ABSTRACT:

Good manufacturing practices (GMP) are part of the quality assurance that ensures products are in place it is produced consistently and regulated to the right quality levels for their intended use and as required for sales authorization. The GMP guidelines provide a number of requirements a pharmaceutical manufacturer or food product manufacturer must meet to ensure that the products are of high quality and does not endanger the consumer or the public.

Keywords: Good Manufacturing Practice, GMP, Pharmaceutical Inspection

Introduction

The name GMP was coined to rule manufacturing and packaging operations in pharmaceutical industry. The medicine Inspector of the Department of Health and Social Security of England, in consultation with other interested organizations compiled a guide to GMP is also known as the Orange Guide. First The draft plan was published in the year 1971, drug dealing under The Medicines Act. It was a simple volume Twenty pages, and it also received a third appearance 1972, with the addition of two-page supplement medicinal herbal products. Its color cover, known as the Orange Guide. The second edition (52 pages, including five appendices) was published in 1977. The third plan (110 pages, five appendices) was published in the year 1983 [1].

Medicines and Health Products the Regulatory Agency (MHRA) has published a new one the Orange Guide program in 2007. United Country, the first GMP rules were issued at 1963 also outlined the GMP to be followed manufacture, packaging, and storage used pharmaceutical products. GMP the regulations were developed by the US FDA and issued United States CFR Chapter 21 at 1978. Regulation was similar in the sense that Orange guide, but it works legally and the UK guide is advisor. US the congress passed the Federal Ani-tempering Act in 1983, making it a criminal offense integrated consumer product [2]. In 1980, the US FDA began publishing a series of guide texts with great effect in our definition of current GMP (cGMP). A “A Guide to Computer Software Testing in Drug Processing” published in 1983 n “A Guide to General Procedures for Process Authentication” was published in 1987. March 1997, The USFDA has issued CFR Part 11 that has been effective and the use of electronic records and signatures. In 2000, the US FDA introduced a guidance document on the incorporation of risk management into device development [3].


Guideline

Many countries have enacted such legislation pharmaceutical and pharmaceutical companies make their own GMP guidelines complies with their rules. Basic concepts GMP guidelines for protection patient life and good productivity standard medicine, medical or functional devices pharmaceutical products [4]. Editing of The GMP began in the 1960's with its consequences more than 100 countries from Afghanistan to Zimbabwe. Examples of these include next.

a. Pharmaceutical Inspection Convention (PIC):

 Guide to GMP for medicines products — Australia, Austria, Belgium, Canada, Italy, Latvia, Liechtenstein, Denmark, Finland, France, Hungary, Ireland, Malaysia, The Netherlands, Norway, Poland, Portugal, Romania, Singapore, Slovak Republic, Spain, Sweden, Switzerland, and the United Kingdom.

b. Association of Southeast Asian Nations (ASEAN):

General guidelines Brunei, Darussalam, Indonesia, Lao PDR, Malaysia, Cambodia, Myanmar, Philippines, Singapore, Thailand, and Vietnam.

c. European Economic Community (EEC):

A guide to GMP for medical products Austria, Belgium, Denmark, Ireland, Italy, Luxembourg, Netherlands, Finland, France, Germany, Greece, Portugal, Spain, Sweden, and United State. In general, GMP has issued guidelines for achieving consistent product quality, with one interpretation and difference of being accepted. GMP compulsory in the US is US FDA, under Section 501 (B) of 1938 Food, Drugs, and Cosmetic Act (21 USCS § 351).The regulations use the phrase “good now production practices ”(cGMP) too describes the guidelines [5].World Health Organization (WHO) of GMP is used by pharmaceutical regulators and the pharmaceutical industry more than one 100 countries around the world, especially in the developing countries including a country like Nepal. European Union's GMP (EU-GMP) Enforcement Same requirements for WHO GMP, as it does Food and Drug Administration US Similar GMPs are used in other countries, and Australia, Japan, Canada, Singapore and others are very old / professional GMP Requirements. In the United Kingdom, The Medicines Act (1968) covers many aspects of The GPP is called “The Orange Guide ", officially known as the Rules and Directory of Pharmaceutical Manufacturers With distributors [6]

The GMP test was done in United State of Medicine and Healthcare Product Control Agency (MHRA); to Republic of Korea (South Korea) is Korea Food and Drug Administration (KFDA); Australia by the Therapeutically Goods Administration (TGA); In South Africa by Medicines Control Council (MCC); in Brazil by Agencia Nacional de Vigilancia Sanitaria (National Health Brazil Land Survey Agency (ANVISA). India GMP assays are done with state food and the Drug Administration (FDA) and these FDA report to Central Drug Standard Control Organization: Nepal, GMP survey It is done by the Department of Drugs Administration (DDA) and Pakistan Department of Health. Nigeria has a National Agency Food and Drug Administration and Control (NAFDAC) [7].


