1) GMP (Good Manufacturing Practice) guidelines are important regulations that help ensure animal vaccines and other drugs/medical products are produced safely and are effective. They cover all aspects of production from materials to equipment to staff training. 2) Key components of GMP include quality management, quality control, sanitation, validation, documentation and more. Strict adherence to GMP helps reduce risks like contamination and errors that could harm patients. 3) For animal vaccines specifically, following GMP is critical given the live organisms involved and safety precautions needed. Facilities must be designed to properly handle biosafety requirements as well as aseptic processing.

1. An Assignment
On
Importance of GMP (Good Manufacturing Practice) in the Production of Animal
Vaccine
Prepared by Dr. Md. Salauddin
DVM, M.S in Microbiology

2. *Source- WHO (World Health Organization)
*International Society for Pharmaceutical Engineering
*FDA (Food and Drug Administration)
*www.outbreaknewstoday.com; Aug-19, 2015
Page - 1
Introduction
GMP stands for Good Manufacturing Practice (s). GMP is not only a guideline but also a
control measure. GMP is to be read and learned also practiced and implemented. Good
manufacturing practices are constantly evolving called cGMP which is stands for Current
Good Manufacturing Practice (s). Good Manufacturing Practice (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 systems to provide documented proof that
correct procedures are consistently followed at each step in the manufacturing process every
time a product is made. Good Manufacturing Practices are critical to successfully evaluating
global vendors. Equally important, GMP is also essential to produce high-quality products.
In short, good quality starts with Good Manufacturing Practices. Without GMP in place,
quality problems will multiply quickly.
The Essentials of GMP
There are multiple departments in a factory that are involved in high-quality production.
Skilled personnel, well-maintained equipment, process control and risk management are
critical to GMP. When evaluating vendors, factory evaluators should assess followings-
Importance of GMP
Good Manufacturing Practices are systems created and mandated by the government to
regulate production, verification and validation of drugs, food and/or medical devices,
ensuring that finished products are effective and safe for market distribution. It’s important
to have GMPs because they are guidelines which are enacted to ensure food, drugs,
cosmetics, medical devices and related products have no harmful substances. These
regulations, enforced by the FDA, help reduce the instances of product recalls, harmful
effects and eventual lawsuits that may arise from defective products.
Importance of GMP (Good Manufacturing Practice) in the Production of Animal Vaccine

3. Page 1
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*Source- WHO (World Health Organization)
*International Society for Pharmaceutical Engineering
*FDA (Food and Drug Administration)
*www.outbreaknewstoday.com; Aug-19, 2015
Page - 2
Today, GMPs are more commonly known as CGMPs, and have been established flexibly to
permit every manufacturer to use their discretion in implementing the best controls for their
own organization. This flexibility also allows manufacturers to make use of the latest and
most innovative technologies to result in products of better/higher quality.
The ‘current’ addition is also used to imply that the FDA expects companies to continuously
stay up-to-date with regulations as they are altered to suit changing market and consumer
needs. The reason for this is that systems, machines or equipment that were in use, say a
few years ago, are not as efficient/effective today, and are hence inadequate in ensuring
maximum consumer protection. In the United States the Center for Drug Evaluation and
Research (CDER) promotes and protects public health by assuring that safe
and effective drugs that guided by GMP. Also different types of risk with medicines can be
avoided by effective implementation of GMP.
Focusing points and components of GMP
GMP is an acronym for Good Manufacturing Practice regulations put in place by the U.S.
Food and Drug Administration (FDA). GMP is typically used in facilities where drugs or
medication are manufactured. These regulations address a variety of areas, including
cleanliness, personnel qualifications and record-keeping, all in an attempt to ensure safety
in the manufacture and care of FDA-regulated products by minimizing the chance of
contamination or human error. The components of GMP/cGMPs are as given bellows-
1. Quality management
2. Quality control
3. Sanitation and Hygiene
4. Validation
5. Complaints
6. Self-inspection and Quality audit
7. Personnel
8. Premises
9. Equipment
10. Documentation
These may also be used as training material for government medicines inspectors, as well as
for production, QC and QA personnel in the industry.
GMP in Animal Vaccine Production
The manufacturer must assume responsibility for the quality of the pharmaceutical products
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 development and production of vaccines makes high demands on the manufacturing
pharmaceutical industry. The special requirements on handling and safety with live
organisms necessitate measures which exceed the requirements of classic pharmaceutical
manufacturing. Topics like the enhanced risk of cross-contaminations, questions about
individual safety of staff and the issues of cleaning and disinfection of rooms and equipment
concern a vaccine manufacturer in a considerable scale. Specifically the demands of the
necessary bio safety classes with negative pressure of rooms versus that of aseptic
processing with positive pressure requires a well thought-out design of vaccine facilities.
Also, the safety of environment and waste disposal should receive proper attention already
in the design phase. But the dedicated requirements on staff safety are also a challenge in
vaccine manufacturing.
This will give the possibility to see the theoretical background as well as the practical
implementation of GMP requirements in the vaccine production. A combination of theoretical

4. *Source- WHO (World Health Organization)
*International Society for Pharmaceutical Engineering
*FDA (Food and Drug Administration)
*www.outbreaknewstoday.com; Aug-19, 2015
Page - 3
*Source- WHO (World Health Organization)
*International Society for Pharmaceutical Engineering
*FDA (Food and Drug Administration)
*www.outbreaknewstoday.com; Aug-19, 2015 Page - 3
requirements and practical case studies is the best way to learn this. Speakers from
regulatory bodies, consulting and practising experts will give the chance to get to know the
different views and you will have ample opportunity to discuss with speakers and other
participants about specific issues.
Role of GMP in production
Good manufacturing practice is that 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 is aimed primarily at
diminishing the risks inherent in any pharmaceutical production, which may broadly be
categorized in two groups: cross contamination/mix-ups and false labelling. Above all,
manufacturers must not place patients at risk due to inadequate safety, quality or efficacy;
for this reason, risk assessment has come to play an important role in WHO quality assurance
guidelines.
The expansion of GMP to the manufacture of IVMPs (immunological veterinary medicinal
products) in regions where it is currently not applied will bring significant benefits in terms
of product quality, safety and efficacy. A key role in the development and promotion of
harmonised GMP standards for all types of medicinal products is being played by PIC/S (The
Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme)
However, other organisations, such as Pan African Veterinary Vaccine Centre (PANVAC),
which already have an important part to play in the improvement of quality for veterinary
vaccines may be candidates for a more prominent role in the future promotion of harmonised
application of GMP standards for IVMP manufacture, particularly in developing countries.
Whilst the application of these standards may have significant cost implications, it is
considered that these should be outweighed in the long term by the benefits to animal health,
and consequently to human health, in these regions through the availability of safe,
efficacious veterinary vaccines, manufactured to high quality standards.
Conclusion
In the quality control world, Good Manufacturing Practice (GMP) is only just a part of the
quality control systems that govern the guidelines recommended by agencies that control
authorization and licensing for manufacture and sale of food, drug products and active
pharmaceutical products. A product that is according to the guidelines is considered to be
of high quality and will pose no risk to the consumers or the general public. No specific
guidelines or instructions are laid down by GMP for how to manufacture a product but lays
down general principles which must be observed during the manufacturing process. The
manufacturer has to decide how to set up the manufacturing system so as to best follow up
the guidelines.