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[isocertificationrequirements]

cGMP Certification

Defining cGMP

cGMP Certification is a quality product certification that is specific to the pharmaceutical and biotechnology industries. The cGMP certification is overseen by the FDA and is designed to ensure that manufacturers are producing products in accordance with Good Manufacturing Practices (GMPs). To receive this certification, a facility must demonstrate compliance with GMP requirements for the manufacture of pharmaceuticals and biologics.

Importance

The gmp certification is important for companies that want to ensure their products are manufactured to the highest quality standards. The certification also helps protect companies from potential product liability lawsuits. By demonstrating compliance with GMP requirements, a company can show that it has taken all necessary steps to ensure the safety and quality of its products.

Benefits

It demonstrates that you are committed to producing high-quality products in compliance with FDA regulations.

It proves that you have the necessary systems and procedures in place to produce safe and effective products.

It indicates that you are a responsible manufacturer who takes product quality seriously.

It can help you win new business and keep existing customers.

It can improve your reputation within the industry.

It can help you maintain compliance with FDA regulations.

It can help you avoid costly product recalls.

Which Organizations Can Apply?

GMP certificate is available to facilities that produce pharmaceuticals and biologics. This includes:

Pharmaceutical manufacturers

Biotech companies

Contract manufacturing organizations (CMOs)

Testing labs

How to Get cGMP Certified?

The process of getting cGMP certified can vary depending on the organization. In general, a company will need to submit an application and provide documentation demonstrating compliance with GMP requirements. The FDA will then conduct an inspection of the facility to verify that it meets all applicable standards.

Once a facility has been certified, it must undergo regular inspections to ensure continued compliance with GMP requirements. Facilities that do not maintain compliance may be subject to enforcement actions by the FDA, including fines and product recalls.

Conclusion

The cGMP training certification is an important quality product certification that is specific to the pharmaceutical and biotech industries. It is overseen by the FDA and is designed to ensure that manufacturers are producing products in accordance with Good Manufacturing Practices (GMPs). To receivethis certification, a facility must demonstrate compliance with GMP requirements for the manufacture of pharmaceuticals and biologics. The benefits include improved product quality, compliance with FDA regulations, and avoidance of costly product recalls.

how to get gmp certification in sri lanka

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[yesilovehorses-blog1]

The Otherwise Apparently Healthy Collapsing Horse

New Post has been published on http://lovehorses.net/the-otherwise-apparently-healthy-collapsing-horse/

The Otherwise Apparently Healthy Collapsing Horse

Horses need paradoxical sleep,withthey need to lie downto getthis sleep. Theycanonlygooftwo weeks without it before the body begins responding,occasionallyin odd ways suchAt the timecollapse.

Photo: iStock

Stray voltage. Sleep terrors. Melatonin. Medical marijuana. These ingredients made upanlively lunchtime table topic veterinary discussionabouthorse collapse—aconditionwith primary causes ranging from sleep deprivationwithpain to muscle disordersandpregnancy.

Key to treatingonecollapsing horse successfully is pinpointing the cause, whichcantakesomesleuthing.

Joe Bertone, DVM, MS, Dipl. ACVS,withStephen Reed, DVM, Dipl. ACVIM, described their approaches to these cases while moderating the discussion at the 2016 Americanassociationof Equine Practitioners Convention, held in December in Orlando, Florida. Bertone isoneprofessor of equine medicine at Western University of Health Science's College of Veterinary Medicine, in Pomona, California,andhas adistinctiveinterest in sleep deprivation. Reed isaninternistandshareholder at Rood & Riddle Equine Hospital,andhis bailiwick is equine neurology; this means he seesonesteady caseload of what hesporadicallycalls “clumsy horses,” or uncoordinated animals because of neurologic disorders. Both veterinarians possessoneinfectious enthusiasm for difficult-to-diagnose cases.

