GMP is a system for ensuring that products are consistently produced and controlled according to quality standards appropriate to their intended use and as required by the product specification. The quality and safety of locally-manufactured products can only be ensured if national regulatory authorities with operational inspectorates implement and enforce appropriate GMP standards.

The Federal Food, Drug and Cosmetic Act prohibits the introduction or delivery for introduction into interstate commerce of cosmetics that are adulterated or misbranded (Sec. 301).

A cosmetic may be deemed adulterated (Sec. 601) for essentially four reasons, namely:

1. It may be injurious to users under conditions of customary use because it contains, or its container is composed of, a potentially harmful substance.

2. It contains filth.3. It contains a non-permitted, or in some instances non-certified, color additive.4. It is manufactured or held under insanitary conditions whereby it may have become

injurious to users or contaminated with filth.

A cosmetic may be deemed misbranded (Sec. 602) for reasons of:

1. False or misleading labeling.2. Failure to state prominently and conspicuously any information required by or under

authority of this act.3. Misleading container presentation or fill.

To determine whether cosmetic firms manufacture, hold or deliver for introduction into interstate commerce cosmetics that are adulterated or misbranded, and to prevent these and other practices violating Sec. 301 of the FD&C Act, the law gives the agency the authority to enter the establishments of such firms and inspect their facilities as well as all pertinent equipment, finished and unfinished materials, containers and labeling therein. See Sec. 704(a) of the FD&C Act.

Rigorous adherence to good manufacturing practice minimizes the risk of adulteration or misbranding of cosmetics. The following cosmetic establishment instructions, excerpted from FDA's Inspection Operations Manual, may serve as guidelines for effective self-inspection. A good inspection score means that an establishment follows good manufacturing practice.

Guidelines1. Building and Facilities. Check whethera. Buildings used in the manufacture or storage of cosmetics are of suitable size, design and

construction to permit unobstructed placement of equipment, orderly storage of materials, sanitary operation, and proper cleaning and maintenance.

b. Floors, walls and ceilings are constructed of smooth, easily cleanable surfaces and are kept clean and in good repair.

c. Fixtures, ducts and pipes are installed in such a manner that drip or condensate does not contaminate cosmetic materials, utensils, cosmetic contact surfaces of equipment, or finished products in bulk.

d. Lighting and ventilation are sufficient for the intended operation and comfort of personnel.

e. Water supply, washing and toilet facilities, floor drainage and sewage system are adequate for sanitary operation and cleaning of facilities, equipment and utensils, as well as to satisfy employee needs and facilitate personal cleanliness.

2. Equipment. Check whether:a. Equipment and utensils used in processing, holding, transferring and filling are of

appropriate design, material and workmanship to prevent corrosion, buildup of material, or adulteration with lubricants, dirt or sanitizing agent.

b. Utensils, transfer piping and cosmetic contact surfaces of equipment are well-maintained and clean and are sanitized at appropriate intervals.

c. Cleaned and sanitized portable equipment and utensils are stored and located, and cosmetic contact surfaces of equipment are covered, in a manner that protects them from splash, dust or other contamination.

3. Personnel. Check whether:a. The personnel supervising or performing the manufacture or control of cosmetics has the

education, training and/or experience to perform the assigned functions.b. Persons coming into direct contact with cosmetic materials, finished products in bulk or

cosmetic contact surfaces, to the extent necessary to prevent adulteration of cosmetic products, wear appropriate outer garments, gloves, hair restraints etc., and maintain adequate personal cleanliness.

c. Consumption of food or drink, or use of tobacco is restricted to appropriately designated areas.

4. Raw Materials. Check whether:a. Raw materials and primary packaging materials are stored and handled in a manner which

prevents their mix-up, contamination with microorganisms or other chemicals, or decomposition from exposure to excessive heat, cold, sunlight or moisture.

b. Containers of materials are closed, and bagged or boxed materials are stored off the floor.c. Containers of materials are labeled with respect to identity, lot identification and control

status.d. Materials are sampled and tested or examined in conformance with procedures assuring the

absence of contamination with filth, microorganisms or other extraneous substances to the extent necessary to prevent adulteration of finished products. Pay particular attention to materials of animal or vegetable origin and those used in the manufacture of cosmetics by cold processing methods with respect to contamination with filth or microorganisms.

e. Materials not meeting acceptance specifications are properly identified and controlled to prevent their use in cosmetics.

