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GMP Assignment: How Good Manufacturing Practice Affect Sterilization


Task: You work in Excellence Pharma as a GMP specialist. Excellence Pharma manufactures tablets for renal diseases. The company has an opportunity to take over another pharmaceutical company that produces sterile peritoneal fluids using terminal sterilisation.

Your CEO has limited knowledge in sterile manufacturing. She knows that you are studying a course of Master of GMP at UTS, and there is a subject on sterile manufacturing.

Your CEO wants you to provide a report to her about sterile manufacturing using terminal sterilisation.

Your report should include:

  • The concept of sterilisation
  • Risk factors in sterilisation
  • Compliance requirements
  • Methods of sterilisation
  • Sterilisation metrics
  • Measure of sterilisation effectiveness
  • Detail explanation of terminal sterilisation
  • Control processes to ensure GMP compliance

The final paper should be approximately 1500 words not including references. References should be acknowledged and some examples of reference citations using the Harvard system are as below:

1. European Medicines Agency 2014, European Medicines Agency post-authorisation procedural advice for users of the centralized procedure, viewed July 25, 2016, GB/document library/Regulatory and procedura I guideline/2009/1 01WC500003981.pdf

2. Sarker, DK 2008, Quality Systems and Controls for Pharmaceuticals, John Wiley & Sons Ltd, Chichester, West Sussex.

3. Cassiday. L 2014, ‘Structural biology: More than a crystallographer’, Nature, 505, pp. 711-713.


Executive Summary
The aim of GMP assignment is to guide the CEO of Excellence Pharma about sterile manufacturing using terminal sterilization through the eyes of a Good Manufacturing Practice specialist. The CEO of the aforesaid pharmaceutical company has minimal knowledge about sterile manufacturing and therefore, she needs a report from a GMP specialist that covers information like what sterilization is all about, risks associated in sterilization, various methods of sterilization, metrics of sterilization, compliance related matters, fulfillment of GMP compliance, how effective is sterilization and what terminal sterilization is all about.

A GMP specialist is one that has an appropriate knowledge and experience in biotech, device manufacturing or pharmaceutical manufacturing (Abdellah et al. 2015). A GMP specialist makes sure that the medicinal arrangements received by the patients are of best quality. This GMP assignment ensures that all the necessary compliance requirements are fulfilled and the quality standards are necessarily maintained right from the manufacture to storage of medications. All the individuals that are employed in pharmaceutical organizations or are supplier must necessarily abide by all the GMP regulations as stated by Durivage (2016). Excellence Pharma is a pharmaceutical company that currently manufactures medicines used for curing kidney ailments. The company is planning of taking over a company that is engaged in sterile manufacturing. Excellence Pharma is seeking to take professional advice on sterile manufacturing in the form of an elaborated report from a GMP specialist currently employed in the company so as to get an insight on sterilization and various associated factors.

Concept of sterilization
Sterilization is a contraception method. According to Fletcher (2015) sterilization is a birth control method where an individual chooses to become un-reproductive. Sterilization is irreversible in most cases. Therefore, it must be preferred by individuals who are sure enough that they want any more children. The process of sterilization prevents pregnancy as it disallows the collusion of eggs and sperms. It can be opted by both men and women. The methods of sterilization discussed in this Good Manufacturing Practice assignment can either be surgical or non-surgical or sometimes both. It is a permanent method which is hardly reversible. Therefore, it must be preferred by individuals who are affirmed that they don’t want children ahead. Vasectomy and castration used by males while hysterectomy and tubal ligation used by females are the preferred methods of sterilization. However, there are various other methods of sterilization too. Sterilization doesn’t provide protection against STIs (sexually transmitted diseases). Sterilization prevents pregnancy while the menstrual cycle remains unaffected.

Risks of sterilization
The risks of sterilization are different for men and women. As per Liu et al. (2015) vasectomy for men is not much riskier method of sterilization as compared to tubal ligation for women. Vasectomy takes around a minimum of two months and a maximum of four months to allow male semen to become sperm free completely. Until then the couple must necessarily use temporary birth control method. Vasectomy can be performed under local anesthesia and the risks include mild inflection and little blood loss. Higgins et al. (2016) states that tubal ligation for women shows very acute chances of women getting pregnant. It may happen that a woman might face ectopic pregnancy within a year of tubal ligation. The ectopic pregnancy is one of the most prominent causes of mortality and maternal morbidity in the initial 3 months. There are few other risks that are completely dependent on the type of process used by the doctors.

