Pharmaceutical quality assurance consulting, or pharmaceutical QA consulting, plays an important rule in the pharmaceutical manufacturing industry. Pharma QA consultants work with drug manufacturers to ensure their operations meet current good manufacturing practices (cGMP) set down by the Food and Drug Administration (FDA) or sometimes the World Health Organization (WHO).
Pharma quality assurance consulting is a broad term; quality assurance pharmaceutical companies may pay a role in developing manufacturing practices, distribution practices and inspection procedures. Most sources of pharmaceutical quality assurance consulting news and trends fall in with news on pharmaceutical manufacturing, but there are some exceptions. When researching pharma QA issues, you should consider:
1. Keeping tabs on cGMP as they are updated by the FDA and WHO.
2. Professional organizations for pharma quality assurance consulting firms.
3. Online pharma trade publications that let you pick out pharma QA news.
Action Steps
The best contacts and resources to help you get it done
Read information vital to pharmaceutical quality assurance consultants
Pharma QA consultants are usually hired to make sure manufacturing companies comply with cGMP. Both the FDA and WHO publish their cGMPs in full, online. These organizations update their sites as new practices are developed, and post papers and records from expert panels that clarify aspects of the cGMPs.
I recommend: The
WHO's website posts recent cGMP news and links to relevant publications. It also posts notes from the
Expert Committee on Specifications for Pharmaceutical Preparations. The
FDA publishes its most recent guidance for drug manufacturers.
FDANews reports issues a drug GMP report that covers regulatory changes and pharmaceutical manufacturing news.
Connect with fellow pharmaceutical QA consultants and share information
The quickest way to find out what's happening in the pharma QA industry is to talk to your consulting peers. How are they reacting to changing regulations? What practices are they advising their clients on?
I recommend: The
Pharmaceutical Quality Group is a trade organization for pharma QA consultants. In addition to newsletters and a risk management guide, it also provides a forum where experienced QA consultants can share tips with young professionals. The
Global Pharma Manufacturing Summit is attended by all the big names in the pharma manufacturing. Just scrolling through the program gives you an idea of current industry issues.
Follow the news to keep your pharma QA consulting knowledge sharp
There are many trade publications for the pharma industry. Some focus on development and marketing, others on manufacturing practices. Online publications that cover all sectors of the pharma industry usually allow you to focus your reading on specific topics.
I recommend: FiercePharmaManufacturing is a news aggregator that pulls headlines and press releases from all over the web; it also offers some original content. The
Pharmaceutical Business Review has page devoted to manufacturing.
Pharmaceutical Manufacturing News allows you to view QA trends.
In-Pharma Technologist.com has a feed of QA headlines.
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