GOOD MANUFACTURING PRACTICE (GMP)

Good Manufacturing practices is a quality system which ensure that the products are consistently produced and controlled as per the quality standards. GMP regulation provides guidance for manufacturing, testing and quality assurance to ensure that the manufactured product is safe for human consumption or use.

Implantation of GMP assures that the identity, strength, quality and purity of the products as the consumer cannot detect the safety of the product.

FDA inspects drug manufacturing facilities around the world which includes API manufacturers to check whether these companies implemented drug GMP regulations as per 21 CFR part 211. FDA will consider these drugs as adulterated if the company is not complying with GMP regulations.

Medical Device manufacturers must follow and implement quality system to ensure that their products consistently meet all medical device GMP regulations as per 21 CFR part 820. This quality system regulation is applicable to all finished device manufacturers who are planning to do commercial distribution in US. As per 21 CFR 820.3(i) a finished device is any type of device or attachment to any device that is fit for use or capable of working, whether or not it is packaged, labeled, or sterilized.

FDA has classified certain type of medical devices are exempt for GMP regulations, however it does not exempt the manufacturers of finished devices from GMP requirements.

FDA’s GMP regulation as per 21 CFR 820 is aligned with ISO 13485: 2016 to a greater extent than ISO 9001:2015 which is an internationally recognized quality system.

FDA inspects medical device manufacturing facilities to check whether their establishment is in compliance with 21 CFR 820 regulations.  If the company is not in compliance with GMP regulations at the time of inspection, FDA will issue an Establishment inspection Report in observations listed on FDA form 483.  It is the company’s responsibility to respond FDA 483 warning letter within 15 days and the response has to include the corrective measures taken by the company and preventive solutions taken to stop the recurrence.

Liberty Management Group, a leading FDA consulting group in the United States, provides assistance with 21 CFR 820 GMP regulations, ISO 13485 : 2016 and FDA 483 warning letters.

Sudha S

Regulatory Consultant

Mail : office@libertymanagement.us

http://www.fdahelp.uss

DRUG LABELING

Drug label is a printed information which is included with any OTC drugs, prescription drugs or any dietary supplements. Drugs labels are regulated by FDA and provide information to healthcare providers and patients on safe and effective use of the product. The information on the labels must be accurate and should not be misleading

All drugs or drug products in finished package form is considered as misbranded if it does not comply with FDA labeling requirements. The labels needs to have the name and place of business of the manufacturer, packer or distributor.

All registered drug establishments which includes API manufacturer, bulk manufacturer, contract manufacturer, repackers, relabelers are required to list their products under their own labeler code, however NDC number is not required to appear on all drug labels, including the label of any prescription drugs given to a customer.

Drugs labels should contain all drug facts which includes active ingredients, purpose and uses of the drug, directions, other information, inactive ingredients, phone numbers if there is any questions or comments.

When there is an expiration date on the drug products, it should appear on the container and also in outer package. However, if it is a single dose drug product packed in individual cartons, the expiry date should be on the individual carton not on the product container.

Manufacturers, Contract manufacturers, repackers, relabelers, and private label distributors of a human prescription drugs or an over-the-counter (OTC) drugs that is regulated under the FD&C act are not required to have bar code on the products. However, if the same drug product that are sold or used in the hospitals are required to put bar code on their products.

Liberty Management Group provides assistance with drug establishment registration, drug listing and label review.

Sudha S

Regulatory Consultant

Email : office@libertymanagement.us

www.fdahelp.us

CLASSIFICATION OF MEDICAL DEVICES

Medical Devices are any instrument, appliance, machine, software or any other device including part or accessory of a device which is

  • Recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them
  • Intended to diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals.
  • intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes.”

FDA has categorized classifications of nearly around 1,700 different generic types of devices and collected them into 16 medical specialties referred to as panels. Medical devices are classified in to Class I, Class II or Class III depending upon the risk of the device.

  • Class I devices are in general recognized as low risk devices with general controls with or without exemptions.
  • Class II devices are in general recognized medium risk to the user with general controls and Special control with or without exemptions.
  • Class III devices are recognized as high risk device that support life, and present high risk of illness and injury. Class III devices requires general controls, special controls and also premarket approval.

