Biosafety guidelines and regulations for GMOs, GLP and GMP

Biosafety guidelines and regulations for GMOs, GLP and GMP

Biosafety guidelines and regulations for GMOs, GLP and GMP

Introduction

  • BIOSAFETY” refers to the efforts that ensure safety in using, transporting, transferring, handling, releasing and disposing of biological organism including genetically modified organism which are capable of harming human, animals, plants or environment.
  • It also refers to the policies and procedures adapted to ensure the environmentally safe application of biological agents.
  • Genetically modified organism defined as an organism whose hereditary traits have been modified by human intervention using any method that results in the introduction, rearrangement or removal of genetic material from the genome of an organism.
  • The Biosafety Guidelines are developed to contribute to ensuring an adequate level of protection in the fields of safe transfer, handling and use of living modified organisms resulting from modern biotechnology that may have adverse effects on the conservation and sustainable use of biological diversity, and to reduce risks to human health.

Guidelines for genetically modified plants for field test

  • For experimental plants, considered to have a history of safe use in field work as follows:
    1. Modified plants that result from conventional breeding practices (e.g. selective breeding, mutagenesis, protoplast fusion or embryo rescue).
    2. Genetically modified plants, having inherent characteristics typical of modified plants from conventional breeding practices.
    3. Plants, with genetic inserts that are known to be harmless and inoffensive to the environment.
  • For field testing of experimental plants with a history of prior field work, a project notification or proposal form has to be submitted to the Institutional Biosafety Committee (IBC).
  • The IBC shall evaluate the proposed ambient working conditions through the accredited containment resources, in determining the sufficiency of Biosafety provisions. Measures for the control and containment of field work should observe relevant past regulations and address the particular plant under study.
  • Only after receiving IBC endorsement, work may begin. IBC must forward all proposals and the committees, assessments thereof, to the National Biosafety Committee (NBC) for records and information.
  • For experimental plants that do not have history of safe use, the works should proceed under the appropriate containment level if any of the following conditions is met.
    1. There is no cross-hybridization.
    2. There are arrangements to contain the dispersal of plants and plant materials.
    3. Introduced gene expression is stable, and does not fluctuate with changing environmental conditions.
  • Field testing experimental plants with no history of prior field work should proceed under the advice, counsel, and direction of the IBC and NBC.
  • In both cases, committee recommendations and the command of work shall be grounded on the Biosafety concerns that may be gathered from the written proposals submitted.
  • The project supervisor is prohibited from initiating work before consent is granted directly by the NBC.

Regulation for GMOs in India

  • Ministry of Environment and Forests, Government of India notified the rules and procedures for the manufacture, import, use, research and release of GMOs as well as products made by the use of such organisms on December 5, 1989 under The Environment (Protection) Act, 1986 (EPA).
  • These rules and regulations commonly referred as Rules 1989 cover areas of research as well as large scale applications of GMOs and its products. These Rules are implemented by the Ministry of Environment and Forests and the Department of Biotechnology, Government of India.

Six competent Authorities and their composition have been notified under this Rules which are as follows:

    1. Recombinant DNA Advisory Committee (RDAC)
    2. Institutional Biosafety Committees (IBSC)
    3. Review Committee on Genetic Manipulation (RCGM)
    4. Genetic Engineering Appraisal Committee (GEAC)
    5. State Biosafety Coordination Committee (SBCC)
    6. District Level Committees (DLC)
  • While the RDAC is of advisory in function, the IBSC, RCGM and GEAC are of regulatory function; SBCC and DLC are for monitoring purposes.

Good laboratory Practice (GLP)

  • Good laboratory Practice (GLP) is a managerial concept covering the organizational process and the conditions under which laboratory studies are planned, performed, monitored, recorded and reported.
  • The intention is to promote the quality and validity of the data which go to make up studies. The policy of “GLP” has been observed to varying degrees by private and public laboratories for years.
  • The act also established a Testing Laboratory Registration Council, with functions and powers ‘to promote the development and maintenance of good laboratory practice in testing.’
  • The final GLP regulations were published in the federal register on 22nd December, 1978 and they became a legal entity in the United States from 20th June, 1979.
  • Publications of the revised GLP regulations took place on September 4th, 1987 in the federal register and were entitled GLP regulations, the final rule.
  • Good Laboratory Practice (GLP) is a system evolved by OECD, used for achieving the above goals. The OCED principles of GLP have been internationally accepted.
  • In India, national GLP compliance monitoring authority was set up in April 2002 with approval of the cabinet to help Indian industries to obtain GLP certification for their test facilities, so that data generated by these test facilities is eventually acceptable in OECD countries.
  • Good Laboratory Practice regulates all non-clinical safety studies that support or are intended to support applications for research or marketing permits for products regulated by national legislation.
  • GLP is to promote the development of quality test data, for the mutual acceptance of test data among countries. This includes medicinal and veterinary drugs, aroma and color additives in food, nutrition supplements for livestock and biological products.
  • It is mainly needed for non-clinical safety studies of development of drugs, agricultural pesticide development, and development of toxic chemicals, food control, and test of substance with regard to explosive hazards.

