Everything You Need to Know About GMP Compliance

Effec­tive­ly oper­at­ing a GMP-com­pli­ant facil­i­ty pos­es unique chal­lenges on top of those that every oth­er facil­i­ty man­ag­er or own­er has to han­dle. If you own, man­age, or use a GMP-com­pli­ant facil­i­ty, there are some impor­tant things to know. We’ll cov­er every­thing, includ­ing how a com­pa­ny with Good Man­u­fac­tur­ing Prac­tice expe­ri­ence can make it eas­i­er to man­age the facility.

What to Know About GMP Compliance

What Is GMP Compliance?

GMP (short for Good Man­u­fac­tur­ing Prac­tice) com­pli­ance is a sys­tem that ensures that prod­ucts are pro­duced and con­trolled to meet a cer­tain qual­i­ty stan­dard. If you’ve ever won­dered, ​“What is Good Man­u­fac­tur­ing Prac­tice,” you’ll find that a key part of it reduces risk and pro­motes safe­ty in a facility.

You may also see GMP com­pli­ance referred to as cGMP, where the ​“c” stands for ​“cur­rent.” This nam­ing con­ven­tion high­lights the need to stay up-to-date with the most recent pro­to­cols and reg­u­la­tions. cGMP looks at the most recent ver­sions of the rules in the Code of Fed­er­al Reg­u­la­tion (CFR).

“What is GMP com­pli­ance” is a ques­tion that can also be answered by the way it can pro­tect your com­pa­ny and your con­sumers. Cus­tomers are pro­tect­ed from microbes, oth­er harm­ful con­t­a­m­i­nants, or chem­i­cals in the prod­ucts they pur­chase. The robust test­ing that comes with Good Man­u­fac­tur­ing Prac­tices deliv­ers a bet­ter test­ing method than just exam­in­ing sam­ples. Mean­while, your com­pa­ny reduces your risk of waste, loss­es, and recalls. More impor­tant­ly, you reduce the risk of fines, seizure of prod­ucts, or an inter­rup­tion in production.

GMP com­pli­ance also improves the rep­u­ta­tion of your com­pa­ny, reveal­ing that you pri­or­i­tize qual­i­ty and con­firm­ing that you meet FDA require­ments. Your cus­tomers can then have peace of mind and be encour­aged to choose your com­pa­ny over those that are not GMP-compliant.

What Are the 5 Ps of Good Man­u­fac­tur­ing Practices?

The Good Man­u­fac­tur­ing Process stan­dard can be bro­ken down into the ​“5 Ps of GMP.” These ​“P”s stand for peo­ple, prod­ucts, process­es, pro­ce­dures, and premises.

Peo­ple need to under­stand their roles and respon­si­bil­i­ties. Prod­ucts must include clear spec­i­fi­ca­tions through­out every pro­duc­tion stage. All process­es should be doc­u­ment­ed, con­sis­tent, and sim­ple. Pro­ce­dures out­line how to under­take crit­i­cal process­es. Final­ly, the premis­es should be clean and the equip­ment cal­i­brat­ed at all times.

Addi­tion­al­ly, prod­ucts apply to raw mate­ri­als and fin­ished prod­ucts. You need to pri­or­i­tize get­ting qual­i­ty raw mate­ri­als and stor­ing them prop­er­ly before they even enter the pro­duc­tion line. It is also worth not­ing that the out­lined process­es and pro­ce­dures must be strict­ly fol­lowed. Prop­er train­ing for your work­force, includ­ing com­pli­ance train­ing, can ensure this is the case. Stan­dard­iz­ing pro­ce­dures and process­es ensures that your man­u­fac­tur­ing is effi­cient and con­sis­tent in pro­duc­ing qual­i­ty products.

How to Become GMP Compliant

If you haven’t achieved GMP com­pli­ance, it will typ­i­cal­ly take three to twelve months for you to do so. From there, you will need to make an ongo­ing effort to con­tin­ue meet­ing require­ments and stay up-to-date with changes or updates to it.

You can start this process by cre­at­ing a team ded­i­cat­ed to ensur­ing the facil­i­ty is GMP-com­pli­ant – this will like­ly entail work­ing with con­trac­tors expe­ri­enced in GMP-com­pli­ant facilities.

One of the first things to do is to assess your cur­rent oper­a­tions and process­es. This lets you iden­ti­fy prac­tices that need to change before you can become GMP-com­pli­ant. You will also need to start doc­u­ment­ing your process­es, which is cru­cial to GMP com­pli­ance. Make sure you set up a method of keep­ing records, con­firm­ing that all the steps out­lined in your pro­ce­dures and process­es are fol­lowed. You can achieve this man­u­al­ly or using record­ing instruments.

Once you think you are ready to offi­cial­ly become GMP com­pli­ant, do an inter­nal audit. After get­ting your GMP cer­ti­fi­ca­tion, you must con­tin­ue mon­i­tor­ing your facil­i­ty, includ­ing equip­ment, process­es, and staff. An essen­tial part of con­tin­ued com­pli­ance is train­ing your team and hir­ing con­trac­tors that can com­fort­ably work in GMP-com­pli­ant spaces. Remem­ber that the FDA reg­u­lar­ly checks for GMP vio­la­tions, so you must con­tin­ue to fol­low the rel­e­vant standards.