When Bertone getsancallaboutthecollapsing horse, 90% of the time the horse is sleep-deprived. The other 10% of the time the horse is suffering solely fromanneurologic, musculoskeletal, or othersortof condition.plainreasons Bertone sees for horses collapsing that could fit in the sleep-deprivationelementinclude boredom (think ofashow horse collapsing in the crossties at 4 a.m. while being braided), dominance displacement (when anhardgelding keeps vigil and, thus, never sleeps),withthe pain andpregnantmentioned earlier.

Horses need paradoxical, or deep, sleep (akabriskeye movement, or REM sleep) justlikewe do, said Bertone. They need to lie downto receivethis sleep,withcanonlygoabouttwo weeks without it before the body begins responding,sporadicallyin odd ways.

Veterinarians in the room regaled the group with storiesaboutcollapsing sleep-deprived horses they’ve treated,innumerableof which weregreatforsomeknown or unknown reason.someexamples included:

anmare that never lay down to sleep though wouldperiodicallyroll. She’d collapse intermittently, startling herself,andjump back to her feet. She could be riddenandworked because she was not neurologic. Fifty percent of the time the mare appeared either nervous or exhausted, said her veterinarian.

Another mare that collapsed regularlywithwassurelyanxiousofeveryday happenings, suchAt the timeanpalm frond falling to the ground near her stall. (Bertone said that 87% of his sleep deprivation cases are geldings—there just happened to be more mares described here.)

angroup of horses that were chronically sleep-deprived, collapsing,andunwell that improved when the owner moved them away from buzzing overhead powerlines.

thehorse that was treated for Lyme diseaseandfirstlay downandgotsome onessleep.

Horses thatHaving“sleep terrors,” which prevent the horse from going into that restful period of paradoxical sleep. These horses paddlewithkick and, justAshumans, often dothereforewith their eyes wide open.

Other types of cases described included muscle diseases (myopathies) in which horsesHavingtrouble getting to their feet because of muscle tissue pain,thusthey never lie downto receivethe deep paradoxical sleep that they need. Among these were mules suffering from hyperkalemic periodic paralysis (HYPP), which veterinarians said often leaves them recumbent (unable to rise)andunrecoverable.

Working Up Falling Down

When Reed works upancollapsing-horse case,andpain has already been ruled out, he checks the horse’s heart first, listening for atrial fibrillation or other types of conduction disturbances. Next, he conductsanneurologic exam, looking foronevariety of signs that could predisposeanhorse to losing balancewithfalling, or that would cause the horse enough pain that it would avoidmendacitydown.

nexthe considers the horse’s metabolism. “Think of endocrinologic problems,” he said. “If they’re 17andthey haven’t developed PPID,nextthey certainlyHavethat potential. When thesechancesare suspected, further testing to rule out PPID or hypothyroidism is indicated.

“A physical exam, neurologic exam, along withsome onesstableblood panels forcompleteblood countandmaster panel looking for underlying gastrointestinal, hepatic, or renal disease (can providesomeinsight)At the timewellOncegivinganindication of whether inflammation or infection are present,” Reed said. “Beyond this, in search of morespecificendocrinologic disorders, I would look forabnormallevels of blood glucosewithinsulin levels in blood.

“Horses thatHavingPPID but fail to respond to treatment require reassessment of the clinical signswithconsideration ofextradiagnostic testing,” he added.heapsof the horses Reed assesses typically suffer from spinal trauma, acute onset equine protozoal myeloencephalitis (EPM), or cervical stenotic myelopathy (CVM, or wobbler syndrome).

Bertone asks owners to set up 24/7 video for casesthushecanregardfor night terrors or simply look for signs of pain or behaviors that would prevent paradoxical sleep.

Amy Johnson, DVM, Dipl. ACVIM, of the University of Pennsylvania’s School of Veterinary Medicine atrecentBolton Center, chimed in, saying sheandher colleaguesHavefound it valuable to work up these horses that collapse using video. Sue McDonnell, PhD,thecertified applied animal behavioristandthe founding head of the equine behavior program at the school reviews the footage.