The Fundamental Points of GLP

  • The GLP regulations set out the rules for good practice and help researchers perform their work in compliance with their own pre-established plans and standardized procedures.
  • All GLP texts, irrespective of their origin, stress the importance on the following point’s five points:
    1. Resources: organization, personnel, facilities and equipment
    2. Characterization: test items and test systems
    3. Rules: study plans and written procedures
    4. Results: raw data, final report and archives
    5. Quality assurance.
  • The major points are summarized below:

    1. Resources
      • Organization and Personal: – GLP regulations require that the structure of R&D organization and the responsibilities of R&D personnel be clearly defined.
      • Facilities and Equipment: – The regulations emphasize the need for sufficient facilities and equipment to perform the studies. All equipment must be in working order.
    2. Characterization: – In order to perform a study correctly, it is essential to know as much as possible about the materials used during the study.
    3. Rules
      • Protocols and Written procedures: – The main steps o research studies are prescribed in the study plan or protocol. The protocol, which provides the experimental design and timeframe for the study, does not contain all the technical detail necessary to conduct the study. These details are found in written standard operating procedures (SOPs). With the protocol and the SOPs it should be possible to repeat the study exactly, if necessary.
    4. Results
      • Raw data: – All studies generate raw data. These are the outcome of research and form the basis for establishing scientific interpretation and arriving at conclusions. The raw data must also reflect the procedures and conditions of the study.
      • Final report: – The study report contains an account of the way in which the study was performed, incorporates the study results and includes the scientific interpretation of the data.
      • Archives: – Storage of records must ensure safekeeping for many years and allow for prompt retrieval.
    5. Quality Assurance: – Quality Assurance must be independent from scientists involved in the operational aspects of the study being performed. QA functions as a witness to the whole non-clinical research process.

Good manufacturing practice (GMP)

 

GMP

  • 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 system to provide documented proof that correct procedures are consistently followed at each step in the manufacturing process- every time a product is made.
  • GMP promulgated by the US food and drug administration under the authority of the federal food, drug and cosmetic act.
  • These regulations, which have the force of law, require that manufactures, processors and packagers of drugs, medical devices, some food, and blood take proactive steps to ensure that their products are safe, pure, and effective.
  • GMP regulations require a quality approach to manufacturing, enabling companies to minimize or eliminate instances of contamination, mix-ups, and errors.
  • This in turn, protects the consumer from purchasing a product which is not effective or even dangerous. Failure of firms to comply with GMP regulations can result in very serious consequences including recall, seizure, fines and jail time.
  • GMP regulations address issues including record keeping, personnel qualifications, sanitation, cleanliness, equipment verification, process validation and complaint handling.
  • Most GMP requirements are very general and open-ended, allowing each manufacturer to decide individually how to best implement the necessary controls.
  • This provides much flexibility, but also requires that the manufacturer interpret the requirements in a manner which makes sense for each individual business.
  • GMP is also sometimes referred to as “cGMP”. The “c” stands for “current”, reminding manufacturers that they must employ technologies and systems which are up-to-date in order to comply with the regulation.
  • Systems and equipment used to prevent contamination, mix-ups and errors, which may have been “top-of-the-line” 20 years ago, may be less than adequate by today’s standards.

References

  • D. Singh. Biotechnology.2006. Chapter 20 ‘Biosafety’. Pp.762-788.
  • Shaleesha A. Stanley. Bioethics. 2008. Chapter 13 ‘GLP and Bioethics’. Pp.170-175.
  • World Health Organization. Good Laboratory Practice (GLP).2008. Pp.1-10.
  • Suresh Kumar. Biosafety Issues of Genetically Modified Organisms. Biosafety. Volume 3, issue 2, 2167-0331. (2014).

Biosafety guidelines and regulations for GMOs, GLP and GMP

 

 

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