Classification of devices depends upon the intended use and indications for use of the device. Device classification can be found in two ways, one is to check at Classification database or can be checked at device panel at which the device belongs to.

Companies that involved in manufacturing and distribution of medical devices intended for commercial distribution are required to register with FDA annually and pay fees. Most companies are required to list their devices and need to notify the activities done on those devices at their establishment.

If a device requires Premarket notification (510K) or Premarket approval (PMA) or Humanitarian Device Exemption (HDE), the owner/operator should get above clearance from FDA before they start marketing the device in US.

All Medical devices marketed in United States has be in compliance with FDA labeling requirements, if not, FDA will considered them as misbranded.

Liberty Management Group Ltd, provides assistance with medical device establishment registration, device listings, label review and US agent service to foreign facilities.

Sudha S

Regulatory Consultant

Mail : office@libertymanagement.us

www.fdahelp.us

HOMEOPATHIC DRUG REGISTRATION AND LISTING WITH FDA

Homeopathy is an alternative medicine created by a German Scientist which claims that a substance that causes the symptoms of a disease in healthy people would cure similar symptoms in sick people.

Any drugs labeled as homeopathic has to be listed in the Homeopathic Pharmacopeia of the United States (HPUS).

FDA does not approve products labeled as homeopathic products. The products labeled as homeopathic contains a range of substances resulting from plants, healthy or dead animal or human sources, minerals and chemicals.

Homeopathic products currently marketed here in US have not been reviewed by FDA to check its safety and effectiveness to treat, diagnose, cure or prevent any disease or conditions.

Under FD&C act, Homeopathic drugs products are subject to same regulations as OTC drugs.

As per FDA, companies which manufacture, prepare, propagate and compound homeopathic drugs must register with FDA as drug establishment and list their drugs with FDA by creating a SPL.

Homeopathic drug product labeling must comply in same regulations as any other drugs products.

Liberty Management Group Ltd, provides assistance with homeopathic drugs establishment registration, drug listings and US agent service to foreign facilities.

Sudha S

Regulatory Consultant

Mail : office@libertymanagement.us.

www.fdahelp.us

COMPOUNDING PHARMACY REGISTRATION

Compounding is a method of mixing, combines or alters ingredients of a drug to manufacture a medication custom made to the needs to individual patient under the supervision of licensed pharmacist, or a licensed physician or an outsourcing facility.

Compounded drugs are not FDA-approved. FDA does not check these drugs to assess their safety or efficiency before they reach patients. It is only the responsibility of State board of pharmacy to monitor state-licensed pharmacies that compound drugs in accordance with regulation of section 503A of the FD&C, although FDA has some control over their operations.

Outsourcing facilities registered under section 503B are regulated by FDA and must stratify cGMP requirements and will be inspected by FDA.

An outsourcing facility is geographic location or address where the drugs are compounded. An outsourcing facility has to be in compliance with section 503B and must comply with cGMP requirements.

If an outsourcing facility engages in compounding non-sterile drugs and animal drugs, mixing, diluting or repacking biological products do not need to register as an outsourcing facility as the drugs compounded are not eligible for exemption form 503B for FD&C act.

All Outsourcing facilities that engages in compounding sterile human drugs needs to register with FDA using CEDR system.

All outsourcing facilities must renew their registration between Oct 1st and Dec 31st and pay the annual establishment registration fees for every year as long as they wish to register as an outsourcing facility.

PRODUCT REPORTING PROCEDURES

The drug products manufactured from December 1 through May 31 must submit drug product reporting between June 1 and June 30. In the same way, the drug products manufactured from June 1 through November 30 must submit drug product reporting between December 1 and December 30.

Each product report must include all sterile and non-sterile drug compounded in the outsourcing facility must include active ingredient and its strength, NDC number of source drug or bulk active ingredient, dosage and route of administration, package description, number of individual units manufactured and NDC number of end product (If assigned)

LMG provide assistance with FDA registration of Outsourcing facilities.

Sudha S

Regulatory Consultant

Mail – office@libertymanagement.us

http://www.fdahelp.us

Published on: January 9, 2019