake, and when violations become visible, there’s no way you can downplay critical errors or skew routine records. With transparency, FDA takes its own route to check that respective rules are followed in every possible manner.

Well, all in all, if a pharma company abides by all regulations every single day, then anytime, any day a surprise visit from a governmental official will not be an upsetting experience.

It’s factual that there may be plethora of pharma companies that don’t follow the system set by the FDA. Sometimes any significant deviations may be due:

· Inappropriate evaluation of data and methods

· Inadequate controls for manufacturing, processing, packing or holding

· Irregular management reviews

· No records of internal audits performed

· Deficiency of hygiene plan

· Improper facility design and cramped storage areas

· Insufficient data on risk analysis conducted

· Incomplete records of raw materials and finished goods

· Insufficient procedures for batch release

· Unsatisfactory CAPA procedures

· Lack of training

· Lack of competent and qualified manpower

· Lack of annual product/processes performance evaluations

· Lack of ample reassessment or a gap analysis of previous process efforts

· Lack of resources, such as planned procurement or timely deliveries

· Human errors such as operator’s ignorance, improper calibrations

· Insufficient data or justification for any activity and validation protocol

In fact, going against the rules and regulations, nothing will work, and that’s worrisome when your manufacturing operations and documentation practices are not in FDA compliance. 

Indeed, it’s responsibility of every single person who’s responsible to scrutinize those deviations for determining the reasons, for averting their repetition and for avoiding objectionable conditions. 

With with regular adherence to SOPs, internal audits, CAPA management and by taking remedial actions to manage regulatory and compliance issues, your company remains in an inspection-ready state. Fantastic isn’t that?

Image source:  pharmamanufacturing.com