Nine ways to improve on preparing pharmaceutical standard operating procedures

By |December 14th, 2015|

Three words that have been in the pharmaceutical industry for years are Standard operating procedure (SOP). These procedures control the steps someone takes to produce a product. An SOP can usually be written by anyone who has knowledge of the work flow.

But if you are in a highly regulated operation, trying to prepare pharmaceutical standard operating […]

The Best Way to Get Through an FDA Inspection is Advance Preparation

By |December 7th, 2015|

Any company that manufactures pharmaceutical products or active pharmaceutical ingredients should expect to have their facility inspected by the Food and Drug Administration. The federal Food, Drug and Cosmetic Act calls for “registered domestic drug establishments” to be inspected by the FDA at least once every two years. The reality is that limited number of […]

Writing Better Pharmaceutical Standard Operating Procedures

By |November 30th, 2015|

The key to preparing pharmaceutical standard operating procedures is a using a methodical approach. Standard operating procedures are an important way that today’s pharmaceutical companies demonstrate their accountability to regulatory bodies and other stakeholders. Each standard operating procedure is actually part of a larger process or policy within the organization. These tips will help pharmaceutical companies […]

Medical Marijuana Consulting Firm Explains How to Obtain an MMPR License

By |November 24th, 2015|

The Marijuana Medical Access Program, or MMPR, opens the door for patients to use marijuana for medicinal purposes. But companies that want to serve this patient market still must comply with strict licensing and production requirements in order to sell medicinal marijuana products. Confusion about the new regulations has led to Health Canada inspections of […]

Sterility Test Preparation and Failure

By |November 16th, 2015|

Any company that manufactures or provides wholesale medicinal products, including but not limited to pharmaceutical companies, must undergo sterility testing before the release of the product. The sterility test is a microbiological test that determines if a company can sell or release a sterile product. If a company fails a sterility test, the following weeks or months are time-consuming […]

8 Things About Pharma Companies That Provide Support For Consent Decree You Should Really Know

By |November 16th, 2015|

Saying the words “entering into a consent decree with the Food and Drug Administration (FDA)” can and does strike fear into many corporate hearts. But these words are less frightening when you can say the words “we have third-party representation”?

What this means is that instead of trying to figure out all the logistics of how […]

Spotting Particles That Cause Sterility Failure Issues in Pharmaceutical Manufacturing

By |October 30th, 2015|

When batches of pharmaceutical product go through a production run, foreign particles can find their way into the active pharmaceutical ingredients (APIs). These particles can contaminate the end product and potentially lead a regulator to issue a recall. In many cases, these particles are visible, which makes problem batches easy to spot before they leave the […]

Data Integrity Issues in the Biopharmaceutical Industry

By |October 28th, 2015|

A biopharmaceutical, also known as a biologic medical product or biologic, is any medicinal product manufactured in, extracted from, or semi-synthesized from biological sources. Biopharmaceuticals include vaccines, blood (or blood components), allergenics, somatic cells, gene therapies, tissues, recombinant therapeutic protein, and living cells used in cell therapy.  Compared with conventional drugs, biologics offer less discomfort […]

Not In Compliance With CGMP Requirements? FDA Can Revoke A Drug Approval

By |October 23rd, 2015|

If you think that getting drug approval puts you in the clear and you won’t have to worry about the Food and Drug Administration’s regulatory scrutiny, think again. What the FDA gives, it can take away. While it doesn’t happen often, companies that have received regulatory approval can have that authorization revoked if regulators find […]

Worried About 483 Reports? Take A Look At Your Electronic Data

By |October 23rd, 2015|

Pharmaceutical manufacturers who are concerned about risking a 483 report, or worse, a warning letter, are rightfully taking steps to guard against any manufacturing violations in their plants. But the data for the Food and Drug Administration’s enforcement activity in fiscal 2015 are in, and they show some surprising findings about where the regulator […]