5. Production. Check whether manufacturing and control have been established and written instructions, i.e., formulations, processing, transfer and filling instructions, in-process control methods etc., are being maintained. Determine whether such procedures require that:

a. The equipment for processing, transfer and filling the utensils, and the containers for holding raw and bulk materials are clean, in good repair and in sanitary condition.

b. Only approved materials are used.c. Samples are taken, as appropriate, during and/or after processing, transfer or filling for

testing for adequacy of mixing or other forms of processing, absence of hazardous microorganisms or chemical contaminants, and compliance with any other acceptance specification.

d. Weighing and measuring of raw materials is checked by a second person, and containers holding the materials are properly identified.

e. Major equipment, transfer lines, containers and tanks are used for processing, filling or holding cosmetics are identified to indicate contents, batch designation, control status and other pertinent information.

f. Labels are examined for identity before labeling operations to avoid mix-up.g. The equipment for processing, holding, transferring and filling of batch is labeled regarding

identity, batch identification and control status.h. Packages of finished products bear permanent code marks.i. Returned cosmetics are examined for deterioration or contamination.6. Laboratory Controls. Check whether:a. Raw materials, in-process samples and finished products are tested or examined to verify

their identity and determine their compliance with specifications for physical and chemical properties, microbial contamination, and hazardous or other unwanted chemical contaminants.

b. Reserve samples of approved lots or batches of raw materials and finished products are retained for the specified time period, are stored under conditions that protect them from contamination or deterioration, and are retested for continued compliance with established acceptance specifications.

c. The water supply, particularly the water used as a cosmetic ingredient, is tested regularly for conformance with chemical-analytical and microbiological specifications.

d. Fresh as well as retained samples of finished products are tested for adequacy of preservation against microbial contamination which may occur user reasonably foreseeable condition of storage and consumer use.

7. Records. Check whether control records are maintained of:a. Raw materials and primary packaging materials, documenting disposition of rejected

materials.b. Manufacturing of batches, documenting the:

i. Kinds, lots and quantities of material used.ii. Processing, handling, transferring, holding and filling.

iii. Sampling, controlling, adjusting and reworking.iv. Code marks of batches and finished products.

c. Finished products, documenting sampling, individual laboratory controls, test results and control status.

d. Distribution, documenting initial interstate shipment, code marks and consignees.8. Labeling. Check whether the labels of the immediate and outer container bear:a. On the principal display panel:

i. In addition to the name of the product, the statements of identity and net contents,ii. The statement "Warning--The safety of this product has not been determined" if the safety

of the respective product has not adequately been substantiated. Determine whether and what toxicological and/or other testing the firm has conducted to substantiate the safety of its products. See 21 CFR 740.10.

b. On the information panel:i. The name and address of the firm manufacturing the product or introducing it into

interstate commerce.ii. the list of ingredients (only on outer container) if intended for sale or customarily sold to

consumers for consumption at home.

iii. The warning statement(s) required at 21 CFR 740.11, 740.12 and 740.17.iv. Any other warning statement necessary or appropriate to prevent a health hazard.

Determine the health hazard or their basis for a warning statement.v. Any direction for safe use of product.

vi. In case of a hair dye product, the caution statement of Sec. 601(a) of the Act and appropriate directions for preliminary patch testing. This warning only applies to coal-tar hair dyes which, if so labeled, are then exempted from the adulteration provision of the Act.

9. Complaints. Check whether the firm maintains a consumer complaint file and determine:a. The kind and severity of each reported injury and the body part involved.b. The product associated with each injury, including the manufacturer and code number.c. The medical treatment involved, if any, including the name of the attending physician..d. The name(s) and location(s) of any poison control center, government agency, physician's

group etc., to whom formula information and/or toxicity data are provided.10. Other. Check whether the firm is:a. Participating in the program of voluntary registration of:

i. Cosmetic manufacturing establishments (21 CFR 710).ii. Cosmetic product ingredient and cosmetic raw material composition statements (21 CFR

720).b. Using a color additive which is not listed for use in cosmetics (21 CFR 73, 74, and 82) or

which is not certified (21 CFR 80).c. Using a prohibited cosmetic ingredient (21 CFR 700).

What is GMP?