What GMP Com­pli­ance Applies To

GMP com­pli­ance applies to any con­trolled envi­ron­ment. It is extreme­ly com­mon in food and phar­ma­ceu­ti­cals, as well as elec­tron­ics and chip man­u­fac­tur­ing. More and more facil­i­ties are work­ing to become GMP com­pli­ant as they local­ize man­u­fac­tur­ing. Oth­ers have real­ized that hav­ing their own facil­i­ties pre­vents delays in their process­es. By main­tain­ing their own GMP-com­pli­ant facil­i­ties, time­lines in pro­duc­tion are not affect­ed or com­pro­mised by exter­nal fac­tors that cause delays.

Who Is Involved in Main­tain­ing and Build­ing GMP-Com­pli­ant Facilities?

Any enti­ty that builds, main­tains, or ren­o­vates GMP-com­pli­ant facil­i­ties needs to under­stand its impor­tance to a busi­ness. Some spe­cif­ic tasks are com­mon­ly over­looked but cru­cial to fol­low­ing Good Man­u­fac­tur­ing Prac­tice. Specif­i­cal­ly, you must make sure you hire GMP-com­pli­ant con­trac­tors in projects involv­ing a facility’s floor­ing, paint­ing, and caulking.

Floor­ing

A facility’s floor­ing is a major con­cern for GMP com­pli­ance. A big chal­lenge is choos­ing the appro­pri­ate amount of aggre­gate. If you don’t include enough aggre­gate in the floor, you run the risk of inci­dents of slip­ping and falling. On the flip side, too much aggre­gate can tear booties and trap bac­te­ria, which can cause an FDA flag and the entire oper­a­tion to be compromised.

Anoth­er impor­tant con­sid­er­a­tion for GMP-com­pli­ant floor­ing is find­ing con­trac­tors who can turn it out quick­ly. After all, down­time hurts your pro­duc­tiv­i­ty and prof­its, so a con­trac­tor that gets the job done swift­ly is price­less. For exam­ple, you want to look for some­one who can come in the after­noon and use polyas­par­tic mate­ri­als that cure in an hour so that the space can be oper­a­tional the next day.

Paint­ing

One of the many con­sid­er­a­tions in regard to GMP com­pli­ance for paint­ing is Spor-Klenz, which is a strong chem­i­cal for wash­ing a sur­face. Using it fre­quent­ly proves to be incred­i­bly tough on sur­faces. As such, your paint­ing con­trac­tors must under­stand com­plex epox­ies, includ­ing prop­er mix­ing and application.

Caulk­ing

Caulk­ing is also a pre­ci­sion job that requires GMP com­pli­ance train­ing. You need to use the right FDA-approved 100% sil­i­cone caulk, espe­cial­ly on dis­sim­i­lar sur­faces and drop ceil­ings. This is a pre­ci­sion job that requires experience.

Care­ful­ly Choose Ven­dors for GMP Compliance

Due to the impor­tance of GMP cer­ti­fi­ca­tion, you need to be care­ful when choos­ing your ven­dors and con­trac­tors. Most clean­room con­trac­tors may be unfa­mil­iar with your pro­ce­dures and how to work in the space. As such, you want to choose a ven­dor that reg­u­lar­ly works in clean­rooms and GMP-com­pli­ant facil­i­ties. Ide­al­ly, they will also pro­vide GMP com­pli­ance train­ing for their team, whether for­mal train­ing or via exten­sive experience.

GMP Facil­i­ty Maintenance

Once you under­stand what GMP com­pli­ance is, its effect on main­te­nance pro­ce­dures should be a bit clear­er. To put it into even more per­spec­tive, con­sid­er the size of bac­te­ria. Most bac­te­ria are between one and two microns. For ref­er­ence, human hair is 100 microns, and the naked eye is unable to see 50 microns. There­fore, with the human eye alone, you have no chance of see­ing the bac­te­ria that needs clean­ing to pre­vent it from accumulating.

You must edu­cate your employ­ees about these mat­ters so they under­stand why fol­low­ing pro­ce­dures is impor­tant. Remem­ber that the end goal is to cre­ate a clean­able space that doesn’t pro­mote bac­te­r­i­al growth. While there are com­mon­ly sim­i­lar pro­ce­dures across dif­fer­ent facil­i­ties, there will always be some vari­a­tion in each company’s systems.

Choose a Com­pa­ny That Stays on Top of GMP Compliance

The rules and best prac­tices that make up GMP com­pli­ance occa­sion­al­ly change, mak­ing it all the more chal­leng­ing. Even the con­stant rules and prac­tices can be incred­i­bly detailed and require a great deal of thought.

You can reduce the bur­den on your team by choos­ing a com­pa­ny that stays on top of GMP com­pli­ance. Kaloutas is high­ly expe­ri­enced in this area. As we stay on top of your facility’s com­pli­ance, you can spend your time and effort on oth­er impor­tant busi­ness mat­ters. We also offer ser­vices in all the pre­vi­ous­ly-men­tioned areas that are impor­tant and chal­leng­ing for GMP com­pli­ance, includ­ing floor­ing, caulk­ing, and paint­ing. Our GMP com­pli­ance strate­gies min­i­mize or com­plete­ly elim­i­nate the need for down­time, reduc­ing lost rev­enue com­mon­ly asso­ci­at­ed with upgrades or maintenance.

At the same time, Kaloutas can assist with oth­er types of com­pli­ance, such as fire­proof­ing and fire maintenance.

Kaloutas Makes GMP Com­pli­ance Sig­nif­i­cant­ly Easier

Let Kaloutas keep your facil­i­ty com­pli­ant with the most recent GMP guide­lines. From floor­ing to paint­ing to caulk­ing to GMP main­te­nance, we are hap­py to be your part­ner in fol­low­ing Good Man­u­fac­tur­ing Practices.