Well, I have an interview the day after tomorrow. My agency sorted it out for me. I am well experienced for the job, but in the spec it mentions CGMP. And I know nothing, so would like at least to tell them that in a knowledgable way. Anyone know any links that can clue me up on this?
Google is your friend:
Maybe, cybersnark, and maybe not. I don’t know the OP’s background and I don’t know the company, but cGMP (in my industry) stands for “current Good Manufacturing Practices,” a collection of regulations for the manufacture of drugs. I don’t know how to begin describing it to you, save that it’s based on developing well-defined and well-controlled processes that will consistently produce a quality product, along with monitoring and record-keeping procedures that will preserve written evidence that those processes were followed correctly.
While GMPs (current “c” in the States, and just GMP in Canada) are a set of guidelines, they are also more than that - they are a matter of criminal law (unlike ISO standards, which are an optional thing). A company can be fined or certain personnel imprisoned for not following these guidelines. GMP requirements set out the minimum standards which companies must meet, but the FDA, HPFBI (formerly TPD) or other country’s equivalent department usually expect more than the minimum when they audit you. This is where SOPs come in - a company will set up a series of Standard Operating Procedures that meet and surpass the minimum requirements. the ©GMPs are constantly changing, so it’s good for a company to keep on top of them. If one company starts doing something that turns out to be a fantastic idea with regards to some procedure or other, than there’s a good chance everyone will be required to do so shortly thereafter!
These guidelines apply to all aspects of food and drug manufacturing, packaging and handling. For example, GMPs might cover the method for cleaning a piece of equipment, as well as define minimum acceptable residue and bacterial loads following cleaning. Or a GMP will define the air flow and circulation allowed in and out of a manufactuing suite, or the type of pest control needed, or the way in which data must be documented and stored, or the ways in which products must be tested to ensure purity, or the types of stability programs needed, or how to label things, etc. Basically everything has a GMP for it in the food and pharmaceutical industries!
http://www.fda.gov/cder/dmpq/cgmpregs.htm this website has the current GMPs from the US. There’s a lot to read, but I recommend you at least skim it and get a sense of what they are all about.
http://www.hc-sc.gc.ca/hpfb-dgpsa/inspectorate/gmp_guidelines_2002_entire_e.html These are the current Canadian ones, which I am somewhat more familiar with.
Note: I don’t work for the FDA or TPD, but I do work in a GMP pharmaceutical company, and have had basic training on these regulations.
mnemosyne, this is quite incorrect. The GMP regulations do not specify ANYTHING. There is, for example, a chapter requiring that “Adequate laboratory facilities for the testing and approval (or rejection) of components, drug product containers, closures, packaging materials, in-process materials, and drug products shall be available to the quality control unit.” That is the entire law on what a QC laboratory should be, as well as almost everything in a drug manufacturing facility: “adequate.”
More specific guidance is available in FDA technical documents and in the USP (United States Pharmacopeia), but those do not carry the force of law, and they are not part of the GMPs; they are officially recognized by FDA, and you’re usually pretty safe if you adhere to them, but the FDA can always decide that what you’ve done isn’t “adequate,” even if you’ve followed the letter of every regulation, guideline, monograph, and industry standard.
We also don’t know if that’s what the OP is asking about.
Thank you for your answers. The job is working for a consultancy that does work in the European pharmaceutical, fine chemical and food sectors, so I imagine the CGMP referred to is closely related to your N American models. I will give you links a look and will hopefully be better prepared for my interview.
I know this is very nitpicky, but I’d rephrase that as “everything has a GMP, GLP, or GCP for it in the pharmaceutical industries!” GLP is Good Laboratory Practices, and GCP is Good Clinical Practices. You need to watch those too!
Nametag - I guess I wasn’t clear, in how the GMPs don’t realy specify how a company should go about doing something, but they do say what should be done to ensure a good environment. I did say that they were the MINIMUM standard.The booklet on Canadian GMPs in front of me (2002 edition Version 2) also includes an Interpretation section, which gives more specific details on standards which are not explained in the GMP itself.
To clarify that: The GMP for sanitation says
That is the entire GMP Guideline (I suppose the keyword there is guideline) as listed in the Food and Drug regulations for canada, but under it, it says (among other things):
So while it doesn’t say HOW you must do something, the information provided by the HPFBI in Canada certainly spells out a little more clearly what they expect to see when they come audit you. The fact that a cleaning method must be validated means that they expect to see documentation on that validation, with a good rationale on why it is a good method or not. The mention of pest control measures means that they expect to see things like rodent traps around the buildings and well-sealed windows and such. A lot of it is common sense, and you are correct that just meeting the minimum is not necessarily enough, but they are the beginnings of a good set of regulations for a company. The specific details are left to the company itself, in their SOPs.
I hope I made things a little clearer? I don’t disagree with your post, but I wanted to explain what I meant.
And dmartin - yes, GCP and GLPs and all that are important too! I just tend to lump GLP into GMP since so much of our SOPs cover both anyways, it isn’t really something I keep separate in my mind! And since I don’t do clinical testing, well, that doesn’t really come up much in my tiny brain either 
InvidiousCourgette - if your company/clients want to market their things to canada or the US, then they must also follow these standards, but I’m sure Europe has their own set too. Good luck on your interview - I hope you get the job!