Good manufacturing practice (GMP) is a system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product. The main risks are: unexpected contamination of products, causing damage to health or even death; incorrect labels on containers, which could mean that patients receive the wrong medicine; insufficient or too much active ingredient, resulting in ineffective treatment or adverse effects. GMP covers all aspects of production; from the starting materials, premises and equipment to the training and personal hygiene of staff. Detailed, written procedures are essential for each process that could affect the quality of the finished product. There must be systems to provide documented proof that correct procedures are consistently followed at each step in the manufacturing process - every time a product is made. WHO has established detailed guidelines for good manufacturing practice. Many countries have formulated their own requirements for GMP based on WHO GMP. Others have harmonized their requirements, for example in the Association of South-East Asian Nations (ASEAN), in the European Union and through the Pharmaceutical Inspection Convention.Is GMP necessary if there is a quality control laboratory?

Yes. Good quality must be built in during the manufacturing process; it cannot be tested into the product afterwards. GMP prevents errors that cannot be eliminated through quality control of the finished product. Without GMP it is impossible to be sure that every unit of a medicine is of the same quality as the units of medicine tested in the laboratory.

Can manufacturers afford to implement GMP?

Yes. Making poor quality products does not save money. In the long run, it is more expensive finding mistakes after they have been made than preventing them in the first place. GMP is designed to ensure that mistakes do not occur. Implementation of GMP is an investment in good quality medicines. This will improve the health of the individual patient and the community, as well as benefiting the pharmaceutical industry and health professionals. Making and distributing poor quality medicines leads to loss of credibility for everyone: both public and private health care and the manufacturer.WHO works to strengthen GMP

WHO GMP guidelines are available online. If you require more information, please contact the WHO representative in your country, your WHO regional office or WHO headquarters in Geneva.A GMP is a system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product.GMP covers all aspects of production from the starting materials, premises and equipment to the training and personal hygiene of staff. Detailed, written procedures are essential for each process that could affect the quality of the finished product. There must be systems to provide documented proof that correct procedures are consistently followed at each step in the manufacturing process - every time a product is made.

- See more at: http://www.ispe.org/gmp-resources#sthash.e6o2NXQ1.dpufGood manufacturing practices (GMP) refer to guidelines laid down by agencies which control authorization and licensing for manufacture and sale of food, drug products , and active pharmaceutical products. These guidelines are laid down with the intention of providing minimum requirements that a pharmaceutical or a food product manufacturer must meet while manufacturing drugs or food products ,which then assures that the products manufactured/produced are of high quality and do not pose any risk to the consumer or public. Good manufacturing practice guidelines provides guidance for manufacturing, testing, and quality assurance in order to ensure that drug product is safe for human consumption. Many countries have legislated that pharmaceutical and medical device manufacturer must follow GMP procedures, and have created their own GMP guidelines that correspond with their legislation. Basic concepts of all of these guidelines remain more or less similar to the ultimate goals of safeguarding the health of patient as well as producing good quality medicine, medical devices or active pharmaceutical products. In the U.S.A a drug may be deemed adulterated even though it has passed all of the specifications tests and it is found to be manufactured in a facility or condition which violates or do not comply with current good manufacturing guideline. Therefore complying with GMP is a mandatory aspect in pharmaceutical manufacturing.

Although there are a number of them, all guidelines follow a few basic principles:

Hygiene: Pharmaceutical manufacturing facility must maintain a clean and hygienic manufacturing area.

Controlled environmental conditions in order to prevent cross contamination of drug product from other drug or extraneous particulate matter which may render the drug product unsafe for human consumption.

Manufacturing processes are clearly defined and controlled. All critical processes are validated to ensure consistency and compliance with specifications.

Manufacturing processes are controlled, and any changes to the process are evaluated. Changes that have an impact on the quality of the drug are validated as necessary.

Instructions and procedures are written in clear and unambiguous language. (Good Documentation Practices)

Operators are trained to carry out and document procedures. Records are made, manually or by instruments, during manufacture that demonstrate

that all the steps required by the defined procedures and instructions were in fact taken and that the quantity and quality of the drug was as expected. Deviations are investigated and documented.

Records of manufacture (including distribution) that enable the complete history of a batch to be traced are retained in a comprehensible and accessible form.

