Sometimes I feel like I come across as a bit too “QA crazy,” but quality in the pharma sense isn’t really something of which you can have too much. From start (order processing and materials procurement) to finish (consignment shipping to customer), every step must be subjected to quality oversight and monitored.
It goes without saying that pharma isn’t an industry that lends itself to flexibility in quality. You don’t hear: “Sorry, toxicity levels were off the charts. We’ll make it up in the next shipment…it’ll all average out.” (FYI – if you do hear it, you’d better run. Then give us a call.)
An Eye Towards the Future
Quality, as we in the pharma industry know it, is a collection of standards, methods, data and processes. In a post earlier this month, we discussed building API impurity profiles and mentioned some of those standards, methods, etc. But ‘Quality’ goes far beyond that. It is better viewed as an evolving, vibrant process that is subject to constant review as our collective knowledge – and our ability to produce products to standards that improve both health and outcomes – increases.
The evolution of this thinking has led to practices such as Quality by Design and other continuous process improvement measures. Quality has transformed from static, required measures & procedures into an ongoing, improvement-focused philosophy.
Staying Ahead: Delivering Tomorrow’s Quality Today
There are a number of ways in which companies – especially contract manufacturers, who are often subject to numerous regulatory regimes – address quality issues. At Neuland, for example, maintaining a clear understanding of the possible direction of regulations and standards is essential. We believe it is important to implement policy ahead of legislation.
We continuously monitor compliance with cGMP guidelines established by ICH (Q7A), as well as relevant requirements of the U.S. FDA, ICH, EMEA and EDQM. Stringent controls are built-in to our quality programs to ensure each product meets not only all pharmacopeia specifications, but also those of the customer (which are sometimes even more stringent).
Some of the specific techniques Neuland uses to ensure the quality of every product include:
- Sampling and analyzing products and impurities
- In-process tests for production
- Microbiology laboratory in line with international standards
- Sampling, testing and selection of starting materials
- Sampling, testing and selection of all subsequent inputs, intermediates, and finished products
- Analytical methods development & validation
- In-process control of production operations
- Specific internal instrument qualification and calibration programs
- Stability testing of products
- Microbial limit testing & BET testing of products