Good Manufacturing Practice: The DNA of Pharmaceutical Quality

Posted by Wellspring Pharma Services

stockvault-medical-icon127437Good Manufacturing Practices or GMP's are the pharma industry’s fundamental guidance set up by regulatory authorities to describe what is necessary to manufacture safe, effective drugs. Essentially, GMPs (referred to as current Good Manufacturing Practices or cGMPs in the U.S.) provide a framework of manufacturing best practice standards that pharmaceutical processors are compelled to adopt and incorporate into their drug-making processes.

GMPs, as promulgated, are intended not to be prescriptive. To be compliant, drug manufacturers need to demonstrate to regulators that their drug-making processes within the production environment meet what the industry recognizes as best practice, not what regulators tell you they are. In other words, GMPs guide pharma manufacturers on what they should do, not how they should do it. By design, these regulating standards prompt drug manufacturers to assure drug quality and therefore drug safety, by incorporating the best, most up-to-date manufacturing technologies and processes into their standard operations.

Good Manufacturing Practice Is The Key To Product Quality and Compliance

Reading newer GMPs, such as the Canadian GMP guidelines or API guidelines, will likely provide even more insight into how pharmaceutical manufacturers can achieve high levels of compliance. It's also important to note there are mutual recognition agreements among the European Union countries and Canada which harmonizes the GMP standards between the two countries, allowing for quicker product approval within these recognized countries.

WPCC_ManufacturingGMPs are really the minimum requirements necessary to conform to the regulations enforced by various regulatory agencies and are necessary to receive market approval for a given drug innovator’s products. Good manufacturing practices are applicable to pharmaceutical manufacturers, packagers, laboratories, distributors, and now, appropriately, to active pharmaceutical ingredient manufacturers as well.

GMPs are pervasive, covering facility design, testing programs, analytical and processing equipment, manufacturing operations including packaging, release processes and more. When designed appropriately, GMPs ensure the product is safe, it's pure, it will be effective with a high level of quality and purity.

Be Proactive In Ensuring High Compliance For All Systems and Processes

Assuring-Pharmaceutical-Technology-Transfer-Success-eBook For any competent successful pharmaceutical manufacturer, operating to GMP standards is not a burden because operating compliantly, in this case, should deliver a number of cost-effective efficiencies – in other words, higher quality at lower cost.

The downside to not being complaint starts with the likelihood of increasingly higher manufacturing costs and an ever-tightening regulatory noose starting with FDA warning letters or 483 observations (official letters of sanction) which eventually hinders product approvals in and hence the business success of the non-compliant company. If you don't meet the GMP requirements, you would be issued with an observation, and in Canada, how that is applied is through the facility’s drug establishment license, where they actually give you a license every year to perform certain activities like distribution, manufacturing, packaging, fabricating, testing, and if you're found deficient, bestow non-compliant status, which would effectively stop that company’s operations.

For pharmaceutical manufacturers, personnel are really paramount to maintaining proactively compliant GMP operations. Ensuring high compliance requires the right people in the right positions with the right qualifications. In Canada, certain individuals in the organization need to have bachelor's degrees in science, including the head of manufacturing and the head of quality. True compliance, which means manufacturing drugs to the highest technical standards and methods, starts with personnel, and embraces all the systems in place, including the quality systems and standard operating procedures surrounding those systems. To be successfully GMP compliant, manufacturing operations need to be robust, pursue excellence and kept current with industry standards and FDA and Health Canada expectations.

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Topics: Quality & Regulatory

WellSpring Pharma Services is a full-service provider of pharmaceutical contract manufacturing and packaging outsourcing solutions for solids, semi-solids, and non-sterile liquids. WellSpring offers full-service contract cGMP manufacturing, packaging and analytical testing services from a single FDA inspected and Health Canada licensed facility.

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