Bio-pharmaceutical and Medical device









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Why Validation is required for the Manufacture of a Medicinal Product


Validation is a vital process in the manufacture of medicinal products. Not only does validation allows us to enhance the quality of the medicine but also increases our knowledge on the authenticity and robustness of various procedures. Validation is simply the process of ensuring the safety of users while acquiring medical benefits in a medical device. It involves testing, inspecting, and case analysis. Validation can either be done by the use of quality management system or the V model. Quality management systems keenly monitor the accreditation procedures while the V model speculates the measurement and validation of the requirements. Various methods of drug administration will be covered in the introduction part of the paper. They include enteral, parenteral, topical, etc. I will also discuss Good Manufacturing Practices (GMPs) and quality risk management (Wingate, 2016, p. 16)


European Drug Agency defines a drug as an active ingredient whose mission is to accomplish a pharmacological activity (Tinkle etl. 2014, pp.35-56). The drug can also have an impact on human structure and functioning of the human body through the process of treatment, diagnosis, and cure of infections.

The knowledge about drug administration is a vital process in offering clinical services. It helps one to gauge the extent of clinical benefits and the impact of the administered medicine on the patient. Additionally, a drug can be administered through various routes which include enteral, tropical, and tropical. The implication of these methods not only helps in the effectiveness of the drug therapy but also enables one to understand the patient’s experience of drug treatment. However, the properties of the drug and the therapeutic objectives greatly influence the methods of administration.

Enteral administration involves oral, sublingual and rectal methods. The most commonly applied method is oral administration. Here, the drug is directly given in the mouth and swallowed. Tablets and capsules are the common solid drugs given orally because they have a highly soluble and provide accurate dosage. Since oral drugs are easily administered, they decrease the numbers complications from systemic infections. On the other hand, the alteration of the PH, motility and emptying time of the gastrointestinal tract may affect the rate of absorption of the drug. Secondly, sublingual administration entails placing the drug substance under the tongue and allowing it to dissolve. In the process of dissolution, it diffuses into the blood vessels and joins the circulatory system. This method is convenient because it enables the drug to mitigate harsh GI environment.

In Parenteral administration, the drug is introduced into the circulatory system by-passing the body’s barrier defenses. It is either administered by intramuscular (IM), subcutaneous and IV. Most of the drugs administered are those that are poorly absorbed in the IG. This route can cause pain and infections since the routes are invisible. It is also costly and requires a lot of training.

Lastly, tropical administration involves the application of lotions .creams, and patches on the skin. The application is made at the intended site of action. Examples include the application of eye drops in the eye to treat glaucoma, inhalation f bronchodilators to control asthma and application of steroids in the treatment of dermatitis. The main disadvantage of this method is that it may cause irritation of the skin and discomfort to the patient.

Good Manufacturing Practices (GMPs)

GPM are the one that adheres to the guidelines formulated by the regulatory agencies. The guidelines generate principles for the control, authorization and licensing of pharmaceutical products to ensure quality standards. The purpose of these practices is helping mitigate risks associated with the manufacture of pharmaceutical products that are skipped during the testing of the final product. The basic GPM guidelines cover aspects such as material production, premises, equipment, and hygiene. Manufacturers are recommended to maintain clean hygiene and minimize cross-examination of drugs. Additionally, manufacturing procedures must be clear and precise defined and documented and consistently followed at each step in the manufacturing process – every time a product is made. This process enhances the safety and effectiveness of the products. GMP compliance is widely-accepted as the best way to conduct business, putting product quality first (Nally, 2016, p. 200)

The administration of GMPs is restricted to specific agencies which include the Food and Drug Administration (USFDA) in the USA, the European Medicine Agency (EMA) which harmonizes the GMP at EU level, Medicine and Health Product Regulatory Agency (MHRA) in British, Pharma Inspection Corporation Scheme (PIC).

Medical Devices

Medicinal gadget are instrument, device, actualize, machine, apparatus, embed, in vitro reagent or calibrator, programming, material or other comparable or related article, expected by the producer to be utilized, alone or in blend, for people for at least one of the particular purposes conclusion, anticipation, checking, treatment or lightening of ailment. According to the federal law, medical device systems are classified on the basis of their risks. There are three regulatory classes to which each device is placed. They include Class I, Class II, and Class III. These levels of classifications ensure the safety and effectiveness of the machine. The regulatory control increases with an increase in class level. For instance, Class has general control regulations, Class II has general controls and special controls regulations while Class III has General Controls and Premarket Approval (PMA) which is of the highest risk (Jacobson and Murray, 2007, pp 330-340).

