A REVIEW ON GOOD MANUFACTURING PRACTICE (GMP) FOR MEDICINAL PRODUCTS

 

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ABOUT AUTHORS:
Vikash Kumar Chaudhari1*, Vijay Yadav2, Praveen Kumar Verma1, Amit Kumar Singh2
1Department of Pharmaceutical Chemistry,
2Department of Pharmacognosy,
Kunwar Haribansh Singh College of Pharmacy, Jaunpur, U.P.
*vikashk464@gmail.com

ABSTRACT
Good manufacturing practices (GMP) is a part of quality assurance which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing authorization. GMP guidelines provide minimum requirements for pharmaceutical or a food product manufacturer must meet to assure that the products are of high quality and do not pose any risk to the consumer or public.

REFERENCE ID: PHARMATUTOR-ART-2245

PharmaTutor (ISSN: 2347 - 7881)

Volume 2, Issue 9

Received On: 06/07/2014; Accepted On: 15/07/2014; Published On: 01/09/2014

How to cite this article: VK Chaudhari, V Yadav, PK Verma, AK Singh; A Review on Good Manufacturing Practice (GMP) for Medicinal Products; PharmaTutor; 2014; 2(9); 8-19

INTRODUCTION
The term GMP was introduced to regulate manufacturing and packaging operations in the pharmaceutical industry. The Medicine Inspector of the Department of Health and Social Security of England, in consultation with other interested bodies compiled the guide to GMP also known as the Orange Guide. The first edition of the guide was published in 1971, the manufacturing of drug carried out under the Medicines Act. It was a relatively light volume of 20 pages, and was reissue third impression in 1972, with the addition of a 2-page appendix on sterile medicinal products. The color of its cover, it known as the Orange Guide. The second edition (52 pages, including five appendices) was published in 1977. The third edition (110 pages, five appendices) was published in 1983[1].

The Medicines and Healthcare products Regulatory Agency (MHRA) has published new edition of the Orange Guide in 2007. In United States, the first GMP regulations were issued in 1963 and described the GMP to be followed in the manufacture, packaging, and storage of finished pharmaceutical products. GMP regulations were developed by the US FDA and issued the United States CFR Chapter 21 in 1978. The regulation was similar in concept to the Orange Guide, but enforceable by law whereas the UK guide as an advisory. US congress passed the Federal Ani-tempering Act in 1983, making it a crime to tamper with packaged consumer products [2].

In the 1980, US FDA began publishing series of guidance documents that have a major effect on our interpretation of current GMP (cGMP). A “Guide to Inspection of Computerized Systems in Drug Processing” was published in 1983 and “Guideline on General Principles of Process Validation” was published in 1987. March 1997, the US FDA issued 21 CFR Part 11 which dealt with the use of electronic records and signatures. In 2000, US FDA introduced a guidance document on the incorporation of risk management into device development [3].

GOOD MANUFACTURING PRACTICES (GMP) GUIDELINES
Many countries have legislated that pharmaceutical and medical device companies created their own GMP guidelines that correspond with their legislation. Basic concepts of GMP guidelines goal of safeguarding the health of the patient as well as producing good quality medicine, medical devices or active pharmaceutical products[4]. The formalization of GMP commenced in the 1960s and their effect in over 100 countries ranging from Afghanistan to Zimbabwe. Examples of these include the following.

a. Pharmaceutical Inspection Convention (PIC):- Guide to GMP for pharmaceutical 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 South-East Asia Nations (ASEAN):- General guidelines Brunei Darussalaam, Indonesia, Lao PDR, Malaysia,Cambodia, Myanmar, Philippines, Singapore, Thailand, and Vietnam.

c. European Economic Community (EEC):- Guide to GMP for medicinal products Austria, Belgium, Denmark, Ireland, Italy, Luxembourg, the Netherlands, Finland, France, Germany, Greece, Portugal, Spain, Sweden, and the United Kingdom.

In general, GMP has been issued guides to the achievement of consistent product quality, with interpretation and individual variations being accepted. GMP enforced in the United States by the US 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) and it describes the guidelines [5].

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 including country like Nepal. The European Union's GMP (EU-GMP) enforces similar requirements to WHO GMP, as does the Food and Drug Administration's version in the US. Similar GMPs are used in other countries, with Australia, Japan, Canada, Singapore and others having highly developed/sophisticated GMP requirements. In the United Kingdom, the Medicines Act (1968) covers most aspects of GMP commonly referred to as "The Orange Guide", which is officially known as Rules and Guidance for Pharmaceutical Manufacturers and Distributors [6].

