What is a GMP Certified Manufacturer?

Posted by Wellspring Pharma Services

Imagine this scenario: you work for a pharmaceutical company and have just purchased a product and need to find a manufacturer to make this product for you. Your boss has just told you to find a GMP certified manufacturer. Sounds easy enough, but what exactly is a GMP certified manufacturer and why do you need one?

The acronym stands for Good Manufacturing Practices, and to be GMP certified means that the manufacturer has demonstrated a strong regulatory commitment and compliance to international GMP standards.

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5 Key Considerations for Choosing a Pharmaceutical Contract Manufacturing Facility

Here’s a check list of information that we recommend you obtain from any facility you’re considering to manufacture your product:

  1. Is the manufacturer registered with the Food and Drug Administration (FDA)? It’s a simple process for any manufacturer to do and it’s the baseline fact to check off the list.

  2. Has the facility been inspected by the FDA, preferably within the last two years? Manufacturing facilities need to prove to the FDA that they have a facility in compliance with current GMP standards (cGMP). The specific inspection group is the CDER Group (Center for Drug Evaluation and Research) or the FDA Office of Compliance.  Their inspectors will do a full systems-based cGMP inspection on that facility.

  3. What is the facility’s FDA rating? Once the FDA inspectors have completed their inspection, the facility is rated. The FDA rates facilities with three types of classifications:

  • VAI - which is Voluntary Action Indicated; this is a good rating

  • NAI - which is No Action Indicated; this is also a good rating

  • OAI - this is not a good rating. If a facility gets an OAI rating it means there’s been some objectionable activities or there are systems that are deficient. In all OAI cases, the FDA is looking for improvements or changes to that facility before the rating can be upgraded.

  1. Does the facility have an FDA acceptance letter?

  2. A copy of the FDA Establishment Inspection Report (EIR).  The EIR details everything the FDA inspectors reviewed: what was good, what was bad, as well as comments from the inspection. It’s a very thorough 20 - 40 page report that the FDA issues which is made available to the public.

Make Sure The Manufacturing Site is Paying Their Generic Drug User Fee for US Distribution

Determining-Best-Manufacturing-Processes-Guide-For-Pharmaceutical-ProductsIf you’re looking for a manufacturing site to produce generic products for sale in the US, you’ve got to make sure that the facility is paying their GDUFA (Generic Drug User Fee Act). This is a substantial fee that the manufacturing site has to pay in order to manufacture generic products for the US marketplace. This is something fairly new. That’s another due diligence step to take if you are moving generic drug production to a new international facility, so be sure to confirm these fees have been paid.

Pharmaceutical Drug Production in Canada: Choose a Facility with a Drug Establishment License

If you wish to produce generic drugs in Canada, Health Canada has a similar process. The facility you’re considering should have a drug establishment license that identifies the facility and all the activities they can perform in Canada, detailing each activity: manufacturing, packaging, labelling, testing, distribution, and wholesaling.

Health Canada also does inspections every 2 years and issues a compliance rating. Noncompliant is not good, compliant is good. Ask for the facility's most recent inspection report, known as an "Inspection Exit Notice", issued by Health Canada.

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It’s very important to emphasize what’s at stake when using manufacturing sites outside the US. The facility must be FDA approved in order for the pharmaceutical company to market the product in the US. We had one particular client come to us with this exact problem. They were producing a gel product in an international facility that wasn’t fully GMP compliant, and then ran into difficulties bringing the product to the US market.  If they had used the checklist provided above, they would have avoided the nightmare of a situation they found themselves in. An oversight, such as this one, can cost a pharmaceutical company hundreds of thousands, if not millions, of dollars in extra expenses and lost market opportunities.

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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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