Good Manufacturing Practices

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Table of Contents

Introduction
The process involved in changing of the drugs
Testing of the drug
Impurity profiles
How to ensure high quality products are produced
Conclusion
References

Introduction

Good manufacturing practices are the set guideline that outlines the process of manufacturing and testing to enhance on the quality of the pharmaceutical drugs (Moynihan 2003). This set of regulations and guidelines must be strictly followed although in some areas, to encourage innovation there is some latitude offered as long as the following steps are followed and documented:

Ensure raw materials are of quality.
Record detailing the whole process of manufacturing should be kept
High standards of cleanliness should be maintained
Confirm the qualifications of the manufacturing personnel.
Do in house testing immediate after manufacture.
Ensure that high standards are maintained in the production processes.
Maintain proper channels of storage as well as of distribution (Finn 1999).

The process involved in changing of the drugs

The actual stage of manufacture is the last stage in the pharmaceutical drug production. Thus to change the profile content of an existing drug is treated the same as manufacturing because the side effects of this new ingredients are not yet known. This process requires strict and rigorous documentation for the drug to comply with the good manufacturing process.

Recording of the entire manufacturing process is mandatory because the records can be used in the case of a problem or when challenged by legal hurdles (Leape 1994). The first documents involved are the research documents. Before any pharmaceutical drugs are manufactured for public use, research must be undertaken. First in the labs to ensure that, they will work for the intended purposes.

This is done by testing the compounds that are thought to contain substrates that can help to combat or help to alleviate the symptoms of the disease the drug is intended. The process is complicated and can be achieved using many methods including use of computer simulation or testing the combinations nature if different compounds.

At this point, the research findings must be documented and the total R&D funds used in the process documented as well. The handling of the new material should be handled with care and should be treated as raw materials until all the tests have been concluded.

The raw materials should be tested to ensure that they comprise of the required substrates The Q&C manager should be able determine their origin and method of manufacture. This is because the sources could be natural or synthetic (Rang, et al. 2003). This is because most of the raw materials that had been produced naturally in the past now are now being produced synthetically.

Their production process production should be investigated by the Q&C manager to ensure that it is up to all the standards set out by the drug controlling body of the respective country. He should ensure that the raw materials are also inclusive of active pharmaceutical ingredients that are pharmaceutically safe and that they contain the desired effects on the body (Ray 2003).

After being certain that, the raw materials are well according to standards, the next step should be the production of the sample of the drugs so that they can be used for testing and for obtainment of a license. After the manufacture of the sample, the testing of the drug is ready and can be done (Ray and Alan 2005).

Testing of the drug

The testing of the drug is carried out through drug trials where a sample of people are administered the drugs and the effects it has on the people recorded for further analysis. The first step in the testing is the use of preclinical studies. These are done in vitro tubes or on animal and cell structure experiments (Ruesch 1991).

The next step is the use of a small number of volunteers to investigate whether the drug has any therapeutic effect on the human body as was expected. This stage does not deal with safety or even the efficacy of the drug (Ruesch 1992).

Phase 1 involves using groups of about 20-100 healthy volunteers to establish the safeness of the drug and also the total time the body can absorb and make use of it. The stage also include dose ranging so that the exact amount of dose that be used for therapeutic purposes is established. Payments of the volunteers are done according to the agreed amount and the time spent on the testing facilities.

The other stage of testing involves the use of a large number of patients’ volunteers. They test on the drug to establish how effective it is against the symptoms of the disease, the amounts of the doses that are effective and the side effects that might occur.

The final stage involves the use of a large number of volunteers to test the drug. At this point the effective nature of the drug is investigated as well as the side effects that can occur in the event of the usage of the drug. After the success of this stage, then the drug is licensed and given a trademark name ready to be sold to the public ( Burgos 1986).

Impurity profiles

Impurities are common in drugs because they are also part of the ingredients used in their manufacturing process and purity tests must be undertaken to ensure their complete elimination. The most famous and effective is the use of chromatography that separates the impurities from the real ingredients if they are any available (Braithwaite 1984).

After the impurities have been identified, ways should be formulated to ensure their removal and also to minimize their effects on the drug. This should be by elimination of some of the manufacturing practices that are practiced in the firm.

There should be manufacture of fine crystals while the process of isolation, the drying of the tablets should be done by a vacuum dryer and finely stability studies should be undertaken and detailed investigations on the process of preparation (Barnett 2003).

How to ensure high quality products are produced

To ensure that high quality products are produced, quality control should be applied at every stage of manufacture. This is to make sure that there is early identification of any production problems especially the weakness of the drugs. If a problem is identified then, production should stop and the problem determined (Baker 1994).

Conclusion

Good manufacturing practices are guidelines which are set for the safety of the public while using the pharmaceutical drugs. The entire process should be adhered to ensure that only quality kinds of drugs are available to the public.

There have been cases of some pharmaceutical companies using undue methods to get their drugs approved but later these drugs cause some un repairable damage or even death. The governing body such as the FDA in the United States should that the process is strictly followed and only quality drugs are licensed for sale.

References

Baker, A., 1994. Awakening Our Self-Healing Body – A Solution to the Health Care Crisis. California: Self Health Care Systems, LA.

Barnett, A., 2003. Revealed: how drug firms ‘hoodwink’ medical journals. London: The Observer.

Braithwaite, J., 1984. Corporate Crime in the Pharmaceutical Industry. London: Routledge & Kegan Paul.

Burgos, J., 1986. Hidden Crimes (Film), SUPRESS. California: Pasadena.

Finn, R., 1999. Cancer Clinical Trials: Experimental Treatments and How They Can Help You. Sebastopol: O’Reilly & Associates.

Leape, L., 1994. Error in medicine. Journal of the American Medical Association (JAMA), 272 (23), p. 1851.

Moynihan, R., 2003. Who pays for the pizza? Redefining the relationships between doctors and drug companies. 2: Disentanglement. BMJ: British Medical Journal, 326 (7400), pp. 1193–1196.

Rang, et al., 2003. Pharmacology 5 ed. Edinburgh: Churchill Livingstone.

Ray, M., 2003. Drug company sponsorship of education could be replaced at a fraction of its cost. BMJ: British Medical Journal, 326 (7400), p.1163.

Ray, M. and Alan, C., 2005. Selling Sickness: How Drug Companies are Turning Us All Into Patients. Allen & Unwin. New York.

Ruesch, H., 1991. Slaughter of the Innocent. Hartsdale NY: CIVITAS Publications.

Ruesch, H., 1992. Naked Empress – the Great Medical Fraud, CIVIS. Switzerland: Massagno/Lugano.

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