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Certification Schemes and Marks: a New Mandate for Quality Assurance of Food and Drugs

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Certification Schemes and Marks: a New Mandate for Quality Assurance of Food and Drugs Available online on www.ijpqa.com International Journal of Pharmaceutical Quality Assurance 2013; 4(4); 67-73 ISSN 0975 9506 Research Article Certification Schemes and Marks: A New Mandate for Quality Assurance of Food and Drugs Basatiya Bakul, *Nanda Sanju Department of Pharmaceutical Sciences, Maharshi Dayanand University, Rohtak, Haryana (India)-124001 Available online: 1st October, 2013 ABSTRACT Quality products are the demand of the day and the consumers have become more aware about their health and health related products. To develop a high degree of confidence about the safety and efficacy of medicines and food, specially packaged or processed food available in the market, various certifying agencies are involved. They issue quality “certificates”, “marks”, “logos” or “symbols” to the product after evaluating certain quality parameters developed and validated by them. Presently, one can see many certification schemes existing for drugs like “Product Certification Scheme” by Bureau of Indian Standards (BIS), “Good Manufacturing Practices (GMP) Certification Scheme” by World Health Organization (WHO), “Premium Mark” and “Standard Mark” by Department of Ayurveda, Yoga and Naturopathy, Unani, Sidha and Homeopathy, and “Fruits Product Order (FPO) Mark” and “Organic certifications” for food products. This paper shall discuss various certification schemes and marks for food and drugs across the globe and their role in assuring quality. Key words: Organic certification, Halal, Standard Mark, Premium Mark INTRODUCTION the product in the same country or State, for example, In the present times, the demand for safe, effective and ‘Natural’ and ‘Organic’ certification of the product is quality products is on the rise, especially with the increase mandatory if the label claims the term organic. in consumer awareness. The customer is the king today and Voluntary Certification: This certificate is issued by the expects full return for his money. Like consumers, certifying body /bodies at the request of either the vendor manufacturers are also now very particular in providing a or manufacturer or the customer of the goods. This is not a quality product which is safe and effective so as to gain the legal requirement for a particular country or state but it confidence of the customer. Therefore, quality is a matter takes place on voluntary basis for suitability to those of concern for both the manufacturers as well as the standards that are declared by the manufacturer or supplier consumers in the present competitive market. The quality of the product, for example, certification of AYUSH of the product is ensured by its quality assurance which is products is a type of voluntary certification [5]. a mandate and can be defined as a process or procedure There exist numerous certification bodies which are encompassing systemic evaluation and monitoring of authorized to issue ‘certificates’ and ‘marks’ after the different aspects [1]. This act also leads to ensure that the process of evaluation is completed and they are assured of product is being developed in compliance with the the quality. Certification schemes for Drugs as well as specified quality standards [2]. Quality of a product can be Food products are being discussed below. assured by different frameworks which include Certification Schemes for Drugs: As per The Drugs and determination of adequate technical requirements, quality Cosmetics Act 1940, Rules 1945, Drugs can be defined as audits of the products and certifications [3]. Certification (i) all medicines for internal or external use of human is the process to assure that a specified quality or standard beings or animals and all substances intended to be used has been achieved. It is an evaluation and recognition for or in the diagnosis, treatment, mitigation or prevention process of a product meeting a set of requirements or of any disease or disorder in human beings or animals, criteria (standards) already established by the concerned including preparations applied on human body for the authority [4]. Certifications not only act as a confidence purpose of repelling insects like mosquitoes; building measure to the consumers but also help in (ii) such substances (other than food) intended to affect the contributing towards social responsibility and environment structure or any function of human body or intended to be sustainability. They can be used as an effective tool for the used for the destruction of (vermin) or insects which cause marketing of the product too. Certifications can be broadly disease in human beings or animals, as may be specified classified as either mandatory or voluntary