COMPONENTS OF GMP

GMP needs that process to be done fully explained before the start and everything necessary facilities are provided. She works, employees must be adequately trained, they should the equipment and equipment used, is correct materials used, approved procedures adopted, appropriate storage space and transportation available, and relevant records have been made [8]. The essential elements of GMP are summarized In Figure 1.

Indian M GMP schedule and requirements for buildings, plants and medical equipment products. Part I covers general requirements, Warehousing area, manufacturing area, Quality control Location, Personnel, Ancillary Area, Health, Clothing and Sanitation, Manufacturing Jobs and controls, Sanitation, Non-functional materials, Resources, Documents an Records, labels and other printed materials, Quality Assurance, Self-Inspection and Quality Inspection, Quality control system, precision, Master formula records, packing records, Batch parking records, Batch performance records, standard operating procedures (SOPs) and records, Support samples, Recovery, distribution records, Validation and process validation, the product recalls, Complaints and poor response to Site-master file. Part A to part I-E is specifically mentioned Requirements for the production of different products and the specifications of Part F in that regard Requirements for the properties, plants and materials of active pharmaceutical ingredients (many drugs). Part II outlines the need for the Department of Plants and the provision of different dosages [4].


QUALITY MANAGEMENT

Owner of production authorization must make medicinal products in order to make sure they are ready for their intended use, compliance with marketing requirements authorization and don't put patients at risk due to insufficient safety, quality or efficiency. The attainment of this quality purpose the responsibility of senior management and it requires participation and commitment staff in many different departments and levels within the company, is the company suppliers and distributors [9]. In the major, pharmaceutical industry management is often described as a feature of decisive administrative work implements “quality policy”, e.g. Purpose and direction of the organization about quality, as it is officially revealed too authorized by senior management [10].


QUALITY ASSURANCE (QA)

QA is a multidimensional, all-encompassing concept stories, individually or collectively influence product quality. It's a sum a total of systematic arrangements has been made the purpose of ensuring that in a pharmacy product are of the required quality intended use. Therefore, QA incorporates GMP and other factors such as product design and development [11].QA program relevant the production of pharmaceutical products should make sure:

    Pharmaceutical products are also designed developed in a manner that causes GMP and other requirements codes like these works well in the laboratory (GLP) and good clinical practice (GCP).

 Production and control functions are clear expressed in written form and GMP requirements are accepted.

       Arrangements were made, rendering and use of proper origin and inputs.

       All necessary controls for the first items, medium products, and many products other practical tools for controlling, calculating, and validation is performed.

 The finished product has been thoroughly processed and examined, subject to specifications processes, pharmaceutical products do not sold or given before authorized people verified that each batch of production has it produced and managed in accordance and marketing needs authorization and other laws suitable for production, control and rescue pharmaceutical products.

 There are satisfactory arrangements for certification, as far as possible, that of medicine products are stored by the manufacturer, was distributed, and followed to quality is maintained throughout their lifetime;

       The deviation is said to be investigated engraved.

       Regular evaluation of the quality of pharmaceutical products should be manufactured

    for the purpose of ensuring consistency process and to ensure its continuity improved.


GOOD MANUFACTURING PRACTICE (GMP) FOR PHARMA COMPANY

GMP is part of the QA that ensures that products are produced consistently and regulated by appropriate quality standards in their intended use and as required by authorization for the sale or product for clarification. GMP is intended reducing the risk of any pharmaceutical production [12].

The basic requirements of GMP are:

a.     All production processes are clear described, systematically reviewed in the light of experience, and shown to be capable constantly producing a drug required quality products that comply with their details.

b.     Eligibility and validation are performed.

c.      All necessary resources are provided.

d.     Instructions and procedures are listed in clear and unambiguous language, precisely applies to the facilities provided.

e.      Online operators are trained to perform procedures rightly.

f.       Records generated during the production process indicate that all necessary steps are described procedures and instructions actually be it is taken that the value and quality of the product is expected; whichever is more important deviations are completely recorded and investigated.

g.     Records production and distribution,  let the complete batch history be followed, kept to be understood again accessible form.

h.     Proper storage and distribution of products reduce any risk to their quality.

i.       The system is available to remember any batch  product for sale or for distribution.

j.       Complaints about products sold evaluate the causes of quality damage investigated, and appropriate action taken in relation to products with defects to prevent multiplication [13].