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 Therapeutically Goods Administration (TGA); in South Africa by the Medicines Control Council (MCC); in Brazil by the Agencia Nacional de Vigilancia Sanitaria (National Health Surveillance Agency Brazil) (ANVISA). In India GMP inspections are carried out by state Food and Drug Administration (FDA) and these FDA report to Central Drugs Standard Control Organization: in Nepal, GMP inspections are carried out by the Department of Drug Administration (DDA) and in Pakistan by the Ministry of Health. Nigeria has National Agency for Food and Drug Administration and Control (NAFDAC) [7].

COMPONENTS OF GMP
GMP requires that the manufacturing process is fully defined before being initiated and all the necessary facilities are provided. In practice, personnel must be adequately trained, suitable premises and equipment used, correct materials used, approved procedures adopted, suitable storage and transport facilities available, and appropriate records made[8]. The essential components of GMP are summarized in Figure 1.

Fig.1. Components of Good Manufacturing Practice

Indian schedule M for GMP and requirements of premises, plant and equipment for pharmaceutical products. Part I includes general requirements, Warehousing area, Production area, Quality control area, Personnel, Ancillary area, Health, clothing and sanitation of workers, Manufacturing operations and controls, Sanitation in the manufacturing premises, Raw materials, Equipment, Documentation and Records, Labels and other printed materials, Quality assurance, Self inspection and quality audit, Quality control system, Specification, Master formula records, Packing records, Batch packaging records, Batch processing records, Standard operating procedures (SOPs) and records, Reference samples, Reprocessing and recoveries, Distribution records, Validation and process validation, Product recalls, Complaints and adverse reactions and Site-master file. Part I-A to part I-E mentions about the specific requirements for manufacture of different products and Part I-F mentions about the specific requirements of premises, plant and materials for manufacture of active pharmaceutical ingredients (bulk drugs). Part II describes the Requirement of plant and equipments for various dosage forms [4].

Fig. 2. Consolidated Components of Good Manufacturing Practices

QUALITY MANAGEMENT
The holder of a manufacturing authorization must manufacture medicinal products so as to ensure that they are fit for their intended use, comply with the requirements of the marketing authorization and do not place patients at risk due to inadequate safety, quality or efficacy. The attainment of this quality objective is the responsibility of senior management and requires the participation and commitment by staff in many different departments and at all levels within the company, by the company’s suppliers and by the distributors [9].

In the pharmaceutical industry at large, quality management is usually defined as the aspect of management function that determines and implements the “quality policy”, i.e. the overall intention and direction of an organization regarding quality, as formally expressed and authorized by top management[10].

QUALITY ASSURANCE (QA)
QA is a wide ranging concept, which covers all matters, which individually or collectively influence the quality of a product. It is the sum total of the organized arrangements made with the objective of ensuring that pharmaceutical products are of the quality required for their intended use. QA, therefore, incorporates GMP and other factors such as product design and development [11].

The system of QA appropriate for the manufacture of pharmaceutical products should ensure that:
a.
Pharmaceutical products are designed and developed in a way that takes account of the requirements of GMP and other associated codes such as those of good laboratory practice (GLP) and good clinical practice (GCP).
b.
Production and control operations are clearly specified in a written form and GMP requirements are adopted.
c.
Arrangements are made for the manufacture, supply and use of the correct starting and packaging materials.
d.
All necessary controls on starting materials, intermediate products, and bulk products and other in-process controls, calibrations, and validations are carried out.
e.
The finished product is correctly processed and checked, according to the defined procedures, pharmaceutical products are not sold or supplied before the authorized persons have certified that each production batch has been produced and controlled in accordance with the requirements of the marketing authorization and any other regulations relevant to the production, control and release of pharmaceutical products.
f.
Satisfactory arrangements exist to ensure, as far as possible, that the pharmaceutical products are stored by the manufacturer, distributed, and subsequently handled so that quality is maintained throughout their shelf-life;
g.
Deviations are reported, investigated and recorded.
h.
Regular evaluations of the quality of pharmaceutical products should be conducted with the objective of verifying the consistency of the process and ensuring its continuous improvement.

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