certification. from time to time by the Central Government by Mandatory Certification: This certification is required by notification in the Official Gazette the law of the country or State for manufacture or sale of *Author for correspondence: E-mail:[email protected] Basatiya Bakul, Nanda Sanju / Certification Schemes and… Table 1: Organic Certifications for Food S. No. Name Logo Country 1 USDA NOP US 2 Canada Organic Logo Canada 3 Organic Logo EU 4 NASAA Australia 5 India Organic India Table 2: Mandatory Certifications for Food Products in India S. No. Name Logo Country 1 FPO mark India 2 AGMARK India 3 Vegetarian and India Non-Vegetarian Mark 68 Page IJPQA, Vol4, Issue4, October-December, 2013, 67-73 Basatiya Bakul, Nanda Sanju / Certification Schemes and… (iii) all substances intended for use as components of a reliability of products to the ultimate customer. Presence drug including empty gelatin capsules; and of ISI certification mark known as Standard Mark on a (iv) such devices intended for internal or external use in product is an assurance of conformity to the specifications. the diagnosis, treatment, mitigation or prevention of The conformity is ensured by regular surveillance of the disease or disorder in human beings or animals, as may be licensee's performance by surprise inspections and testing specified from time to time by the Central Government by of samples, drawn both from the market and factory [9]. notification in the Official Gazette, after consultation with World Health Organization (Who) Certification Scheme the Board. for the Quality of Pharmaceuticals Moving in International Though the quality of drugs is governed by Commerce pharmacopoeial standards, still there are some more For the assurance about the status and quality of agencies, which can help in assuring the quality of drug pharmaceutical products, requirements for “Good products in addition to the official requirements. Their role Practices in Manufacture and quality control of drugs is being accepted by one and all because a pragmatic shift (GMP)” and “WHO Certification Scheme on the Quality is seen towards the demand of quality products and of Pharmaceutical Products Moving in International consumers are very peculiar about their safety and Commerce” were adopted by World Health Assembly in efficacy. Various certification schemes which are available 1969, in resolution WHA 22.50 [8]. Under the provisions to ensure the same are as follows: of this Scheme, three types of certificates can be requested: International Organization for Standardization (ISO) Certificate of Pharmaceutical Product (Product Certificate) Quality Management System which is a confidential document and is issued by the There are various set of standards published by exporting country only with the permission of International Organization for Standardization viz., ISO applicant/product license holder. 9000 series, ISO 9001 series, ISO 9004 series for the Statement of Licensing Status of Pharmaceutical Product quality assurance. ISO 9001:2008 sets out the criteria for which assures that a license has been granted for the Quality Management system and is the only standard in the product for use in exporting country. ISO 9000-Quality Management family that can be certified Batch Certificate which is issued by the manufacturer of to. It has been in place for over a decade and is used by the drug product. In case of some biological products, it is companies as a method of controlling their quality [6]. issued by the competent authority of the exporting country Management System Certification –Bureau of Indian [10]. Standards (BIS) Good Manufacturing Practices (GMP) Certification Bureau of Indian Standards also provides certification The Good Manufacturing Practice (GMP) is a system that against IS/ISO 9001:2008 under its Management Systems assures quality by ensuring that the product is being Certification activity. BIS is the National Standards Body manufactured according to the quality standards. The first of India and represents India in ISO. It also provides International Standards for GMP were developed by the certification against IS/ISO 9001:2000 under its World Health Organization (WHO) during 1967-69. In Management Systems Certification activity. The scheme India, statutory status was given to GMP in 1988 and was was launched in 1991 covering a wide range of industry as incorporated as Schedule ‘M’ under Drugs and Cosmetics well as service sectors including food and pharmaceuticals Rules 1945 but implemented only in 2005 [11]. [7]. WHO GMP covers all aspects of production; from the Product Certification Scheme: This Scheme of BIS aims at starting materials, premises and equipment to the training providing Third Party Guarantee of quality, safety and and personal hygiene of staff. Many countries have Table 3: AYUSH Logos under Voluntary Certification Scheme for AYUSH
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