# CGMP Process Engineering **URL:** \ **Category:** Factual Questions\ **Created:** [July 5, 2004, 8:35pm UTC](https://boards.straightdope.com/t/cgmp-process-engineering/253687 "2004-07-05T20:35:41Z")\ **Posts on this page:** 8\ **Page:** 1
**Author:** ![InvidiousCourgette](https://avatars.discourse-cdn.com/v4/letter/i/e47c2d/32.png) [@InvidiousCourgette](https://boards.straightdope.com/u/InvidiousCourgette)\ **Post date:** [July 5, 2004, 8:35pm UTC](https://boards.straightdope.com/t/cgmp-process-engineering/253687/1 "2004-07-05T20:35:41Z")
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? ---
**Author:** ![cybersnark](https://avatars.discourse-cdn.com/v4/letter/c/b9e5f3/32.png) [@cybersnark](https://boards.straightdope.com/u/cybersnark)\ **Post date:** [July 5, 2004, 9:37pm UTC](https://boards.straightdope.com/t/cgmp-process-engineering/253687/2 "2004-07-05T21:37:04Z")
Google is your friend: [http://www.ncne.org/documentation/faq/mcast\_eng\_faq.html#16](http://www.ncne.org/documentation/faq/mcast_eng_faq.html#16) ---
**Author:** ![Nametag](https://sea3.discourse-cdn.com/straightdope/user_avatar/boards.straightdope.com/nametag/32/406_2.png) [@Nametag](https://boards.straightdope.com/u/Nametag)\ **Post date:** [July 5, 2004, 10:33pm UTC](https://boards.straightdope.com/t/cgmp-process-engineering/253687/3 "2004-07-05T22:33:07Z")
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. ---
**Author:** ![mnemosyne](https://avatars.discourse-cdn.com/v4/letter/m/c4cdca/32.png) [@mnemosyne](https://boards.straightdope.com/u/mnemosyne)\ **Post date:** [July 6, 2004, 1:11am UTC](https://boards.straightdope.com/t/cgmp-process-engineering/253687/4 "2004-07-06T01:11:41Z")
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](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](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. ---
**Author:** ![Nametag](https://sea3.discourse-cdn.com/straightdope/user_avatar/boards.straightdope.com/nametag/32/406_2.png) [@Nametag](https://boards.straightdope.com/u/Nametag)\ **Post date:** [July 6, 2004, 4:49am UTC](https://boards.straightdope.com/t/cgmp-process-engineering/253687/5 "2004-07-06T04:49:15Z")
**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. ---
**Author:** ![InvidiousCourgette](https://avatars.discourse-cdn.com/v4/letter/i/e47c2d/32.png) [@InvidiousCourgette](https://boards.straightdope.com/u/InvidiousCourgette)\ **Post date:** [July 6, 2004, 6:41am UTC](https://boards.straightdope.com/t/cgmp-process-engineering/253687/6 "2004-07-06T06:41:24Z")
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. ---
**Author:** ![Canadjun](https://avatars.discourse-cdn.com/v4/letter/c/76d3ee/32.png) [@Canadjun](https://boards.straightdope.com/u/Canadjun)\ **Post date:** [July 6, 2004, 2:28pm UTC](https://boards.straightdope.com/t/cgmp-process-engineering/253687/7 "2004-07-06T14:28:55Z")
> [@mnemosyne](#): > > Basically everything has a GMP for it in the food and pharmaceutical industries! 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! ---
**Author:** ![mnemosyne](https://avatars.discourse-cdn.com/v4/letter/m/c4cdca/32.png) [@mnemosyne](https://boards.straightdope.com/u/mnemosyne)\ **Post date:** [July 7, 2004, 12:05am UTC](https://boards.straightdope.com/t/cgmp-process-engineering/253687/8 "2004-07-07T00:05:24Z")
**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 > [@](#): > > C.02.007 > (1) Every person who fabricates or packages/labels a drug shall have a written sanitation program that shall be implemented under the supervision of qualified personnel. > (2) The sanitation program referred to in subsection (1) shall include: > (a) cleaning procedures for the premises where the drug is fabricated or packaged/labelled and for the equipment used in the fabrication or packaging/labeling of the drug: and > (b)instructions on the sanitary fabrication and packaging/labelling of drugs and the handling of materials used in the fabrication and packaging/labelling of drugs 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): > [@](#): > > Interpretation > (1) A written sanitation program is available on the premises of every person who fabricates, packages, labels a drug > (2) The sanitation program contains procedures that outline the following: > 2.1 cleaning requirements applicable to all production areas of the plant with emphasis on manufacturing areas that require special attention > … > 2.3 cleaning intervals > 2.4 products for cleaning and disinfecting, along with their dilution and the equiment to be used > … > 2.7 pest control measures > … > 2.9 microbial and environmental monitoring procedures with alert and action limits in areas where susceptible products are fabricated and packaged > … > 3 (several points summarise): cleaning of manufacturing equipment are validated based on the Cleaning Validation Guidelines, ensure that no residues of cleaning agents are left behind, ensure that microbial growth is prevented on equipment in use and in storage, analytical methods used to detect these things are validated, etc etc. 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!