The distribution of the drugs minimizes any risk to their quality. A system is available for recalling any batch of drug from sale or supply. Complaints about marketed drugs are examined, the causes of quality defects are

investigated, and appropriate measures are taken with respect to the defective drugs and to prevent recurrence.

GMP guidelines are not prescriptive instructions on how to manufacture products. They are a series of general principles that must be observed during manufacturing. When a company is setting up its quality program and manufacturing process, there may be many ways it can fulfill GMP requirements. It is the company's responsibility to determine the most effective and efficient quality process.

GMPs are enforced in the United States by the U.S. Food and Drug Administration (FDA), under Section 501(B) of the 1938 Food, Drug, and Cosmetic Act (21 USCS § 351). The regulations use the phrase "current good manufacturing practices" (cGMP) to describe these guidelines. Courts may theoretically hold that a drug product is adulterated even if there is no specific regulatory requirement that was violated as long as the process was not performed according to industry standards.[citation needed] Since June 2010, a different set of cGMP requirements have applied to all manufacturers of dietary supplements.[1]

The World Health Organization (WHO) version of GMP is used by pharmaceutical regulators and the pharmaceutical industry in over one hundred countries worldwide, primarily in the developing world. The European Union's GMP (EU-GMP) enforces similar requirements to WHO GMP, as does the FDA's version in the US. Similar GMPs are used in other countries, with Australia,Canada, Japan, Singapore, Philippines and others having highly developed/sophisticated GMP requirements. In the United Kingdom, the Medicines Act (1968) covers most aspects of GMP in what is commonly referred to as "The Orange Guide", which is named so because of the color of its cover; it is officially known as Rules and Guidance for Pharmaceutical Manufacturers and Distributors.[2]

Since the 1999 publication of GMPs for Active Pharmaceutical Ingredients, by the International Conference on Harmonization (ICH), GMPs now apply in those countries and trade groupings that are signatories to ICH (the EU, Japan and the U.S.), and applies in other countries (e.g., Australia, Canada, Singapore) which adopt ICH guidelines for the manufacture and testing of active raw materials.

Enforcement[edit]

Within the European Union, GMP inspections are performed by National Regulatory Agencies (e.g., GMP inspections are performed in the United Kingdom by the Medicines and Healthcare products Regulatory Agency (MHRA)); in the Republic of Korea (South Korea) by the Korea Food & Drug Administration (KFDA); in Australia by the Therapeutical Goods Administration (TGA); in Bangladesh by the Drug Administration (DGDA); in South Africa by the Medicines Control Council (MCC); in Brazil by the Agência Nacional de Vigilância Sanitária (National Health Surveillance Agency Brazil) (ANVISA); in Iran, in India gmp inspections are carried out by state FDA and these FDA report to Central Drugs Standard Control Organization [3] and Pakistan by the Ministry of Health;,[4] Nigeria has NAFDAC and by similar national organisations worldwide. Each of the inspectorates carry out routine GMP inspections to ensure that drug products are produced safely and correctly; additionally, many countries perform pre-approval inspections (PAI) for GMP compliance prior to the approval of a new drug for marketing.

Regulatory agencies (including the FDA in the U.S. and regulatory agencies in many European nations) are authorized to conduct unannounced inspections, though some are scheduled. FDA routine domestic inspections are usually unannounced, but must be conducted according to 704(A) of the FD&C Act (21 USCS § 374), which requires that they are performed at a "reasonable time". Courts have held that any time the firm is open for business is a reasonable time for an inspection.

Other good practices[edit]

Other good-practice systems, along the same lines as GMP, exist:

Good laboratory practice (GLP), for laboratories conducting non-clinical studies (toxicology and pharmacology studies in animals);

Good clinical practice (GCP), for hospitals and clinicians conducting clinical studies on new drugs in humans;

Good regulatory practice (GRP), for the management of regulatory commitments, procedures and documentation.

Good Distribution Practice (GDP) deals with the guidelines for the proper distribution of medicinal products for human use

Good Transportation Practice (GTP) deals with the guidelines for the proper domestic and international transportation of medicinal products for human use

Collectively, these and other good-practice requirements are referred to as "GxP" requirements, all of which follow similar philosophies. (Other examples include good agriculture practices, good guidance practices, and good tissue practices.) In the U.S., medical device manufacturers must follow what are called "quality system regulations" which are deliberately harmonized with ISOrequirements, not cGMPs