What is GMP ?

 Good Manufacturing Practices (GMP) is the minimum standard that a pharmaceutical manufacturer must meet in their production processes. Process must:

  • Be of consistent high quality.
  • Be appropriate to their intended use.
  • Meet the requirements of the marketing authorization (MA) and product specification.

  Pharmaceutical organizations which comply with GMP must have manufacturer license. Regulatory agencies carries out in section on these pharmaceutical organizations to check if manufacturing sites comply with GMP. Sites are inspected when applied for a manufacturer license and then periodically based on risk assessments.

CGMP Legal Principles

Quality built into product

  • By "taking care" in making medicine.
  • Quality system is based on the principle of Quality by Design instead of quality by Inspection.
Without/Inadequate cGMP
  • Product(s) adulterated(defects need not be shown).
  • Firm and its management are responsible.
Current = Dynamic
  • Standards evolve over time.
Good Practices
  • Minimal standards.
  • Not "best practices". (Unless "best" is, in fact, current minimal.)


  • Is a legal requirement enforced and mandated through law, regulations and directives by each country government.
  • To protect public health of each and every individual.
  • Prevent contamination and mix-ups.
  • Prevents mislabeling and adulteration.
  • Consistent maintenance of Quality product supply throughout the product life cycle.
  • Ensure high standard quality product supplied into the market is safe and effective.
  • Satisfy stakeholders, customers and consumers.
  • To meet the requirement of the marketing authorization (MA) and product specification.
  • Enhance the organization image and reputation.

Responsibility of GMP

  • Quality and GMP compliance are independent of job title and have no boundaries.
  • Everyone involves in the process regulatory compliance, manufacturing, packing, Quality Control, distribution and supply of pharmaceuticals product has the responsibility to make sure it reaches to the patient with registered quality standards.
  • Building quality into the entire process of an operation makes sustainable compliance more achievable. However, it requires commitment by Senior management and the allocation of adequate resources (personnel, facilities, training, etc.).

Applications of Biotechnology in Various Fields

 Biotechnology is a branch of biology involving the use of living organisms and bioprocesses in engineering, technology, medicine, and other fields using bioproducts. The term biotechnology indicates the use of living organisms or their products for modifying the human health and environment.

Applications of Biotechnology in various fields

1] Medicine:

Modern biotechnology finds promising applications in medicine as in:

i) Drug Production :

  • Most of the traditional pharmaceutical drugs used for treating the symptoms of a disease are simpler molecules found through trials and errors. Small molecules are manufactured chemically, but the larger ones are created by human cells, bacterial cells, yeast cells, and animal or plant cells.
  • Modern biotechnology involves the use of genetically altered microorganisms (e.g., E.coli or yeast) for producing insulin or antibiotics via synthetic means. Modern biotechnology can also be used for producing plant-made pharmaceuticals. Biotechnology is also used in the development of molecular diagnostic devices used to define the target patient population for a given biopharmaceutical. For example, herceptin was the first drug to be used with a matching diagnostic test for treating breast cancer in women whose cancer cells expressed HER2 protein.

ii) Pharmacogenomics :

  • It is the study of how the genetic inheritance of an individual affects his/her body's response to drugs. The term pharmacogenomics was derived from the words pharmacology and genomics, thus it involves studying the relationship between pharmaceuticals and genetics. 
  • Pharmacogenomics aims to design and produce drugs adapted to each individual's genetic makeup.

iii) Gene Therapy :

  • It is used for the treatment of genetic and acquired diseases like cancer and AIDS. Gene therapy utilises normal genes for supplementing or replacing the defective genes or for strengthening immunity. This therapy targets either the somatic cells (i.e., body) or the gametes (ie., egg and sperm). 
  • In somatic gene therapy, the recipient's genome is altered; however, this alteration is not passed on to the next generation. On the other hand, in germline gene therapy, the egg and sperm cells of the parents are altered to be passed on to their offspring.

iv) Genetic Testing : 

This involves direct examination of the DNA, and is used for:
  • Carrier screening, or identifying unaffected individuals who carry one copy of a gene for a disease that requires two copies for the disease to manifest,
  • Confirming the diagnosis of symptomatic individuals,
  • Determining sex,
  • Forensic/identity testing.
  • New-born screening.
  • Prenatal diagnostic screening.
  • Pre-symptomatic testing for determining the risk of developing adult-onset cancers, and
  • Pre-symptomatic testing for predicting adult-onset disorders.

2] Cloning :

  In this method, the nucleus from one cell is removed and is transferred to an unfertilised egg cell whose nucleus has either been deactivated or removed. Cloning can be done in the following two ways:

i) Reproductive Cloning :

  •  In this method, the egg cell after a few divisions is transferred to a uterus for its development into a foetus that is genetically identical to the donor of the original nucleus.

ii) Therapeutic Cloning :

  • In this method, the egg is placed in a petridish for its development into embryonic stem cells that are potential for treating several ailments.

3] Agriculture :

Biotechnology in the agricultural field is used for the following purposes:

i) Crop Yield :

  • For increasing the crop yield, one or two genes are transferred to a highly developed crop variety for imparting a new character. The current techniques of genetic engineering are best for the effects controlled by a single gene. Some genetic characteristics related to yield (e.g., enhanced growth) can be controlled by various genes, each posing a nominal effect on the yield.

ii) Reduced Vulnerability of Crops to Environmental Stresses :

  • Such crops which can be made resistant to biotic and abiotic stresses can be developed with the help of genes; for example, drought and salty soil are the two limiting factors in crop productivity.

iii) Increased Nutritional Qualities :

  • The nutritional value of proteins contained in foods can be enhanced; for example, proteins in legumes and cereals can be transformed such that they also provide amino acids required in the balanced diet of humans.

iv) Reduced Dependence on Fertilisers :

  • Modern biotechnology can also be used to reduce the dependence of farmers on agrochemicals; for example, Bacillus thuringiensis (Bt) is a soil bacterium that produces a protein having insecticidal properties. Conventionally, these bacteria were used to produce an insecticidal spray by a fermentation process. 
  • In this form, the Bt toxin occurs as an inactive protoxin, which becomes effective when digested by an insect. There are several Bt toxins and each has a specificity for some target insects.

v) Production of Novel Substances in Crop Plants :

  • Biotechnology is also applied for novel uses apart from food; for example, oilseed is genetically modified to produce fatty acids for detergents, substitute fuels, and petrochemicals. Potatoes, tomatoes, rice tobacco, lettuce, safflowers, and other plants are genetically engineered to produce insulin and certain vaccines.

4] Biological Engineering :

 It is a branch of engineering that involves biotechnologies and biological science. It includes different disciplines such as biochemical engineering, biomedical engineering, bio-process engineering, biosystem engineering, etc.