Class I (General Controls) are applied to all medical devices. However, some devices are exempted by regulations. FD&C Act, under sections 501, 502, 510, 516, 518, 519, and 520 is responsible for the authorization of the general controls and regulatory requirements. For example the general control for a manual toothbrush include, it is an adulterated, misbranded device, 501-502 (Mansfield etl, 2007, pp. 2-7). Examples of devices that fall under this class include hand-held surgical instruments, examination gloves, and elastic bandages.

According to FDA, in Class II (Specific controls) the assurance, safety, and effectiveness of the devices and not sufficiently attained by the general controls alone hence the need to establish specific controls. The specific controls supplement the requirements that are not met by the general control. They include Performance standards, Post-market surveillance, Patient registries, Special labeling requirements, Premarket data requirements, Guidelines. Examples include air purifiers, infusion pumps, and surgical grapes.

Class III (Premarket Approval (PMA)) are subject to approval under the federal law. They include devices that do not lie within the Medical Device Amendments of 1976. Also, the FDA orders into class III gadgets proposed to be utilized as a part of supporting or managing human life or avoiding weakness of human wellbeing, or that may exhibit a potential preposterous danger of ailment or harm for which general controls and exceptional controls are lacking to give sensible affirmation of the security and adequacy of a gadget, or for which there is deficient data to make such an assurance. Examples include HIV diagnostic tests, endosseous implants, and implantable pacemaker.

Quality Risk Management

Risk management approach assumes a direct proportionality between the degree of regulation imposed on any devices and its potential hazard. Risk assessment and management are the two stages in which decision making can be based on. The probability of occurrence of a harm to human health and its risk level determines the action chosen to achieve the regulatory compliance. A certain degree of risks accompanies each medical device. If not dealt with, the risk can cause problems under various circumstances. In this section of the paper, I am going to discuss how science-based decision can be made using the classical risk management process.

The need for a competent, consistent use of the Scientific Method in risk assessment, and of an analogous set of “Good Practices” in risk management is discussed. Whenever the Scientific Method was applied, science has sooner or later been successful in identifying the best model; and what we call modern science is the set of models which has resulted from a consistent application of this process. In risk assessment, the same method should be applied to all models which are needed for the estimation of a risk

The quality of medicinal products usually determines the safety of the patients using it. Currently, defective products have been the main cause of medical injuries. Poor quality products have a negative impact on the patient’s body. When the defective drug reacts with the body it can cause some side effects including dehydration, kidney failure, and cancer.

Key Product Quality Attributes and Process Parameters

Attributes are medical-devices regulatory systems that are based on sound science, uses appropriate scientific methods and post marketing information. They include a science based process, a clear straightforward and fair process, it should be relevant and appropriate, it should ensure the safety of the community, and it should be risk based. There are various processes involved in validation of medicinal products. These processes start from collection and evaluation of data in the designed stage throughout the production. Scientific evidence is used to evaluate the quality of the products. Current Good Manufacturing Practices for finished pharmaceuticals (21CFR 211) and of the GMP regulations for medical devices (21 CFR 820) utilizes validation concept this means that validation is essential to both the production of drugs and manufacture of medical devices. The production and processing activities from a series of the lifecycle. These activities are explained in different stages. The Process Design forms the first stage. At this stage, the commercial process is defined based on the development and scale-up activities knowledge. The second stage involves the confirmation of the process design and is known as Process Qualification stage. The third stage Continued Process Verification, Ongoing assurance is gained during routine production that the process remains in a state of control.



GMP Compliance Efficiencies

Regulatory authorities inspect a pharmaceutical manufacturer first to determine whether he/she is educated, trained/experienced to perform the assigned functions. (Schallmoser etl. 2009, pp. 271-276). Second is to ensure that the identifications of the final products are verified. To determine their compliance with specifications for physical and chemical properties, microbial contamination, and hazardous or other unwanted chemical contaminants. To ensure that the manufacturer maintains maintain adequate personal cleanliness (Bliesner, 2006, pp. 270).