Compliance requirements
The sterile manufacturing can be done by companies abiding by all the compliance requirements (Pirnay et al. 2018). The companies that are engaged or seeking to engage in sterile manufacturing using textile sterilization must necessarily maintain hygiene at the site and due care must be taken so as to make sure that the process is not compromised out of validation, nutrient medium must be taken into use while aseptic processing is validated that comprises of simulating the overall process, facilities and equipments are updated, disinfection and cleaning, risk assessment, validation, approval from vendor, raw materials management, maintenance of machinery and premises, regular improvement, regulating consequences on environment, and so on. APSIC (Asia Pacific Society of Infection Control) has updated guidelines that offer recommendations that are precise and sufficient enough to assist healthcare domain that aims at attaining high standards in disinfection and sterilization.

Methods of sterilization
There are various methods of sterilization discussed in this GMP assignment. The most preferred method of sterilization is steam sterilization. It is also commonly known as Wet Heat or Heat Method. The heat in this method helps the substance to remain free from any microbes, viruses and bacteria groups. It is one of the most conventional techniques of sterilization where saturated steam is used under hot air or pressure. The pressure is basically used to get the desired steam temperature. As per Li et al. (2016) steam sterilization must be used for aqueous preparations and for medical devices and surgical dressings. Dry heat sterilization is another method that needs a longer exposure time and higher temperature over moist heat. Filtration is a sterilization method used generally for thermolabile solutions. It is a heatless method. Gas sterilization discussed in this good manufacturing practice assignment is a method where volatile substances like ethylene oxide are used as an active agent. Humidity, temperature, time of exposure, and etc decides the sterilizing effectiveness of ethylene oxide.

Sterilization metrics
There is an ever rising interest in developing best quality metrics for sterilization. As per Dehlendorf et al. (2015) the potential measures for sterilization are sought by various groups such as SRH Workforce Summit and PPFA (Planned Parenthood Federation of America). Sterilization is an effective method to curb ever rising population as it helps in avoiding unwanted pregnancies. The efficiency of the contraception methods have allowed women to freely intercourse without having the risk of getting pregnant. Sterilization gives men and women the liberty to avoid unplanned pregnancies permanently. Sterilization helps women achieve a better health by avoiding unintended pregnancies, risks of miscarriage and abortion.

Discussion on measure of sterilization effectiveness in GMP assignment
The effectiveness of sterilization can be obtained by assessing the growth of bacteria. According to Iwata et al. (2016) the instant measurement of the effectiveness of sterilization is possible by assessing microbial Adenosine triphosphate (ATP) in bioluminescence process. For the purpose of cold sterilization, a manufacture must opt for microbial control substance which is super effective. Carboxymethylation must be deactivated with the help of DMDC (dimethyl dicarbonate). DMDC being a food additive must be applied to the final product and that too in very little doses, so that the Carboxymethylation gets deactivated. Then within some hours, ester converts into very little amounts of carbon dioxide and methanol. Many vegetable juices and fruits naturally contain amounts of methanol and carbon dioxide in them. In this context of Good Manufacturing Practice assignment, it can be said that cold sterilizations are highly safe as it has negligible chances of imposing risks on health.

Terminal sterilization
Dearth et al. (2016) provides that terminal sterilization is a very crucial method. The sterility of the product remains intact after terminal sterilization. It is a method where a product is sterilized in its last container. Methods like filtration are commonly used in order to lower the chances of a product getting damaged or contaminated. It is always made sure that any sort of microbial growth is prevented or otherwise the product’s quality might get impacted. Irradiation, ethylene oxide and steam sterilization are methods used in terminal sterilization. The methods must be chosen appropriately on the basis of the product that is taken into use. To affirm if the product is manufactured under high level of standards, it is always important to go for validation as it is a very essential part of manufacturing process.