QUALITY CONTROL (QC)

QC is part of the GMP concerned samples, specifications and tests, and organization, documentation and release procedures that ensure the necessary and proper tests are also performed that materials are not released for use, either products released for sale or supply, until owned the quality is judged to be satisfactory. QC is he did not end up working in the lab, but he would agree participates in many related decisions product quality. QC establishes, validates and implementing all QC processes, evaluating, maintain, and maintain reference levels of items, to confirm the correct label for containers of materials and products, to be sure that the durability of the active pharmacy Ingredients (APIs) and products are employed, so that participates in the investigation of complaint related to product quality, and that participates in environmental monitoring [14].


SANITATION AND HYGIENE

The higher level of sanitation and hygiene there should be It is done in all aspects of the process pharmaceutical products. Width range too good hygiene includes workers, buildings, equipment machinery, equipment and containers, cleaning products and to kill germs, and whatever it might be source of product contamination. Potential sources of contamination should be eliminated through the combination A comprehensive sewage system and hygiene [15].

Places, locations, and tools inside and out. made products should be kept clean. Dirt, as well as germs that cannot keep it, should do not opt-in or access products. Vaccines can be no pollution will work. Dirt (especially oily or fat saturated films and protein-like matter) are also Protect microorganisms from the activities of it kills germs. So, before the virus is killed, of course It is important to first clean the areas. Where the whole dump rates are available, it may be it is necessary to first remove most of it exclamation point. Then the area can be cleaned by use of cleaning agent, followed rinsing [16].


QUALIFICATION AND VALIDATION

Qualification is the act of providing for any buildings, systems and equipment work properly and actually lead to your expectations results. Validation is defined as inventory of documentary evidence giving the highest the degree of confidence that a formal process will be acts consistently in accordance with the intended purpose specified results. Validation courses are a must strengthen GMP and be done in compliance and procedures described. Results and the conclusions should be in writing. When something is new production formula or method of Preparation is accepted, action must be taken to demonstrate its suitability for the process processing [17].

Eligibility and validity should be established and provide proof of writing:

a.     Buildings, supporting aids, equipment and processes have been developed and built into subject to GMP requirements (Design qualification or DQ).

b.     Properties, supporting facilities and Built and installed appliances inside consistency in the specification of their composition (Grading or IQ).

c.  Properties, supporting facilities and machines operate in accordance with design details (Working title or OQ).

d.   A specific process will produce a Product assembly is decided in advance information and high-quality features (Procedure inforcement or PV, also called performance qualification or PQ).


COMPLAINTS AND PRODUCT RECALLS

QA and GMP are all about preventing mistakes. However, in this imperfect universe there is none something like a completely flawless system, too an important feature of any QA program is the system dealing with complaints, or error reports products, just in case. The need to be to cover this happening in all GMP notable directions. Complaints received from consumers, professionals and trades serve as the basis ways to get product feedback quality after distribution. Required, Therefore, that each complaint or inquiry be evaluated by experienced and responsible personnel employees [3].

Packaging, manufacturing records and distribution of drugs and stored samples provide a basis for assessing the validity of the fact and the seriousness of the alleged deviation led to a complaint. Complaint file itself also plays an important role in it to determine whether any of the same is true complaints received from that in between question, or any other similar product. Appeal checks are in effect several important purposes. First, there is an urgent need to verify the existence of consumers which can be at risk and start any appropriate action. The second value is the review of the product and its manufacturing process to find out if anything has changed is required. Third is the need for immediate response customer, thus trying to take care confidence in product and company [18].


CONCLUSION

The process of producing and testing that it helps to ensure a quality product that is built. Many countries have enacted that law companies should follow GMP procedures, too have developed their own GMP guidelines complies with their rules. Basic concepts of all directions are always more or less similar to the last objectives of protection patient life and good productivity Medicinal drugs. The purpose of quality can only be achieved carefully plan and execute QA carefully plan and effective implementation of GMP. Effective implementation of GMP requires extensive care and information about different parts of GMP that should be included the method of establishment of building design and product development to productivity.


REFERENCES

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17. 21CFR 211: 2011, PART 211; current good manufacturing practice for finished pharmaceuticals, title 21-food and drugs, chapter I-food and drug administration, Department of health and human services subchapter C-Drugs: General, [Code of  federal regulations, title 21, Volume 4, Revised as of April 1, 2011], 21.03.2012,accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRart=211& show FR=1.

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