“Thetrulyinvaluable thing is Dr. McDonnell’s differentiating the horses that are sleep deprived,” said Johnson. “She picks uponelot of pain behaviors that we missAsclinicians. They hide theirdiscomfortfrom us.”

Added Bertone, “About half the time we cannot findthediagnosis.OnceI’ve ruled out pain, made sure there’s no Lyme or sleep terrors,firstIventureDifferentdrugs.”

Let’s Talk Treatment

Reed said he prescribes two drugs for anxiety to help horses relaxandsleep: Dilantin (phenytoin,ananticonvulsant, which also hassomesedative properties)withZylkene,anproduct that contains alpha-casozepine,anprotein found in mare’s milk that promotes relaxation in patients that are anxiouswithstall-walking,reallyafter surgical repairs.

For sleepterrorcases, Bertone uses melatonin or changes up the horse’s environment, moving the horse to anothersectionof the barn or addinganpony or other companion. Noting that research showedsome oneschildren with sleep terrors were hypoglycemic, he suggested feeding affected horsesthereafterat night tonoticeifthat makes any difference.

Bertone also administers melatonin to anxious, sleep-deprived horsesandsaid he’s surprised at how well it works. Still another option he prescribes is Prozac (fluoxetine), which he saidcanwork, but takesaboutamonth to become effective.

“But whatofmedical marijuana?” askedanveterinarian in attendance.

“Itmaywork, inthestate where it’s legal,” said Bertone, when other approaches haven't worked,andwhen the practitioner has working knowledge of dosing in the species ormayconsultaveterinarian who does.

everyEars withtheEagle Eye

Forsomeof the more unusual causes of collapse, treatmentcanbeanprocess of elimination after atotalworkup, involvingonewalk around the barn, looking forwithlistening for potential causes. For example,onehorse that began collapsing didaccordinglyafter moving into arecentbarn. The veterinarian noticedthetreebranchwas rhythmically scratching the roofAt the timethe wind blew. The owners moved the horse away from the repetitive noisewiththe collapsing behavior stopped. At another farmonehorse began collapsing after the farm owners changed the voltage of the barn’s lightbulbs; there was somethingapproximatelytheir sound that bothered the horses.

Finally, simply looking at your barn withancritical eye for safetycanspreadthecollapsing horse’s trigger.anveterinarian describedthegelding that appeared healthy in his stall, but would knuckle overwithcollapseAt the timesoonWhenthe owner wouldproceedthe horse into the aisle. None of the other horses behaved this way … butallthe other horses were barefootwiththis horse was shod. Ultimately, the veterinarian noticed anexperiencedextension cordlyingnearby in amoistaisle—stray voltage was the culprit.

Anewextension cord, stowed neatly away from the damp, was the cure.

About the Author

Stephanie L. Church, Editor-in-Chief

Stephanie L. Church, Editor-in-Chief, receivedoneB.A. in JournalismandEquestrian Studies from Averett College in Danville, Virginia.anPony Clubwith4-H graduate, her background is in eventing,andshe is schooling her recently retired Thoroughbred racehorse, Happy, towardonecareer in that discipline. She also enjoys traveling, photography, cycling,withcooking in her free time.

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[isocertificationrequirements]

cGMP Certification

Defining cGMP

cGMP Certification is a quality product certification that is specific to the pharmaceutical and biotechnology industries. The cGMP certification is overseen by the FDA and is designed to ensure that manufacturers are producing products in accordance with Good Manufacturing Practices (GMPs). To receive this certification, a facility must demonstrate compliance with GMP requirements for the manufacture of pharmaceuticals and biologics.