How GMP compliances can be ensured
As per Nally (2016) the GMPs are issued as guidelines so that the quality of the product is not compromised. GMP compliances not only ensures that the product quality remains at par but also the personnel that are engaged in the pharmaceutical company or are suppliers must also necessarily hold a qualification in medicine, pharmacy, chemistry, biology, veterinary medicine, or pharmaceutical chemistry. The manufacture must enter into a contract where the responsibilities pertaining to purchases, testing and release of materials, process controls, final testing, and release of product is defined. The contractor must also agree upon the access of his premises for routine checks by the officials. Individuals who are well-versed with GMP requirements must draft the aforesaid contract. Branning (2015) mentions that a manufacturer must understand the quality of the final product is dependent on the process impact for designing the processes and employment of analytical tools and determining the internal controls.

As per the study of GMP assignment, it can be concluded that sterilization is a process where a person opts for a permanent contraception method. Once sterilization is opted, the reversal of the same cannot happen. The reversal of sterilization is difficult and expensive. Both males and females can chose to get sterilized. The sterilization method used for men and women are different from one another. Vasectomy and tubal ligation are the most preferred options available in the current times. Steam sterilization, dry heat sterilization, gas sterilization and filtration are the methods of sterilization. A manufacturer must ensure that all the GMP compliances are duly met in the process of sterile manufacturing using terminal sterilization. He must ensure that the sterile manufacturing is performed in utmost hygiene and individuals holding formal qualification in pharmaceuticals, biology, chemistry, medicine, pharmaceutical chemistry and veterinary medicines are only employed. A manufacturer must not compromise on the quality of sterilization medicines and must be compliant enough during the overall process of sterile manufacturing.

Reference List
Abdellah, A., Noordin, M.I. and Ismail, W.A.W., 2015. Importance and globalization status of good manufacturing practice (GMP) requirements for pharmaceutical excipients. Saudi Pharmaceutical Journal, 23(1), pp.9-13.

Branning, R., 2015. Quality systems for continuous manufacturing.

Dearth, C.L., Keane, T.J., Carruthers, C.A., Reing, J.E., Huleihel, L., Ranallo, C.A., Kollar, E.W. and Badylak, S.F., 2016. GMP assignment. The effect of terminal sterilization on the material properties and in vivo remodeling of a porcine dermal biologic scaffold. Acta biomaterialia, 33, pp.78-87.

Dehlendorf, C., Bellanca, H. and Policar, M., 2015. Performance measures for contraceptive care: what are we actually trying to measure?. Contraception, 91(6), pp.433-437.

Durivage, M.A. ed., 2016. The Certified Pharmaceutical GMP Professional Handbook. ASQ Quality Press.

Fletcher, J.F., 2015. Morals and Medicine: the moral problems of the patient's right to know the truth, contraception, artificial insemination, sterilization, euthanasia. Princeton University Press.

Higgins, J.A. and Smith, N.K., 2016. The sexual acceptability of contraception: reviewing the literature and building a new concept. The Journal of Sex Research, 53(4-5), pp.417-456.

Iwata, M., Ota, K.T., Li, X.Y., Sakaue, F., Li, N., Dutheil, S., Banasr, M., Duric, V., Yamanashi, T., Kaneko, K. and Rasmussen, K., 2016. Psychological stress activates the inflammasome via release of adenosine triphosphate and stimulation of the purinergic type 2X7 receptor. Biological psychiatry, 80(1), pp.12-22.

Li, X., Guo, B., Xiao, Y., Yuan, T., Fan, Y. and Zhang, X., 2016. Influences of the steam sterilization on the properties of calcium phosphate porous bioceramics. Journal of Materials Science: Materials in Medicine, 27(1), p.5.

Liu, Z., Liu, X., Ran, X., Ju, E., Ren, J. and Qu, X., 2015. Good manufacturing practice assignment. Single-layer tungsten oxide as intelligent photo-responsive nanoagents for permanent male sterilization. Biomaterials, 69, pp.56-64.

Nally, J.D., 2016. 23 Worldwide Good Manufacturing Practices. Good Manufacturing Practices for Pharmaceuticals, p.335.

Pirnay, J.P., Merabishvili, M., Van Raemdonck, H., De Vos, D. and Verbeken, G., 2018. Bacteriophage production in compliance with regulatory requirements. In Bacteriophage Therapy (pp. 233-252). Humana Press, New York, NY.


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