The quality by plan (QbD) approach for pharmaceutical advancement is expected to incorporate quality with medication items in light of attributes that characterize wellbeing and viability. Particular physical, substance, natural or potentially different properties that may affect item quality are basic quality traits (CQA) that can be distinguished utilizing hazard administration devices and therefore basic process parameters (CPP). This kind of improvement model depends on a multidimensional space utilizing input factors that will decide the extents in which a reliable quality item can be accomplished. The quality, wellbeing, and adequacy of a medication item can be connected to the appropriateness of a compartment conclusion framework (CCS), and late administrative desires are to acquire learning of the CCS right on time in the medication advancement procedure to add to the way toward building quality medication items.

Priority Testing for Medical Devices

Priority testing involves both simple and complex processes. Priority items are those that need quick inspection so that they can be put back to use immediately. During the priority testing, each procedure must be followed step by step to avoid shortcuts. This procedure involves cleaning, sterilizing, and drying the devices afterward the instruments are inspected to ensure that they are in undamaged, they meet manufacturer’s specifications, and are intact and complete.

Each medical device has its own quality that is usually tested and verified by FDA and exceeds a broad range of demanding specifications. For instance, examination gloves are either latex vinyl or nitrile. The priority for the gloves is washing them, clean and dry the gloves, identify the signs of being damaged and ensure that they have a valid use by date.

The use of Infusion pumps a class II device requires ensuring the following quality attributes safety, interoperability, context-awareness, autonomy, security and privacy, and certification. They require continuous monitoring and care since they are highly expensive. The data carried by this equipment is always sensitive and tampering with it may lead to privacy loss, discrimination, and physical harm. Lastly, an HIV diagnostic test instrument is an example of a class III device. This instrument produces quick results usually within 30 min. It must be kept at a temperature of 2-30 degrees.




To sum it up all, validation is an important procedure in the manufacture of medicines because it enhances the quality of the drugs. It ensures the safety of users while acquiring medical benefits in a medical device. There are various risks associated with the use of medical devices and products. The probability of occurrence of a harm to human health and its risk level determines the action chosen to achieve the regulatory compliance. It is therefore recommended to use GMPs. These practices is helping mitigate risks associated with the manufacture of pharmaceutical products that are skipped during the testing of the final product.

The process of validation is enhanced worldwide through various agencies such as the administration of GMPs is restricted to specific agencies which include the Food and Drug Administration (USFDA) in the USA, the European Medicine Agency (EMA) which harmonizes the GMP at EU level, Medicine and Health Product Regulatory Agency (MHRA) in British, Pharma Inspection Corporation Scheme (PIC) among others. Additionally, scientific based decision making has played a major role in the identification, priority specification and testing activities of manufacturing systems.











Mansfield, E., O’Leary, T.J. and Gutman, S.I., 2005. Food and Drug Administration regulation of in vitro diagnostic devices. The Journal of Molecular Diagnostics, 7(1), pp.2-7.

Bertil Jacobson, A. M., 2007. Medical Devices: Use and Safety. London: Elsevier Health Sciences.

Bliesner, D. M., 2006. Establishing A CGMP Laboratory Audit System: A Practical Guide. New York: John Wiley & Sons.

Nally, J. D., 2016. Good Manufacturing Practices for Pharmaceuticals, Sixth Edition. Los Angeles: CRC Press.

Wingate, G., 2016. Pharmaceutical Computer Systems Validation: Quality Assurance, Risk Management, and Regulatory Compliance. New York: CRC Press.

Bek, R., Qin, J., Gaiser, J., Utley, D.S., and Barnett, J.J., Curon Medical, Inc., 2004. Systems and methods for monitoring and controlling the use of medical devices. U.S. Patent 6,733,495.

Tinkle S., McNeil, S.E., Mühlebach, S., Bawa, R., Borchard, G., Barenholz, Y.C., Tamarkin, L. and Desai, N., 2014. Nanomedicines: addressing the scientific and regulatory gap. Annals of the New York Academy of Sciences, 1313(1), pp.35-56.

Schallmoser, K., Rohde, E., Bartmann, C., Obenauf, A.C., Reinisch, A. and Strunk, D., 2009. Platelet-derived growth factors for the GMP-compliant propagation of mesenchymal stromal cells. Bio-medical materials and engineering, 19(4-5), pp.271-276.



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