Importance

The gmp certification is important for companies that want to ensure their products are manufactured to the highest quality standards. The certification also helps protect companies from potential product liability lawsuits. By demonstrating compliance with GMP requirements, a company can show that it has taken all necessary steps to ensure the safety and quality of its products.

Benefits

It demonstrates that you are committed to producing high-quality products in compliance with FDA regulations.

It proves that you have the necessary systems and procedures in place to produce safe and effective products.

It indicates that you are a responsible manufacturer who takes product quality seriously.

It can help you win new business and keep existing customers.

It can improve your reputation within the industry.

It can help you maintain compliance with FDA regulations.

It can help you avoid costly product recalls.

Which Organizations Can Apply?

GMP certificate is available to facilities that produce pharmaceuticals and biologics. This includes:

Pharmaceutical manufacturers

Biotech companies

Contract manufacturing organizations (CMOs)

Testing labs

How to Get cGMP Certified?

The process of getting cGMP certified can vary depending on the organization. In general, a company will need to submit an application and provide documentation demonstrating compliance with GMP requirements. The FDA will then conduct an inspection of the facility to verify that it meets all applicable standards.

Once a facility has been certified, it must undergo regular inspections to ensure continued compliance with GMP requirements. Facilities that do not maintain compliance may be subject to enforcement actions by the FDA, including fines and product recalls.

Conclusion

The cGMP training certification is an important quality product certification that is specific to the pharmaceutical and biotech industries. It is overseen by the FDA and is designed to ensure that manufacturers are producing products in accordance with Good Manufacturing Practices (GMPs). To receivethis certification, a facility must demonstrate compliance with GMP requirements for the manufacture of pharmaceuticals and biologics. The benefits include improved product quality, compliance with FDA regulations, and avoidance of costly product recalls.

gmp certification in sri lanka

[isocertificationrequirements]

cGMP Certification

Defining cGMP

cGMP Certification is a quality product certification that is specific to the pharmaceutical and biotechnology industries. The cGMP certification is overseen by the FDA and is designed to ensure that manufacturers are producing products in accordance with Good Manufacturing Practices (GMPs). To receive this certification, a facility must demonstrate compliance with GMP requirements for the manufacture of pharmaceuticals and biologics.

Importance

The cgmp certification is important for companies that want to ensure their products are manufactured to the highest quality standards. The certification also helps protect companies from potential product liability lawsuits. By demonstrating compliance with GMP requirements, a company can show that it has taken all necessary steps to ensure the safety and quality of its products.

Benefits

It demonstrates that you are committed to producing high-quality products in compliance with FDA regulations.

It proves that you have the necessary systems and procedures in place to produce safe and effective products.

It indicates that you are a responsible manufacturer who takes product quality seriously.

It can help you win new business and keep existing customers.

It can improve your reputation within the industry.

It can help you maintain compliance with FDA regulations.

It can help you avoid costly product recalls.

Which Organizations Can Apply?

GMP certificate is available to facilities that produce pharmaceuticals and biologics. This includes:

Pharmaceutical manufacturers

Biotech companies

Contract manufacturing organizations (CMOs)

Testing labs

How to Get cGMP Certified?

The process of getting cGMP certified can vary depending on the organization. In general, a company will need to submit an application and provide documentation demonstrating compliance with GMP requirements. The FDA will then conduct an inspection of the facility to verify that it meets all applicable standards.

Once a facility has been certified, it must undergo regular inspections to ensure continued compliance with GMP requirements. Facilities that do not maintain compliance may be subject to enforcement actions by the FDA, including fines and product recalls.

Conclusion

The cGMP  training certification is an important quality product certification that is specific to the pharmaceutical and biotech industries. It is overseen by the FDA and is designed to ensure that manufacturers are producing products in accordance with Good Manufacturing Practices (GMPs). To receivethis certification, a facility must demonstrate compliance with GMP requirements for the manufacture of pharmaceuticals and biologics. The benefits include improved product quality, compliance with FDA regulations, and avoidance of costly product recalls.